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1.	Carlander, Anders, 1979, et al. (författare) COVID-19 related distress in the Swedish population: Validation of the Swedish version of the COVID Stress Scales (CSS) 2022 Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:2 Tidskriftsartikel (refereegranskat)abstract Background The COVID Stress Scales (CSS) assess health- and contamination-related distress in the face of a medical outbreak like the ongoing COVID-19 pandemic. Though the CSS is translated into 21 languages, it has not been validated in a Swedish national sample. Aim Our general objective is to provide a translation, replication, and validation of the CSS and test its convergent- and discriminant validity in relation to anxiety, health anxiety, depression, and stress in the general Swedish population. We also present latent psychometric properties by modelling based on item response theory. Methods Participants consisted of 3044 Swedish adults (> 18 years) from a pre-stratified (gender, age, and education) sample from The Swedish Citizen Panel. Mental health status was assessed by validated instruments, including the CSS, PHQ-4, SHAI-14, and PSS-10. Results Results indicate that our Swedish translation of CSS has good psychometric properties and consists of 5 correlated factors. Discussion The CSS is useful either as a unidimensional or multidimensional construct using the CSS scales to measure key facets of pandemic-related stress. Conclusions The findings support the cross-cultural validity of the CSS and its potential utility in understanding many of the emotional challenges posed by the current and future pandemics.
2.	Carlander, Anders, 1979, et al. (författare) The ever gap: The relationship between self-rated health and socio-economic inequalities in Sweden between 1999 and 2021 2023 Ingår i: Social Sciences & Humanities Open. - 2590-2911. ; 8:1 Tidskriftsartikel (refereegranskat)abstract Health inequality linked to socioeconomic status (SES) has increased in many parts of the world. Since economic inequality also has been reported to be on the rise, it is pivotal to investigate how socioeconomic inequality affects health disparities annually. The present study is based on a yearly repeated cross-sectional probability sample of Swedish citizens (N = 141 619) collected between 1999 and 2021. We show that the relative level of SES has increased significantly in Sweden. In addition, the level of economic inequality has also increased. Based on self-rated health (SRH), we report a clear disparity between low and high SES and subjective social class (SSS), where higher SES and SSS are associated with better SRH. We observe a stronger association between SRH and reported present SSS (i.e., subjective social class aimed at capturing current situation) than between SRH and reported childhood SSS (i.e., subjective social class focusing on the situation when growing up). We show that the annual marginal effect of SES is not increasing but instead contributes with a stable annual contribution on SRH. Interestingly, the annual effect of education on SRH was substantially attenuated when adjusting for income, whereas the effect of income on SRH was only moderately different when adjusting for education. Potential mechanisms and remedies are discussed.
3.	Janeva, Slavica, et al. (författare) Adjuvant chemotherapy and survival in women aged 70 years and older with triple-negative breast cancer: a Swedish population-based propensity score-matched analysis 2020 Ingår i: The Lancet Healthy Longevity. - 2666-7568. ; 1:3 Tidskriftsartikel (refereegranskat)abstract Background: Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer associated with poor survival, in which adjuvant systemic treatments are limited to chemotherapy. Due to competing mortality risks and comorbidities, older patients with TNBC are often undertreated with adjuvant chemotherapy, and clinical trials on this problem are scarce, despite a growing patient population. This study aimed to assess outcomes for patients aged 70 years and older with TNBC with or without chemotherapy in a national population-based registry, to provide information that can assist in treatment decisions for these patients. Methods: In this population-based registry study, data on all patients aged 70 years and older diagnosed with primary early TNBC (larger than 5 mm in diameter and without distant metastasis) and surgically treated between Jan 1, 2009, and Dec 31, 2016, were retrieved from the Swedish National Breast Cancer Register, the Swedish Patient Register, and the Swedish Cause of Death Register. Patients with incomplete data (on oestrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2 status, surgical procedure in the breast, or information about chemotherapy) were excluded. A propensity score-matched (PSM) model was used to examine the outcomes of adjuvant chemotherapy on 5-year breast cancer-specific survival (BCSS) and 5-year overall survival (OS), adjusted for age, tumour size, tumour grade, nodal status, and comorbidities. Findings: Of 1130 women eligible for analysis, 368 (32·6%) received adjuvant chemotherapy, 45 (4·0%) received neoadjuvant treatment, and 717 (63·5%) did not receive chemotherapy. 5-year BCSS was significantly improved in patients who received adjuvant chemotherapy (85% [95% CI 81–89]) compared with patients who did not receive chemotherapy (68% [64–72]; p<0·0001). A similar benefit was observed in 5-year OS (79% [95% CI 75–84] vs 49% [45–53]; p<0·0001). In our PSM analysis, 5-year BCSS in patients treated with adjuvant chemotherapy was 83% (95% CI 78–89), versus 73% (67–80; p=0·014) in patients not treated with chemotherapy. 5-year OS in patients treated with adjuvant chemotherapy was 75% (95% CI 69–82), versus 63% (57–71; p=0·029) in patients who did not receive chemotherapy. Interpretation: In this PSM registry analysis of surgically treated female patients aged 70 years and older with TNBC without distant metastasis, we identified a significant benefit both in 5-year BCSS and 5-year OS with adjuvant chemotherapy versus no chemotherapy, which persisted when adjusting for age and comorbidities. These results underline the importance of considering adjuvant chemotherapy in older patients. Funding: Knut and Alice Wallenberg Foundation, Assar Gabrielsson Foundation.
4.	Janeva, Slavica, et al. (författare) Clinical evaluation of molecular surrogate subtypes in patients with ipsilateral multifocal primary breast cancer 2023 Ingår i: Breast Cancer Research. - 1465-5411. ; 25:1 Tidskriftsartikel (refereegranskat)abstract BackgroundWhen ipsilateral multifocal primary breast cancer (IMBC) is detected, standard routine is to evaluate the largest tumor with immunohistochemistry (IHC). As all foci are not routinely characterized, many patients may not receive optimal adjuvant treatment. Here, we assess the clinical relevance of examining at least two foci present in patients with IMBC.MethodsPatients diagnosed and treated for IMBC at Sahlgrenska University Hospital (Gothenburg, Sweden) between 2012 and 2017 were screened. In total, 180 patients with >= 2 invasive foci (183 specimens) were assessed with IHC and included in this study. Expression of the estrogen (ER) and progesterone (PR) receptors, Ki67, HER2, and tumor grade were used to determine the molecular surrogate subtypes and discordance among the foci was recorded. An additional multidisciplinary team board was then held to re-assess whether treatment recommendations changed due to discordances in molecular surrogate subtype between the different foci.ResultsDiscordance in ER, PR, HER2, and Ki67 was found in 2.7%, 19.1%, 7.7%, and 16.9% of invasive foci, respectively. Discordance in the molecular surrogate subtypes was found in 48 of 180 (26.7%) patients, which resulted in therapy changes for 11 patients (6.1%). These patients received additional endocrine therapy (n = 2), chemotherapy (n = 3), and combined chemotherapy and trastuzumab (n = 6).ConclusionTaken together, when assessing at least two tumor foci with IHC, regardless of shared morphology or tumor grade between the different foci, 6.1% of patients with IMBC were recommended additional adjuvant treatment. A pathologic assessment using IHC of all foci is therefore recommended to assist in individualized treatment decision making.
5.	Karakatsanis, Andreas, et al. (författare) Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study) 2019 Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 106:6 Tidskriftsartikel (refereegranskat)abstract Background: One-fifth of patients with a preoperative diagnosis of ductal carcinoma in situ (DCIS) have invasive breast cancer (IBC) on definitive histology. Sentinel lymph node dissection (SLND) is performed in almost half of women having surgery for DCIS in Sweden. The aim of the present study was to try to minimize unnecessary SLND by injecting superparamagnetic iron oxide (SPIO) nanoparticles at the time of primary breast surgery, enabling SLND to be performed later, if IBC is found in the primary specimen. Methods: Women with DCIS at high risk for the presence of invasion undergoing breast conservation, and patients with DCIS undergoing mastectomy were included. The primary outcome was whether this technique could reduce SLND. Secondary outcomes were number of SLNDs avoided, detection rate and procedure-related costs. Results: This was a preplanned interim analysis of 189 procedures. IBC was found in 47 and a secondary SLND was performed in 41 women. Thus, 78.3 per cent of patients avoided SLND (P<0.001). At reoperation, SPIO plus blue dye outperformed isotope and blue dye in detection of the sentinel node (40 of 40 versus 26 of 40 women; P<0.001). Costs were reduced by a mean of 24.5 per cent in women without IBC (3990 versus 5286; P<0.001). Conclusion: Marking the sentinel node with SPIO in women having surgery for DCIS was effective at avoiding unnecessary SLND in this study. Registration number: ISRCTN18430240 (http://www.isrctn.com).
