National long-term patient-reported outcomes following mastectomy with or without breast reconstruction: The Swedish Breast Reconstruction Outcome Study Part 2 (SweBRO 2).

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 PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study.

BACKGROUND: Correct preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery. The sensitivity of mammography is lower in dense breasts, and additional imaging techniques are sometimes warranted. Contrast-enhanced mammography (CEM) has shown similar sensitivity and in some cases better specificity, than magnetic resonance imaging (MRI) in small, observational studies. CEM may be more cost-effective than MRI, and may provide better identification of the tumor extent, however, no randomized trials have been performed to date to investigate the added value of CEM. In a feasibility study, we found that the treatment was changed in 10/47 (21%) cases after additional CEM. The purpose of the present study is to evaluate the added value of CEM in preoperative staging of breast cancer in a randomized study. METHOD: This prospective randomized study will include 440 patients with strongly suspected or established diagnosis of breast malignancy, based on assessment with mammography, ultrasound and core biopsy/cytology, and for whom primary surgery is planned. Patients will be randomized 1:1 using a web-based randomization tool to additional investigation with CEM or no further imaging. The CEM findings will be taken into consideration, which may lead to changes in primary treatment, which is the primary endpoint of this study. Secondary endpoints include rate of reoperation and number of avoidable mastectomies, as well as a cost-benefit analysis of additional CEM. Patient-reported health-related quality of life will be investigated at 1 year with the validated Breast-Q™ questionnaire. The rate of local recurrence or new cancer ipsi- or contralaterally within 5 years will be assessed from medical records and pathology reports. DISCUSSION: The aim of this trial is to explore the added value of CEM in preoperative staging of breast cancer. The results obtained from this study will contribute to our knowledge on CEM as an additional imaging method to standard investigation with digital mammography and ultrasound. The findings may also provide additional information on which patient groups would benefit from CEM, and on the economic aspects of CEM in standard preoperative practice. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov , registration no: NCT04437602 , date of registration: June 18, 2020.

Breast reconstruction patterns from a Swedish nation-wide survey.

OBJECTIVES: The 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 METHODS: This 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. RESULTS: Mean 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. CONCLUSIONS: To 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.

Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study.

OBJECTIVES: The aim of this feasibility study was to evaluate the added value of contrast-enhanced mammography (CEM) in preoperative staging of malignant breast lesions, beyond standard assessment with digital mammography and ultrasound, as a base for a future prospective randomized trial. MATERIALS AND METHODS: Forty-seven patients, with confirmed or strongly suspected malignant breast lesions after standard assessment (digital mammography (DM) and ultrasound (US)), scheduled for primary surgery, were invited to undergo CEM as an additional preoperative procedure. The primary endpoint was change in treatment due to CEM findings, defined as mastectomy instead of partial mastectomy or contrariwise, bilateral surgery instead of unilateral or neoadjuvant treatment instead of primary surgery. Accuracy in tumour extent estimation compared to histopathology was evaluated by Bland-Altman statistics. Number of extra biopsies and adverse events were recorded. RESULTS: In 10/47 patients (21%), findings from CEM affected the primary treatment. Agreement with histopathology regarding extent estimation was better for CEM (mean difference - 1.36, SD ± 18.45) in comparison with DM (- 4.18, SD ± 26.20) and US (- 8.36, SD ± 24.30). Additional biopsies were taken from 19 lesions in 13 patients. Nine biopsies showed malignant outcome. No major adverse events occurred. CONCLUSION: The feasibility of preoperative additional CEM was found to be satisfactory without any serious negative effects. Results imply an added value of CEM in preoperative staging of breast cancer. Further evaluation in larger prospective randomized trials is needed. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03402529. Registered 18 January 2018-retrospectively registered.

Patient satisfaction after unilateral oncoplastic volume displacement surgery for breast cancer, evaluated with the BREAST-Q™.

