| 1. |
- Kaidar-Person, Orit, et al.
(författare)
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The Lucerne Toolbox 2 to optimise axillary management for early breast cancer : a multidisciplinary expert consensus
- 2023
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Ingår i: EClinicalMedicine. - 2589-5370. ; 61
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Forskningsöversikt (refereegranskat)abstract
- Clinical axillary lymph node management in early breast cancer has evolved from being merely an aspect of surgical management and now includes the entire multidisciplinary team. The second edition of the “Lucerne Toolbox”, a multidisciplinary consortium of European cancer societies and patient representatives, addresses the challenges of clinical axillary lymph node management, from diagnosis to local therapy of the axilla. Five working packages were developed, following the patients’ journey and addressing specific clinical scenarios. Panellists voted on 72 statements, reaching consensus (agreement of 75% or more) in 52.8%, majority (51%–74% agreement) in 43.1%, and no decision in 4.2%. Based on the votes, targeted imaging and standardized pathology of lymph nodes should be a prerequisite to planning local and systemic therapy, axillary lymph node dissection can be replaced by sentinel lymph node biopsy ( ± targeted approaches) in a majority of scenarios; and positive patient outcomes should be driven by both low recurrence risks and low rates of lymphoedema.
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| 2. |
- Karihtala, Peeter, et al.
(författare)
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Clinical trials in older patients with cancer : typical challenges, possible solutions, and a paradigm of study design in breast cancer
- 2024
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Ingår i: Acta Oncologica. - : Taylor & Francis. - 0284-186X .- 1651-226X. ; 63, s. 441-447
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Forskningsöversikt (refereegranskat)abstract
- BACKGROUND AND PURPOSE: While the prevalence of older breast cancer patients is rapidly increasing, these patients are greatly underrepresented in clinical trials. We discuss barriers to recruitment of older patients to clinical trials and propose solutions on how to mitigate these challenges and design optimal clinical trials through the paradigm of IMPORTANT trial.PATIENTS AND METHODS: This is a narrative review of the current literature evaluating barriers to including older breast cancer patients in clinical trials and how mitigating strategies can be implemented in a pragmatic clinical trial. RESULTS: The recognized barriers can be roughly divided into trial design-related (e.g. the adoption of strict inclusion criteria, the lack of pre-specified age-specific analysis), patient-related (e.g. lack of knowledge, valuation of the quality-of-life instead of survival, transportation issues), or physician-related (e.g. concern for toxicity). Several strategies to mitigate barriers have been identified and should be considered when designing a clinical trial dedicated to older patients with cancer. The pragmatic, de-centralized IMPORTANT trial focusing on dose optimization of CDK4/6 -inhibitors in older breast cancer patients is a paradigm of a study design where different mitigating strategies have been adopted.INTERPRETATION: Because of the existing barriers, older adults in clinical trials are considerably healthier than the average older patients treated in clinical practice. Thus, the study results cannot be generalized to the older population seen in daily clinical practice. Broader inclusion/exclusion criteria, offering telehealth visits, and inclusion of patient-reported, instead of physician-reported outcomes may increase older patient participation in clinical trials.
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| 3. |
- Karihtala, Peeter, et al.
(författare)
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Clinical trials in older patients with cancer - typical challenges, possible solutions, and a paradigm of study design in breast cancer
- 2024
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Ingår i: Acta Oncologica. - : Medical Journals Sweden. - 0284-186X .- 1651-226X. ; 63:1, s. 441-447
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Forskningsöversikt (refereegranskat)abstract
- Background and purpose: While the prevalence of older breast cancer patients is rapidly increasing, these patients are greatly underrepresented in clinical trials. We discuss barriers to recruitment of older patients to clinical trials and propose solutions on how to mitigate these challenges and design optimal clinical trials through the paradigm of IMPORTANT trial.Patients and methods: This is a narrative review of the current literature evaluating barriers to including older breast cancer patients in clinical trials and how mitigating strategies can be implemented in a pragmatic clinical trial.Results: The recognized barriers can be roughly divided into trial design -related (e.g . the adoption of strict inclusion criteria, the lack of pre-specified age-specific analysis), patient-related (e.g . lack of knowledge, valuation of the quality-of-life instead of survival, transportation issues), or physician-related (e.g . concern for toxicity). Several strategies to mitigate barriers have been identified and should be considered when designing a clinical trial dedicated to older patients with cancer. The pragmatic, de-centralized IMPORTANT trial focusing on dose optimization of CDK4/6 -inhibitors in older breast cancer patients is a paradigm of a study design where different mitigating strategies have been adopted.Interpretation: Because of the existing barriers, older adults in clinical trials are considerably healthier than the average older patients treated in clinical practice. Thus, the study results cannot be generalized to the older population seen in daily clinical practice. Broader inclusion/exclusion criteria, offering telehealth visits, and inclusion of patient -reported, instead of physician -reported outcomes may increase older patient participation in clinical trials.
