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Physiotherapy Theory and Practice May 2018Lymphedema is known as a secondary complication of breast cancer treatment, caused by reduction on lymphatic flow and lymph accumulation on interstitial space. The... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Lymphedema is known as a secondary complication of breast cancer treatment, caused by reduction on lymphatic flow and lymph accumulation on interstitial space. The Kinesio Taping (KT) has become an alternative treatment for lymphedema volume reduction. The objective of the study was to evaluate the literature through a systematic review on KT effects on lymphedema related to breast cancer.
METHODS
Search strategies were performed by the following keywords: "Kinesio Taping," "Athletic Tape," "Cancer," "Neoplasm," "Lymphedema," and "Mastectomy" with derivations and different combinations. The following databases were accessed: SCIELO, LILACS, MEDLINE via PubMed, and PEDro, between 2009 and 2016. Studies published in English, Portuguese, and Spanish were considered for inclusion. The studies' methodological quality was assessed by the PEDro scale.
RESULTS
Seven studies were identified by the search strategy and eligibility. All of them showed positive effect in reducing lymphedema (perimeter or volume) before versus after treatment. However, with no effects comparing the KT versus control group or others treatments (standardized mean difference = 0.04, confidence interval 95%: -0.24; 0.33), the average score of the PEDro scale was 4.71 points.
CONCLUSIONS
KT was effective on postmastectomy lymphedema related to breast cancer; however, it is not more efficient than other treatments.
Topics: Athletic Tape; Breast Neoplasms; Clinical Trials as Topic; Female; Humans; Lymphedema; Mastectomy; Physical Therapy Modalities; Risk Factors; Treatment Outcome
PubMed: 29308967
DOI: 10.1080/09593985.2017.1419522 -
The Cochrane Database of Systematic... Apr 2018Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010.
OBJECTIVES
(i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes.
SEARCH METHODS
For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English.
SELECTION CRITERIA
Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer.
DATA COLLECTION AND ANALYSIS
At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias.
MAIN RESULTS
All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM.
AUTHORS' CONCLUSIONS
While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Genetic Predisposition to Disease; Humans; Observational Studies as Topic; Patient Satisfaction; Postoperative Complications; Prophylactic Mastectomy; Risk Assessment; Unilateral Breast Neoplasms
PubMed: 29620792
DOI: 10.1002/14651858.CD002748.pub4 -
Journal of Clinical Oncology : Official... Jun 2020To develop recommendations concerning the management of male breast cancer.
PURPOSE
To develop recommendations concerning the management of male breast cancer.
METHODS
ASCO convened an Expert Panel to develop recommendations based on a systematic review and a formal consensus process.
RESULTS
Twenty-six descriptive reports or observational studies met eligibility criteria and formed the evidentiary basis for the recommendations.
RECOMMENDATIONS
Many of the management approaches used for men with breast cancer are like those used for women. Men with hormone receptor-positive breast cancer who are candidates for adjuvant endocrine therapy should be offered tamoxifen for an initial duration of five years; those with a contraindication to tamoxifen may be offered a gonadotropin-releasing hormone agonist/antagonist plus aromatase inhibitor. Men who have completed five years of tamoxifen, have tolerated therapy, and still have a high risk of recurrence may be offered an additional five years of therapy. Men with early-stage disease should not be treated with bone-modifying agents to prevent recurrence, but could still receive these agents to prevent or treat osteoporosis. Men with advanced or metastatic disease should be offered endocrine therapy as first-line therapy, except in cases of visceral crisis or rapidly progressive disease. Targeted systemic therapy may be used to treat advanced or metastatic cancer using the same indications and combinations offered to women. Ipsilateral annual mammogram should be offered to men with a history of breast cancer treated with lumpectomy regardless of genetic predisposition; contralateral annual mammogram may be offered to men with a history of breast cancer and a genetic predisposing mutation. Breast magnetic resonance imaging is not recommended routinely. Genetic counseling and germline genetic testing of cancer predisposition genes should be offered to all men with breast cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms, Male; Chemotherapy, Adjuvant; Consensus; Delphi Technique; Evidence-Based Medicine; Genetic Counseling; Genetic Testing; Humans; Magnetic Resonance Imaging; Male; Mammography; Mastectomy; Medical Oncology; Predictive Value of Tests; Treatment Outcome
PubMed: 32058842
DOI: 10.1200/JCO.19.03120 -
The Cochrane Database of Systematic... Oct 2021Oncoplastic breast-conserving surgery (O-BCS) involves removing the tumour in the breast and using plastic surgery techniques to reconstruct the breast. The adequacy of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Oncoplastic breast-conserving surgery (O-BCS) involves removing the tumour in the breast and using plastic surgery techniques to reconstruct the breast. The adequacy of published evidence on the safety and efficacy of O-BCS for the treatment of breast cancer compared to other surgical options for breast cancer is still debatable. It is estimated that the local recurrence rate is similar to standard breast-conserving surgery (S-BCS) and also mastectomy, but the aesthetic and patient-reported outcomes may be improved with oncoplastic techniques.
