Phase II study of carboplatin, irinotecan, and thalidomide in patients with advanced non-small cell lung cancer
Phase II study of carboplatin, irinotecan, and thalidomide in patients with advanced non-small cell lung cancer
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DOI：
10.1097/01243894-200610000-00012
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发表时间：
2006-10-01
影响因子：
20.4
通讯作者：
Bearden, James D.
中科院分区：
文献类型：
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作者：
Miller, Antonius A.;Case, Doug;Bearden, James D.
背景：我们假设沙利度胺可以改善卡铂和伊立替康化疗的疗效和毒性。方法：关键的合格标准是IIIB期(恶性胸腔积液)和IV期非小细胞肺癌、可测量的疾病、既往没有化疗、既往仅对脑转移进行放射治疗、功能状态为0或1、以及血液、肝和肾功能良好。治疗包括卡铂在曲线下的计算面积，第1天静脉滴注30min，伊立替康50 mg/m(2)静脉滴注，第1天，第8天，每21天静脉滴注90min。从第一天开始每晚口服沙利度胺，直到病情进展；起始剂量为每天200毫克，如果耐受，每周递增100毫克(每天最大剂量为1000毫克)。研究的目标是确定有效率、进展时间、总生存期和毒副作用。结果：共有46名患者入选，但3名从未接受过方案治疗的患者被排除在分析之外。符合条件并接受治疗的43例患者中，年龄中位数63岁(47~79岁)，男女比例13/30，黑/白比例3/40，PS 0/1比例10/33，分期3/4比例6/37。客观有效率：完全缓解1例(2%)，部分缓解5例(12%)，稳定24例(56%)，进展9例(21%)，无效4例(9%)。中位进展时间为3.7个月(95%可信区间为2.5-4.9)。中位生存期8.1个月(95%CI，5.0~12.9)。常见的毒副作用是中性粒细胞减少、疲倦/不适和恶心/呕吐。结论：卡铂、伊立替康、沙利度胺治疗方案可耐受，主要毒性为可逆性中性粒细胞减少，仅有少量腹泻。总体应答率没有达到我们预定的疗效水平，值得进一步研究。
Background: We hypothesized that thalidomide would improve the response and toxicity profile of chemotherapy with carboplatin and irinotecan.Methods: The key eligibility criteria were stage IIIB (malignant pleural effusion) and IV non-small cell lung cancer, measurable disease, no prior chemotherapy, prior radiation only for brain metastasis, performance status 0 or 1, and adequate hematologic, hepatic, and renal function. Treatment consisted of carboplatin at a calculated area under the curve of 5 and infused intravenously for 30 min on day 1 and irinotecan (50 mg/m(2) intravenously for 90 min on days 1 and 8 every 21 days). Thalidomide was given orally every evening starting on day I until progressive disease; the starting dose was 200 mg per day, which was escalated by 100 mg per week if tolerated (maximum 1000 mg per day). The objectives were to determine the response rate, time to progression, overall survival, and toxicity profile.Results: In all, 46 patients were enrolled, but three who never received protocol treatment were excluded from the analysis. The characteristics of the 43 eligible and treated patients included median age 63 (47-79), female/male 13/30, black/white 3/40, PS 0/1 in 10/33, and stage 3/4 in 6/37. The objective response rates were complete response 1 (2%), partial response 5 (12%), stable disease 24 (56%), progressive disease 9 (21%), and unevaluable for response 4 (9%). The median time to progression was 3.7 months (95% confidence interval [CI], 2.5-4.9). The median survival time was 8.1 months (95% Cl, 5.0-12.9). Frequent toxicities were neutropenia, fatigue/malaise, and nausea/vomiting. Diarrhea was uncommon and mild.Conclusions: This treatment regimen of carboplatin, irinotecan, and thalidomide was tolerable, with reversible neutropenia as the major toxicity and only minor diarrhea. The overall response rate did not meet our predetermined level of efficacy to merit further investigation.