Second-line Paclitaxel/Carboplatin Versus Vinorelbine/Carboplatin in Patients Who Have Advanced Non¨CSmall-Cell Lung Cancer Pretreated With Non¨CPlatinum-Based Chemotherapy: A Multicenter Randomized Phase II Study

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• 作者：Athanasios G. Pallis ; Kostas Syrigos ; Athanasios Kotsakis ; Niki Karachaliou ; Aris Polyzos ; Vassilis Chandrinos ; Ioannis Varthalitis ; Charalambos Christophyllakis ; Alexandros Ardavanis ; Lambros Vamvakas ; Nikolaos Vardakis ; Zacharenia Saridaki ; George Samonis ^{georgsec@med.uoc.gr} ; Stylianos Giassas ; Vassilis Georgoulias ; Sophia Agelaki ; ^{agelaki@med.uoc.gr}
• 关键词：Anemia ; Docetaxel/gemcitabine ; PC ; Stage IV disease ; Thrombocytopenia ; VC
• 刊名：Clinical Lung Cancer
• 出版年：2011
• 出版时间：March 2011
• 年：2011
• 卷：12
• 期：2
• 页码：100-105
• 全文大小：361 K

文摘

Purpose

This study evaluates the activity and toxicity of the paclitaxel/carboplatin (PC) doublet versus vinorelbine/carboplatin (VC) doublet as second-line treatment in patients who have advanced non¨Csmall-cell lung cancer (NSCLC).

Patients and Treatment

Patients pretreated with front-line docetaxel and gemcitabine were randomized to receive either PC (n = 75), which consisted of paclitaxel at a dose of 140 mg/m² and carboplatin area under the curve (AUC3), or VC (n = 78), which consisted of vinorelbine at a dose of 45 mg/m² orally and carboplatin AUC3; both drugs were administered on days 1 and 15.

Results

The overall response rate was 18.6 % (95 % confidence interval, 9.85 % -27.49 % ; one complete and 13 partial responses) in the PC arm and 7.7 % (95 % confidence interval, 1.78 % -13.61 % ; one complete and five partial responses) in the VC arm (P = .056). Median time to tumor progression was 3.5 months (range, 0.3 - 23.73 months) and 3.07 months (range, 0.37-18.5) in the PC and VC arm, respectively (P = .287). Median overall survival was 7.83 months (range, 0.3-45.03 months) and 7.60 months (range, 0.5-30.27 months) for PC and VC arms, respectively (P value = .633). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed.

Conclusions

Platinum-based doublets with either paclitaxel or vinorelbine in patients with advanced/metastatic NSCLC pretreated with front-line docetaxel/gemcitabine show comparable efficacy when used in the second-line setting.