Abstract：
The role of breast surgery in the treatment of patients with de novo metastatic breast cancer(dnMBC) remains controversial, with conflicting trial results. We did a meta-analysis to comprehensively investigate and assess whether breast surgery is associated with survival and quality of life outcomes in patients with dnMBC.We systematically searched PubMed, Embase, Google Scholar, Scopus, and Web of Science, from database inception to March 30, 2022, for randomized controlled trials(RCTs) that compared breast surgery or locoregional therapy with non-surgical treatment based on systemic therapy for managing dnMBC.We also reviewed abstracts and presentations from major conference proceedings. We excluded non-randomised trials and considered only papers published in English. The primary outcomes were overall survival(OS),locoregional progression-free survival(LPFS), distant progression-free survival(DPFS), and quality of life(QoL). The quality of RCTs was appraised with the Cochrane Collaboration risk of bias tool. Random-effects model or fixed effects model were used to calculate the effect sizes of included RCTs.Quality of evidence was assessed with GRADE criteria. Data analysis was performed with STATA 17.0. A total of 1018 women from seven randomized clinical trials were included in the analysis. Pooled analyses revealed that compared with systemic therapy, breast surgery was not associated with beneficial outcomes in OS(hazard ratio [HR],0.87; 95%CI,0.68 to 1.11; I2 = 53.08 %; p = 0.265),DPFS(HR,1.20; 95%CI,0.94 to 1.54; I2 = 86.45 %; p = 0.136), or QoL-global health status (standardized mean difference[SMD],0.08; 95%CI,-0.15 to 0.32; I2 = 79.45 %; p = 0.478) and QoL-mental-physical functionality(SMD,-0.19; 95%CI,-0.50 to 0.13; I2 = 0.00 %; p = 0.255), but was associated with a benefit in LPFS(HR,0.27; 95%CI,0.19 to 0.38; I2 = 84.16 %; p < 0.001). These findings were consistent in subgroup analyses of the timing of surgery, site and number of metastases and tumor molecular subtype. The evidence grade was moderate because of the substantial heterogeneity among studies. Based on the RCTs evidence, we found that breast surgery may benefit locoregional control but does not prolong OS and improve QoL in patients with dnMBC. The Prospero registration number: CRD42020206460.
摘要：
乳腺手术在治疗新发转移性乳腺癌（dnMBC）患者中的作用仍存在争议，试验结果相互矛盾。我们进行了一项荟萃分析，以全面调查和评估乳腺手术是否与dnMBC患者的生存和生活质量结果相关。我们系统地搜索了PubMed,Embase,谷歌学者，Scopus,和WebofScience,从数据库开始到2022年3月30日的随机对照试验(RCTs)比较了乳腺手术或局部治疗与基于全身治疗的非手术治疗管理dnMBC.我们还审查了主要会议记录的摘要和演示文稿。我们排除了非随机试验，只考虑了以英文发表的论文。主要结果是总生存期（OS），局部无进展生存期（LPFS），远处无进展生存期（DPFS），和生活质量(QoL)。使用Cochrane协作偏倚风险工具评估RCT的质量。随机效应模型或固定效应模型用于计算所包含的RCT的效应大小。根据GRADE标准评估证据质量。使用STATA17.0进行数据分析。来自7项随机临床试验的1018名妇女被纳入分析。汇总分析显示，与全身治疗相比，乳腺手术与OS的有益结局无关(风险比[HR]，0.87；95CI，0.68至1.11；I2=53.08%；p=0.265），DPFS（HR，1.20；95CI，0.94至1.54；I2=86.45%；p=0.136），或QoL-全球健康状况(标准化平均差[SMD]，0.08；95CI，-0.15至0.32；I2=79.45%；p=0.478）和QoL-心理-身体功能（SMD，-0.19；95CI，-0.50至0.13；I2=0.00%；p=0.255），但与LPFS的获益相关(HR，0.27；95CI，0.19至0.38；I2=84.16%；p<0.001）。这些发现在手术时机的亚组分析中是一致的，转移的部位和数量以及肿瘤分子亚型。由于研究之间的异质性，证据等级中等。根据RCT的证据,我们发现,在dnMBC患者中,乳腺手术可能有利于局部控制,但不会延长OS和改善QoL.Prospero注册号：CRD42020206460。
