A Phase II Study of the Docetaxel–Carboplatin Chemotherapy Regimen in Advanced Non-Small-Cell Lung Cancer
A Phase II Study of the Docetaxel–Carboplatin Chemotherapy Regimen in Advanced Non-Small-Cell Lung Cancer
复制标题
多西紫杉醇-卡铂化疗方案治疗晚期非小细胞肺癌的 II 期研究
作者：
N. Tsavaris;C. Kosmas;E. Skopelitis;K. Gennatas;A. Zorbala;Paris Papas;P. Gouveris;G. Antypas;S. Rokana;G. Tzelepis
在各种II期研究中研究了紫杉醇-卡铂联合化疗的疗效。基于这些数据，我们的目的是在既往未接受过治疗的晚期非吸烟肺癌（NSCLC）患者中测试多西他赛80 mg/m2（AUC = 5的标准剂量卡铂）的治疗方案，试图在一项开放标签II期研究中确定该组合的疗效和耐受性。组织学确诊的晚期NSCLC IIIB期和IV期患者是本研究的候选人。多西他赛以80 mg/m2静脉（IV）输注1小时，随后在30分钟内静脉输注卡铂，AUC = 5，均在第1天给药，每21天重复一次。60例患者共接受了263个疗程; 231/263例（88%）患者按照计划剂量给药，48/60例（80%）患者接受了化疗，未减量; 32/263例（12%）患者减量10%-30%。完全缓解（CR）5例（8.3%），部分缓解（PR）16例（26.7%），总缓解率为35%。中位缓解持续时间为7.5个月[95%置信区间（CI）-7.1-7.9]，至进展时间（TIP）为11.5个月（95% CI-8.2-14.8），中位总生存期（OS）为15.0个月（95% CI-10.8-19.2）。1年生存率为61.7%。毒性可接受;根据给药周期计算，主要是中性粒细胞减少：3级，9%和4级，2%;贫血：3级，8%;恶心和呕吐：3级，8%。多西他赛-卡铂门诊方案治疗晚期NSCLC有效，毒性可接受。
The efficacy of the docetaxel–carboplatin combination chemotherapy was studied in various phase II studies. Based on these data we aimed to test the regimen in previously untreated patients with advanced advanced non-smoking lung cancer (NSCLC) with docetaxel 80 mg/m2 a standard dose of carboplatin at AUC = 5, in an attempt to define the efficacy and tolerability of the combination in an open-label phase II study. Patients with histologically confirmed advanced NSCLC stage IIIB and IV were candidates for the present study. Docetaxel was administered at 80 mg/m2 over 1 h by intravenous (IV) infusion followed by carboplatin AUC = 5 in 30 min IV infusion, both on day 1, and recycled every 21 days. Sixty patients received 263 courses of therapy in total; 231/263 (88%) were administered according to the planned doses, and 48/60 (80%) patients received chemotherapy without decrement of the dose; 32/263 (12%) of the courses were administered with a 10%–30% dose reduction. Complete responses (CR) were seen in 5 patients (8.3%) and partial responses (PR) in 16 patients (26.7%) for an overall response rate of 35%. Median duration of response was 7.5 months [95% confidence interval (CI)-7.1–7.9], time to progression (TIP) 11.5 months (95% CI-8.2–14.8), median overall survival (OS) 15.0 months (95% CI-10.8–19.2). One-year survival was 61.7%. Toxicity was acceptable; it was calculated according to the administered cycles and was mainly neutropenia: grade 3, 9% and grade 4, 2%; anemia: grade 3, 8%; nausea and vomiting: grade 3, 8%. The outpatient regimen of docetaxel–carboplatin is effective with acceptable toxicity in patients with advanced NSCLC.