Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer
Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer
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DOI：
10.1093/annonc/mdm467
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发表时间：
2008-02-01
影响因子：
50.5
通讯作者：
Heinemann, V.
中科院分区：
文献类型：
--
作者：
Boeck, S.;Hoehler, T.;Heinemann, V.
背景资料：比较三种不同的化疗双联治疗晚期胰腺癌（PC）的疗效和安全性。患者和方法：共有190例患者被随机分配接受卡培他滨1000 mg/m2，每日两次，第1-14天，奥沙利铂130 mg/m2，第1天（CapOx），卡培他滨825 mg/m2，每日两次，第1-14天加吉西他滨1000 mg/m2，第1和8天（CapGem）或吉西他滨1000 mg/m2，第1和8天加奥沙利铂130 mg/m2，第8天（mGemOx）。每三周重复一次治疗周期。主要终点是3个月时的无进展生存率（PFS）;次要终点包括客观反应率、碳水化合物抗原19-9反应、临床获益反应、总生存期和毒性。CapOx组3个月后的PFS率为51%，CapGem组为64%，mGemOx组为60%。估计中位PFS为4.2个月，分别为5.7个月和3.9个月（P = 0.67）。相应的中位生存期分别为：8.1个月（CapOx）、9.0个月（CapGem）和6.9个月（mGemOx）（P = 0.56）。3/4级血液学毒性更常见的两个含宝石武器; 3/4级非血液学毒性率不超过15%，在任何arm.Conclusion：CapOx，CapGem和mGemOx晚期PC的临床疗效相似。每种方案都有不同但可管理的耐受性特征。
Background: To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC).Patients and methods: At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m(2) twice daily on days 1-14 plus oxaliplatin 130 mg/m(2) on day 1 (CapOx), capecitabine 825 mg/m(2) twice daily on days 1-14 plus gemcitabine 1000 mg/m(2) on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus oxaliplatin 130 mg/m(2) on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity.Results: The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm.Conclusion: CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.