Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.
Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea.
Eur J Cancer. 2019 May;112:20-28. doi: 10.1016/j.ejca.2018.11.029. Epub 2019 Mar 19.
Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF).
Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile.
A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated.
SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.
复发性/转移性胃癌的一线化疗标准方案尚未达成共识。在这项随机 II 期研究中，我们比较了四种二联方案：S-1 和顺铂（SP）；奥沙利铂和 5-FU（FOLFOX）；多西他赛和 5-FU（DF）以及紫杉醇和 5-FU（PF）。
无复发性/转移性胃癌化疗史的患者被平均随机分配到每个方案组。主要终点是无进展生存期（PFS）。次要终点是总生存期（OS）、缓解率（RR）和安全性。
2010 年 3 月至 2015 年 5 月，共纳入 179 例韩国患者。由于入组缓慢，该研究提前终止。数据截止时，SP 的中位 PFS 为 8.4 个月，FOLFOX 为 5.8 个月，DF 为 5.7 个月，PF 为 4.2 个月（P=0.023）。SP 的中位 OS 为 14.7 个月，FOLFOX 为 11.3 个月，DF 为 11.7 个月，PF 为 10.8 个月（P=0.143）。RR 分别为 SP 组 18%、FOLFOX 组 23%、DF 组 16%和 PF 组 32%。铂类组的 PFS 趋势长于紫杉烷组（7.2 与 4.9 个月，P=0.058），但 OS 无显著差异。值得注意的是，105 例患者在整个治疗过程中均接受了三种药物（铂类、紫杉烷和氟嘧啶）治疗，起始使用铂类或紫杉烷的 OS 相同（13.3 与 13.3 个月，P=0.997）。所有方案均耐受良好。
SP 在 PFS 方面显示出最佳结果，而四种方案的 OS 无显著差异。