6.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Erratum to: Health-Related Quality of Life for Patients Who have In-Transit Melanoma Metastases Treated with Isolated Limb Perfusion. 2016 Ingår i: Annals of surgical oncology. - : Springer Science and Business Media LLC. - 1534-4681 .- 1068-9265. Annan publikation (övrigt vetenskapligt/konstnärligt)
7.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Förmedla hälsopsykologisk kunskap utan att öka hälsorelaterad oro 2019 Ingår i: Psykologtidningen. - 0280-9702 .- 2002-8342. ; :3, s. 36-37 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
8.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Health-related quality of life (FACT-GP) in Sweden 2020 Ingår i: Health and Quality of Life Outcomes. - : Springer Science and Business Media LLC. - 1477-7525. ; 18:1 Tidskriftsartikel (refereegranskat)abstract Background Many studies have used disease-specific instruments, such as the Functional Assessment of Cancer Therapy (FACT), when studying health-related quality of life (HRQOL) in patients. Few studies however, have described normative HRQOL values in the general population using FACT - General Population (FACT-GP). The general aim of the present study is thus to describe the normative HRQOL values in the general Swedish population by using the FACT-GP instrument and to investigate to what degree sociodemographic factors and status of self-rated health (SRH) correlate with HRQOL. Methods The participants consisted of a pre-stratified (gender, age and education) sample of Swedish citizens that previously had enrolled to be a part of a web panel hosted by a research institute (SOM Institute) at the University of Gothenburg in Sweden. The HRQOL was assessed by using the FACT-GP and SRH. Results A higher FACT-GP score was mainly associated with males, higher age, higher income and better SRH. The results showed that the Swedish sample scored lower on FACT-GP than previous studies. Conclusions Since HRQOL is frequently used as an important endpoint in healthcare research, there is an increasing need for normative data. The results from this study serve as a general population standard against which other studied HRQOL-data could be evaluated.
9.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Health-Related Quality of Life for Patients Who have In-Transit Melanoma Metastases Treated with Isolated Limb Perfusion 2016 Ingår i: Annals of Surgical Oncology. - : Springer Science and Business Media LLC. - 1068-9265 .- 1534-4681. ; 23:6, s. 2062-2069 Tidskriftsartikel (refereegranskat)abstract The incidence of malignant melanoma is increasing, and up to 5 % of patients will experience in-transit metastases. Normally, the initial treatment is surgical excision, but when not possible, locoregional treatment options such as isolated limb perfusion (ILP) are an alternative. This study aimed to assess health-related quality of life (HRQoL) prospectively for patients whose in-transit metastases is treated with ILP. More specifically, the study aimed to describe HRQoL for patients with in-transit extremity melanoma metastases, to describe changes in HRQoL after ILP, and to correlate HRQoL with local toxicity and clinical response after ILP. The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) consists of 51 items comprising the Functional Assessment of Cancer Therapy-General (FACT-G), the melanoma subscale , and the melanoma surgery scale. Forty-five patients answered the FACT-M questionnaire before ILP (52 procedures) and at 3, 6 and 12 months after ILP. Response and toxicity were analyzed and correlated with the changes in the HRQoL of the patients. Patients with in-transit metastasis have an HRQoL mainly influenced by tumor burden, defined as more or < 10 tumors (FACT-M: 142.5 vs. 128.4 points; p = 0.02). After ILP, there was a trend toward a decrease in FACT-G (+0.1 vs. -7.3 points; p = 0.05) and FACT-M (+1.6 vs. -8.9 points; p = 0.08) when Wieberdink classifications 1-2 and 3-4 were compared at 3 months. A significant difference in FACT-G (+1.0 vs. -13.0 points; p = 0.04) was observed 12 months after ILP as well as a trend for FACT-M (+1.7 vs. -14.6 points; p = 0.08) when the patients who had a complete response were compared with those who did not. This study found that patients with in-transit metastases have an HRQoL mainly influenced by tumor burden. After ILP, there is an initial decrease in HRQoL due to local toxicity. After 12 months, the patients with a complete response maintained an HRQoL at baseline level, strengthening the use of ILP as a palliative treatment.
10.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Health-related quality of life using the FACT-M questionnaire in patients with malignant melanoma: A systematic review. 2022 Ingår i: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. - : Elsevier BV. - 1532-2157. ; 48:2, s. 312-319 Tidskriftsartikel (refereegranskat)abstract Since there are no formal definition of health-related quality of life (HRQOL) there may be a lack of coherence and understanding of how to interpret HRQOL-data. The aim of this study is to summarize HRQOL-results that have used the FACT-M questionnaire in patients with melanoma, and specifically to summarize FACT-M between tumor stage.This review was conducted in accordance with the PRISMA guidelines.original studies on cutaneous melanoma between 2005 and 2020, written in English, containing "Functional Assessment of Cancer Therapy Melanoma" OR "Functional Assessment of Cancer Therapy M" OR FACT-M OR FACT/M OR FACTM OR "FACT M" OR FACT-melanoma OR "FACT Melanoma" together with FACT-M numbered data and basic patient characteristics, using the databases Scopus, Web of Science, PubMed and PsycINFO.16 articles describing 14 patient cohorts published 2008-2020 were included. The majority of the studies did not report subscale scores in accordance with FACT-M guidelines. The results did indicate that FACT-M total scores were inversely correlated with AJCC stage. Subscale analysis demonstrated varying degrees of correlation with AJCC stage. The Melanoma Surgery Subscale score was lowest in stage III patients, probably reflecting more advanced surgical procedures in this group of patients.Though this review is based on a questionnaire limited to the assessment of melanoma patients, it highlights the universal need for clinical studies to describe their selected HRQOL-questionnaires, its definition of HRQOL and its dimensions, as well as comply with the questionnaire's guidelines when reporting HRQOL-data.
11.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Mental health, stress, and well-being measured before (2019) and during (2020) COVID-19 : a Swedish socioeconomic population-based study 2023 Ingår i: Psychology and Health. - : Taylor & Francis Group. - 0887-0446 .- 1476-8321. Tidskriftsartikel (refereegranskat)abstract Objectives: Compare mental health, stress, and well-being in the Swedish population as measured before and during the COVID-19 pandemic. Methods: Repeated cross-sectional design using data measured before (Jan-2019; n = 2791) and during (Oct/Nov-2020; n = 2926) COVID-19 pandemic in Swedish population-representative cohorts. Following constructs were measured: anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory-II), stress (Perceived Stress Scale-10 items), health-related quality of life (HRQOL[Functional Assessment of Cancer Therapy-General Population]) and self-rated health (SRH) was assessed with a single-item question. Results: When adjusting for age, sex, education, and income there were significantly higher levels of anxiety (M = 9.15 vs. 8.48, p < 0.01) and depression (M = 3.64 vs. 3.30, p = 0.03), lower levels of stress (M = 14.06 vs. 14.91, p < 0.001), but worsened HRQOL (M = 76.40 vs. 77.92, p < 0.01) and SRH (M = 6.91 vs. 7.20, p < 0.001), observed in 2020 compared to 2019. For the negative effects seen in anxiety, depression, HRQOL, and SRH, higher income and education had a protective effect. The decrease in stress was also correlated with higher income. Conclusions: The COVID-19 pandemic led to a small but significant worsening in mental health and well-being in the general Swedish population, where higher socioeconomic status seemed to have a protective effect.
12.	Lindqvist Bagge, Ann-Sophie, et al. (författare) Ökad hälsomedvetenhet kan öka människors hälsoångest? 2019 Ingår i: Läkartidningen. - 0023-7205. ; 116:13 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
13.	Wesslau, Hanna, et al. (författare) Tumor burden and health-related quality of life in patients with melanoma in-transit metastases 2023 Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 15:1 Tidskriftsartikel (refereegranskat)abstract Background: Few studies have investigated the health-related quality of life (HRQOL) in patients with melanoma in-transit metastases (ITM). The aim was to investigate the association between tumor burden and HRQOL, including disparities pertaining to sex and age, in treatment-naïve patients with ITM. Methods: Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire was used to assess HRQOL Pairwise comparisons using t-tests between clinical cutoffs are presented and multiple linear regression analysis showing the unique associations of gender, age, number of tumors, tumor size, presence of lymph node metastases, and tumor localization. Results: A total of 95 patients, 47% females and 53% males (median age 72 years) were included between 2012 and 2021. Women scored significantly lower on emotional well-being (p = 0.038) and lower on FACT-M (p = 0.058). Patients who had ≥10 tumors scored significantly lower on FACT-M (p = 0.015), emotional- and functional well-being (p = 0.04, p = 0.004, respectively), melanoma scale (p = 0.005), and FACT-G (p = 0.027). There was no significant difference in HRQOL depending on age, size of tumors, localization, or presence of lymph node metastases. Conclusion: For patients with melanoma ITMs, the female sex and higher tumor burden (i.e., number of tumors) were significantly correlated with lower HRQOL. However, these findings do not fully explain HRQOL for this patient population, and future research should consider the possibility that there are specific questions for patients with ITM where current instruments might fail to measure their discomfort to the full extent.
14.	Wesslau, Hanna, et al. (författare) Tumour burden and female sex is negatively associated with health-related quality of life in patients with melanoma in-transit metastases 2023 Ingår i: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983. Konferensbidrag (refereegranskat)
15.	Ahlstedt Karlsson, Susanne, et al. (författare) An intervention mapping-based support program that empowers patients with endocrine therapy management 2022 Ingår i: Evaluation and Program Planning. - : Elsevier BV. - 0149-7189. ; 92 Tidskriftsartikel (refereegranskat)abstract Background: For women diagnosed with hormone-receptor-positive breast cancer, endocrine therapy (ET) is recommended. Patients experience diverse side effects, and difficulties in managing these side effects have been identified as obstacles for treatment continuation. The aim of this study was to describe the development of a support program for patients prescribed ET. Methods: Intervention mapping (IM) a comprehensive theory-based approach was used in the support program development. A participatory design was used and four advisory groups was formed including both patients and healthcare professionals. Results: This study employed the systematic stages of IM to develop a theory-based support program with the goal to empower patients prescribed ET to manage ETrelated symptoms and problems, and to illuminate the healthcare structure. The needs assessment identified three performance objectives: (1) Patients have knowledge of and understand their symptoms and their management strategies. (2) Patients have the knowledge and confidence to express their care needs and to ask for guidance from healthcare professionals. (3) Patients are active in and lead their healthcare process. Conclusion: This is a systematic developed model, built upon aspects of ET both from a patient´ perspective as well as from healthcare professionals’ perspectives.
