Kataoka Kensuke, Suzuki Ryujiro, Taniguchi Hiroyuki, Noda Yasunobu, Shindoh Joe, Matsumoto Syuichi, Watanabe Yoshiaki, Honda Kousuke, Suzuki Kiyoshi, Baba Kenji, Imaizumi Kazuyoshi, Kume Hiroaki, Hasegawa Yoshinori, Takagi Kenzo
Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya 466-8550, Japan.
Lung. 2006 May-Jun;184(3):133-9. doi: 10.1007/s00408-005-2572-1.
A phase I/II study was conducted to determine the maximum-tolerated dose, the safety and tolerability, and the clinical efficacy of carboplatin and docetaxel in combination in patients with stage IV non-small-cell lung cancer. Patients with measurable, previously untreated, good performance status, and stage IV non-small-cell lung cancer were eligible. Increasing doses of docetaxel were given in combination with a fixed dose of carboplatin except at level 5. Cycles were repeated every four weeks. Seventy-seven patients were registered. In phase I, 27 patients were entered at five different dose levels. A docetaxel dose of 60 mg/m(2) and carboplatin area under the concentration time curve 6 was recommended for phase II, and an additional 50 patients were entered at this level for a total of 56 patients. Grade 3/4 neutropenia was the most common adverse event and occurred in 70% of the patients. Two patients had febrile neutropenia. Fifty-six patients were assessable for response; 21 partial responses were observed for an overall response rate of 37.5%. The median time to tumor progression was 4.0 months (range, 1.0-21.0 months), and the median survival was 12.9 months (range, 0.4-51.3 months). The one-year survival rate was 46.4%. The combination of docetaxel 60 mg/m(2) and carboplatin area under the concentration time curve 6 is feasible and effective in patients with stage IV non-small-cell lung cancer.
开展了一项I/II期研究，以确定卡铂和多西他赛联合用药治疗IV期非小细胞肺癌患者的最大耐受剂量、安全性和耐受性以及临床疗效。符合条件的患者为IV期非小细胞肺癌患者，具有可测量病灶、此前未接受过治疗、体能状态良好。除第5剂量水平外，多西他赛剂量递增并与固定剂量的卡铂联合使用。每四周重复一个周期。登记了77例患者。在I期，27例患者在五个不同剂量水平入组。推荐II期使用的多西他赛剂量为60 mg/m²、卡铂浓度时间曲线下面积为6，另有50例患者在此剂量水平入组，共56例患者。3/4级中性粒细胞减少是最常见的不良事件，70%的患者发生该事件。2例患者出现发热性中性粒细胞减少。56例患者可评估疗效；观察到21例部分缓解，总缓解率为37.5%。肿瘤进展的中位时间为4.0个月（范围1.0 - 21.0个月），中位生存期为12.9个月（范围0.4 - 51.3个月）。一年生存率为46.4%。多西他赛60 mg/m²与卡铂浓度时间曲线下面积为6的联合用药方案对IV期非小细胞肺癌患者可行且有效。
