DataSheet_2_Efficacy and Safety of Capecitabine for Triple-Negative Breast Cancer: A Meta-Analysis.pdf

BackgroundTriple-negative breast cancer (TNBC) is the most aggressive subtype of breast cancer with limited treatment options and poor prognosis. Capecitabine, as a novel adjuvant chemotherapy for TNBCs, remains controversial. Therefore, we conducted this meta-analysis to assess the efficacy and safety of capecitabine for early-stage TNBCs combined with neo-/adjuvant chemotherapy.
MethodsWe searched Medline, Embase, Web of Science, and Cochrane databases updated on Mar 18, 2022 for relevant RCTs. In all, 11 RCTs with 5,175 patients were included. We used hazard ratios (HRs) and odds ratios (ORs) to assess the differences between disease-free survival (DFS), overall survival (OS), and adverse events.
ResultsOur study demonstrated significance differences in both DFS and OS (DFS: HR=0.77; 95% CI 0.68–0.86; OS: HR=0.73, 95% CI 0.63–0.85). In subgroup analysis, the lower dosage group showed higher DFS (HR=0.79, 95% CI 0.69–0.91), higher frequency (HR=0.72, 95%CI 0.62–0.83), and adjuvant chemotherapy (HR=0.74, 95% CI 0.65–0.84). However, capecitabine was also associated with a higher risk of diarrhea (OR=3.10, 95% CI 2.32–4.15), hand–foot syndrome (OR=25.79, 95% CI 15.32–43.42), and leukopenia (OR=2.08, 95% CI 1.13–3.84).
ConclusionThe addition of capecitabine to early-stage TNBC patients receiving standard adjuvant chemotherapy showed significant DFS and OS improvement with tolerable adverse events. The lower dosage and higher frequency of capecitabine combined with adjuvant chemotherapy demonstrated a better survival outcome.

研究背景：三阴性乳腺癌（Triple-negative breast cancer, TNBC）是侵袭性最强的乳腺癌亚型，具有治疗选择有限、预后不佳的临床特征。卡培他滨（Capecitabine）作为针对三阴性乳腺癌的新型辅助化疗药物，其临床应用仍存在争议。因此，本研究开展此项荟萃分析，以评估卡培他滨联合新辅助/辅助化疗用于早期三阴性乳腺癌的疗效与安全性。
研究方法：本研究于2022年3月18日更新检索了Medline、Embase、Web of Science及Cochrane数据库，筛选相关随机对照试验（Randomized Controlled Trial, RCT）。最终纳入11项随机对照试验，共包含5175例受试者。本研究采用风险比（hazard ratio, HR）与比值比（odds ratio, OR）评估无病生存期（disease-free survival, DFS）、总生存期（overall survival, OS）及不良事件的组间差异。
研究结果：本研究显示，早期三阴性乳腺癌患者的无病生存期与总生存期均存在显著组间差异：无病生存期的HR=0.77，95%置信区间（95% CI）为0.68~0.86；总生存期的HR=0.73，95% CI为0.63~0.85。亚组分析结果显示，低剂量给药组、高给药频率组及接受辅助化疗的患者群体无病生存期更优，对应的HR分别为0.79（95% CI 0.69~0.91）、0.72（95% CI 0.62~0.83）与0.74（95% CI 0.65~0.84）。但卡培他滨也会提升腹泻（OR=3.10，95% CI 2.32~4.15）、手足综合征（OR=25.79，95% CI 15.32~43.42）及白细胞减少症（OR=2.08，95% CI 1.13~3.84）的发生风险。
研究结论：在接受标准辅助化疗的早期三阴性乳腺癌患者中加用卡培他滨，可显著改善患者的无病生存期与总生存期，且不良事件耐受良好。低剂量、高给药频率的卡培他滨联合辅助化疗方案，可使患者获得更优的生存结局。