16.	Ahlstedt Karlsson, Susanne, et al. (författare) Experiences of endocrine therapy after breast cancer surgery 2019 Ingår i: Annals of Oncology. Abstract Book of the 44th ESMO Congress (ESMO 2019) 27 September – 1 October 2019, Barcelona, Spain. Vol. 30, Suppl. 5, s. v840. - : Elsevier BV. - 0923-7534. Konferensbidrag (refereegranskat)abstract Background For patients diagnosed with hormone-receptor-positive breast cancer, endocrine therapy (ET) is prescribed, which reduces recurrence and mortality rates (Early Breast Cancer Trialists’ Collaborative Group, 2011). Despite the prognostic benefits of ET, the adherence to treatment varies, and 30%–70% of the patients discontinue their treatment within five years (Daly et al., 2017; Tinari et al., 2015; Ursem et al., 2015), often during their first year of treatment (He et al., 2015), due to the fact that ET is associated with adverse side-effects (Regan et al., 2011). Methods The study was conducted in a surgical out-patient care unit at a hospital in Sweden. Inclusion criteria were women diagnosed with breast cancer and treated with ET after surgery. Forty-eight patients were invited to participate, of which 23 declined, thus 25 women were included. Seven focus group interviews, with two to five participants in each group, were conducted using an interview guide according to Krueger’s (2014) strategy. The interview guide contained six open-ended questions aiming to explore the women’s experiences of ET after breast cancer surgery. Inductive qualitative content analysis was used (Graneheim & Lundman, 2004). Results The analysis resulted in three categories that described the women’s experiences: the treatment “creates discomfort”; “promotes levels of management”; and “causes feelings of abandonment”. Women’s experiences of treatment could at first glance be seen as positive, as perceived protection, but after further analysis, a deeper meaning was identified: protection with reservation. When experiencing discomfort, the women were urged to manage the situation, although the mode of management sometimes varied. The women reported that they needed support, but when the support did not appear, they felt as though they had been abandoned. Moreover, knowledge about side-effects became an obstacle. The participants described feeling abandoned, but they also described their disease as “cancer light”. Conclusions Professionals need to explore the pre-knowledge and preconceptions that patients might have. This could be achieved by listening to the patient before providing them with information. The information needs to be customized specifically to each person. Funding Assar Gabrielsson’s Foundation, Herbert and Karin Jacobsson’s Foundation, and the Swedish Society of Nursing. Disclosure All authors have declared no conflicts of interest.
17.	Ahlstedt Karlsson, Susanne, et al. (författare) “It is not just any pill”—Women’s experiences of endocrine therapy after breast cancer surgery 2019 Ingår i: European Journal of Cancer Care. - : Hindawi Limited. - 0961-5423 .- 1365-2354. ; 28:3 Tidskriftsartikel (refereegranskat)abstract Objective: For patients diagnosed with hormone-receptor-positive breast cancer, endocrine therapy (ET) is usually prescribed to reduce recurrence and mortality rates. Despite the benefits, compliance with treatment varies. The aim of this study was to provide qualitative data about women's experiences with ET after breast cancer surgery. Methods: Twenty-five women, treated with Tamoxifen after breast cancer surgery, were interviewed in seven focus groups. Six open-ended questions were used to explore their experiences. The interviews were recorded, transcribed verbatim and analysed using inductive content analysis. Results: The analysis resulted in three categories that described the women's experiences: the treatment “creates discomfort”; “promotes levels of management”; and “causes feelings of abandonment”. Women's experiences of treatment could at first glance be seen as positive, as perceived protection, but after further analysis, a deeper meaning was identified: protection with reservation. When experiencing discomfort, the women tried to manage the situation, although the mode of management sometimes varied. The women reported that they needed support, but when the support did not appear, they felt as though they had been abandoned. Moreover, knowledge about side effects became an obstacle, as it could create fear of more severe symptoms. They also described that their disease was perceived by healthcare professionals as “cancer light”. Conclusion: The information needs to be customised specifically to each person. © 2019 John Wiley & Sons Ltd
18.	Ahlstedt Karlsson, Susanne, et al. (författare) Person-centred support programme (RESPECT intervention) for women with breast cancer treated with endocrine therapy: a feasibility study 2022 Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 12:10 Tidskriftsartikel (refereegranskat)abstract Objective The peRson-cEntred Support Programme EndoCrine Therapy intervention is a complex intervention encompassing a person-centred support programme for patients with breast cancer being treated with endocrine therapy (ET). The aim of this study was to explore the feasibility of the trial design and patient acceptability of the intervention and outcome measures and to provide data to estimate the parameters required to design the final intervention. Design A controlled before-and-after design following the Consolidated Standards of Reporting Trials 2010 statement for feasibility trials. Setting A surgical outpatient clinic in Sweden. Participants Forty-one patients (aged 47-85) with breast cancer who were treated with ET. Interventions Eligible patients were assigned to the control group or intervention group, which included individual education material, an individualised learning plan and a personalised reminder letter using a person-centred approach. The intervention could be delivered as a telephone or digital follow-up during a 12-week follow-up. Outcome measures The aims were to determine the recruitment rate, assess the rate of retention, explore whether the intervention was delivered according to the protocol, assess the preferred form of educational support, rate of education sessions, length per education session and length between each education session, determine the distribution of education materials and assess completion rates of patient-reported instruments, including the General Self-efficacy Scale, the Quality of Care from the Patient's Perspective Questionnaire and the Memorial Symptom Assessment Scale. Results Eighty-six per cent of the patients in the intervention group completed the intervention and questionnaires 3 months after their inclusion. The call attendance was 90%. During the intervention, the contact nurse complied with the intervention protocol. For self-efficacy, symptoms and quality of care, there were no differences in effect size between the control and intervention groups. Conclusions This intervention seems to be feasible and acceptable among patients.
19.	Ahlstedt Karlsson, Susanne, et al. (författare) Women’s coping strategies during the first three months of adjuvant endocrine therapy for breast cancer 2020 Ingår i: Nursing Open. - : Wiley. - 2054-1058. ; 7:2, s. 605-612 Tidskriftsartikel (refereegranskat)abstract Abstract Aim: The aim was to explore stressful events, experienced problems and used coping strategies during the first three months of undergoing ET. Design: This study used a mixed method design. Methods: A consecutive sample of 39 women newly diagnosed with breast cancer were included at the start of their adjuvant endocrine therapy. A daily coping assessment was used to create daily reports about stressful events or experienced problems and coping strategies. Results: The most frequently reported physical problems were sleeping difficulties. Anxiety was the most reported emotional problem. Patients used both emotion-and problem-focused coping, and sleeping difficulties were coped by relaxing, and anxiety was coped by thinking about something else. Conclusions: Patients experienced a variety of stressful events or problems during the first three months of endocrine therapy. They also used several coping strategies to endure the treatment.
20.	Belgrano, Valerio, et al. (författare) BRAF status as a predictive factor for response in isolated limb perfusion. 2019 Ingår i: International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group. - : Informa UK Limited. - 1464-5157. ; 36:1, s. 511-15 Tidskriftsartikel (refereegranskat)abstract Isolated limb perfusion (ILP) is a treatment option for unresectable in-transit melanoma metastases of the extremities. Approximately two-thirds of the patients have a complete response, and known predictive factors mainly regard tumor burden. In an attempt to identify subgroups with higher response rates, we retrospectively analyzed the predictive value of the BRAF V600E/K mutation for response at our institution.Between January 2012 and December 2017, 98 consecutive patients underwent first-time ILP with melphalan for melanoma in-transit metastases and were included in the study. Data was retrieved from our prospectively kept database. Tumor burden was assessed preoperatively as number of lesions and largest tumor diameter. BRAF status was determined according to clinical routine. Response rates were classified according to WHO criteria.Of the 98 patients included in the analysis, 32 patients had a BRAF V600E/K mutation (33%) and 66 patients were BRAF wild type (wt). There was no difference in age, sex or tumor burden between the groups. Comparing response between BRAF V600E/K mutation and BRAF wt, the overall response rate was 69% vs. 77% (p=.36) and the complete response rate was 47% vs. 52% (p=.67). There was no difference in survival, with a median survival of 47 months.In this consecutive series of patients, BRAF V600E/K mutation was not found to be a significant factor for response or survival following ILP.
21.	Belgrano, V., et al. (författare) Extraction of a foreign body in the liver using single incision laparoscopic surgery: A new application for minimally invasive surgical procedures 2015 Ingår i: Wideochirurgia I Inne Techniki Maloinwazyjne. - : Termedia Sp. z.o.o.. - 1895-4588 .- 2299-0054. ; 10:1, s. 129-132 Tidskriftsartikel (refereegranskat)abstract Ingestion of foreign bodies is a common medical problem frequently observed in children, psychiatric patients and prisoners. Various cases have been found in the medical literature, with different diagnostic and therapeutic approaches. We report a case of a 41-year-old male inmate, hospitalized for right upper quadrant pain of the abdomen due to the ingestion of two syringe needles two weeks previously. We describe the diagnostic procedure and the removal of one of the two needles that had migrated into the liver parenchyma, using a single-incision laparoscopic surgical technique. The operation was carried out safely through a 2.5 cm transverse incision below the umbilicus. The dissection and the removal of the foreign body were easily conducted under direct visualization using a minimally invasive surgical technique. Our case report demonstrates the efficacy and the security of the laparoscopic treatment in such a challenging area, employing a single port access only.
