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      Systematic review of therapeutic nipple‐sparing versus skin‐sparing mastectomy

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          Abstract

          Background

          The use of nipple‐sparing mastectomy (NSM) is increasing, despite unproven oncological safety in the therapeutic setting. The aim of this systematic review was to determine the safety and efficacy of NSM compared with skin‐sparing mastectomy (SSM).

          Methods

          A literature search of all original studies including RCTs, cohort studies and case–control studies comparing women undergoing therapeutic NSM or SSM for breast cancer was undertaken. Primary outcomes were oncological outcomes; secondary outcomes were clinical, aesthetic, patient‐reported and quality‐of‐life outcomes. Data analysis was undertaken to explore the relationship between NSM and SSM, and preselected outcomes. Heterogeneity was assessed using the Cochrane tests.

          Results

          A total of 690 articles were identified, of which 14 were included. There was no statistically significant difference in 5‐year disease‐free survival and mortality for NSM and SSM groups, where data were available. Local recurrence rates were also similar for NSM and SSM (3·9 versus 3·3 per cent respectively; P = 0·45). NSM had a partial or complete nipple necrosis rate of 15·0 per cent, and a higher complication rate than SSM (22·6 versus 14·0 per cent respectively). The higher overall complication rate was due to the rate of nipple necrosis in the NSM group (15·0 per cent).

          Conclusion

          In carefully selected cases, NSM is a viable choice for women with breast cancer who need to have a mastectomy. More research is needed to help further refine which surgical approaches to NSM optimize outcomes.

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          Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial.

          Umberto Veronesi, Roberto Orecchia, Patrick Maisonneuve … (2013)
          Intraoperative radiotherapy with electrons allows the substitution of conventional postoperative whole breast irradiation with one session of radiotherapy with the same equivalent dose during surgery. However, its ability to control for recurrence of local disease required confirmation in a randomised controlled trial. This study was done at the European Institute of Oncology (Milan, Italy). Women aged 48-75 years with early breast cancer, a maximum tumour diameter of up to 2·5 cm, and suitable for breast-conserving surgery were randomly assigned in a 1:1 ratio (using a random permuted block design, stratified for clinical tumour size [<1·0 cm vs 1·0-1·4 cm vs ≥1·5 cm]) to receive either whole-breast external radiotherapy or intraoperative radiotherapy with electrons. Study coordinators, clinicians, and patients were aware of the assignment. Patients in the intraoperative radiotherapy group received one dose of 21 Gy to the tumour bed during surgery. Those in the external radiotherapy group received 50 Gy in 25 fractions of 2 Gy, followed by a boost of 10 Gy in five fractions. This was an equivalence trial; the prespecified equivalence margin was local recurrence of 7·5% in the intraoperative radiotherapy group. The primary endpoint was occurrence of ipsilateral breast tumour recurrences (IBTR); overall survival was a secondary outcome. The main analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01849133. 1305 patients were randomised (654 to external radiotherapy and 651 to intraoperative radiotherapy) between Nov 20, 2000, and Dec 27, 2007. After a medium follow-up of 5·8 years (IQR 4·1-7·7), 35 patients in the intraoperative radiotherapy group and four patients in the external radiotherapy group had had an IBTR (p<0·0001). The 5-year event rate for IBRT was 4·4% (95% CI 2·7-6·1) in the intraoperative radiotherapy group and 0·4% (0·0-1·0) in the external radiotherapy group (hazard ratio 9·3 [95% CI 3·3-26·3]). During the same period, 34 women allocated to intraoperative radiotherapy and 31 to external radiotherapy died (p=0·59). 5-year overall survival was 96·8% (95% CI 95·3-98·3) in the intraoperative radiotherapy group and 96·9% (95·5-98·3) in the external radiotherapy group. In patients with data available (n=464 for intraoperative radiotherapy; n=412 for external radiotherapy) we noted significantly fewer skin side-effects in women in the intraoperative radiotherapy group than in those in the external radiotherapy group (p=0·0002). Although the rate of IBTR in the intraoperative radiotherapy group was within the prespecified equivalence margin, the rate was significantly greater than with external radiotherapy, and overall survival did not differ between groups. Improved selection of patients could reduce the rate of IBTR with intraoperative radiotherapy with electrons. Italian Association for Cancer Research, Jacqueline Seroussi Memorial Foundation for Cancer Research, and Umberto Veronesi Foundation. Copyright © 2013 Elsevier Ltd. All rights reserved.
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            External Validation of a Measurement Tool to Assess Systematic Reviews (AMSTAR)

