Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: A final report of the AIO colorectal study group
Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: A final report of the AIO colorectal study group
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DOI：
10.1200/jco.2006.09.2684
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发表时间：
2007-09-20
影响因子：
45.3
通讯作者：
Schmoll, Hans-Joachim
中科院分区：
文献类型：
--
作者：
Porschen, Rainer;Arkenau, Hendrik-Tobias;Schmoll, Hans-Joachim
目的比较卡培他滨联合奥沙利铂（CAPOX）与氟尿嘧啶（FU）/亚叶酸联合奥沙利铂（FUFOX）一线治疗转移性结直肠癌（MCRC）的疗效。（卡培他滨1，000 mg/m（2）bid，第1 - 14天加奥沙利铂70 mg/m（2），第1和8天，每22天重复一次））或FUFOX（奥沙利铂50 mg/m2，随后甲酰四氢叶酸500 mg/m2 + FU 2，000 mg/m2，22小时输注，第1、8、15和22天，每36天重复一次）。主要终点是无进展生存期（PFS）。次要终点是反应率（RR）、总生存期（OS）、治疗失败时间和毒性。结果CAPOX组和FUFOX组的中位PFS分别为7.1个月和8.0个月（风险比[HR]，1.17; 95%CI，0.96 - 1.43; P = 0.117）。中位OS为16.8个月（CAPOX）和18.8个月（FUFOX; HR，1.12; 95% CI，0.92 - 1.38; P = 0.26）。CAPOX的总体RR为48%（95% CI，41%至54%），FUFOX为54%（95% CI，47%至60%）。两种治疗方案的耐受性均良好，但CAPOX组2/3级手足综合征（HFS）的发生率明显高于FUFOX组（P = 0.028）。关于PFS，HR的最佳估计值1.17在预先规定的等效性范围内。然而，不能排除相关的劣势。两种方案的耐受性均良好，但CAPOX组2/3级HFS的发生率显著较高。
Purpose To compare the use of capecitabine plus oxaliplatin (CAPOX) with infusional fluorouracil (FU)/folinic acid plus oxaliplatin (FUFOX) as first-line therapy for patients with metastatic colorectal cancer (MCRC).Patients and Methods A total of 474 patients with MCRC received either CAPOX (capecitabine 1,000 mg/m(2) bid, days 1 to 14 plus oxaliplatin 70 mg/m(2) days 1 and 8, repeated every 22 days)) or FUFOX (oxaliplatin 50 mg/m(2) followed by leucovorin 500 mg/m(2) plus FU 2,000 mg/m(2) as a 22-hourinfusion days 1, 8, 15, and 22, repeated every 36 days). The primary end point was progression-free survival (PFS). Secondary end points were response rate (RR),overall survival (OS), time to treatment failure, and toxicity. The study was designed to determine noninferiority for the CAPOX regimen.Results Median PFS was 7.1 months in the CAPOX arm and 8.0 months in the FUFOX arm (hazard ratio [HR], 1.17; 95% CI, 0.96 to 1.43; P = .117). Median OS was 16.8 months (CAPOX) and 18.8 months (FUFOX; HR, 1.12; 95% CI, 0.92 to 1.38; P = .26). Overall RRs were 48% for CAPOX (95% CI, 41% to 54%) and 54% for FUFOX (95% CI, 47% to 60%). Both regimens were generally well tolerated, although there was a significantly higher incidence of grade 2/3 hand-foot syndrome (HFS) in the CAPOX arm (P = .028).Conclusion CAPOX resulted in a slightly inferior efficacy than FUFOX. With respect to PFS, the best estimate of the HR of 1.17 was within the prespecified equivalence range. However, a relevant inferiority cannot be excluded. Both regimens were generally well tolerated but there was a significantly higher rate of grade 2/3 HFS in the CAPOX arm.