22.	Belgrano, Valerio, et al. (författare) Isolated limb perfusion as a treatment option for rare types of tumours 2016 Ingår i: International Journal of Hyperthermia. - : Informa UK Limited. - 0265-6736 .- 1464-5157. ; 32:6, s. 595-599 Tidskriftsartikel (refereegranskat)abstract Background: Isolated limb perfusion (ILP) is an established and effective treatment for advanced melanoma and soft tissue sarcomas of the extremities with a high overall response rate. The aim of this study was to describe our experience of ILP for more rare types of tumours. Methods: Patients with Merkel cell carcinoma (MCC) (n = 4), squamous cell carcinoma (SCC) (n = 2), B-cell lymphoma (n = 1), desmoid tumours (n = 3), pigmented villonodular synovitis (PVNS) (n = 1) and giant cell tumour (n = 1) were treated with ILP and analysed retrospectively. Results: The four patients with in-transit MCC had three complete responses (CR) and one partial response (PR); the two patients with SCC had one CR and one stable disease (SD); the patients with desmoid tumours had two PR and one SD. A CR was also observed for the patient with a giant cell tumour, but the patient with PVNS had a SD. The patient with cutaneous metastases of B-cell lymphoma showed a CR, however with rapid systemic progression. Local toxicity according to Wieberdink was grade II in 10 patients (83%) and grade III in two patients (17%). Conclusions: These results show that ILP can be used as a treatment option also for more rare disease entities when other treatments have failed.
23.	Belgrano, Valerio, et al. (författare) Response and Toxicity of Repeated Isolated Limb Perfusion (re-ILP) for Patients With In-Transit Metastases of Malignant Melanoma. 2019 Ingår i: Annals of surgical oncology. - : Springer Science and Business Media LLC. - 1534-4681 .- 1068-9265. ; 26:4, s. 1055-1062 Tidskriftsartikel (refereegranskat)abstract Isolated limb perfusion (ILP) is a safe and well-established treatment for in-transit metastases of melanoma. In case of relapse or disease progression, ILP can be repeated (re-ILP). This study aimed retrospectively to analyze a large consecutive series of re-ILP and compare clinical outcomes with first-time ILP.Between 2001 and 2015, 290 consecutive patients underwent 380 ILPs. Of these, 90 were re-ILPs including 68second ILPs, 16 third ILPs, 4 fourth ILPs, and two fifth ILPs. The study evaluated response (using World Health Organization [WHO] criteria), local toxicity (using the Wieberdink scale), and complications (using Clavien-Dindo).The results were compared between the first ILP, the second ILP, and the third to fifth ILP. The overall response rate was respectively 83%, 80% and 68%, with a complete response (CR) rate of 60%, 41%, and 59%. In the re-ILP group, the patients with a CR after the first ILP had a 65% CR rate after the second ILP compared with 8% for the patients without a CR (p=0.001). The risk for local toxicity or complications was not increased after re-ILP. The median overall survival periods were respectively 34, 41, and 93months (p=0.02).As a therapeutic option, ILP can be repeated safely for in-transit metastases of melanoma, achieving similar high response rates without increasing complications or toxicity. Re-ILP is mainly indicated for patients who already had a CR after the first ILP, whereas other treatment options should be considered for primary non-responders.
24.	Belgrano, Valerio, et al. (författare) Sentinel node for malignant melanoma: An observational study of a consecutive single centre experience 2019 Ingår i: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983 .- 1532-2157. ; 45:2, s. 225-230 Tidskriftsartikel (refereegranskat)abstract © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology Introduction: Sentinel node biopsy (SNB) for melanoma gives prognostic information, however the success is dependent on several factors. The aim of this study was to describe outcome data after the introduction of the technique at our centre, including analysis of false negative rate (FNR), predictive factors for positive sentinel node (SN) and non-sentinel node (NSN), as well as prognostic factors for melanoma-specific survival (MSS). Materials and methods: This is a retrospective observational study of a prospectively kept database at Sahlgrenska University Hospital. Between March 2000 and December 2013, 769 consecutive patients with cutaneous malignant melanoma undergoing SNB were included. The median follow-up time was 55 months (2–179 months). Tumour load in the SN was categorized according to the largest tumour deposit, low when ≤1 mm and high when >1 mm. Results: The FNR was 20% and the SN positivity rate was 14% with a decrease in both FNR and SN positivity rate during the study period. In multivariate analysis the only predictive factor for a positive SN was Breslow thickness. The 5-year melanoma specific survival (MSS) was 81% and in multivariate analysis the prognostic factors were SN-status (low metastatic load HR = 2.6, p = 0.001; high metastatic load HR = 2.7, p = 0.004) followed by Breslow thickness and ulceration. Conclusions: In this study Breslow thickness was the only independent predictive factor for a positive SN, no predictive factors were identified for NSN. Independent prognostic factors for MSS were SN status, Breslow thickness and ulceration. Interestingly, there was no survival difference depending on SN tumour burden when using 1 mm as cut-off.
25.	Ben-Shabat, Ilan, et al. (författare) Isolated hepatic perfusion as a treatment for liver metastases of uveal melanoma. 2015 Ingår i: Journal of visualized experiments : JoVE. - : MyJove Corporation. - 1940-087X. ; :95 Tidskriftsartikel (refereegranskat)abstract Isolated hepatic perfusion (IHP) is a procedure where the liver is surgically isolated and perfused with a high concentration of the chemotherapeutic agent melphalan. Briefly, the procedure starts with the setup of a percutaneous veno-venous bypass from the femoral vein to the external jugular vein. Via a laparotomy, catheters are then inserted into the proper hepatic artery and the caval vein. The portal vein and the caval vein, both supra- and infrahepatically, are then clamped. The arterial and venous catheters are connected to a heart lung machine and the liver is perfused with melphalan (1 mg/kg body weight) for 60 min. This way it is possible to locally perfuse the liver with a high dose of a chemotherapeutic agent, without leakage to the systemic circulation. In previous studies including patients with isolated liver metastases of uveal melanoma, an overall response rate of 33-100% and a median survival between 9 and 13 months, have been reported. The aim of this protocol is to give a clear description of how to perform the procedure and to discuss IHP as a treatment option for liver metastases of uveal melanoma.
26.	Ben-Shabat, Ilan, et al. (författare) Long-Term Follow-Up Evaluation of 68 Patients with Uveal Melanoma Liver Metastases Treated with Isolated Hepatic Perfusion. 2016 Ingår i: Annals of surgical oncology. - : Springer Science and Business Media LLC. - 1534-4681 .- 1068-9265. ; 23:4, s. 1327-34 Tidskriftsartikel (refereegranskat)abstract This report describes the outcomes and long-term follow-up data from all isolated hepatic perfusions (IHPs) performed at a single institution in Sweden between the years 1989 and 2013 for patients with isolated uveal melanoma metastases.
27.	Ben-Shabat, Ilan, et al. (författare) The effect of perfusate buffering on toxicity and response in isolated hepatic perfusion for uveal melanoma liver metastases 2017 Ingår i: International Journal of Hyperthermia. - : Informa UK Limited. - 0265-6736 .- 1464-5157. ; 33:4, s. 483-488 Tidskriftsartikel (refereegranskat)abstract Background: Isolated hepatic perfusion (IHP) is a treatment option for patients with liver metastases. Previous studies have found that liver toxicity is one of the limiting factors, and in an attempt to reduce the toxicity a buffering agent was added to the perfusate. The aim was to retrospectively analyse if this buffering reduced toxicity and complication rates.Methods: A retrospective review of 52 consecutive patients with uveal melanoma liver metastases treated with IHP between 2005 and 2013. Patients were followed by daily liver function tests (LFT). Toxicity was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE; United States Department of Health & Human Services, Washington, D.C), complications according to Clavien-Dindo and response according to RECIST-criteria.Results: Thirty-six patients were treated with a buffered perfusate and 16 patients without buffer. There was no difference in age, gender, largest tumour size or number of tumours between the groups. There was a significantly lower mean in peak ALT, AST, PK (INR) and bilirubin when comparing buffer with no-buffer. There were five major complications without a significant difference between the groups (8.3 vs. 12.5%, p=0.33). There was a lower complete response (CR) rate (11 vs. 44%, p=0.023) and a trend for shorter time to local progression (9.2 vs. 17.6 months, p=0.096); however, not significant in multivariate analysis. There was no difference in survival (24.2 vs. 26.0 months, p=0.43) between the two groups.Conclusions: Adding buffer to the perfusate during IHP significantly reduces postoperative LFTs; however, without a reduced complication rate. Interestingly, buffering also seems to reduce the response rate; however, this did not translate into a survival difference. To address if buffering adds any clinical benefit to the patients concerning toxicity, a larger prospective trial is necessary.