OBJECTIVES
Our primary objective was to assess oncological control outcomes following O-BCS compared with other surgical options for women with breast cancer. Our secondary objective was to assess surgical complications, recall rates, need for further surgery to achieve adequate oncological resection, patient satisfaction through patient-reported outcomes, and cosmetic outcomes through objective measures or clinician-reported outcomes.
SEARCH METHODS
We searched the Cochrane Breast Cancer Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via OVID), Embase (via OVID), the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov on 7 August 2020. We did not apply any language restrictions.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) and non-randomised comparative studies (cohort and case-control studies). Studies evaluated any O-BCS technique, including volume displacement techniques and partial breast volume replacement techniques compared to any other surgical treatment (partial resection or mastectomy) for the treatment of breast cancer.
DATA COLLECTION AND ANALYSIS
Four review authors performed data extraction and resolved disagreements. We used ROBINS-I to assess the risk of bias by outcome. We performed descriptive data analysis and meta-analysis and evaluated the quality of the evidence using GRADE criteria. The outcomes included local recurrence, breast cancer-specific disease-free survival, re-excision rates, complications, recall rates, and patient-reported outcome measures.
MAIN RESULTS
We included 78 non-randomised cohort studies evaluating 178,813 women. Overall, we assessed the risk of bias per outcome as being at serious risk of bias due to confounding; where studies adjusted for confounding, we deemed these at moderate risk. Comparison 1: oncoplastic breast-conserving surgery (O-BCS) versus standard-BCS (S-BCS) The evidence in the review found that O-BCS when compared to S-BCS, may make little or no difference to local recurrence; either when measured as local recurrence-free survival (hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.61 to 1.34; 4 studies, 7600 participants; very low-certainty evidence) or local recurrence rate (HR 1.33, 95% CI 0.96 to 1.83; 4 studies, 2433 participants; low-certainty evidence), but the evidence is very uncertain due to most studies not controlling for confounding clinicopathological factors. O-BCS compared to S-BCS may make little to no difference to disease-free survival (HR 1.06, 95% CI 0.89 to 1.26; 7 studies, 5532 participants; low-certainty evidence). O-BCS may reduce the rate of re-excisions needed for oncological resection (risk ratio (RR) 0.76, 95% CI 0.69 to 0.85; 38 studies, 13,341 participants; very low-certainty evidence), but the evidence is very uncertain. O-BCS may increase the number of women who have at least one complication (RR 1.19, 95% CI 1.10 to 1.27; 20 studies, 118,005 participants; very low-certainty evidence) and increase the recall to biopsy rate (RR 2.39, 95% CI 1.67 to 3.42; 6 studies, 715 participants; low-certainty evidence). Meta-analysis was not possible when assessing patient-reported outcomes or cosmetic evaluation; in general, O-BCS reported a similar or more favourable result, however, the evidence is very uncertain due to risk of bias in the measurement methods. Comparison 2: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy alone O-BCS may increase local recurrence-free survival compared to mastectomy but the evidence is very uncertain (HR 0.55, 95% CI 0.34 to 0.91; 2 studies, 4713 participants; very low-certainty evidence). The evidence is very uncertain about the effect of O-BCS on disease-free survival as there were only data from one study. O-BCS may reduce complications compared to mastectomy, but the evidence is very uncertain due to high risk of bias mainly resulting from confounding (RR 0.75, 95% CI 0.67 to 0.83; 4 studies, 4839 participants; very low-certainty evidence). Data on patient-reported outcome measures came from single