Phase II study of carboplatin-paclitaxel combination chemotherapy in elderly patients with advanced non-small cell lung cancer
Phase II study of carboplatin-paclitaxel combination chemotherapy in elderly patients with advanced non-small cell lung cancer
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DOI：
10.1093/jjco/hyi059
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发表时间：
2005-04-01
影响因子：
2.4
通讯作者：
Matsumoto, M
中科院分区：
文献类型：
--
作者：
Okamoto, I;Moriyama, E;Matsumoto, M
背景：超过30%的非小细胞肺癌（NSCLC）发生在70岁以上的患者中。一项II期试验评估了卡铂-紫杉醇联合化疗治疗老年晚期NSCLC患者的有效性和安全性。方法：2001年1月至2003年7月，25例未经化疗的晚期非小细胞肺癌患者，年龄bb0 = 70岁（中位76岁，范围70-83岁）。其他标准包括存在可测量的病变，东部肿瘤合作组的表现状态为0或1，器官功能充足。患者在连续3周的第一天接受曲线下面积为5mg /ml/min的卡铂和180 mg/m(2)紫杉醇治疗。结果：IIIB期4例，IV期19例，复发2例。治疗周期的中位数为3个（范围1-4）。1例完全缓解，6例部分缓解，客观缓解率为28%。中位生存时间为12.3个月，1年生存率为52%。3级或4级的血液学毒性包括白细胞减少（40%）、中性粒细胞减少（68%）和贫血（4%）。3级非血液学毒性包括关节痛-肌痛（16%）和神经病变（12%）。年龄>= 75岁的患者（n = 15）的客观缓解率为26%，与年龄< 75岁的患者相比，这些患者没有明显的过度毒性证据。结论：这些剂量的卡铂-紫杉醇联合治疗适合老年晚期NSCLC患者，是一种可行的治疗方案，具有良好的毒性。
Background: More than 30% of cases of non-small cell lung cancer (NSCLC) arise in patients aged >= 70 years. The efficacy and safety of carboplatin-paclitaxel combination chemotherapy in elderly patients with advanced NSCLC were evaluated in a phase II trial.Methods: Twenty-five patients aged >= 70 years (median, 76; range, 70-83) with chemotherapy-naive advanced NSCLC were enrolled between January 2001 and July 2003. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Patients received carboplatin at an area under the curve of 5 mg/ml/min and paclitaxel at 180 mg/m(2) on the first day of consecutive 3 week periods.Results: The patients included four with stage IIIB, 19 with stage IV and two with recurrent disease. The median number of treatment cycles was three (range, 1-4). One complete response and six partial responses, yielding an objective response rate of 28%, were obtained. The median survival time was 12.3 months and the 1-year survival rate was 52%. Hematological toxicities of grade 3 or 4 included leukopenia (40%), neutropenia (68%) and anemia (4%). Non-hematological toxicities of grade 3 included arthralgia-myalgia (16%) and neuropathy (12%). The objective response rate for patients aged >= 75 years (n = 15) was 26%, and no evidence of excessive toxicity in these patients was apparent compared with those aged < 75 years.Conclusion: The combination carboplatin-paclitaxel at these doses is a feasible treatment option with a favorable toxicity profile for fit elderly patients with advanced NSCLC.