BACKGROUND: Breast fat necrosis (BFN) is a non-cancerous condition affecting the adipose tissue. Despite incidence rates of up to 25% after breast surgery, little is known about risk factors and postoperative outcomes following the surgical treatment of BFN. METHODS: The National Surgical Quality Improvement Program of the American College of Surgeons (2008-2021) was queried to identify female patients diagnosed with and surgically treated for BFN. Outcomes of interest included 30-day surgical and medical complications, reoperation, and readmission. We performed confounder-adjusted multivariable analyses to determine risk factors. RESULTS: The study population included 1179 female patients (mean age: 55.8 ± 13.8 years), of whom 96% (n = 1130) underwent direct excision and 4.2% (n = 49) received debridement of necrotic tissue. The majority of cases were operated on by general surgeons (n = 867; 74%) in the outpatient setting (n = 1107; 94%). Overall, 74 patients (6.3%) experienced postoperative adverse events, most of which were surgical complications (n = 43; 3.7%). Twenty-one (1.8%) women had to return to operating room, while readmission was reported in 18 (1.5%) cases. Adverse events were significantly more likely to occur in patients with chronic heart failure (p = 0.002) and higher wound classes (p = 0.033). CONCLUSION: Complication rates following the surgical management of BFN were found to be relatively high and seen to correlate with the setting. We identified chronic heart failure and wound contamination as risk factors for complication occurrence. These evidence-based insights may sensitize surgeons to critically balance patients' eligibility for BFN surgery and refine perioperative algorithms.
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace epidemiologie etiologie diagnóza MeSH
- prsy * patologie MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční selhání * MeSH
- tuková nekróza * epidemiologie etiologie MeSH
- zlepšení kvality MeSH
- znovupřijetí pacienta MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND: We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. METHODS: We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratified by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-effects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. FINDINGS: Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6·6 years (IQR 5·8-7·6), no patients had any grade 4 toxities, and three (<1%) of 484 patients in the APBI group and seven (2%) of 393 in the whole-breast irradiation group had grade 3 late skin toxicity (p=0·16). No patients in the APBI group and two (<1%) in the whole-breast irradiation group developed grade 3 late subcutaneous tissue toxicity (p=0·10). The cumulative incidence of any late side-effect of grade 2 or worse at 5 years was 27·0% (95% CI 23·0-30·9) in the whole-breast irradiation group versus 23·3% (19·9-26·8) in the APBI group (p=0·12). The cumulative incidence of grade 2-3 late skin toxicity at 5 years was 10·7% (95% CI 8·0-13·4) in the whole-breast irradiation group versus 6·9% (4·8-9·0) in the APBI group (difference -3·8%, 95% CI -7·2 to 0·4; p=0·020). The cumulative risk of grade 2-3 late subcutaneous tissue side-effects at 5 years was 9·7% (95% CI 7·1-12·3) in the whole-breast irradiation group versus 12·0% (9·4-14·7) in the APBI group (difference 2·4%; 95% CI -1·4 to 6·1; p=0·28). The cumulative incidence of grade 2-3 breast pain was 11·9% (95% CI 9·0-14·7) after whole-breast irradiation versus 8·4% (6·1-10·6) after APBI (difference -3·5%; 95% CI -7·1 to 0·1; p=0·074). At 5 years' follow-up, according to the patients' view, 413 (91%) of 454 patients had excellent to good cosmetic results in the whole-breast irradiation group versus 498 (92%) of 541 patients in the APBI group (p=0·62); when judged by the physicians, 408 (90%) of 454 patients and 503 (93%) of 542 patients, respectively, had excellent to good cosmetic results (p=0·12). No treatment-related deaths occurred, but six (15%) of 41 patients (three in each group) died from breast cancer, and 35 (85%) deaths (21 in the whole-breast irradiation group and 14 in the APBI group) were unrelated. INTERPRETATION: 5-year toxicity profiles and cosmetic results were similar in patients treated with breast-conserving surgery followed by either APBI with interstitial brachytherapy or conventional whole-breast irradiation, with significantly fewer grade 2-3 late skin side-effects after APBI with interstitial brachytherapy. These findings provide further clinical evidence for the routine use of interstitial multicatheter brachytherapy-based APBI in the treatment of patients with low-risk breast cancer who opt for breast conservation. FUNDING: German Cancer Aid.
- MeSH
- brachyterapie škodlivé účinky MeSH
- časové faktory MeSH
- celková dávka radioterapie MeSH
- duktální karcinom prsu patologie radioterapie chirurgie MeSH
- intraduktální neinfiltrující karcinom patologie radioterapie chirurgie MeSH
- kombinovaná terapie MeSH
- kosmetické přípravky * MeSH
- lidé středního věku MeSH
- lidé MeSH
- lobulární karcinom patologie radioterapie chirurgie MeSH
- mastektomie škodlivé účinky MeSH
- nádory prsu patologie radioterapie chirurgie MeSH
- následné studie MeSH
- prognóza MeSH
- radiodermatitida diagnóza etiologie MeSH
- segmentální mastektomie škodlivé účinky MeSH
- senioři MeSH
- staging nádorů MeSH
- stupeň nádoru MeSH
- tuková nekróza diagnóza etiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Klíčová slova
- hepatotoxická látka Interphane (ITPH) je synonymem pro Atophane,
- MeSH
- experimenty na zvířatech MeSH
- globuliny izolace a purifikace účinky léků MeSH
- hematologické testy metody využití MeSH
- hepatocyty cytologie enzymologie účinky léků MeSH
- histologické techniky metody využití MeSH
- mononukleární fagocytární systém anatomie a histologie cytologie účinky léků MeSH
- potkani Wistar MeSH
- statistika jako téma MeSH
- tuková nekróza * etiologie chemicky indukované veterinární MeSH
- ztučnělá játra * chemicky indukované veterinární MeSH
- zvířata MeSH
- Check Tag
- zvířata MeSH