studies; it was not possible to meta-analyse the data. Comparison 3: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy with reconstruction O-BCS may make little or no difference to local recurrence-free survival (HR 1.37, 95% CI 0.72 to 2.62; 1 study, 3785 participants; very low-certainty evidence) or disease-free survival (HR 0.45, 95% CI 0.09 to 2.22; 1 study, 317 participants; very low-certainty evidence) when compared to mastectomy with reconstruction, but the evidence is very uncertain. O-BCS may reduce the complication rate compared to mastectomy with reconstruction (RR 0.49, 95% CI 0.45 to 0.54; 5 studies, 4973 participants; very low-certainty evidence) but the evidence is very uncertain due to high risk of bias from confounding and inconsistency of results. The evidence is very uncertain for patient-reported outcome measures and cosmetic evaluation.
AUTHORS' CONCLUSIONS
The evidence is very uncertain regarding oncological outcomes following O-BCS compared to S-BCS, though O-BCS has not been shown to be inferior. O-BCS may result in less need for a second re-excision surgery but may result in more complications and a greater recall rate than S-BCS. It seems that O-BCS may give better patient satisfaction and surgeon rating for the look of the breast, but the evidence for this is of poor quality, and due to lack of numerical data, it was not possible to pool the results of different studies. It seems O-BCS results in fewer complications compared with surgeries involving mastectomy. Based on this review, no certain conclusions can be made to help inform policymakers. The surgical decision for what operation to proceed with should be made jointly between clinician and patient after an appropriate discussion about the risks and benefits of O-BCS personalised to the patient, taking into account clinicopathological factors. This review highlighted the deficiency of well-conducted studies to evaluate efficacy, safety and patient-reported outcomes following O-BCS.
Topics: Breast Neoplasms; Cohort Studies; Disease-Free Survival; Female; Humans; Mastectomy; Mastectomy, Segmental
PubMed: 34713449
DOI: 10.1002/14651858.CD013658.pub2 -
Clinical Breast Cancer Apr 2023Mastectomy skin-flap necrosis (MSFN) is one of the most feared complications of immediate implant-based breast reconstruction (IIBR). Traditionally, mastectomy skin-flap... (Review)
Review
Mastectomy skin-flap necrosis (MSFN) is one of the most feared complications of immediate implant-based breast reconstruction (IIBR). Traditionally, mastectomy skin-flap viability was based only on surgeons' clinical experience. Even though numerous studies have already addressed the patients' risk factors for MSFN, few works have focused on assessing quality of breast envelope. This review investigates mastectomy's flap viability-assessment methods, both preoperative (PMFA) and intraoperative (IMFA), to predict MSFN and its sequalae. Between June and November 2022, we conducted a systematic review of Pubmed/MEDLINE and Cochrane electronic databases. Only English studies regarding PMFA and IMFA applied to IIBR were selected. The use of digital mammography, ultrasound, magnetic resonance imaging, and a combination of several methods before surgery was shown to be advantageous by several authors. Indocyanine performed better than other IMFA, however both thermal imaging and spectroscopy demonstrated novel and promising results. Anyway, the best prediction comes when preoperative and intraoperative values are combined. Particularly in prepectoral reconstruction, when mastectomy flaps are essential to determine a successful breast reconstruction, surgeons' clinical judgment is insufficient in assessing the risk of MSFN. Preoperative and intraoperative assessment techniques play an emerging key role in MSFN prediction. However, although there are several approaches to back up the surgeon's processing choice, there is still a dearth of pertinent literature on the subject, and more research is required.
