Suppr超能文献

原发性乳腺癌患者的肿瘤整形保乳手术。

Oncoplastic breast-conserving surgery for women with primary breast cancer.

机构信息

Department of Breast Surgery, Oxford University Hospitals, Oxford, UK.

Division of Breast Surgery, National University Health System, Singapore, Singapore.

出版信息

Cochrane Database Syst Rev. 2021 Oct 29;10(10):CD013658. doi: 10.1002/14651858.CD013658.pub2.

Abstract

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.

摘要

背景

肿瘤整形保乳术(O-BCS)涉及切除乳房中的肿瘤,并使用整形手术技术来重建乳房。关于 O-BCS 治疗乳腺癌与其他乳腺癌手术选择相比的安全性和疗效的已发表证据仍然存在争议。据估计,局部复发率与标准保乳术(S-BCS)和乳房切除术相似,但使用肿瘤整形技术可能会改善美容和患者报告的结果。

目的

我们的主要目的是评估 O-BCS 与乳腺癌其他手术选择相比的肿瘤学控制结果。我们的次要目的是评估手术并发症、召回率、为实现充分的肿瘤学切除而进一步手术的需要、患者对手术的满意度(通过患者报告的结果进行评估)和美容效果(通过客观测量或临床医生报告的结果进行评估)。

检索方法

我们于 2020 年 8 月 7 日在 Cochrane 乳腺癌组专业注册库、Cochrane 对照试验中心注册库(CENTRAL)、医学文献在线数据库(通过 OVID)、Embase(通过 OVID)、世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 进行了检索。我们没有应用任何语言限制。

入选标准

我们选择了随机对照试验(RCTs)和非随机对照研究(队列研究和病例对照研究)。研究评估了任何 O-BCS 技术,包括容积移位技术和部分乳房体积置换技术,与任何其他手术治疗(部分切除或乳房切除术)相比,用于治疗乳腺癌。

数据收集和分析

四名综述作者进行了数据提取并解决了分歧。我们使用 ROBINS-I 评估了基于结果的偏倚风险。我们进行了描述性数据分析和荟萃分析,并使用 GRADE 标准评估证据质量。结局包括局部复发、乳腺癌特异性无病生存率、再次切除术率、并发症、召回率和患者报告的结果测量。

主要结果

我们纳入了 78 项非随机队列研究,共纳入 178813 名女性。总体而言,我们认为由于混杂因素,每个结局的偏倚风险都很高;对于那些调整了混杂因素的研究,我们认为它们存在中度偏倚风险。比较 1:肿瘤整形保乳术(O-BCS)与标准保乳术(S-BCS) 本综述中的证据发现,与 S-BCS 相比,O-BCS 对局部复发率的影响可能很小或没有影响;无论是通过局部复发无病生存率(风险比(HR)0.90,95%置信区间(CI)0.61 至 1.34;4 项研究,7600 名参与者;极低质量证据)还是局部复发率(HR 1.33,95%CI 0.96 至 1.83;4 项研究,2433 名参与者;低质量证据)进行测量,但由于大多数研究没有控制混杂的临床病理因素,证据非常不确定。与 S-BCS 相比,O-BCS 对无病生存率的影响可能很小或没有影响(HR 1.06,95%CI 0.89 至 1.26;7 项研究,5532 名参与者;低质量证据)。O-BCS 可能减少为实现肿瘤学切除而需要的再次切除术率(风险比(RR)0.76,95%CI 0.69 至 0.85;38 项研究,13341 名参与者;极低质量证据),但证据非常不确定。O-BCS 可能增加至少有一次并发症的女性人数(RR 1.19,95%CI 1.10 至 1.27;20 项研究,118005 名参与者;极低质量证据)和增加活检召回率(RR 2.39,95%CI 1.67 至 3.42;6 项研究,715 名参与者;低质量证据)。当评估患者报告的结果或美容评估时,无法进行荟萃分析;一般来说,O-BCS 报告了相似或更有利的结果,但由于测量方法存在偏倚,证据非常不确定。比较 2:肿瘤整形保乳术(O-BCS)与单纯乳房切除术 O-BCS 可能会增加局部无复发生存率,与乳房切除术相比,但证据非常不确定(HR 0.55,95%CI 0.34 至 0.91;2 项研究,4713 名参与者;极低质量证据)。关于 O-BCS 对无病生存率的影响的证据非常不确定,因为只有一项研究的数据。与乳房切除术相比,O-BCS 可能会减少并发症,但证据非常不确定,主要是由于偏倚(RR 0.75,95%CI 0.67 至 0.83;4 项研究,4839 名参与者;极低质量证据)。患者报告结果的测量数据来自单一研究;无法对数据进行荟萃分析。比较 3:肿瘤整形保乳术(O-BCS)与乳房切除术加重建 O-BCS 与乳房切除术加重建相比,局部无复发生存率(HR 1.37,95%CI 0.72 至 2.62;1 项研究,3785 名参与者;极低质量证据)或无病生存率(HR 0.45,95%CI 0.09 至 2.22;1 项研究,317 名参与者;极低质量证据)的影响可能很小或没有,但证据非常不确定。与乳房切除术加重建相比,O-BCS 可能会降低并发症发生率(RR 0.49,95%CI 0.45 至 0.54;5 项研究,4973 名参与者;极低质量证据),但由于混杂和结果不一致,证据非常不确定。关于患者报告的结果和美容评估,证据非常不确定。

作者结论

与 S-BCS 相比,O-BCS 治疗后的肿瘤学结果证据非常不确定,尽管 O-BCS 尚未显示出劣势。O-BCS 可能导致较少需要再次进行切除术,但与 S-BCS 相比,可能会导致更多的并发症和更高的召回率。O-BCS 似乎可以提供更好的患者满意度和外科医生对乳房外观的评价,但证据质量较差,并且由于缺乏数值数据,无法对不同研究的结果进行汇总。O-BCS 似乎与乳房切除术相比,导致的并发症较少。基于本综述,无法确定帮助决策者的任何明确结论。应该在适当讨论 O-BCS 对患者的风险和益处后,由临床医生和患者共同做出关于进行哪种手术的决策,O-BCS 个性化考虑到患者的临床病理因素。本综述强调了缺乏良好设计的研究来评估 O-BCS 治疗后的疗效、安全性和患者报告的结果。

相似文献

1
Oncoplastic breast-conserving surgery for women with primary breast cancer.原发性乳腺癌患者的肿瘤整形保乳手术。
Cochrane Database Syst Rev. 2021 Oct 29;10(10):CD013658. doi: 10.1002/14651858.CD013658.pub2.
9
Systemic treatments for metastatic cutaneous melanoma.转移性皮肤黑色素瘤的全身治疗
Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD011123. doi: 10.1002/14651858.CD011123.pub2.

引用本文的文献

本文引用的文献

7
Increasing Role of Oncoplastic Surgery for Breast Cancer.乳腺癌中整形手术作用的提升。
Curr Oncol Rep. 2019 Dec 14;21(12):111. doi: 10.1007/s11912-019-0860-9.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验