            Beverley Shea, Lex Bouter, Joan Peterson … (2007)
            Background Thousands of systematic reviews have been conducted in all areas of health care. However, the methodological quality of these reviews is variable and should routinely be appraised. AMSTAR is a measurement tool to assess systematic reviews. Methodology AMSTAR was used to appraise 42 reviews focusing on therapies to treat gastro-esophageal reflux disease, peptic ulcer disease, and other acid-related diseases. Two assessors applied the AMSTAR to each review. Two other assessors, plus a clinician and/or methodologist applied a global assessment to each review independently. Conclusions The sample of 42 reviews covered a wide range of methodological quality. The overall scores on AMSTAR ranged from 0 to 10 (out of a maximum of 11) with a mean of 4.6 (95% CI: 3.7 to 5.6) and median 4.0 (range 2.0 to 6.0). The inter-observer agreement of the individual items ranged from moderate to almost perfect agreement. Nine items scored a kappa of >0.75 (95% CI: 0.55 to 0.96). The reliability of the total AMSTAR score was excellent: kappa 0.84 (95% CI: 0.67 to 1.00) and Pearson's R 0.96 (95% CI: 0.92 to 0.98). The overall scores for the global assessment ranged from 2 to 7 (out of a maximum score of 7) with a mean of 4.43 (95% CI: 3.6 to 5.3) and median 4.0 (range 2.25 to 5.75). The agreement was lower with a kappa of 0.63 (95% CI: 0.40 to 0.88). Construct validity was shown by AMSTAR convergence with the results of the global assessment: Pearson's R 0.72 (95% CI: 0.53 to 0.84). For the AMSTAR total score, the limits of agreement were −0.19±1.38. This translates to a minimum detectable difference between reviews of 0.64 ‘AMSTAR points’. Further validation of AMSTAR is needed to assess its validity, reliability and perceived utility by appraisers and end users of reviews across a broader range of systematic reviews.
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              The oncological safety of skin sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction: an extended follow-up study.

              Bernd Gerber, Jeanette Krause, Toralf Reimer … (2009)
              To find out if skin sparing mastectomy (SSM) and nipple sparing mastectomy (NSM) with immediate autologous reconstruction as safe in oncological terms as modified radical mastectomy (MRM). The oncological safety of less radical surgical procedures like SSM and NSM cannot be evaluated by randomized trials. A careful and long lasting follow-up of patients, treated with SSM or NSM, is urgently needed. Between 1994-2000, 246 selected patients with an indication for MRM were treated with SSM, NSM, or MRM. Short term results were published in 2003. After a mean follow-up of 101 months (range 32-126), 238 evaluable patients with SSM (N = 48), NSM (N = 60), or MRM (N = 130) were analyzed for local and distant recurrences, breast cancer specific death, and esthetic results. Local recurrences occurred in 10.4% (SSM), 11.7% (NSM) and 11.5% (MRM) of all patients (P = 0.974). With regard to isolated DM (25.0%, 23.3%, respectively 26.2%; P = 0.916) and breast cancer specific death (20.8%, 21.7%, respectively 21.5%; P = 0.993), there were no significant differences between subgroups. The re-evaluation of esthetic results by surgeons revealed a significant shift from 78.4% excellent results after 59 months to 47.9% after 101 months follow-up (SSM; P = 0.004) and from 73.8% to 51.7% (NSM; P = 0.025). An important risk factor for decreased cosmetic score was application of adjuvant radiotherapy. In patients who are candidates for a mastectomy, skin sparing mastectomy or nipple sparing mastectomy with immediate autologous reconstruction are oncologically safe techniques. Adjuvant radiotherapy decreases the esthetic results even after a longer period of time.
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                Author and article information

                Contributors
                Y. Al Omran:
                ORCID: https://orcid.org/0000-0002-5608-216X
                yasseralomran@yahoo.com
                Journal
                Journal ID (nlm-ta): BJS Open
                Journal ID (iso-abbrev): BJS Open
                Journal ID (doi): 10.1002/(ISSN)2474-9842
                Journal ID (publisher-id): BJS5
                Title: BJS Open
                Publisher: John Wiley & Sons, Ltd (Chichester, UK )
                ISSN (Electronic): 2474-9842
                Publication date (Electronic): 19 December 2018
                Publication date Collection: April 2019
                Volume: 3
                Issue: 2 ( doiID: 10.1002/bjs5.2019.3.issue-2 )
                Pages: 135-145
                Affiliations
                [ 1 ] Department of Plastic Surgery, Royal Free NHS Foundation Trust London UK
                [ 2 ] GKT School of Medical Education, King's College London London UK
                [ 3 ] Imperial College School of Medicine London UK
                [ 4 ] Department of Plastic Surgery University Hospitals of North Midlands Stoke‐on‐Trent UK
                [ 5 ] Ear, Nose and Throat Department, Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich UK
                [ 6 ] Department of Orthopaedics, Oxford University Hospitals NHS Foundation Trust Oxford UK
                [ 7 ] Breast Surgical Unit, The Royal Marsden NHS Foundation Trust Sutton UK
                [ 8 ] Division of Plastic Surgery, Stanford University Stanford California USA
                [ 9 ] Division of Plastic Surgery, Brigham and Women's Hospital Boston Massachusetts USA
                Author notes
                [*] [* ] Correspondence to: Mr Y. Al Omran, Department of Plastic Surgery, University Hospitals of North Midlands, Newcastle Road, Stoke‐on‐Trent ST4 6QG, UK (e‐mail: yasseralomran@ 123456yahoo.com )
                Author information
                https://orcid.org/0000-0002-5608-216X
                Article
                Publisher ID: BJS550119
                DOI: 10.1002/bjs5.50119
                PMC ID: 6433323
                PubMed ID: 30957059
                SO-VID: cf50d655-83aa-4841-919c-6d6480bb23d9
                Copyright © © 2018 The Authors. BJS Open published by John Wiley & Sons Ltd on behalf of BJS Society Ltd
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 08 April 2018
                Date accepted : 10 October 2018
                Page count
                Figures: 2, Tables: 3, Pages: 11, Words: 6020
                Categories
                Subject: Systematic Review
                Subject: Systematic Reviews
                Custom metadata
                source-schema-version-number 2.0
                component-id bjs550119
                cover-date April 2019
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.1 mode:remove_FC converted:25.03.2019

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