Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, Xining, 810000, China.
Peking University Cancer Hospital and Institute, Beijing, 100142, China.
BMC Cancer. 2021 Jan 19;21(1):78. doi: 10.1186/s12885-021-07791-y.
The role of capecitabine in neoadjuvant and adjuvant chemotherapy for early-stage triple-negative breast cancer (TNBC) is highly controversial. Our meta-analysis was designed to further elucidate the effects of capecitabine on survival in early-stage TNBC patients and its safety.
PubMed, Embase, and papers presented at several main conferences were searched up to December 19, 2019, to investigate capecitabine-based versus capecitabine-free neoadjuvant and adjuvant chemotherapy in TNBC patients. Heterogeneity was assessed using I test, combined with hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CI) computed for disease-free survival (DFS), overall survival (OS), and over grade 3 adverse events (AEs).
A total of 9 randomized clinical trials and 3842 TNBC patients were included. Overall, the combined capecitabine regimens in neoadjuvant and adjuvant chemotherapy showed significantly improved DFS (HR = 0.75; 95% CI, 0.65-0.86; P < 0.001) and OS (HR = 0.63; 95% CI, 0.53-0.77; P < 0.001). In subgroup analysis, there were improvements in DFS in the groups with addition of capecitabine (HR = 0.64; 95% CI, 0.53-0.78; P < 0.001), adjuvant chemotherapy (HR = 0.73; 95% CI, 0.63-0.85; P < 0.001), and lymph node positivity (HR = 0.62; 95% CI, 0.44-0.86; P = 0.005). Capecitabine regimens were related to higher risks of diarrhea (OR = 2.88, 95% CI 2.23-3.74, P < 0.001), stomatitis (OR = 2.01, 95% CI 1.53-2.64, P < 0.001) and hand-foot syndrome (OR = 8.67, 95% CI 6.70-11.22, P < 0.001).
This meta-analysis showed that neoadjuvant and adjuvant chemotherapy combined with capecitabine significantly improved both DFS and OS in early-stage TNBC patients with tolerable AEs. There were benefits to DFS in the groups with the addition of capecitabine, adjuvant chemotherapy, and lymph node positivity.
卡培他滨在早期三阴性乳腺癌（TNBC）的新辅助和辅助化疗中的作用存在很大争议。我们的荟萃分析旨在进一步阐明卡培他滨对早期 TNBC 患者生存的影响及其安全性。
检索了 PubMed、Embase 和几次主要会议上发表的论文，截至 2019 年 12 月 19 日，以调查卡培他滨为基础的新辅助和辅助化疗与 TNBC 患者的无病生存（DFS）、总生存（OS）和 3 级以上不良事件（AE）的卡培他滨免费新辅助和辅助化疗。使用 I 检验评估异质性，并用风险比（HR）和比值比（OR）结合计算 95%置信区间（CI）来评估疾病无进展生存（DFS）、总生存（OS）和 3 级以上不良事件（AE）。
共纳入 9 项随机临床试验和 3842 例 TNBC 患者。总的来说，新辅助和辅助化疗中联合卡培他滨的方案显著改善了 DFS（HR=0.75；95%CI，0.65-0.86；P<0.001）和 OS（HR=0.63；95%CI，0.53-0.77；P<0.001）。亚组分析显示，DFS 改善与加用卡培他滨（HR=0.64；95%CI，0.53-0.78；P<0.001）、辅助化疗（HR=0.73；95%CI，0.63-0.85；P<0.001）和淋巴结阳性（HR=0.62；95%CI，0.44-0.86；P=0.005）有关。卡培他滨方案与腹泻（OR=2.88，95%CI 2.23-3.74，P<0.001）、口腔炎（OR=2.01，95%CI 1.53-2.64，P<0.001）和手足综合征（OR=8.67，95%CI 6.70-11.22，P<0.001）风险升高有关。
这项荟萃分析表明，新辅助和辅助化疗联合卡培他滨可显著改善早期 TNBC 患者的 DFS 和 OS，同时 AE 可耐受。在加用卡培他滨、辅助化疗和淋巴结阳性的患者中，DFS 获益。
