Phase II study of oxaliplatin in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines
Phase II study of oxaliplatin in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines
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DOI：
10.1093/jjco/hym069
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发表时间：
2007-06-01
影响因子：
2.4
通讯作者：
Tanigawara, Yusuke
中科院分区：
文献类型：
--
作者：
Boku, Narikazu;Ohtsu, Atsushi;Tanigawara, Yusuke
背景资料：虽然奥沙利铂（L-OHP）联合输注5-氟尿嘧啶（5-FU）和甲酰四氢叶酸（LV）是转移性或复发性结直肠癌的标准化疗方案之一，但其在日本的引入已被推迟。在日本进行的L-OHP单药治疗的I期研究显示，在国际推荐剂量130 mg/m2每3周一次时，没有剂量限制性毒性，与西方受试者相比，药代动力学也没有种族差异。本研究旨在阐明L-OHP单药治疗对氟尿嘧啶难治的转移性结直肠癌患者的有效性和安全性。方法：对氟尿嘧啶化疗无效的转移性结直肠癌患者接受L-OHP治疗，剂量为130 mg/m2，每3周一次。2例不合格患者和1例未接受治疗的患者从分析中排除。中位治疗周期数为4（范围：1-6）。总体缓解率为9%（5/57，95% CI：4-19%）。中位进展时间为2.7个月，中位生存时间为11.1个月。3级主要毒性包括血小板减少症（12%）和恶心（11%）。无4级毒性。所有患者都经历了轻度至中度的感觉神经毒性，没有功能障碍，干扰日常living.Conclusions活动：L-OHP的疗效和毒性的转移性结直肠癌难治性氟嘧啶类药物在日本患者显然是相似的西方患者。
Background: Although oxaliplatin (L-OHP) combined with infusional 5-fluorouracil (5-FU) and leucovorin (LV) is one of the standard chemotherapy regimens for metastatic or recurrent colorectal cancer, its introduction to Japan has been delayed. Phase I studies of L-OHP monotherapy in Japan showed no dose-limiting toxicity at the internationally recommended dose of 130 mg/m(2) every 3 weeks, as well as no racial differences in pharmacokinetics as compared with Western subjects. This study aimed to clarify the efficacy and safety of L-OHP monotherapy in patients with metastatic colorectal cancer refractory to fluoropyrimidines.Methods: Patients with metastatic colorectal cancer who had failed to respond to fluoropyrimidine-based chemotherapy received L-OHP at a dose of 130 mg/m(2) every 3 weeks.Results: Sixty patients were enrolled. Two ineligible patients and one untreated patient were excluded from analysis. The median number of treatment cycles was 4 (range, 1-6). The overall response rate was 9% (5/57, 95% Cl: 4-19%). The median time to progression was 2.7 months, and the median survival time was 11.1 months. Grade 3 major toxicity comprised thrombocytopenia (12%) and nausea (11%). There was no grade 4 toxicity. All patients experienced mild to moderate sensory neurotoxicity without functional impairment interfering with activities of daily living.Conclusions: The efficacy and toxicity of L-OHP in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines is apparently similar to those in Western patients.