Ishimoto Osamu, Sugawara Shunichi, Inoue Akira, Ishida Takashi, Munakata Mitsuru, Koinumaru Sadahiro, Hasegawa Yukihiro, Suzuki Toshiro, Miki Hiroshi, Saijo Yasuo, Nukiwa Toshihiro
Tohoku Lung Cancer Clinical Study Group, Sendai Kousei Hospital, Aobaku, Sendai, Miyagi, Japan.
J Thorac Oncol. 2006 Nov;1(9):979-83.
The combination of carboplatin and docetaxel has been considered one of the standard treatments for advanced non-small cell lung cancer (NSCLC). To investigate a safer and more convenient schedule for outpatient, we conducted a phase II study to evaluate the efficacy and the safety of carboplatin plus biweekly docetaxel for advanced NSCLC.
Patients with stage IIIB, IV, or postoperative recurrent NSCLC with good performance status were administered docetaxel at a dose of 35 mg/m on days 1 and 15 and carboplatin at an area under the curve (AUC) of 6 on day 1 every 4 weeks for at least three cycles.
Fifty patients were treated with median of three cycles (range 1-6). Grade 3/4 toxicities included neutropenia in 18 patients (36%), thrombocytopenia in 4 patients (8%), and anemia in 10 patients (20%). No patient experienced febrile neutropenia. Nonhematological toxicities were also mild to moderate, and there were no treatment-related deaths. The overall response rate was 30%, and the disease control rate was 70%. Among the elderly population, 54% of patients achieved partial response. Median progression-free survival was 4.8 months, and median overall survival was 11.8 months.
Biweekly docetaxel plus carboplatin has a similar efficacy and lower toxicity compared with a standard triweekly regimen of docetaxel plus carboplatin, which is a suitable regimen for outpatients, including elderly patients.
卡铂和多西他赛联合用药一直被认为是晚期非小细胞肺癌（NSCLC）的标准治疗方案之一。为了探寻一种更安全、更便捷的门诊治疗方案，我们开展了一项II期研究，以评估卡铂联合每两周一次多西他赛治疗晚期NSCLC的疗效和安全性。
对III B期、IV期或术后复发且体能状态良好的NSCLC患者，每4周在第1天和第15天给予多西他赛35mg/m²，第1天给予卡铂，曲线下面积（AUC）为6，至少进行三个周期的治疗。
50例患者接受了治疗，中位周期数为3个周期（范围1 - 6）。3/4级毒性反应包括18例患者（36%）出现中性粒细胞减少，4例患者（8%）出现血小板减少，10例患者（20%）出现贫血。无患者发生发热性中性粒细胞减少。非血液学毒性也为轻至中度，且无治疗相关死亡。总缓解率为30%，疾病控制率为70%。在老年人群中，54%的患者获得部分缓解。中位无进展生存期为4.8个月，中位总生存期为11.8个月。
与多西他赛加卡铂的标准每三周一次方案相比，每两周一次多西他赛加卡铂具有相似的疗效和更低的毒性，是包括老年患者在内的门诊患者的合适治疗方案。