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| 4. |
- Kastora, Stavroula Lila, et al.
(författare)
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Outcomes of Different Quality of Life Assessment Modalities After Breast Cancer Therapy : A Network Meta-analysis
- 2023
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 6:6
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Forskningsöversikt (refereegranskat)abstract
- IMPORTANCE: Improvement in clinical understanding of the priorities of patients with breast cancer (BC) regarding postoperative aesthetic outcomes (AOs) is needed.OBJECTIVE: To assess expert panel and computerized evaluation modalities against patient-reported outcome measures (PROMs), the gold standard of AO assessment, in patients after surgical management of BC.DATA SOURCES: Embase, MEDLINE, PsycINFO, PubMed, the Cochrane Central Register of Controlled Trials, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov were interrogated from inception through August 5, 2022. Search terms included breast conserving AND aesthetic outcome AND breast cancer. Ten observational studies were eligible for inclusion, with the earliest date of database collection on December 15, 2022.STUDY SELECTION: Studies with at least 1 pairwise comparison (PROM vs expert panel or PROM vs computerized evaluation with Breast Cancer Conservation Treatment cosmetic results [BCCT.core] software) were considered eligible if they included patients who received BC treatment with curative intent. Studies reporting solely on risk reduction or benign surgical procedures were excluded to ensure transitivity.DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted study data with an independent cross-check from a third reviewer. The quality of included observational studies was assessed using the Newcastle-Ottawa Scale, and the level of evidence quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. Confidence in network meta-analysis results was analyzed with the Confidence in Network Meta-analysis semiautomated tool. Effect size was reported using random-effects odds ratios (ORs) and cumulative ratios of ORs with 95% credibility intervals (CrIs).MAIN OUTCOMES AND MEASURES: The primary outcome of this network meta-analysis was modality (expert panel or computer software) discordance from PROMs. Four-point Likert responses across PROMs, expert panel assessment, and BCCT.core evaluation of AOs were assessed.RESULTS: A total of 10 observational studies including 3083 patients (median [IQR] age, 59 [50-60] years; median [range] follow-up, 39.0 [22.5-80.5] months) with reported AOs were assessed and homogenized in 4 distinct Likert response groups (excellent, very good, satisfactory, and bad). Overall network incoherence was low (χ22 = 0.35; P = .83). Overall, panel and software modalities graded AO outcomes worse than PROMs. Specifically, for excellent vs all other responses, the panel to PROM ratio of ORs was 0.30 (95% CrI, 0.17-0.53; I2 = 86%) and the BCCT.core to PROM ratio of ORs was 0.28 (95% CrI, 0.13-0.59; I2 = 95%), while the BCCT.core to panel ratio of ORs was 0.93 (95% CrI, 0.46-1.88; I2 = 88%).CONCLUSIONS AND RELEVANCE: In this study, patients scored AOs higher than both expert panels and computer software. Standardization and supplementation of expert panel and software AO tools with racially, ethnically, and culturally inclusive PROMs is needed to improve clinical evaluation of the journey of patients with BC and to prioritize components of therapeutic outcomes.
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| 5. |
- Lång, Kristina, et al.
