| 1. |
- Birgegård, Gunnar, 1944-, et al.
(author)
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Leukemic transformation and second cancers in 3649 patients with high-risk essential thrombocythemia in the EXELS study
- 2018
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In: Leukemia Research. - : Elsevier BV. - 0145-2126 .- 1873-5835. ; 74, s. 105-109
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Journal article (peer-reviewed)abstract
- EXELS, a post-marketing observational study, is the largest prospective study of high-risk essential thrombocythemia (ET) patients, with an observation time of 5 years. EXELS found higher event rates of acute leukemia transformation in patients treated with hydroxycarbamide (HC). In the current analysis, we report age-adjusted rates of malignant transformation from 3460 EXELS patients exposed to HC, anagrelide (ANA), or both. At registration, 481 patients had ANA treatment without HC exposure, 2305 had HC without ANA exposure, and 674 had been exposed to both. Standard incidence ratios (SIRs) were calculated using data from the Cancer Incidence in Five Continents database to account for differences in age-, gender-, and country-specific background rates. SIRs for acute myelogenous leukemia (AML) were high in ET patients. SIRs for AML were high in HC-treated patients, but AML was rare in ANA-treated patients; no cases of AML were found in patients only treated with ANA. No statistically significant difference was seen between SIRs for ANA and HC treatment for AML or skin cancer. SIRs for other cancers were similar in the HC and ANA groups and close to 1, indicating little difference in risk. Although statistically inconclusive, this study strengthens concerns regarding possible leukemogenic risk with HC treatment. (NCT00202644)
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| 2. |
- Gümüscü, Rojda, et al.
(author)
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National long-term patient-reported outcomes following mastectomy with or without breast reconstruction : The Swedish Breast Reconstruction Outcome Study Part 2 (SweBRO 2)
- 2024
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In: BJS Open. - : Oxford University Press. - 2474-9842. ; 8:1
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Journal article (peer-reviewed)abstract
- Background: The Swedish Breast Reconstruction Outcome Study (SweBRO) initiative is a nationwide study with the primary aim of assessing long-term outcomes after mastectomy with and without breast reconstruction (BR). The current part (SweBRO 2) is designed to evaluate health-related quality of life (HRQoL), with the hypothesis that BR has a positive impact on patient-reported HRQoL in the long-term.Methods: Women who underwent mastectomy in Sweden in 2000, 2005, or 2010 and were alive at the time of the survey were identified through the National Breast Cancer Registry. Eligible participants received formal invitation letters to take part in a survey evaluating their HRQoL at 5 , 10, or 15 years post-mastectomy. The EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-3L questionnaires were employed.Results: Of 2904 respondents (50% of 5853 invited), 895 (31%) had received BR. Among them, 516 (58%) were reconstructed with implants and 281 (31%) with autologous tissue. Women with BR scored significantly better in the EORCT QLQ-C30 physical functioning domain (mean 90 versus 81 points), fatigue (mean 21 versus 25), and dyspnoea (mean 16 versus 22) compared to non-reconstructed women. The EORTC QLQ-BR23 revealed that women with BR experienced favourable sexual functioning compared with non-reconstructed women (mean 26 versus 14). The EQ-5D-3L visual analogue scale score was similar between groups.Conclusion: The current study underscores the benefits of BR for long-term well-being, for example, in terms of physical and sexual functioning. These underline the importance of informing women undergoing mastectomy about BR alternatives and its potential benefits in enhancing long-term well-being. The Swedish Breast Reconstruction Outcome Study (SweBRO) initiative is a nationwide study with the primary aim of assessing long-term outcomes after mastectomy with and without breast reconstruction (BR). Women who had undergone mastectomy in Sweden in 2000, 2005, or 2010 and were alive at the time of the survey were identified through the National Breast Cancer Registry. The current study underscores the benefits of BR for long-term well-being, for example, in terms of physical and sexual functioning.
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| 3. |
- Jansson, Fredrik, et al.