28.	Bethlehem, Martijn S., et al. (författare) Meta-Analysis of Isolated Hepatic Perfusion and Percutaneous Hepatic Perfusion as a Treatment for Uveal Melanoma Liver Metastases 2021 Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 13:18 Tidskriftsartikel (refereegranskat)abstract Simple Summary Isolated hepatic perfusion is one of the available treatment options for patients with liver metastases from uveal melanoma. This is an open surgical procedure where the liver is isolated from the circulation and perfused with a chemotherapeutic agent. A modern development is the minimally invasive percutaneous hepatic perfusion, where the liver is endovascularly isolated and then perfused with a chemotherapeutic agent through a catheter in the arterial system. Within this systematic review and meta-analysis, we aim to compare these modalities in terms of overall survival, progression-free survival, complications and response. Background: Uveal melanoma is the most commonly occurring primary intraocular malignancy in adults, and patients have a high risk of developing metastatic disease, mostly in the liver. Isolated hepatic perfusion (IHP) with melphalan is a liver-directed therapy for patients with liver metastases. Percutaneous hepatic perfusion (PHP), a minimally invasive technique, is available as well. PHP benefits from the fact that the procedure can be repeated and therefore possibly offers better survival. We conducted a systematic review and meta-analysis comparing both techniques. Methods: A systematic literature search was performed using the electronic databases of Scopus, MEDLINE, Web of Science, PubMed and Cochrane CENTRAL. A total of nine articles reporting on eight studies were included in the analysis. Individual survival data were extracted from each study. Results: The median overall survival (OS) was 17.1 months for IHP and 17.3 months for PHP. The median progression-free survival (PFS) was 7.2 months for IHP and 9.6 months for PHP. The median hepatic progression-free survival was 10 months for IHP and 9.5 months for PHP. The complication rate and 30-day mortality rate were 39.1% and 5.5% for IHP and 23.8% and 1.8% for PHP. Conclusion: There was no difference in OS or PFS between IHP and PHP for patients with uveal melanoma liver metastases, but patients have significantly less of a risk for complications and mortality following PHP.
29.	Bhadury, Joydeep, et al. (författare) Hypoxia-regulated gene expression explains differences between melanoma cell line-derived xenografts and patient-derived xenografts. 2016 Ingår i: Oncotarget. - : Impact Journals, LLC. - 1949-2553. ; 7:17 Tidskriftsartikel (refereegranskat)abstract Cell line-derived xenografts (CDXs) are an integral part of drug efficacy testing during development of new pharmaceuticals against cancer but their accuracy in predicting clinical responses in patients have been debated. Patient-derived xenografts (PDXs) are thought to be more useful for predictive biomarker identification for targeted therapies, including in metastatic melanoma, due to their similarities to human disease. Here, tumor biopsies from fifteen patients and ten widely-used melanoma cell lines were transplanted into immunocompromised mice to generate PDXs and CDXs, respectively. Gene expression profiles generated from the tumors of these PDXs and CDXs clustered into distinct groups, despite similar mutational signatures. Hypoxia-induced gene signatures and overexpression of the hypoxia-regulated miRNA hsa-miR-210 characterized CDXs. Inhibition of hsa-miR-210 with decoys had little phenotypic effect in vitro but reduced sensitivity to MEK1/2 inhibition in vivo, suggesting down-regulation of this miRNA could result in development of resistance to MEK inhibitors.
30.	Broman, K. K., et al. (författare) Active surveillance of patients who have sentinel node positive melanoma: An international, multi-institution evaluation of adoption and early outcomes after the Multicenter Selective Lymphadenectomy trial II (MSLT-2) 2021 Ingår i: Cancer. - : Wiley. - 0008-543X .- 1097-0142. ; 127:13, s. 2251-2261 Tidskriftsartikel (refereegranskat)abstract Background For patients with sentinel lymph node (SLN)-positive cutaneous melanoma, the Second Multicenter Selective Lymphadenectomy trial demonstrated equivalent disease-specific survival (DSS) with active surveillance using nodal ultrasound versus completion lymph node dissection (CLND). Adoption and outcomes of active surveillance in clinical practice and in adjuvant therapy recipients are unknown. Methods In a retrospective cohort of SLN-positive adults treated at 21 institutions in Australia, Europe, and the United States from June 2017 to November 2019, the authors evaluated the impact of active surveillance and adjuvant therapy on all-site recurrence-free survival (RFS), isolated nodal RFS, distant metastasis-free survival (DMFS), and DSS using Kaplan-Meier curves and Cox proportional hazard models. Results Among 6347 SLN biopsies, 1154 (18%) were positive and had initial negative distant staging. In total, 965 patients (84%) received active surveillance, 189 (16%) underwent CLND. Four hundred thirty-nine patients received adjuvant therapy (surveillance, 38%; CLND, 39%), with the majority (83%) receiving anti-PD-1 immunotherapy. After a median follow-up of 11 months, 220 patients developed recurrent disease (surveillance, 19%; CLND, 22%), and 24 died of melanoma (surveillance, 2%; CLND, 4%). Sixty-eight patients had an isolated nodal recurrence (surveillance, 6%; CLND, 4%). In patients who received adjuvant treatment without undergoing prior CLND, all isolated nodal recurrences were resectable. On risk-adjusted multivariable analyses, CLND was associated with improved isolated nodal RFS (hazard ratio [HR], 0.36; 95% CI, 0.15-0.88), but not all-site RFS (HR, 0.68; 95% CI, 0.45-1.02). Adjuvant therapy improved all-site RFS (HR, 0.52; 95% CI, 0.47-0.57). DSS and DMFS did not differ by nodal management or adjuvant treatment. Conclusions Active surveillance has been adopted for most SLN-positive patients. At initial assessment, real-world outcomes align with randomized trial findings, including in adjuvant therapy recipients. Lay Summary For patients with melanoma of the skin and microscopic spread to lymph nodes, monitoring with ultrasound is an alternative to surgically removing the remaining lymph nodes. The authors studied adoption and real-world outcomes of ultrasound monitoring in over 1000 patients treated at 21 centers worldwide, finding that most patients now have ultrasounds instead of surgery. Although slightly more patients have cancer return in the lymph nodes with this strategy, typically, it can be removed with delayed surgery. Compared with up-front surgery, ultrasound monitoring results in the same overall risk of melanoma coming back at any location or of dying from melanoma.
31.	Broman, K. K., et al. (författare) Surveillance of Sentinel Node-Positive Melanoma Patients with Reasons for Exclusion from MSLT-II: Multi-Institutional Propensity Score Matched Analysis 2021 Ingår i: Journal of the American College of Surgeons. - : Ovid Technologies (Wolters Kluwer Health). - 1072-7515. ; 232:4, s. 424-431 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: In sentinel lymph node (SLN)-positive melanoma, two randomized trials demonstrated equivalent melanoma-specific survival with nodal surveillance vs completion lymph node dissection (CLND). Patients with microsatellites, extranodal extension (ENE) in the SLN, or >3 positive SLNs constitute a high-risk group largely excluded from the randomized trials, for whom appropriate management remains unknown. STUDY DESIGN: SLN-positive patients with any of the three high-risk features were identified from an international cohort. CLND patients were matched 1:1 with surveillance patients using propensity scores. Risk of any-site recurrence, SLN-basin-only recurrence, and melanoma specific mortality were compared. RESULTS: Among 1,154 SLN-positive patients, 166 had ENE, microsatellites, and/or >3 positive SLN. At 18.5 months median follow-up, 49% had recurrence (vs 26% in patients without high-risk features, p < 0.01). Among high-risk patients, 52 (31%) underwent CLND and 114 (69%) received surveillance. Fifty-one CLND patients were matched to 51 surveillance patients. The matched cohort was balanced on tumor, nodal, and adjuvant treatment factors. There were no significant differences in any-site recurrence (CLND 49%, surveillance 45%, p = 0.99), SLN-basin-only recurrence (CLND 6%, surveillance 14%, p = 0.20), or melanoma-specific mortality (CLND 14%, surveillance 12%, p = 0.86). CONCLUSIONS: SLN-positive patients with microsatellites, ENE, or >3 positive SLN constitute a high-risk group with a 2-fold greater recurrence risk. For those managed with nodal surveillance, SLN-basin recurrences were more frequent, but all-site recurrence and melanoma-specific mortality were comparable to patients treated with CLND. Most recurrences were outside the SLN-basin, supporting use of nodal surveillance for SLN-positive patients with microsatellites, ENE, and/or >3 positive SLN. Crown Copyright (C) 2020 Published by Elsevier Inc. on behalf of the American College of Surgeons. All rights reserved.
32.	Chin, Kian, et al. (författare) Tumor-infiltrating lymphocytes as a predictor of axillary and primary tumor pathological response after neoadjuvant chemotherapy in patients with breast cancer: a retrospective cohort study. 2024 Ingår i: Breast Cancer Research and Treatment. - : SPRINGER. - 0167-6806 .- 1573-7217. ; 207:1, s. 49-63 Tidskriftsartikel (refereegranskat)abstract Tumor-infiltrating lymphocytes (TILs) can predict complete pathological response (pCR) of tumor in the breast but not so well-defined in the axilla after neoadjuvant chemotherapy. Since axillary surgery is being increasingly de-escalated after NACT, we aimed to investigate the relationship between TILs and pCR in the axilla and breast, as well as survival amongst NACT patients.Clinicopathological data on patients who underwent NACT between 2013 and 2020 were retrospectively examined. Specifically, pre-TILs (before NACT), post-TILs (after NACT) and ΔTIL (changes in TILs) were assessed. Primary endpoint was pCR and secondary endpoints were breast cancer-free interval (BCFI) and overall survival (OS).Two hundred and twenty patients with nodal metastases were included. Overall axillary and breast pCR rates were 42.7% (94/220) and 39.1% (86/220), respectively, whereas the combined pCR rate was 32.7% (72/220). High pre-TILs (OR 2.03, 95% CI 1.02-4.05; p=0.04) predicted axillary pCR whereas, high post-TILs (OR 0.33, 95% CI 0.14-0.76; p=0.009) and increased ΔTILs (OR 0.25, 95% CI 0.08-0.79; p=0.02) predicted non-axillary pCR. TILs were not a significant predictor for BCFI and OS.This study supports the potential use of pre-TILs to select initially node-positive patients for axillary surgical de-escalation after NACT.
