Open Access Research article

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

Athanasios G Pallis1, Sophia Agelaki1, Athina Agelidou1, Ioannis Varthalitis1, Kostas Syrigos1, Nikolaos Kentepozidis1, Georgia Pavlakou1, Athanasios Kotsakis1, Emmanouel Kontopodis1 and Vassilis Georgoulias12*

Author Affiliations

1 Hellenic Oncology Research Group (HORG), 55 Lombardou str., 114 74 Athens, Greece

2 Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box: 1352, Heraklion 71110, Crete, Greece

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BMC Cancer 2010, 10:633  doi:10.1186/1471-2407-10-633

Published: 19 November 2010

Abstract

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/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).

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.