(author)
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Risk of Postoperative Up Staging or Upgrading among Men with Low Risk Familial Prostate Cancer
- 2020
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In: Journal of Urology. - 0022-5347 .- 1527-3792. ; 204:1, s. 79-81
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Journal article (peer-reviewed)abstract
- Purpose: We investigated whether men with biopsy verified, low grade cancer and a family history of lethal or advanced prostate cancer are at particularly high risk for harboring undetected high grade disease.Materials and Methods: Upgrading and up staging of prostate cancer are common after prostatectomy. In a nationwide population based cohort we identified 6,854 men with low risk prostate cancer who underwent radical prostatectomy. Among these men 1,739 (25%) had a history of prostate cancer in a first-degree relative and 289 (4%) had a first-degree relative with lethal or advanced prostate cancer.Results: Compared to men with no familial occurrence of prostate cancer, the odds ratio for the risk of up staging among men with a familial occurrence of high risk or lethal prostate cancer was 1.06 (95% CI 0.76-1.47). The corresponding odds ratio for upgrading was 1.17 (0.91-1.50).Conclusions: We found no association between family history of prostate cancer and up staging or upgrading after radical prostatectomy.
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| 4. |
- Lund, Lars H, et al.
(author)
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Rationale and design of ENDEAVOR: A sequential phase 2b-3 randomized clinical trial to evaluate the effect of myeloperoxidase inhibition on symptoms and exercise capacity in heart failure with preserved or mildly reduced ejection fraction.
- 2023
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In: European journal of heart failure. - 1879-0844.
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Journal article (peer-reviewed)abstract
- Mitiperstat (formerly AZD4831) is a novel selective myeloperoxidase inhibitor. Currently, no effective therapies target comorbidity-induced systemic inflammation, which may be a key mechanism underlying heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). Circulating neutrophils secrete myeloperoxidase, causing oxidative stress, microvascular endothelial dysfunction, interstitial fibrosis, cardiomyocyte remodelling and diastolic dysfunction. Mitiperstat may therefore improve function of the heart and other organs, and ameliorate heart failure symptoms and exercise intolerance. ENDEAVOR is a combined, seamless phase 2b-3 study of the efficacy and safety of mitiperstat in patients with HFpEF/HFmrEF.In phase 2b, approximately 660 patients with heart failure and ejection fraction >40% are being randomized 1:1:1 to mitiperstat 2.5 mg, 5 mg or placebo for 48 weeks. Eligible patients have baseline 6-min walk distance (6MWD) of 30-400 m with a <50 m difference between screening and randomization and Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) ≤90 points at screening and randomization. The dual primary endpoints are change from baseline to week 16 in 6MWD and KCCQ-TSS. The sample size provides 85% power to detect placebo-adjusted improvements of 21 m in 6MWD and 6.0 points in KCCQ-TSS at overall two-sided alpha of 0.05. Safety is monitored throughout treatment, with a focus on maculopapular rash. In phase 3 of ENDEAVOR, approximately 820 patients will be randomized 1:1 to mitiperstat or placebo.ENDEAVOR is the first phase 2b-3 study to evaluate whether myeloperoxidase inhibition can improve symptoms and exercise capacity in patients with HFpEF/HFmrEF.
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| 5. |
- Svee, Andreas, et al.
(author)
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Use of the Cephalic Vein in DIEP Breast Reconstruction Does Not Increase Risk of Lymphedema of the Ipsilateral Arm
- 2023
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In: Plastic and reconstructive surgery (1963). - : Lippincott Williams & Wilkins. - 0032-1052 .- 1529-4242. ; 151:1, s. 195-201
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Journal article (peer-reviewed)abstract
- Flap failure is a rare but devastating complication in deep inferior epigastric perforator (DIEP) flap reconstructions. Common causes of partial or complete flap failure are related to venous congestion. Although the cephalic vein is usually a safe and reliable recipient vein for additional venous outflow, there is a hypothesized risk of donor-arm lymphedema secondary to lymphatic vessel damage in the vicinity of the cephalic vein or related to scarring and reduced venous backflow of the arm. The aim was to assess whether the cephalic vein as an additional recipient vessel, by means of the superficial inferior epigastric vein in DIEP flap breast reconstruction, was associated with long-term volume changes of the arm and/or symptoms of lymphedema. Arm volume was assessed preoperatively in patients scheduled to undergo unilateral delayed DIEP flap breast reconstruction at Uppsala University Hospital, Sweden, between 2001 and 2007. Long-term postoperative assessments were performed in 2015 to 2016. Water displacement and circumferential measurement were assessed preoperatively and postoperatively by the same lymphedema therapists. Patients were divided into two groups: DIEP reconstruction with the cephalic vein or without. Fifty-four patients fulfilled the inclusion criteria and completed the study, with a mean follow-up time of 136 months. There was no increased occurrence of lymphedema in the group undergoing DIEP flap reconstruction with the cephalic vein as extra venous drainage, based on an analysis of change from baseline in arm volume difference.This study shows that the cephalic vein can be used for secondary venous outflow in DIEP breast reconstruction without long-term risk of ipsilateral arm volume increase or symptoms of lymphedema.