Topics: Humans; Female; Mastectomy; Breast Neoplasms; Breast; Mammaplasty; Postoperative Complications; Skin Diseases; Necrosis; Retrospective Studies; Breast Implants
PubMed: 36725477
DOI: 10.1016/j.clbc.2022.12.021 -
Plastic and Reconstructive Surgery Oct 2022No meta-analysis has examined whether contralateral prophylactic mastectomy increases complication risk for unilateral breast cancer patients undergoing unilateral... (Meta-Analysis)
Meta-Analysis
BACKGROUND
No meta-analysis has examined whether contralateral prophylactic mastectomy increases complication risk for unilateral breast cancer patients undergoing unilateral mastectomy.
METHODS
Fifteen studies on complications of unilateral mastectomy plus contralateral prophylactic mastectomy met inclusion criteria. Meta-analyses compared complications of (1) diseased versus contralateral breasts in unilateral plus contralateral prophylactic mastectomy patients and (2) patients undergoing unilateral plus contralateral prophylactic mastectomy versus unilateral alone when grouped by reconstructive method.
RESULTS
For all unilateral plus contralateral prophylactic mastectomy patients, the diseased breast was significantly more prone to complications versus the contralateral breast (relative risk, 1.24; p = 0.03). In studies that stratified by reconstructive method, the complication risk was significantly higher for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone for patients with no reconstruction (relative risk, 2.03; p = 0.0003), prosthetic-based reconstruction (relative risk,1.42; p = 0.003), and autologous reconstruction (relative risk, 1.32; p = 0.005). The only prospective trial showed similar results, including for more severe complications. Smaller retrospective studies without stratification by reconstructive method showed similar complications for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone (relative risk, 1.06; p = 0.70). These groups had similar incidences of complication-related delay in adjuvant therapy, as demonstrated by one study.
CONCLUSIONS
After unilateral plus contralateral prophylactic mastectomy, diseased breasts are at higher risk for complications. Stronger evidence supports higher complication risk for unilateral plus contralateral prophylactic mastectomy than unilateral alone. More work is needed to determine the effect of complications on timing of adjuvant therapy.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Prophylactic Mastectomy; Prospective Studies; Retrospective Studies
PubMed: 35943952
DOI: 10.1097/PRS.0000000000009493 -
The British Journal of Surgery Nov 2020The growing volume of studies of robot-assisted nipple-sparing mastectomy requires critical assessment. This review synthesizes the data on safety, feasibility,...
BACKGROUND
The growing volume of studies of robot-assisted nipple-sparing mastectomy requires critical assessment. This review synthesizes the data on safety, feasibility, oncological and cosmetic outcomes, and patient-reported outcome measures (PROMs) for robot-assisted nipple-sparing mastectomy.
METHODS
A systematic review was performed using MEDLINE, MEDLINE In-Process/ePubs, Embase/Embase Classic, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, LILACS, PubMed, ClinicalTrials.Gov, WHO ICTRP and the grey literature. Original studies reporting on patients with breast cancer or at increased risk of breast cancer undergoing robot-assisted nipple-sparing mastectomy were included. Risk of bias was assessed using the Institute of Health Economics Case Series Quality Appraisal Checklist.
RESULTS
Of 7177 titles screened, eight articles were included, reporting on 249 robot-assisted nipple-sparing mastectomies in 187 women. The indication was either therapeutic (58·6 per cent) or prophylactic (41·4 per cent), with immediate reconstruction performed in 96·8 per cent. Surgical techniques followed a similar approach, with variations in incision, robot models, camera and insufflation. Postoperative morbidity included skin complications, lymphocele, infection, seroma, haematoma and skin ischaemia/necrosis. Complications specific to the nipple-areolar complex included ischaemia and necrosis. There were two conversions owing to haemorrhage, but no intraoperative deaths. Three patients had positive margins. Follow-up time ranged from 3·4 to 44·8 months. Locoregional recurrences were not observed. PROMs and objective cosmetic outcomes were reported inconsistently. Data on nipple sensitivity were not reported.