BACKGROUND: Oncoplastic breast-conserving surgery allows larger resections in unfavorable locations, with an improved chance of preserving esthetics. Indications and timing for potential contralateral surgery to obtain symmetry are not clear. The aim of this study was to evaluate patient satisfaction after unilateral oncoplastic volume displacement surgery, to investigate potential risk factors for lower patient satisfaction and to assess patient wish for contralateral surgery. METHOD: A cohort of 144 women, consecutively treated for breast cancer with unilateral breast-conserving oncoplastic volume displacement surgery, followed by radiotherapy and with an unoperated contralateral breast, was sent the BREAST-Q™ breast-conserving therapy (BCT) and a study-specific questionnaire. In all, 120 women (83%) responded. For these women, the median value for resected specimen weight was 92 g (range 14-345) and for the estimated percentage of the breast volume excised 15% (range 3-35%). RESULTS: The median patient-reported score for "Satisfaction with breast" (BREAST-Q™ BCT) was 74/100. Factors associated with a score below median value in a simple logistic regression model adjusted for age and BMI were axillary clearance (OR 2.46, 95% CI 1.09-5.56), neoadjuvant chemotherapy (OR 3.26, 95% CI 1.15-9.24), and low breast density (OR 2.32 95% CI 1.02-5.29). Thirteen women (11%) were interested in contralateral surgery. CONCLUSION: Most patients in this study cohort, who had undergone breast-conserving therapy with oncoplastic volume displacement techniques, were satisfied with their breasts without surgery to the contralateral breast. This indicates that contralateral surgery to achieve symmetry only should be performed after individual evaluation and as a delayed procedure.

Impact of aspirin, NSAIDs, warfarin, corticosteroids and SSRIs on the site and outcome of non-variceal upper and lower gastrointestinal bleeding.

OBJECTIVE: To assess the impact of increased use of low-dose aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, corticosteroids and selective serotonin re-uptake inhibitors (SSRIs) on the site and outcome of non-variceal gastrointestinal (GI) bleeds. METHODS: Retrospective review of 731 patients with peptic ulcer bleeds (PUBs), non-ulcer, non-variceal upper (NUUPGIBs) and lower GI bleeds (LGIBs) in 1984, 1994 and 2004 at Lund University Hospital, Sweden. Incidence and mortality rates, risk factors for fatal outcome and associations with different sites of GI bleeds were evaluated. RESULTS: Between 1984 and 2004, incidence of PUBs decreased from 62.0 to 32.1 per 100,000 inhabitants (p<0.001). Incidence of NUUPGIBs (29.0-30.4 per 100,000) and LGIBs (45.5-43.2 per 100,000) was stable. The case-fatality rate ranged from 4-6% (p=0.65) for upper GI bleed to 1-8% (p=0.033) for LGIB. No drug impacted on fatal outcome. Aspirin, warfarin and SSRI users tended to suffer more severe GI bleeds than non-users of these drugs. When comparing non-ulcer GI bleeds with PUBs, aspirin (OR 0.56, 95% CI 0.38-0.82) was more strongly associated with PUBs, whereas SSRIs (OR 3.71, 95% CI 1.39-12.9) and corticosteroids (OR 2.8, 95% CI 1.28-6.82) were more associated with non-ulcer GI bleeds after adjusting for age, gender and co-morbidity. CONCLUSION: Increased use of drugs that promote bleeding has not impacted on incidence and fatal outcome of non-variceal GI bleeds, although the severity of bleeding has increased. Aspirin is more strongly associated with PUBs, while corticosteroids and SSRIs are associated with non-ulcer, non-variceal GI bleeds.

Increased mortality in prostate carcinoma and smoking-related disease after parietal cell vagotomy: a long-term follow-up study.

OBJECTIVE: There is an increased risk of gastrointestinal carcinoma and smoking-related diseases after partial gastrectomy for peptic ulcer disease. The purpose of this study was to evaluate long-term cancer incidence and mortality after parietal cell vagotomy (PCV), a surgical method with a low rate of side effects, but creating hypochlorhydria in the stomach mimicking long-term treatment with antisecretory drugs. MATERIAL AND METHODS: Data on 383 ulcer patients operated on with PCV during 1971-80 at Lund University Hospital were compared with the national registers for cause of death and cancer incidence for selected diagnoses. Median follow-up was 28 years and 31 years, respectively. Standardized mortality ratios (SMRs) and standardized incidence ratios (SIRs) were calculated. RESULTS: An increased incidence of cancer in the respiratory organs (SIR 1.97, 95% CI: 1.08-3.31) and prostate carcinoma (SIR 1.85, 95% CI: 1.22-2.69) was found, and among men also an increased mortality in prostate carcinoma (SMR 3.85, 95% CI: 1.41-8.38) and chronic respiratory disease (SMR 2.76, 95% CI: 1.01-6.02). Overall mortality was similar to that of the background population and no increased risk of gastrointestinal malignancies was observed. CONCLUSIONS: Patients with peptic ulcer operated on with PCV have a long-term increased risk of smoking-related diseases, but PCV does not seem to increase the risk of gastrointestinal carcinoma. An increased risk of, and mortality in prostate carcinoma was found, a cancer previously not found to be related to smoking. This might be the result of surgery-induced hypochlorhydria, which warrants further investigation in patients on long-term proton-pump inhibitors.