Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504
Jacques Cadranel, Radj Gervais, Patrick Merle, Denis Moro-Sibilot, Virginie Westeel, Laurence Bigay-Game, Elisabeth Quoix, Sylvie Friard, Fabrice Barlesi, Claire Lethrosne, Lionel Moreau, Isabelle Monnet, Mathieu Salaun, Gérard Oliviero, Pierre-Jean Souquet, Martine Antoine, Alexandra Langlais, Franck Morin, Marie Wislez, Gérard Zalcman, Intergroupe Francophone de Cancérologie Thoracique (IFCT), Nathalie Baize, Jean-François Morere, Dominique Paillotin, Pierre Mourlanette, Laure Gautier-Felizot, Chrystèle Locher, Michel Poudenx, Daniel Coëtmeur, Pierre Fournel, Saint-Priest en Jarez, Youcef Douadi, Clarisse Audigier-Valette, Philippe Brun, Didier Debieuvre, Patrick Chatellain, Jean-Luc Breton, François Guichard, Alain Vergnenegre, Maurice Perol, Patrice Ray, Bernard Lebeau, Gislaine Fraboulet, Lidia Petit, Alain Prevost, Marielle Sabatini, Philippe Richard, Eric Pichon, Jacques Cadranel, Radj Gervais, Patrick Merle, Denis Moro-Sibilot, Virginie Westeel, Laurence Bigay-Game, Elisabeth Quoix, Sylvie Friard, Fabrice Barlesi, Claire Lethrosne, Lionel Moreau, Isabelle Monnet, Mathieu Salaun, Gérard Oliviero, Pierre-Jean Souquet, Martine Antoine, Alexandra Langlais, Franck Morin, Marie Wislez, Gérard Zalcman, Intergroupe Francophone de Cancérologie Thoracique (IFCT), Nathalie Baize, Jean-François Morere, Dominique Paillotin, Pierre Mourlanette, Laure Gautier-Felizot, Chrystèle Locher, Michel Poudenx, Daniel Coëtmeur, Pierre Fournel, Saint-Priest en Jarez, Youcef Douadi, Clarisse Audigier-Valette, Philippe Brun, Didier Debieuvre, Patrick Chatellain, Jean-Luc Breton, François Guichard, Alain Vergnenegre, Maurice Perol, Patrice Ray, Bernard Lebeau, Gislaine Fraboulet, Lidia Petit, Alain Prevost, Marielle Sabatini, Philippe Richard, Eric Pichon
Abstract
The IFCT-0504 phase II trial evaluated the efficacy of erlotinib versus carboplatin-paclitaxel (CP) as first-line treatment in 130 cases of advanced lepidic-predominant adenocarcinoma (ADC).The primary objective of the study was treatment efficacy, evaluated based on an end-point of disease control at 16 weeks.The primary objective was met, with a disease control in 35 (53%) out of 66 patients treated with CP and in 25 (39.1%) out of 64 patients treated with erlotinib. Median progression-free survival (PFS) for the total population was 3.6 months. The disease control rate did not differ between either the therapeutic arms or pathological subtypes, whereas there was a strong interaction between treatment arms and tumour pathological subtypes for PFS (p=0.009). Mucinous tumour patients treated with erlotinib exhibited an increased progression risk (hazard ratio 3.4, 95% CI 1.7-6.5; p≤0.001). The PFS for nonmucinous tumour patients was similar in both arms. Median overall survival was 20.1 months and did not differ between therapeutic arms. These findings were not further elucidated by molecular analyses and the toxicity profiles were as expected.Our study demonstrated the dominant role of CP alongside erlotinib in the management of advanced lepidic ADC. Based on these findings, erlotinib should not be administered in first-line therapy to patients with lepidic ADC in the absence of an epidermal growth factor receptor mutation.
Trial registration: ClinicalTrials.gov NCT00384826.
Copyright ©ERS 2015.
Source: PubMed