Abstract
BackgroundTo 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).MethodsPatients pre-treated with front-line platinum-free regimens, were randomized to receive either docetaxel/carboplatin (DC), (docetaxel 50 mg/m2; carboplatin AUC4; both drugs administered on days 1 and 15) or docetaxel single-agent (D), (docetaxel 50 mg/m2 on days 1 and 15).ResultsResponse 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.ConclusionsThis 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.
Highlights
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)
NSCLC has been substantially improved during the last decade with the introduction of new cytotoxic agents such as gemcitabine, vinorelbine, gemcitabine, paclitaxel, docetaxel and pemetrexed; combination of these agents with a platinum compound represents the standard of care for front-line treatment [4]
Patient demographics From 08/2004 until 03/2008, 67 patients were enrolled in the DC arm and 65 in the D arm
Summary
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). Lung cancer represents a major health problem worldwide. It is the leading cause of cancer-related death in Europe [1], with a 5-year survival of approximately 15% for all stages [2]. Non-Small Cell Lung Cancer (NSCLC) represents approximately 80-85% of all lung carcinomas. The vast majority of patients are diagnosed with advanced, unresectable disease (stage IIIB/IV) which remains incurable with a 5-year survival rate of less than 5% [3]. NSCLC patients will inevitably experience tumor progression and at that time some patients will still have a good Performance Status (PS) and will be suitable for second-line treatment
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