CONCLUSION
Robot-assisted nipple-sparing mastectomy is feasible with acceptable short-term outcomes but it remains in the assessment phase.
Topics: Female; Humans; Mastectomy; Nipples; Patient Reported Outcome Measures; Robotic Surgical Procedures
PubMed: 32846014
DOI: 10.1002/bjs.11837 -
Journal of Plastic, Reconstructive &... Feb 2017Rare but serious complications of nipple-sparing mastectomy (NSM) include necrosis of the nipple-areolar complex (NAC) and mastectomy skin flaps. NAC and mastectomy flap... (Review)
Review
BACKGROUND
Rare but serious complications of nipple-sparing mastectomy (NSM) include necrosis of the nipple-areolar complex (NAC) and mastectomy skin flaps. NAC and mastectomy flap delay procedures are novel techniques designed to avoid these complications and may be combined with retroareolar biopsy as a first-stage procedure. We performed a systematic review of the literature to evaluate various techniques for NAC and mastectomy flap delay.
METHODS
PubMed and Cochrane databases were searched from January 1975 through April 15, 2016. The following search terms were used for both titles and key words: 'nipple sparing mastectomy' AND ('delay' OR 'stage' OR 'staged'). Two independent reviewers determined the study eligibility, only accepting studies involving patients who underwent a delay procedure prior to NSM and studies with objective results including specific outcomes of NAC and mastectomy flap necrosis.
RESULTS
The literature search yielded 242 studies, of which five studies met the inclusion criteria, with a total of 101 patients. Various techniques for NSM delay have been described, all of which involve undermining the nipple and surrounding mastectomy skin to some degree. Partial NAC necrosis was reported in a total of 9 patients (8.9%). Mastectomy flap necrosis was reported in a total of 8 patients (7.9%). Three of five studies reported positive retroareolar biopsy findings in a total of 7 patients (6.9%).
CONCLUSIONS
Delay procedures for NSM have a good safety profile and may be considered in patients at risk for NAC or mastectomy flap necrosis, such as patients with pre-existing breast scars, active smoking, prior radiation, or ptosis. These procedures have the added benefit of allowing a retroareolar biopsy to be sent for permanent sections prior to mastectomy, allowing the surgical team to plan for the removal of the NAC at the time of mastectomy if indicated and eliminating the risk of a false-negative result on frozen section analysis.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy, Subcutaneous; Nipples; Surgical Flaps
PubMed: 28040452
DOI: 10.1016/j.bjps.2016.11.012 -
Patient Education and Counseling Dec 2017A systematic review of quantitative and qualitative studies, to describe patient satisfaction and regret associated with risk-reducing mastectomies (RRM), and the... (Review)
Review
OBJECTIVE
A systematic review of quantitative and qualitative studies, to describe patient satisfaction and regret associated with risk-reducing mastectomies (RRM), and the patient-reported factors associated with these among women at high risk of developing breast cancer.
METHODS
Studies were identified using Medline, CINAHL, Embase and PsycInfo databases (1995-2016). Data were extracted and crosschecked for accuracy. Article quality was assessed using standardised criteria.
RESULTS
Of the 1657 unique articles identified, 30 studies met the inclusion criteria (n=23 quantitative studies, n=3 qualitative studies, n=4 mixed-method studies). Studies included were cross-sectional (n=23) or retrospective (n=7). General satisfaction with RRM, decision satisfaction and aesthetic satisfaction were generally high, although some women expressed regret around their decision and dissatisfaction with their appearance. Factors associated with both patient satisfaction and regret included: post-operative complications, body image changes, psychological distress and perceived inadequacy of information.
CONCLUSION
While satisfaction with RRM was generally high, some women had regrets and expressed dissatisfaction. Future research is needed to further explore RRM, and to investigate current satisfaction trends given the ongoing improvements to surgical and clinical practice.
PRACTICE IMPLICATIONS
Offering pre-operative preparation, decisional support and continuous psychological input may help to facilitate satisfaction with this complex procedure.
