A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic Non-Small Cell Lung Cancer
A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic Non-Small Cell Lung Cancer
复制标题
DOI：
10.1186/1471-2407-10-633
复制
发表时间：
2010-11-19
期刊：
影响因子：
3.8
通讯作者：
Georgoulias, Vassilis
中科院分区：
文献类型：
--
作者：
Pallis, Athanasios G.;Agelaki, Sophia;Georgoulias, Vassilis
背景资料：比较多西他赛/卡铂（DC）双药方案与多西他赛（D）单药方案二线治疗晚期非小细胞肺癌（NSCLC）的疗效和毒性。（多西他赛50 mg/m（2）;卡铂AUC 4;两种药物均在第1天和第15天给药）或多西他赛单药（D），结果：两组的缓解率相似（DC vs D：10.4% vs 7.7%; p = 0.764）。DC组和D组的中位随访时间分别为28.0个月和34.5个月后，DC组的无进展生存期（PFS）显著更高（DC vs D：3.33个月vs 2.60个月; p值= 0.012），而总生存期（OS）无显著差异（DC vs D：10.3个月vs 7.70个月; p值= 0.550）。化疗耐受性良好，III/IV级毒性相对少见。结论：本研究尚未实现其主要目标，即在未接受一线多西他赛治疗的患者中，多西他赛/卡铂联合治疗较单药多西他赛显著延长OS;然而，多西他赛/卡铂联合治疗在PFS方面具有显著的临床获益。
Background: To compare the activity and toxicity of docetaxel/carboplatin (DC) doublet vs single agent docetaxel (D) as second-line treatment in patients with advanced non-small cell lung cancer (NSCLC).Methods: Patients pre-treated with front-line platinum-free regimens, were randomized to receive either docetaxel/carboplatin (DC), (docetaxel 50 mg/m(2); carboplatin AUC4; both drugs administered on days 1 and 15) or docetaxel single-agent (D), (docetaxel 50 mg/m(2) on days 1 and 15).Results: Response rate was similar between the two arms (DC vs D: 10.4% vs 7.7%; p = 0.764). After a median follow-up time of 28.0 months for DC arm and 34.5 months for D arm, progression free survival (PFS) was significantly higher in the DC arm (DC vs D:3.33 months vs 2.60 months; p-value = 0.012), while no significant difference was observed in terms of overall survival (OS) (DC vs D: 10.3 months vs 7.70 months; p-value = 0.550). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed.Conclusions: This study has not achieved its primary objective of significant OS prolongation with docetaxel/carboplatin combination over single-agent docetaxel in patients who had not received front-line docetaxel; however, the docetaxel/carboplatin combination was associated with a significant clinical benefit in terms of PFS.