PMID- 36972145 OWN - NLM STAT- MEDLINE DCOM- 20230329 LR - 20240328 IS - 1469-493X (Electronic) IS - 1361-6137 (Linking) VI - 3 IP - 3 DP - 2023 Mar 27 TI - Skin-sparing mastectomy for the treatment of breast cancer. PG - CD010993 LID - 10.1002/14651858.CD010993.pub2 [doi] LID - CD010993 AB - BACKGROUND: Skin-sparing mastectomy (SSM) is a surgical technique that aims to maximize skin preservation, facilitate breast reconstruction, and improve cosmetic outcomes. Despite its use in clinical practice, the benefits and harms related to SSM are not well established. OBJECTIVES: To assess the effectiveness and safety of skin-sparing mastectomy for the treatment of breast cancer. SEARCH METHODS: We searched Cochrane Breast Cancer's Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 9 August 2019. SELECTION CRITERIA: Randomized controlled trials (RCTs), quasi-randomized or non-randomized studies (cohort and case-control) comparing SSM to conventional mastectomy for treating ductal carcinoma in situ (DCIS) or invasive breast cancer. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. The primary outcome was overall survival. Secondary outcomes were local recurrence free-survival, adverse events (including overall complications, breast reconstruction loss, skin necrosis, infection and hemorrhage), cosmetic results, and quality of life. We performed a descriptive analysis and meta-analysis of the data. MAIN RESULTS: We found no RCTs or quasi-RCTs. We included two prospective cohort studies and twelve retrospective cohort studies. These studies included 12,211 participants involving 12,283 surgeries (3183 SSM and 9100 conventional mastectomies). It was not possible to perform a meta-analysis for overall survival and local recurrence free-survival due to clinical heterogeneity across studies and a lack of data to calculate hazard ratios (HR). Based on one study, the evidence suggests that SSM may not reduce overall survival for participants with DCIS tumors (HR 0.41, 95% CI 0.17 to 1.02; P = 0.06; 399 participants; very low-certainty evidence) or for participants with invasive carcinoma (HR 0.81, 95% CI 0.48 to 1.38; P = 0.44; 907 participants; very low-certainty evidence). For local recurrence-free survival, meta-analysis was not possible, due to high risk of bias in nine of the ten studies that measured this outcome. Informal visual examination of effect sizes from nine studies suggested the size of the HR may be similar between groups. Based on one study that adjusted for confounders, SSM may not reduce local recurrence-free survival (HR 0.82, 95% CI 0.47 to 1.42; P = 0.48; 5690 participants; very low-certainty evidence). The effect of SSM on overall complications is unclear (RR 1.55, 95% CI 0.97 to 2.46; P = 0.07, I(2) = 88%; 4 studies, 677 participants; very low-certainty evidence). Skin-sparing mastectomy may not reduce the risk of breast reconstruction loss (RR 1.79, 95% CI 0.31 to 10.35; P = 0.52; 3 studies, 475 participants; very low-certainty evidence), skin necrosis (RR 1.15, 95% CI 0.62 to 2.12; P = 0.22, I(2) = 33%; 4 studies, 677 participants; very low-certainty evidence), local infection (RR 2.04, 95% CI 0.03 to 142.71; P = 0.74, I(2) = 88%; 2 studies, 371 participants; very low-certainty evidence), nor hemorrhage (RR 1.23, 95% CI 0.47 to 3.27; P = 0.67, I(2) = 0%; 4 studies, 677 participants; very low-certainty evidence). We downgraded the certainty of the evidence due to the risk of bias, imprecision, and inconsistency among the studies. There were no data available on the following outcomes: systemic surgical complications, local complications, explantation of implant/expander, hematoma, seroma, rehospitalization, skin necrosis with revisional surgery, and capsular contracture of the implant. It was not possible to perform a meta-analysis for cosmetic and quality of life outcomes due to a lack of data. One study performed an evaluation of aesthetic outcome after SSM: 77.7% of participants with immediate breast reconstruction had an overall aesthetic result of excellent or good versus 87% of participants with delayed breast reconstruction. AUTHORS' CONCLUSIONS: Based on very low-certainty evidence from observational studies, it was not possible to draw definitive conclusions on the effectiveness and safety of SSM for breast cancer treatment. The decision for this technique of breast surgery for treatment of DCIS or invasive breast cancer must be individualized and shared between the physician and the patient while considering the potential risks and benefits of available surgical options. CI - Copyright (c) 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. FAU - Mota, Bruna S AU - Mota BS AD - Department of Obstetrics and Gynecology, Instituto do Cancer do Estado de Sao Paulo (ICESP/FMUSP), Sao Paulo, Brazil. FAU - Bevilacqua, Jose Luiz B AU - Bevilacqua JLB AD - Hospital Sirio Libanes, Sao Paulo, Brazil. FAU - Barrett, Jessica AU - Barrett J AD - Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK. FAU - Ricci, Marcos Desiderio AU - Ricci MD AD - Department of Obstetrics and Gynecology, Instituto do Cancer do Estado de Sao Paulo (ICESP/FMUSP), Sao Paulo, Brazil. FAU - Munhoz, Alexandre M AU - Munhoz AM AD - Plastic Surgery, Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, Brazil. FAU - Filassi, Jose Roberto AU - Filassi JR AD - Department of Obstetrics and Gynecology, Instituto do Cancer do Estado de Sao Paulo (ICESP/FMUSP), Sao Paulo, Brazil. FAU - Baracat, Edmund Chada AU - Baracat EC AD - Department of Obstetrics and Gynecology, Instituto do Cancer do Estado de Sao Paulo (ICESP/FMUSP), Sao Paulo, Brazil. FAU - Riera, Rachel AU - Riera R AD - Cochrane Affiliate Rio de Janeiro, Cochrane, Petropolis, Brazil. AD - Center of Health Technology Asessment, Hospital Sirio-Libanes, Sao Paulo, Brazil. AD - Nucleo de Ensino e Pesquisa em Saude Baseada em Evidencias e Avaliacao Tecnologica em Saude (NEP-Sbeats), Universidade Federal de Sao Paulo, Sao Paulo, Brazil. LA - eng GR - MC_UU_00002/5/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Review PT - Systematic Review DEP - 20230327 PL - England TA - Cochrane Database Syst Rev JT - The Cochrane database of systematic reviews JID - 100909747 SB - IM UOF - doi: 10.1002/14651858.CD010993 MH - Humans MH - Female MH - *Carcinoma, Intraductal, Noninfiltrating/surgery/etiology MH - *Breast Neoplasms/surgery MH - Mastectomy/adverse effects/methods MH - *Mammaplasty/adverse effects MH - Necrosis PMC - PMC10042433 COIS- BSM: none known
JLBB: none known
JB: none known. A grant from Hoffman La Roche was awarded to the institution and the work associated with the grant was unrelated to the review topic. 
MDR: none known
AMM: ownership of stock shares in a company that develops breast implant products. 
JRF: none known
ECB: none known
RR: none known EDAT- 2023/03/28 06:00 MHDA- 2023/03/29 06:05 PMCR- 2024/03/27 CRDT- 2023/03/27 12:02 PHST- 2023/03/29 06:05 [medline] PHST- 2023/03/27 12:02 [entrez] PHST- 2023/03/28 06:00 [pubmed] PHST- 2024/03/27 00:00 [pmc-release] AID - CD010993.pub2 [pii] AID - 10.1002/14651858.CD010993.pub2 [doi] PST - epublish SO - Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD010993. doi: 10.1002/14651858.CD010993.pub2.