33.	Chin, Kian, et al. (författare) Tumor-infiltrating lymphocytes as a predictor of axillary and primary tumor pathological response after neoadjuvant chemotherapy in patients with breast cancer: a retrospective cohort study 2024 Ingår i: Breast Cancer Research and Treatment. - : SPRINGER. - 0167-6806 .- 1573-7217. Tidskriftsartikel (refereegranskat)abstract Purpose Tumor-infiltrating lymphocytes (TILs) can predict complete pathological response (pCR) of tumor in the breast but not so well-defined in the axilla after neoadjuvant chemotherapy. Since axillary surgery is being increasingly de-escalated after NACT, we aimed to investigate the relationship between TILs and pCR in the axilla and breast, as well as survival amongst NACT patients.Methods Clinicopathological data on patients who underwent NACT between 2013 and 2020 were retrospectively examined. Specifically, pre-TILs (before NACT), post-TILs (after NACT) and Delta TIL (changes in TILs) were assessed. Primary endpoint was pCR and secondary endpoints were breast cancer-free interval (BCFI) and overall survival (OS).Results Two hundred and twenty patients with nodal metastases were included. Overall axillary and breast pCR rates were 42.7% (94/220) and 39.1% (86/220), respectively, whereas the combined pCR rate was 32.7% (72/220). High pre-TILs (OR 2.03, 95% CI 1.02-4.05; p = 0.04) predicted axillary pCR whereas, high post-TILs (OR 0.33, 95% CI 0.14-0.76; p = 0.009) and increased Delta TILs (OR 0.25, 95% CI 0.08-0.79; p = 0.02) predicted non-axillary pCR. TILs were not a significant predictor for BCFI and OS.Conclusions This study supports the potential use of pre-TILs to select initially node-positive patients for axillary surgical de-escalation after NACT.
34.	Corderfeldt, Anna, et al. (författare) A prospective feasibility trial exploring novel biomarkers for neurotoxicity after isolated limb perfusion 2023 Ingår i: Perfusion-Uk. - 0267-6591. Tidskriftsartikel (refereegranskat)abstract Background: Isolated limb perfusion (ILP) is a regional cancer treatment in which high-dose chemotherapy is administered in an isolated extremity. The main side effect is regional toxicity, which occasionally leads to nerve damage. Measuring neuroaxonal biomarkers, might be a method predicting such complications. Therefore, the primary aim of the study is to investigate if neuronal biomarkers are measurable and alters in an isolated extremity during ILP. Secondly, if postoperative regional toxicity, alterations in sensitivity, and/or muscle strength are correlated to the biomarker levels.Methods: Eighteen scheduled ILP-patients were included in the study. Glial fibrillary acidic protein (GFAP), neurofilament light (NfL), and tau concentrations were measured in plasma sampled preoperatively, at the start and end of the ILP, on days 3 and 30, using ultrasensitive Single molecule array (Simoa) technology. The patients were assessed by a physiotherapist pre- and postoperatively.Results: At ILP end, significantly higher NfL and tau levels were measured in the extremity than in the corresponding systemic circulation (NfL; 17 vs 6 ng/L, p < .01, tau; 1.8 vs 0.6 ng/L, p < .01), and the extremity levels were significantly increased at ILP end (NfL; 66 +/- 37%, p < .001, tau; 75 +/- 45%, p = .001). On days 3 and 30, significantly increased NfL and GFAP levels were measured systemically (NfL day 3: 69 +/- 30%, p < .001; day 30: 76 +/- 26%, p < .001; GFAP day 3: 33 +/- 22%, p < .002; day 30: 33 +/- 23%, p <= .004). Finally, no significant correlations were found between regional toxicity or between postoperative muscle or sensitivity decrease and biomarker release.Conclusion: During ILP, NfL and tau levels increased significantly. No obvious correlations were observed between biomarker release and regional toxicity or decreased muscle strength or sensitivity, although large-scale studies are warranted.
35.	Corderfeldt, Anna, et al. (författare) Is blood a necessary component of the perfusate during isolated limb perfusion - a randomized controlled trial 2019 Ingår i: International Journal of Hyperthermia. - : Informa UK Limited. - 0265-6736 .- 1464-5157. ; 36:1, s. 794-800 Tidskriftsartikel (refereegranskat)abstract Background: Isolated limb perfusion (ILP) is a treatment option for malignancies localized to an extremity and is performed by surgical isolation of the limb which is connected to an extracorporeal circulation system. A high concentration of a chemotherapeutic agent is perfused through the limb, while systemic toxicity is avoided. Currently, the use of packed red blood cells in the priming solution is the norm during ILP. The aim of this study was to investigate the possibility to replace an erythrocyte-based prime solution with a crystalloid-based prime solution while maintaining the regional metabolic oxygen demand during ILP. Methods: In a single-center, randomized controlled, non-blinded, non-inferiority clinical trial, 21 patients scheduled for treatment with ILP were included and randomized 1:1 to either an erythrocyte-based prime solution (control) or a crystalloid-based prime solution (intervention). Results: There was a significant difference in lactate level (mmol/L) during the perfusion between the intervention group and the control group (1.6 +/- 0.4 vs. 3.6 +/- 0.7, p = .001). No significant differences in oxygen extraction (%) (22 +/- 11 vs. 14 +/- 4, p = .06), oxygen delivery (ml/min) (90 +/- 49 vs. 108 +/- 38, p = .39), oxygen consumption (ml/min) (14 +/- 2 vs. 14 +/- 5, p = .85), regional central venous saturation (%) (83 +/- 10 vs. 91 +/- 4, p = .07) or INVOS (%) (76 +/- 14 vs. 81 +/- 11, p = .42) were found between the intervention group and the control group. Conclusion: This study showed no significant improvement with the addition of packed red blood cells into the prime solution in ensuring the metabolic oxygen demand in the treated extremity during ILP, and we, therefore, recommend that a crystalloid-based prime solution should be used.
36.	Corderfeldt, Anna, et al. (författare) Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion 2023 Ingår i: Perfusion-Uk. - : SAGE Publications. - 0267-6591. ; 38:5, s. 1019-1028 Tidskriftsartikel (refereegranskat)abstract Background: Isolated limb perfusion (ILP) is a regional surgical treatment for localized metastatic disease. High doses of chemotherapeutic agents are administered within an extracorporeal circulated isolated extremity, treating the metastasis, while systemic toxicity is avoided. To our knowledge, indexed oxygen supply/demand relationship during ILP has not previously been described. Our aim was to measure and describe oxygen metabolism, specifically oxygen delivery, consumption, and extraction, in an isolated leg/arm during ILP. Also investigate whether invasive oxygenation measurement during ILP correlates and can be used interchangeable with the non-invasive method, near infrared spectroscopy (NIRS). Methods: Data from 40 patients scheduled for ILP were included. At six time points blood samples were drawn during the procedure. DO2, VO2, and O2ER were calculated according to standard formulas. NIRS and hemodynamics were recorded every 10 min. Results: For all observations, the mean of DO2 was 190 +/- 59 ml/min/m(2), VO2 was 35 +/- 8 ml/min/m(2), and O2ER was 21 +/- 8%. VO2 was significantly higher in legs compared to arms (38 +/- 8 vs. 29 +/- 7 ml/min/m(2), p=0.02). Repeated measures showed a significant decrease in DO2 in legs (209 +/- 65 to 180 +/- 66 ml/min/m(2), p=<0.01) and in arms (252 +/- 72 to 150 +/- 57 ml/min/m(2), p=<0.01). Significant increase in O2ER in arms was also found (p=0.03). Significant correlation was detected between NIRS and venous extremity oxygen saturation (SveO(2)) (r(rm)=0.568, p=<. 001, 95% CI 0.397-0.701). When comparing SveO(2) and NIRS using a Bland-Altman analysis, the mean difference (bias) was 8.26 +/- 13.03 (p=<. 001) and the limit of agreement was - 17.28-33.09, with an error of 32.5%. Conclusion: DO2 above 170 ml/min/m(2) during ILP kept O2ER below 30% for all observations. NIRS correlates significant to SveO(2); however, the two methods do not agree sufficiently to work interchangeable.
37.	Crescitelli, Rossella, 1985, et al. (författare) Extracellular vesicle DNA from human melanoma tissues contains cancer-specific mutations 2022 Ingår i: Frontiers in Cell and Developmental Biology. - : Frontiers Media SA. - 2296-634X. ; 10 Tidskriftsartikel (refereegranskat)abstract Liquid biopsies are promising tools for early diagnosis and residual disease monitoring in patients with cancer, and circulating tumor DNA isolated from plasma has been extensively studied as it has been shown to contain tumor-specific mutations. Extracellular vesicles (EVs) present in tumor tissues carry tumor-derived molecules such as proteins and nucleic acids, and thus EVs can potentially represent a source of cancer-specific DNA. Here we identified the presence of tumor-specific DNA mutations in EVs isolated from six human melanoma metastatic tissues and compared the results with tumor tissue DNA and plasma DNA. Tumor tissue EVs were isolated using enzymatic treatment followed by ultracentrifugation and iodixanol density cushion isolation. A panel of 34 melanoma-related genes was investigated using ultra-sensitive sequencing (SiMSen-seq). We detected mutations in six genes in the EVs (BRAF, NRAS, CDKN2A, STK19, PPP6C, and RAC), and at least one mutation was detected in all melanoma EV samples. Interestingly, the mutant allele frequency was higher in DNA isolated from tumor-derived EVs compared to total DNA extracted directly from plasma DNA, supporting the potential role of tumor EVs as future biomarkers in melanoma.
