目的：卡培他滨在多种实体瘤的治疗中有着广泛的应用，其功效已得到证实。其口服给药和临床实践中的最小毒性使其具有优势。然而，对于卡培他滨是否可以替代化疗方案中的蒽环类药物以降低蒽环类药物降解的风险,仍存在不确定性.因此,我们对随机对照试验(RCT)进行了荟萃分析,以评估卡培他滨在乳腺癌化疗方案中替代蒽环类药物的潜力.
方法：我们系统地搜索了PubMed，Embase,WebofScience,和Cochrane对照试验登记册（CENTRAL），以检索2023年7月18日之前发表的合格研究。两名独立的审阅者使用预先建立的数据提取表从所包括的研究中提取相关数据。主要终点包括术后辅助治疗的总生存期（OS）和无进展生存期（PFS），以及新辅助治疗后的病理完全缓解（PCR）。不良事件被认为是次要结果。统计学分析采用Revman5.4.1。
结果：根据选择标准，共有6项研究纳入2348例乳腺癌患者，被认为是合格的。汇总的荟萃分析显示，在四个术后辅助化疗试验中，总生存期（OS）（HR1.06，95％CI0.88-1.28）和无进展生存期（PFS）（HR1.10，95％CI0.90-1.34）的主要结局没有统计学上的显着差异。以及在两项新辅助化疗试验中，当比较含蒽环类药物的方案与不含蒽环类药物的方案时，病理完全缓解（PCR）的主要结局（OR1.65，95％CI0.93-2.95）。在不良事件方面，卡培他滨治疗组出现腹泻(OR3.94,P=0.004)和手足综合征(OR10.89,P=0.004)的概率明显较高,归因于药物特性。相反，蒽环类药物组发生中性粒细胞减少的可能性较高(OR0.50,P=0.03).
结论：根据目前的证据，当卡培他滨替代蒽环类药物时,主要结局无统计学显著差异.因此，在需要排除蒽环类药物的患者亚组中,卡培他滨可被视为可行的替代方案.
OBJECTIVE: Capecitabine has extensive utilization in the treatment of diverse solid tumors, and its efficacy has been substantiated. Its oral administration and minimal toxicity in clinical practice render it advantageous. Nevertheless, uncertainty remains regarding whether capecitabine can substitute anthracycline drugs in chemotherapy regimens to achieve a lower risk of anthracycline-induced degradation. Consequently, we conducted a meta-analysis of randomized controlled trials (RCTs) to assess the potential of capecitabine as a replacement for anthracycline drugs in chemotherapy regimens for breast cancer.
METHODS: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Controlled Trials Register (CENTRAL) to retrieve eligible studies published before July 18, 2023. Two independent reviewers extracted relevant data from the included studies using a pre-established data extraction form. The primary endpoints of interest encompassed overall survival (OS) and progression-free survival (PFS) for postoperative adjuvant therapy, as well as pathological complete response (PCR) following neoadjuvant therapy. Adverse events were considered as secondary outcomes. The statistical analysis was performed using Revman 5.4.1.
RESULTS: A total of six studies involving 2348 breast cancer patients were deemed eligible according to the selection criteria. The pooled meta-analysis revealed that there were no statistically significant differences observed in the primary outcomes of overall survival (OS) (HR 1.06, 95% CI 0.88-1.28) and progression-free survival (PFS) (HR 1.10, 95% CI 0.90-1.34) across the four postoperative adjuvant chemotherapy trials, as well as in the two neoadjuvant chemotherapy trials with respect to the primary outcome of pathological complete response (PCR) (OR 1.65, 95% CI 0.93-2.95) when comparing regimens containing anthracycline drugs to those without. In terms of adverse events, the probability of experiencing diarrhea (OR 3.94, P = 0.004) and hand-foot syndrome (OR 10.89, P = 0.004) was significantly higher in the capecitabine group, attributable to the drug characteristics. Conversely, the likelihood of developing neutropenia (OR 0.50, P = 0.03) was higher in the anthracycline group.
CONCLUSIONS: According to the current evidence, there was no statistically significant difference in the primary outcomes when capecitabine was substituted for anthracycline drugs. Thus, capecitabine can be regarded as a feasible alternative in the subset of patients who necessitate the exclusion of anthracyclines.