Topics: Body Image; Breast Neoplasms; Decision Making; Emotions; Female; Humans; Mastectomy; Patient Reported Outcome Measures; Patient Satisfaction; Personal Satisfaction
PubMed: 28732648
DOI: 10.1016/j.pec.2017.06.032 -
The Cochrane Database of Systematic... Nov 2016The efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of breast cancer are still questionable. It is estimated that the... (Review)
Review
BACKGROUND
The efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of breast cancer are still questionable. It is estimated that the local recurrence rates following nipple-sparing mastectomy are very similar to breast-conserving surgery followed by radiotherapy.
OBJECTIVES
To assess the efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of ductal carcinoma in situ and invasive breast cancer in women.
SEARCH METHODS
We searched the Cochrane Breast Cancer Group's Specialized Register, the Cochrane Center Register of Controlled Trials (CENTRAL), MEDLINE (via PubMed), Embase (via OVID) and LILACS (via Biblioteca Virtual em Saúde [BVS]) using the search terms "nipple sparing mastectomy" and "areola-sparing mastectomy". Also, we searched the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov. All searches were conducted on 30th September 2014 and we did not apply any language restrictions.
SELECTION CRITERIA
Randomised controlled trials (RCTs) however if there were no RCTs, we expanded our criteria to include non-randomised comparative studies (cohort and case-control studies). Studies evaluated nipple-sparing and areola-sparing mastectomy compared to modified radical mastectomy or skin-sparing mastectomy for the treatment of ductal carcinoma in situ or invasive breast cancer.
DATA COLLECTION AND ANALYSIS
Two review authors (BS and RR) performed data extraction and resolved disagreements. We performed descriptive analyses and meta-analyses of the data using Review Manager software. We used Cochrane's risk of bias tool to assess studies, and adapted it for non-randomised studies, and we evaluated the quality of the evidence using GRADE criteria.
MAIN RESULTS
We included 11 cohort studies, evaluating a total of 6502 participants undergoing 7018 procedures: 2529 underwent a nipple-sparing mastectomy (NSM), 818 underwent skin-sparing mastectomy (SSM) and 3671 underwent traditional mastectomy, also known as modified radical mastectomy (MRM). No participants underwent areola-sparing mastectomy. There was a high risk of confounding for all reported outcomes. For overall survival, the hazard ratio (HR) for NSM compared to SSM was 0.70 (95% CI 0.28 to 1.73; 2 studies; 781 participants) and the HR for NSM compared to MRM was 0.72 (95% CI 0.46 to 1.13; 2 studies, 1202 participants). Local recurrence was evaluated in two studies, the HR for NSM compared to MRM was 0.28 (95% CI 0.12 to 0.68; 2 studies, 1303 participants). The overall risk of complications was different in NSM when compared to other types of mastectomy in general (RR 0.10, 95% CI 0.01 to 0.82, 2 studies, P = 0.03; 1067 participants). With respect to skin necrosis, there was no evidence of a difference with NSM compared to other types of mastectomy, but the confidence interval was wide (RR 4.22, 95% CI 0.59 to 30.03, P = 0.15; 4 studies, 1948 participants). We observed no difference among the three types of mastectomy with respect to the risk of local infection (RR 0.95, 95% CI 0.44 to 2.09, P = 0.91, 2 studies; 496 participants). Meta-analysis was not possible when assessing cosmetic outcomes and quality of life, but in general the NSM studies reported a favourable aesthetic result and a gain in quality of life compared with the other types of mastectomy. The quality of evidence was considered very low for all outcomes due to the high risk of selection bias and wide confidence intervals.
AUTHORS' CONCLUSIONS
The findings from these observational studies of very low-quality evidence were inconclusive for all outcomes due to the high risk of selection bias.
Topics: Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Cohort Studies; Female; Humans; Mastectomy; Neoplasm Recurrence, Local; Nipples; Organ Sparing Treatments; Postoperative Complications; Skin
PubMed: 27898991
DOI: 10.1002/14651858.CD008932.pub3