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首页> 外文期刊>Oncology: International Journal of Cancer Research and Treatment >Multicenter phase I study of irinotecan plus raltitrexed in patients with 5-fluorouracil-refractory advanced colorectal cancer.
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Multicenter phase I study of irinotecan plus raltitrexed in patients with 5-fluorouracil-refractory advanced colorectal cancer.

机译：多中心I期研究显示，伊立替康联合雷替曲塞治疗5-氟尿嘧啶难治性晚期大肠癌患者。

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Irinotecan and raltitrexed are active against advanced colorectal cancer, act through different mechanisms, and have non-overlapping toxicity profiles. In vitro studies have shown a schedule-dependent synergism between both drugs. The aim of this multicenter study was to determine the maximum tolerated dose (MTD) of this combination. Patients with 5-fluorouracil-refractory, advanced colorectal cancer were eligible. Dose escalation consisted of irinotecan (250-350 mg/m(2) as a 60-min infusion) in combination with a fixed dose of raltitrexed (3 mg/m(2) as a 15-min infusion, 1 h after irinotecan). Courses were repeated every 21 days. Three to 6 patients were to be included at each dose level. Dose limiting (NCI-CTC grade 3-4) toxicities (DLT) were assessed during the first 2 cycles. Thirteen patients were recruited (4, 3 and 6 in levels I, II and III, respectively). Main toxicity was diarrhea and asthenia, whereas myelotoxicity was mild. At level III, 2/6 patients experienced DLT (grade 4 diarrhea and neutropenia). The MTD was not reached, but further dose escalation was not attempted. Among 12 patients with measurable disease, 2 partial responses were observed for an overall response rate of 17%. The combination of single-agent full doses of irinotecan (350 mg/m(2)) and raltitrexed (3 mg/m(2)) in a 3-weekly schedule is feasible, with mild toxicity and a promising clinical activity. Diarrhea is the DLT, but it is not more common or severe than that described with irinotecan alone.
机译：伊立替康和雷替曲塞对晚期大肠癌具有活性，通过不同的机制起作用，并且具有不重叠的毒性特征。体外研究表明两种药物之间的时间表依赖性协同作用。这项多中心研究的目的是确定该组合的最大耐受剂量（MTD）。患有5-氟尿嘧啶难治性晚期大肠癌的患者符合条件。剂量递增包括伊立替康（250-350 mg / m（2），每60分钟输注一次）与固定剂量的雷替曲塞（3 mg / m（2），每15分钟，伊立替康后1小时）组成。每21天重复一次课程。每个剂量水平应包括3至6名患者。在前两个周期中评估了剂量限制（NCI-CTC 3-4级）毒性（DLT）。招募了13名患者（I，II和III级分别为4、3和6）。主要毒性为腹泻和乏力，而骨髓毒性为轻度。在III级，有2/6名患者经历了DLT（4级腹泻和中性粒细胞减少）。未达到MTD，但未尝试进一步提高剂量。在12例可测量疾病患者中，观察到2例局部缓解，总缓解率为17％。单剂全剂量伊立替康（350 mg / m（2））和雷替曲塞（3 mg / m（2））的组合在3周的时间表中是可行的，具有轻度毒性和有希望的临床活性。腹泻是DLT，但并不比单独使用伊立替康描述的更为普遍或严重。

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