38.	Crescitelli, Rossella, 1985, et al. (författare) Subpopulations of extracellular vesicles from human metastatic melanoma tissue identified by quantitative proteomics after optimized isolation 2020 Ingår i: Journal of Extracellular Vesicles. - : Wiley. - 2001-3078. ; 9:1 Tidskriftsartikel (refereegranskat)abstract The majority of extracellular vesicle (EV) studies conducted to date have been performed on cell lines with little knowledge on how well these represent the characteristics of EVs in vivo. The aim of this study was to establish a method to isolate and categorize subpopulations of EVs isolated directly from tumour tissue. First we established an isolation protocol for subpopulations of EVs from metastatic melanoma tissue, which included enzymatic treatment (collagenase D and DNase). Small and large EVs were isolated with differential ultracentrifugation, and these were further separated into high and low-density (HD and LD) fractions. All EV subpopulations were then analysed in depth using electron microscopy, Bioanalyzer (R), nanoparticle tracking analysis, and quantitative mass spectrometry analysis. Subpopulations of EVs with distinct size, morphology, and RNA and protein cargo could be isolated from the metastatic melanoma tissue. LD EVs showed an RNA profile with the presence of 18S and 28S ribosomal subunits. In contrast, HD EVs had RNA profiles with small or no peaks for ribosomal RNA subunits. Quantitative proteomics showed that several proteins such as flotillin-1 were enriched in both large and small LD EVs, while ADAM10 were exclusively enriched in small LD EVs. In contrast, mitofilin was enriched only in the large EVs. We conclude that enzymatic treatments improve EV isolation from dense fibrotic tissue without any apparent effect on molecular or morphological characteristics. By providing a detailed categorization of several subpopulations of EVs isolated directly from tumour tissues, we might better understand the function of EVs in tumour biology and their possible use in biomarker discovery.
39.	de Boniface, J., et al. (författare) Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial 2017 Ingår i: BMC Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 17 Tidskriftsartikel (refereegranskat)abstract Background: The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference. Methods: The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1: 1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years. Discussion: Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.
40.	de Boniface, J., et al. (författare) The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer 2020 Ingår i: Breast Cancer Research and Treatment. - : Springer Science and Business Media LLC. - 0167-6806 .- 1573-7217. ; 180:1, s. 167-176 Tidskriftsartikel (refereegranskat)abstract Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015
41.	DePalo, D. K., et al. (författare) Oncolytic intralesional therapy for metastatic melanoma 2023 Ingår i: Clinical & Experimental Metastasis. - 0262-0898. Forskningsöversikt (refereegranskat)abstract In-transit metastasis (ITM) develop in approximately 1 in 10 patients with melanoma and the disease course can vary widely. Surgical resection is the gold-standard treatment; however, ITM are often surgically unresectable due to size, distribution, and/or anatomic involvement. Oncolytic viral therapies are one category of non-surgical treatment options available for ITM. They induce tumor cell lysis and systemic anti-tumor activity through selective infection of tumor cells by naturally occurring or genetically modified factors. While there are numerous oncolytic viral therapies in various stages of development for the treatment of ITM, this discussion focuses on the mechanism and available literature for the two most established herpes virus-based therapies.
42.	Dossett, L. A., et al. (författare) Clinical Response and Regional Toxicity Following Isolated Limb Infusion Compared with Isolated Limb Perfusion for In-Transit Melanoma 2016 Ingår i: Annals of Surgical Oncology. - : Springer Science and Business Media LLC. - 1068-9265 .- 1534-4681. ; 23:7, s. 2330-2335 Tidskriftsartikel (refereegranskat)abstract Isolated limb perfusion (ILP) and infusion (ILI) are therapeutic modalities for the treatment of in transit melanoma. A retrospective review of all patients undergoing first-time ILI or ILP for in-transit melanoma metastases between 2007 and 2015 was performed. Demographic and clinical characteristics included age, sex, nodal status at the time of ILI/ILP (N-stage), and burden of disease (BOD). Regional toxicity was categorized by the Wieberdink classification. Clinical response was evaluated at 3 months after treatment. A total of 203 patients were reviewed (ILI = 94, ILP = 109). There were no differences in age, sex, or N-stage between groups; however, BOD was higher for the ILI group (high BOD 58 vs. 44 %, p = 0.04). Regional toxicity was minimal (Grade IV < 1 % in ILI and 2 % in ILP, p = 0.40). Overall response rate (ORR) was 53 % for ILI versus 80 % for ILP (p < 0.001). Median overall survival (OS) was 46 months for ILI versus 40 months for ILP (p = 0.31). A high BOD [hazard ratio (HR) 3.02, 95 % confidence interval (CI) 1.85-4.93, p < 0.001] and N3 disease (HR 1.58, 95 % CI 1.01-2.48, p = 0.04) were associated with worse OS, whereas there was no difference in OS by procedure (p = 0.20). ILP offers an improved ORR, but this does not translate into improved local PFS or OS. Both procedures are well tolerated with minimal regional toxicity.
43.	Einarsdottir, Berglind Osk, 1979, et al. (författare) A patient-derived xenograft pre-clinical trial reveals treatment responses and a resistance mechanism to karonudib in metastatic melanoma 2018 Ingår i: Cell Death & Disease. - : Springer Science and Business Media LLC. - 2041-4889. ; 9:8 Tidskriftsartikel (refereegranskat)abstract Karonudib (TH1579) is a novel compound that exerts anti-tumor activities and has recently entered phase I clinical testing. The aim of this study was to conduct a pre-clinical trial in patient-derived xenografts to identify the possible biomarkers of response or resistance that could guide inclusion of patients suffering from metastatic melanoma in phase II clinical trials. Patient-derived xenografts from 31 melanoma patients with metastatic disease were treated with karonudib or a vehicle for 18 days. Treatment responses were followed by measuring tumor sizes, and the models were categorized in the response groups. Tumors were harvested and processed for RNA sequencing and protein analysis. To investigate the effect of karonudib on T-cell-mediated anti-tumor activities, tumor-infiltrating T cells were injected in mice carrying autologous tumors and the mice treated with karonudib. We show that karonudib has heterogeneous anti-tumor effect on metastatic melanoma. Thus, based on the treatment responses, we could divide the 31 patient-derived xenografts in three treatment groups: progression group (32%), suppression group (42%), and regression group (26%). Furthermore, we show that karonudib has anti-tumor effect, irrespective of major melanoma driver mutations. Also, we identify high expression of ABCB1, which codes for p-gp pumps as a resistance biomarker. Finally, we show that karonudib treatment does not hamper T-cell-mediated anti-tumor responses. These findings can be used to guide future use of karonudib in clinical use with a potential approach as precision medicine.
44.	Einarsdottir, Berglind Osk, 1979, et al. (författare) Melanoma patient-derived xenografts accurately model the disease and develop fast enough to guide treatment decisions. 2014 Ingår i: Oncotarget. - : Impact Journals, LLC. - 1949-2553. ; 5:20, s. 9609-18 Tidskriftsartikel (refereegranskat)abstract The development of novel therapies against melanoma would benefit from individualized tumor models to ensure the rapid and accurate identification of biomarkers of therapy response. Previous studies have suggested that patient-derived xenografts (PDXes) could be useful. However, the utility of PDXes in guiding real-time treatment decisions has only been reported in anecdotal forms. Here tumor biopsies from patients with stage III and IV metastatic malignant melanoma were transplanted into immunocompromised mice to generate PDXes. 23/26 melanoma biopsies generated serially transplantable PDX models, and their histology, mutation status and expression profile resembled their corresponding patient biopsy. The potential treatment for one patient was revealed by an in vitro drug screen and treating PDXes with the MEK inhibitor trametinib. In another patient, the BRAF mutation predicted the response of both the patient and its corresponding PDXes to MAPK-targeted therapy. Importantly, in this unselected group of patients, the time from biopsy for generation of PDXes until death was significantly longer than the time required to reach the treatment phase of the PDXes. Thus, it could be clinically meaningful to use this type of platform for melanoma patients as a pre-selection tool in clinical trials.
