Matsuda Chu, Honda Michitaka, Tanaka Chihiro, Fukunaga Mutsumi, Ishibashi Keiichiro, Munemoto Yoshinori, Hata Taishi, Bando Hiroyuki, Oshiro Mitsuru, Kobayashi Michiya, Tokunaga Yukihiko, Fujii Akitomo, Nagata Naoki, Oba Koji, Mishima Hideyuki
Department of Surgery, Osaka General Medical Center, Osaka, Japan.
Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Int J Clin Oncol. 2016 Jun;21(3):566-72. doi: 10.1007/s10147-015-0911-7. Epub 2015 Oct 16.
The aim of this multicenter, open-label, randomized phase II trial was to evaluate the efficacy of a dose-dense capecitabine and oxaliplatin (XELOX) regimen in patients with metastatic colorectal cancer (mCRC) for whom reintroduction of oxaliplatin had been planned as a third- or later-line regimen.
The patients with mCRC who had received prior chemotherapy including oxaliplatin and were scheduled for reintroduction of oxaliplatin were randomized to capecitabine (1,000 mg/m(2)) twice daily on days 1-14 and oxaliplatin (130 mg/m(2)) on day 1 every 21 days (Q3W group) or capecitabine (2,000 mg/m(2)) twice daily on days 1-7 and oxaliplatin (85 mg/m(2)) on day 1 every 14 days (Q2W group). The primary endpoint was the time-to-treatment failure (TTF). Other endpoints included overall survival (OS), progression-free survival (PFS) and other adverse events (AEs).
A total of 46 patients were enrolled in the trial-22 patients were randomly assigned to the Q3W group and 23 to the Q2W group. The median TTF was 3.4 months in both groups (hazard ratio [HR] 1.053; p = 0.880). The median PFS and OS were 3.3 and 9.2 months in the Q2W group and 4.3 and 12.1 months in the Q3W group, respectively (HR 1.15; p = 0.153 and 0.672; p = 0.836). The most common grade 3-4 AEs in the Q3W and Q2W groups were fatigue (27.3 vs 21.7), neuropathy (9.1 vs 0 %) and diarrhea (9.1 vs 0 %), respectively.
There was no significant inter-group difference in any of the efficacy and safety endpoints, including TTF, OS, RFS and AEs. The results of this clinical trial were convincingly negative.
这项多中心、开放标签、随机II期试验的目的是评估剂量密集型卡培他滨和奥沙利铂（XELOX）方案对计划将奥沙利铂重新引入作为三线或更后线方案的转移性结直肠癌（mCRC）患者的疗效。
曾接受包括奥沙利铂在内的先前化疗且计划重新引入奥沙利铂的mCRC患者被随机分为两组，一组在第1 - 14天每天两次服用卡培他滨（1000 mg/m²），并在每21天的第1天接受奥沙利铂（130 mg/m²）治疗（每3周一次组）；另一组在第1 - 7天每天两次服用卡培他滨（2000 mg/m²），并在每14天的第1天接受奥沙利铂（85 mg/m²）治疗（每2周一次组）。主要终点是治疗失败时间（TTF）。其他终点包括总生存期（OS）、无进展生存期（PFS）和其他不良事件（AE）。
共有46例患者入组试验，22例患者被随机分配至每3周一次组，23例患者被随机分配至每2周一次组。两组的中位TTF均为3.4个月（风险比[HR] 1.053；p = 0.880）。每2周一次组的中位PFS和OS分别为3.3个月和9.2个月，每3周一次组分别为4.3个月和12.1个月（HR 1.15；p = 0.153和0.672；p = 0.836）。每3周一次组和每2周一次组最常见的3 - 4级AE分别为疲劳（27.3%对21.7%）、神经病变（9.1%对0%）和腹泻（9.1%对0%）。
在包括TTF、OS、RFS和AE在内的任何疗效和安全性终点方面，组间均无显著差异。该临床试验结果令人信服地呈阴性。
