SECOND LINE THERAPY IN ELDERLY PATIENTS WITH NSCLC

Eur Respir J. 2013 Oct 10. [Epub ahead of print]

Second-line therapy in elderly patients with advanced non-small cell lung carcinoma: analysis of the IFCT-0501 Phase III study comparing single-agent therapy to carboplatin-based doublet therapy with fixed second-line erlotinib therapy.

Quoix E, Westeel V, Moreau L, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Sennelart H, Tredaniel J, Mennecier B, Morin F, Baudrin L, Milleron B, Zalcman G; on behalf of Intergroupe Francophone de CancérologieThoracique.

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Abstract

There is no dedicated study on second-line treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). We report the results on second-line erlotinib therapy from our previously published Phase III study comparing single-agent therapy withplatin-based doublet (carboplatin + paclitaxel) therapy in 451elderly patients.Erlotinib was given to patients exhibiting disease progression (PD) or experiencing excessive toxicity during first-line therapy, until further PD or non-acceptable toxicity.In total, 292 (64.7%) patients received erlotinib in second-line. Initial performance status (PS) 0-1, Stage IV NSCLC, and ADL6 were independent factors for receiving erlotinib. Median overall survival was 4 months (95% CI: 3.2-6.7) vs. 6.8 months (95% CI: 5.0-8.3) in single-agent arm and doublet arm, respectively(p=0.089). PS 0-1, never-smoking, adenocarcinoma, and weight loss ≤5% were favorable independent prognostic factors of survival, whereas the randomization arm had no significant impact. Among the 292 patients who received erlotinib, 60 (20.5%) experienced Grade 3-4 toxic effects, the most frequent beingrash.Erlotinib as second-line therapy is feasible, leading to efficacy results similar to those obtained in a previous randomized study that was not dedicated to elderly patients, with acceptable toxicity.