Yanagitani Noriko, Tsuchiya Satoshi, Kaira Kyoichi, Sunaga Noriaki, Tsuchiya Yukiko, Sato Koji, Watanabe Satoru, Nomura Shiro, Sakai Shuzo, Saito Ryusei, Mori Masatomo
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
Am J Clin Oncol. 2007 Oct;30(5):487-91. doi: 10.1097/COC.0b013e31804b458f.
The aim of this phase I study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity of the biweekly paclitaxel and carboplatin combination chemotherapy in frail patients with advanced non-small cell lung cancer (NSCLC).
Seventeen unresectable and previously untreated NSCLC patients participated in this study. Frail patients (>80 years old with PS 0-1 and adequate organ functions, or <80 years old with PS 2 or <80 with PS 0-1 and one inadequate organ function of bone marrow, liver, or kidney) of NSCLC were enrolled in this study. Both paclitaxel and carboplatin were administered on day 1 and repeated biweekly. The starting dose of paclitaxel 120 mg/m2 and carboplatin was AUC 3 /d on day 1 every 2 weeks for 4 to 8 cycles.
Seventeen frail patients received a total of 1 to 10 cycles. The major hematologic toxicity was neutropenia. Nonhematologic toxicities, including numbness and constipation, were generally mild and reversible. The MTD of paclitaxel were determined as 140 mg/m2. The recommended phase II study dose of paclitaxel was determined as 120 mg/m2 with area under the curve 3 biweekly for 1 day. An objective response was observed in 8 of 17 patients (47%) with frail patients.
The combination chemotherapy of biweekly paclitaxel and carboplatin appears to be tolerable and sufficiently effective in frail patients with NSCLC. A phase II trial is underway.
本I期研究的目的是确定最大耐受剂量（MTD），并评估每两周一次的紫杉醇和卡铂联合化疗对晚期非小细胞肺癌（NSCLC）体弱患者的毒性。
17例不可切除且未经治疗的NSCLC患者参与了本研究。纳入了NSCLC体弱患者（年龄>80岁且PS为0 - 1且器官功能良好，或年龄<80岁且PS为2，或年龄<80岁且PS为0 - 1且骨髓、肝脏或肾脏有一项器官功能不良）。紫杉醇和卡铂均在第1天给药，每两周重复一次。紫杉醇起始剂量为120mg/m²，卡铂在第1天的剂量为AUC 3/d，每2周一次，共进行4至8个周期。
17例体弱患者共接受了1至10个周期的治疗。主要血液学毒性为中性粒细胞减少。非血液学毒性，包括麻木和便秘，一般较轻且可逆。紫杉醇的MTD确定为140mg/m²。推荐的II期研究剂量为紫杉醇120mg/m²，曲线下面积为3，每两周给药1天。17例体弱患者中有8例（47%）观察到客观缓解。
每两周一次的紫杉醇和卡铂联合化疗在NSCLC体弱患者中似乎耐受性良好且疗效充分。一项II期试验正在进行中。
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