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| 6. |
- Sverrisson, Ingvar, et al.
(author)
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Anastomotic leakage after anterior resection in patients with rectal cancer previously irradiated for prostate cancer
- 2019
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In: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983 .- 1532-2157. ; 45:3, s. 341-346
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Journal article (peer-reviewed)abstract
- Introduction:There are little data on the post-operative outcome of anterior resection (AR) for rectal cancer in men who had received radiotherapy for prostate cancer previously. The aim of this study was to assess the rate of anastomotic leakage (AL) after AR in these patients.Methods:All men who underwent bowel resection because of rectal cancer between 2000 and 2016 and had been diagnosed previously with prostate cancer were identified by linking the Swedish Colorectal Cancer Registry with the National Prostate Cancer Register. The medical records of men who underwent AR and had previously received radiotherapy for prostate cancer were reviewed.Results:In total, 13299 men had undergone a bowel resection for rectal cancer, 188 of whom had previously received radiotherapy for prostate cancer. Among those who had received radiation therapy, 59 men (31%) had an AR: 50 men (85%) received a diverting ileostomy, 42 men (71%) had an American Society of Anesthesiologists score of 1-2 and 36 men (61%) had tumour stage 1-2. AL was found in 12/59 men (20%), one of whom had a re-laparotomy. There was no 90-day mortality.Conclusions:In the combined national population-based registries, a minority of patients with rectal cancer had an AR after previous radiotherapy for prostate cancer. These patients were healthy with early cancer stages and, in this selected group of patients, the AL rate was much lower than that reported previously.
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| 7. |
- Unukovych, Dmytro, et al.
(author)
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Breast reconstruction patterns from a Swedish nation-wide survey
- 2020
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In: European Journal of Surgical Oncology. - : Elsevier BV. - 0748-7983 .- 1532-2157. ; 46:10, s. 1867-1873
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Journal article (peer-reviewed)abstract
- ObjectivesThe overall aim of the Swedish Breast Reconstruction Outcome Study was to investigate national long-term outcomes after mastectomy with or without breast reconstruction. The current report evaluates breast reconstruction (BR) patterns in Sweden over time.Materials and methodsThis is a cross-sectional, registry-based study where all women operated with mastectomy 2000, 2005, 2010 were identified (N = 5853). Geographical differences in type of BR were investigated using heatmaps. Distribution of continuous variables were compared using the Mann-Whitney U test, categorical variables were compared using the chi-square test.ResultsMean age at survey was 69 years (SD=±11.4) and response rate was 50%, responders were on average six years younger than the non-responders and had a more favourable tumor stage (both p < 0.01). Of the 2904 responders, 31% (895/2904) had received a BR: implant-based in 58% (516/895)autologous in 31% (281/895). BR was immediate in 20% (176/895) and delayed in 80% (719/895) women.Women with BR were on average one year older, more often had a normal BMI, reported to be married or had a partner, had a higher educational level and a higher annual income when compared to those without BR (all p < 0.001). The independent factors of not receiving BR were older age and given radiotherapy.ConclusionsTo our knowledge, this is the first national long-term follow-up study on women undergoing mastectomy with and without BR. Around 30% of the survey responders have had a BR with a significant geographical variation highlighting the importance of information, availability and standardisation of indications for BR.
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