A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03)

Gaafar, Rabab M.; Surmont, Veerle F.; Scagliotti, Giorgio V.; Van Klaveren, Rob J.; Papamichael, Demetris; Welch, John J.; Hasan, Baktiar; Torri, Valter; van Meerbeeck, Jan P.

doi:10.1016/J.EJCA.2011.06.045

Title

A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03)

Author

Gaafar, Rabab M.

Surmont, Veerle F.

Scagliotti, Giorgio V.

Van Klaveren, Rob J.

Papamichael, Demetris

Welch, John J.

Hasan, Baktiar

Torri, Valter

van Meerbeeck, Jan P.

Institution/Organisation

EORTC Lung Cancer Group

Italian Lung Cancer Project

Abstract

Background: EORTC study 08021/ILCP 01/03 evaluated the role of consolidation gefitinib, an oral tyrosine kinase inhibitor (TKI), administered in patients with advanced non-small cell lung cancer (NSCLC), not progressing following standard 1st-line chemotherapy. Methods: Patients with advanced NSCLC, not-progressing after four cycles of platinum-based chemotherapy, were randomised to receive either gefitinib 250 mg/d or matched placebo until progression or unacceptable toxicity. The primary end-point was overall survival (OS). Secondary end-points were progression-free survival (PFS) and toxicity. The study was powered to detect a 28% increase in OS from a median of 11-14.1 months (HR = 0.78) and planned to randomise 598 patients to observe 514 deaths. Results: After inclusion of 173 patients, the trial was prematurely closed due to low accrual. Baseline characteristics for gefitinib (n = 86) and placebo (n = 87) arms were well balanced. After a median follow up of 41 months, the difference in median OS in the gefitinib and placebo arms was not statistically significant (10.9 and 9.4 months, HR 0.83 [95% confidence interval (95% CI) 0.60-1.15]; p = 0.2). The difference in median PFS significantly favoured gefitinib (4.1 and 2.9 months, HR = 0.61, [95% CI 0.45, 0.83]), p = 0.0015). Adverse events reported in more than 10% of patients were rash (47% with gefitinib versus 13% with placebo) and diarrhoea (34% with gefitinib versus 13% with placebo). Conclusions: Despite its premature closure, this trial confirms previous evidence that consolidation gefitinib is safe and improves PFS. However, no difference in OS was observed in this study (NCT00091156). (C) 2011 Elsevier Ltd. All rights reserved.

Language

English

Source (journal)

European journal of cancer. - Oxford, 1990, currens

Publication

Oxford : 2011

ISSN

0959-8049 [print]

1879-0852 [online]

DOI

10.1016/J.EJCA.2011.06.045

Volume/pages