45.	Ekenberg, M., et al. (författare) Patient experiences with isolated limb perfusion for malignant melanoma – A qualitative study 2019 Ingår i: European Journal of Oncology Nursing. - : Elsevier BV. - 1462-3889. ; 43 Tidskriftsartikel (refereegranskat)abstract Purpose: In recent years, the incidence of malignant melanoma has rapidly increased worldwide. Among patients with recurrences, approximately 5% develop in-transit metastases, which can potentially be treated with isolated limb perfusion (ILP). However, little is known about patient experiences with this treatment. A more thorough understanding might guide future research and clinical care. In this study, we aimed to describe patients’ experiences of ILP treatment. Methods: This study included eight patients who participated in a semi-structed interviewed, conducted at one occasion between 3 and 11 months after their ILP treatment. The mean interview duration was 26 min. Data were analyzed using qualitative inductive content analysis according to the methods of Elo-Kyngäs and Graneheim and Lundman. Results: Our analysis yielded three categories, each built on two subcategories: positive experiences after ILP treatment emerged from the sub-categories reduced tumor burden and living a less restricted life; negative experiences after ILP was built on the subcategories fear of relapse and complications and side effects; and experiences of healthcare was founded on the subcategories need for correct information and being viewed as sicker then experienced. Conclusion: Participants showed greater focus on the healthy parts of their lives, even when negative symptoms occurred after ILP treatment. They also described how healthcare workers focused on their illness. Based on these findings, we suggest the following means of providing good nursing care to ILP patients: give correct information, strive to reduce patients’ negative symptoms, support their daily living needs, and provide emotional support to reduce fear of recurrence. © 2019 Elsevier Ltd
46.	Ekström, Karin, 1977, et al. (författare) Characterization of surface markers on extracellular vesicles isolated from lymphatic exudate from patients with breast cancer 2022 Ingår i: Bmc Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 22:1 Tidskriftsartikel (refereegranskat)abstract Background Breast cancer is the most common cancer, and the leading cause of cancer-related deaths, among females world-wide. Recent research suggests that extracellular vesicles (EVs) play a major role in the development of breast cancer metastasis. Axillary lymph node dissection (ALND) is a procedure in patients with known lymph node metastases, and after surgery large amounts of serous fluid are produced from the axilla. The overall aim was to isolate and characterize EVs from axillary serous fluid, and more specifically to determine if potential breast cancer biomarkers could be identified. Methods Lymphatic drain fluid was collected from 7 patients with breast cancer the day after ALND. EVs were isolated using size exclusion chromatography, quantified and detected by nanoparticle tracking analysis, electron microscopy, nano flow cytometry and western blot. The expression of 37 EV surface proteins was evaluated by flow cytometry using the MACSPlex Exosome kit. Results Lymphatic drainage exudate retrieved after surgery from all 7 patients contained EVs. The isolated EVs were positive for the typical EV markers CD9, CD63, CD81 and Flotillin-1 while albumin was absent, indicating low contamination from blood proteins. In total, 24 different EV surface proteins were detected. Eleven of those proteins were detected in all patients, including the common EV markers CD9, CD63 and CD81, cancer-related markers CD24, CD29, CD44 and CD146, platelet markers CD41b, CD42a and CD62p as well as HLA-DR/DP/DQ. Furthermore, CD29 and CD146 were enriched in Her2+ patients compared to patients with Her2- tumors. Conclusions Lymphatic drainage exudate retrieved from breast cancer patients after surgery contains EVs that can be isolated using SEC isolation. The EVs have several cancer-related markers including CD24, CD29, CD44 and CD146, proteins of potential interest as biomarkers as well as to increase the understanding of the mechanisms of cancer biology.
47.	Eldh, Maria, 1980, et al. (författare) MicroRNA in exosomes isolated directly from the liver circulation in patients with metastatic uveal melanoma 2014 Ingår i: BMC Cancer. - London : Springer Science and Business Media LLC. - 1471-2407. ; 14 Tidskriftsartikel (refereegranskat)abstract Uveal melanoma is a tumour arising from melanocytes of the eye, and 30 per cent of these patients develop liver metastases. Exosomes are small RNA containing nano-vesicles released by most cells, including malignant melanoma cells. This clinical translational study included patients undergoing isolated hepatic perfusion (IHP) for metastatic uveal melanoma, from whom exosomes were isolated directly from liver perfusates. The objective was to determine whether exosomes are present in the liver circulation, and to ascertain whether these may originate from melanoma cells.
48.	Eriksson, H., et al. (författare) The Proportion Cured of Patients with Resected Stage II-III Cutaneous Melanoma in Sweden 2021 Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 13:10 Tidskriftsartikel (refereegranskat)abstract Simple summary Patients diagnosed with stage II-III cutaneous melanoma (CM) are at high risk of recurrences, but the CM-specific survival ranges from approximately 40-70%. Here, the cure proportions and survival among uncured stage II-III CM patients were estimated. The 1- and 5-year relative survival ratios, cure proportions and the median survival times of uncured stage II-III CM patients in Sweden (n = 6466) were calculated based on data from the nationwide population-based Swedish Melanoma Register 2005-2013 with a follow-up through 2018. Proportions cured by surgery are low for sub-groups of stage II-III cutaneous melanoma showing that cure analyses can serve as a complement to established survival analyses. Background: Cure proportion represents the proportion of patients who experience the same mortality rate as the general population and can be estimated together with the survival of the proportion experiencing excess mortality (the uncured). The aim was to estimate the cure proportions and survival among uncured stage II-III cutaneous melanoma (CM) patients. Methods: 1- and 5-year relative survival ratios, cure proportions and the median survival times of uncured stage II-III CM patients in Sweden (n = 6466) were calculated based on data from the nationwide population-based Swedish Melanoma Register 2005-2013 with a follow-up through 2018. Results: Stages IIB and IIC showed significant differences in standardized cure proportions vs. stage IIA CM (0.80 (95% CI 0.77-0.83) stage IIA; 0.62 (95% CI 0.59-0.66) stage IIB; 0.42 (95% CI 0.37-0.46) for stage IIC). Significant differences in standardized cure proportions were found for stages IIIB and IIIC-D CM vs. stage IIIA (0.76 (95% CI 0.68-0.84) stage IIIA; 0.52 (95% CI 0.45-0.59) stage IIIB; 0.35 (95% CI 0.30-0.39) for stage IIIC-D). Conclusions: The results are emphasizing the poor prognosis with low proportions cured by surgery only for sub-groups of stage II-III CM, specifically within stages IIB-C CM.
49.	Eroglu, Z., et al. (författare) Outcomes with adjuvant anti-PD-1 therapy in patients with sentinel lymph node-positive melanoma without completion lymph node dissection 2022 Ingår i: Journal for Immunotherapy of Cancer. - : BMJ. - 2051-1426. ; 10:8 Tidskriftsartikel (refereegranskat)abstract Until recently, most patients with sentinel lymph node-positive (SLN+) melanoma underwent a completion lymph node dissection (CLND), as mandated in published trials of adjuvant systemic therapies. Following multicenter selective lymphadenectomy trial-II, most patients with SLN+ melanoma no longer undergo a CLND prior to adjuvant systemic therapy. A retrospective analysis of clinical outcomes in SLN+ melanoma patients treated with adjuvant systemic therapy after July 2017 was performed in 21 international cancer centers. Of 462 patients who received systemic adjuvant therapy, 326 patients received adjuvant anti-PD-1 without prior immediate (IM) CLND, while 60 underwent IM CLND. With median follow-up of 21 months, 24-month relapse-free survival (RFS) was 67% (95% CI 62% to 73%) in the 326 patients. When the patient subgroups who would have been eligible for the two adjuvant anti-PD-1 clinical trials mandating IM CLND were analyzed separately, 24-month RFS rates were 64%, very similar to the RFS rates from those studies. Of these no-CLND patients, those with SLN tumor deposit >1 mm, stage IIIC/D and ulcerated primary had worse RFS. Of the patients who relapsed on adjuvant anti-PD-1, those without IM CLND had a higher rate of relapse in the regional nodal basin than those with IM CLND (46% vs 11%). Therefore, 55% of patients who relapsed without prior CLND underwent surgery including therapeutic lymph node dissection (TLND), with 30% relapsing a second time; there was no difference in subsequent relapse between patients who received observation vs secondary adjuvant therapy. Despite the increased frequency of nodal relapses, adjuvant anti-PD-1 therapy may be as effective in SLN+ pts who forego IM CLND and salvage surgery with TLND at relapse may be a viable option for these patients.
50.	Forsberg, Elin, et al. (författare) HER2 CAR-T Cells Eradicate Uveal Melanoma and T-cell Therapy-Resistant Human Melanoma in IL2 Transgenic NOD/SCID IL2 Receptor Knockout Mice 2019 Ingår i: Cancer Research. - 0008-5472. ; 79:5, s. 899-904 Tidskriftsartikel (refereegranskat)abstract Chimeric antigen receptors (CAR) can transmit signals akin to those from activated T-cell receptors when bound to a cell surface target. CAR-expressing T cells against CD19 can cause curative effects in leukemia and lymphoma and is approved for clinical use. However, no CAR-T therapy is currently approved for use in solid tumors. We hypothesize that the resistance of solid tumors to CAR-T can be overcome by similar means as those used to reactivate tumor-infiltrating T lymphocytes (TIL), for example, by cytokines or immune checkpoint blockade. Here we demonstrate that CAR-T cells directed against HER2 can kill uveal and cutaneous melanoma cells in vitro and in vivo. Curative effects in vivo were only observed in xenografts grown in a NOD/SCID IL2 receptor gamma (NOG) knockout mouse strain transgenic for human IL2. The effect was target-specific, as CRISPR/Cas9-mediated disruption of HER2 in the melanoma cells abrogated the killing effect of the CAR-T cells. The CAR-T cells were also able to kill melanoma cells from patients resistant to adoptive T-cell transfer (ACT) of autologous TILs. Thus, CAR-T therapy represents an option for patients that do not respond to immunotherapy with ACT of TIL or immune checkpoint blockade. In addition, our data highlight the use of IL2 transgenic NOG mice as models to prove efficacy of CAR-T-cell products, possibly even in a personalized manner. Significance: These findings demonstrate that a novel humanized mouse model can help clinical translation of CAR-T cells against uveal and cutaneous melanoma that do not respond to TIL therapy or immune checkpoint blockade.

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