(författare)
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Breast Imaging
- 2022. - 1
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Ingår i: Breast Cancer Radiation Therapy : A Practical Guide for Technical Applications - A Practical Guide for Technical Applications. - Cham : Springer International Publishing. - 9783030911706 ; , s. 49-59
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Bokkapitel (refereegranskat)abstract
- Imaging is an integral part of breast cancer diagnosis, staging and follow-up. Breast imaging is also important for radiation therapy planning. The radiation oncologist needs to review patient’s imaging (e.g. mammography) to evaluate the extent of disease (for radiation planning, not for diagnostic purposes) and for treatment planning. Pre-treatment imaging is the key for planning radiation target volumes, especially the radiation tumour bed boost if indicated and regional nodal irradiation. For radiation treatment planning, the radiation oncologist needs to be familiar with patient anatomy as seen on imaging done for treatment planning (e.g. CT simulation, MRI simulation). Therefore, participating in a multidisciplinary meeting with breast radiologist experts, learning how to read/understand breast imaging and consulting with a breast radiologist expert if there is any doubt, is essential for proper breast radiation planning.The current chapter will review breast imaging for screening, preoperative evaluation and provide tools for the radiation oncologist to review breast imaging in clinical practice.
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| 6. |
- Pasquier, David, et al.
(författare)
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Designing clinical trials based on modern imaging and metastasis-directed treatments in patients with oligometastatic breast cancer: a consensus recommendation from the EORTC Imaging and Breast Cancer Groups
- 2023
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Ingår i: The Lancet Oncology. - 1470-2045 .- 1474-5488. ; 24:8
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Forskningsöversikt (refereegranskat)abstract
- Breast cancer remains the most common cause of cancer death among women. Despite its considerable histological and molecular heterogeneity, those characteristics are not distinguished in most definitions of oligometastatic disease and clinical trials of oligometastatic breast cancer. After an exhaustive review of the literature covering all aspects of oligometastatic breast cancer, 35 experts from the European Organisation for Research and Treatment of Cancer Imaging and Breast Cancer Groups elaborated a Delphi questionnaire aimed at offering consensus recommendations, including oligometastatic breast cancer definition, optimal diagnostic pathways, and clinical trials required to evaluate the effect of diagnostic imaging strategies and metastasis-directed therapies. The main recommendations are the introduction of modern imaging methods in metastatic screening for an earlier diagnosis of oligometastatic breast cancer and the development of prospective trials also considering the histological and molecular complexity of breast cancer. Strategies for the randomisation of imaging methods and therapeutic approaches in different subsets of patients are also addressed.
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| 7. |
- Salvestrini, Viola, et al.
(författare)
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Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy : A systematic review and meta-analysis
- 2023
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Ingår i: Radiotherapy and Oncology. - : ELSEVIER IRELAND LTD. - 0167-8140 .- 1879-0887. ; 186
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Forskningsöversikt (refereegranskat)abstract
- Background and Purpose: In recent years, the treatment landscape for breast cancer has undergone significant advancements, with the introduction of several new anticancer agents. One such agent is trastuzumab emtansine (T-DM1), an antibody drug conjugate that has shown improved outcomes in both early and advanced breast cancer. However, there is currently a lack of comprehensive evidence regarding the safety profile of combining T-DM1 with radiation therapy (RT). In this study, we aim to provide a summary of the available data on the safety of combining RT with T-DM1 in both early and metastatic breast cancer settings. Materials and Methods: This systematic review and meta-analysis project is part of the consensus recommendations by the European Society for Radiotherapy and Oncology (ESTRO) Guidelines Committee on integrating RT with targeted treatments for breast cancer. A thorough literature search was conducted using the PUBMED/MedLine, Embase, and Cochrane databases to identify original studies focusing on the safety profile of combining T-DM1 with RT. Results: After applying eligibility criteria, nine articles were included in the meta-analysis. Pooled data from these studies revealed a high incidence of grade 3 + radionecrosis (17%), while the rates of grade 3 + radiation-related pneumonitis (<1%) and skin toxicity (1%) were found to be very low. Conclusion: Although there is some concern regarding a slight increase in pneumonitis when combining T-DM1 with postoperative RT, the safety profile of this combination was deemed acceptable for locoregional treatment in non-metastatic breast cancer. However, caution is advised when irradiating intracranial sites concurrently with T-DM1. There is a pressing need for international consensus guidelines regarding the safety considerations of combining T-DM1 and RT for breast cancer.
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