Azienda Ospedaliera Treviglio-Caravaggio, Treviglio, BG, Italy.
Med Oncol. 2012 Jun;29(2):1020-9. doi: 10.1007/s12032-011-9958-0. Epub 2011 Apr 24.
The aim of this pooled-analysis is to evaluate the benefit of capecitabine (C) versus standard intravenous 5-Fluorouracil (5-FU) as monochemotherapy or combination therapy in advanced colorectal cancer (CRC) in terms of safety and efficacy. Eligible patients have been randomized to receive either C-based or 5-FU-based chemotherapy for the treatment of advanced CRC. Relative risks (RRs) with 95% confidence intervals (CIs) of selected side effects (diarrhea, nausea, vomiting, stomatitis, hand and foot syndrome, neutropoenia, febrile neutropoenia, and cardio toxicity) and overall response rate (ORR) were calculated and hazard ratios (HRs) of progression-free survival (PFS) and overall survival were obtained, respectively, from published data. The RRs of stomatitis and neutropoenia are 0.39 and 0.40, respectively with C (P < 0.00001). In particular high-grade mucositis and neutropoenia, they are reduced by 69 and 74%, respectively (RR: 0.31 and 0.26). Diarrhea, nausea, vomiting, febrile neutropoenia, and cardio toxicity with C are not worse than with 5-FU. The RR of hand and foot syndrome with C compared to 5-FU is 3.45, (P < 0.00001). Response rate, PFS, and OS are equivalent in both C- and 5-FU-based regimens. The use of C instead of 5-FU in advanced colorectal cancer regimens results in significantly less toxicity in terms of stomatitis and neutroponenia. Only hand and foot syndrome is worse with C than with 5-FU. Activity and efficacy are similar. Capecitabine could be therefore considered standard of care in advanced CRC.
本汇总分析旨在评估卡培他滨（C）与标准静脉注射氟尿嘧啶（5-FU）作为单药或联合治疗晚期结直肠癌（CRC）在安全性和疗效方面的益处。合格的患者被随机分配接受基于 C 或基于 5-FU 的化疗，以治疗晚期 CRC。选择的副作用（腹泻、恶心、呕吐、口腔炎、手足综合征、中性粒细胞减少症、发热性中性粒细胞减少症和心脏毒性）和总缓解率（ORR）的相对风险（RR），以及无进展生存期（PFS）和总生存期（OS）的风险比（HR），分别从已发表的数据中获得。与 5-FU 相比，C 的口腔炎和中性粒细胞减少症的 RR 分别为 0.39 和 0.40（P < 0.00001）。特别是，高级粘膜炎和中性粒细胞减少症分别减少了 69%和 74%（RR：0.31 和 0.26）。C 引起的腹泻、恶心、呕吐、发热性中性粒细胞减少症和心脏毒性并不比 5-FU 更严重。与 5-FU 相比，C 引起的手足综合征的 RR 为 3.45（P < 0.00001）。C 与 5-FU 相比，基于 C 和基于 5-FU 的方案的反应率、PFS 和 OS 相当。在晚期结直肠癌方案中，C 的使用而不是 5-FU 的使用导致口腔炎和中性粒细胞减少症的毒性明显降低。只有手足综合征比 5-FU 更严重。活性和疗效相似。因此，卡培他滨可被视为晚期 CRC 的标准治疗方法。
