title: Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504.
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.
authors.affiliation: Dept of Pneumology, APHP Hôpital Tenon and Pierre et Marie Curie Université Paris 6, Paris, France jacques.cadranel@tnn.aphp.fr.
authors.forename: Jacques
authors.initials: J
authors.lastname: Cadranel
authors.affiliation: Centre François Baclesse, Caen, France.
authors.forename: Radj
authors.initials: R
authors.lastname: Gervais
authors.affiliation: Dept of Pneumology-Thoracic Oncology, CHU Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Merle
authors.affiliation: Dept of Thoracic Oncology, PCMAC, CHU Grenoble and INSERM U 823, CS10217, Grenoble, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Moro-Sibilot
authors.affiliation: Dept of Pneumology, CHU Besançon, Besançon, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.affiliation: Dept of Pneumology, Hôpital Larrey, Toulouse, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Bigay-Game
authors.affiliation: Dept of Pneumology, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
authors.affiliation: Dept of Pneumology, Hôpital Foch, Suresnes, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Friard
authors.affiliation: Aix Marseille Université, Assistance Publique Hôpitaux de Marseille, Multidisciplinary Oncology and Therapeutic Innovation Unit, Hôpital Nord, Centre d'investigation clinique, Marseille, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlesi
authors.affiliation: Dept of Pneumology, Centre hospitalier, Chartres, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Lethrosne
authors.affiliation: Dept of Pneumology, CHG de Colmar, Hôpital Louis Pasteur, Colmar, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Moreau
authors.affiliation: Dept of Pneumology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Monnet
authors.affiliation: Dept of Pneumology, CHU Charles Nicolle, Rouen, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Salaun
authors.affiliation: Dept of Pneumology, CHG, Longjumeau, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Oliviero
authors.affiliation: Dept of Pneumology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.affiliation: Dept of Anatomo-pathology, Hôpital Tenon, Paris, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Antoine
authors.affiliation: IFCT, Paris, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Langlais
authors.affiliation: IFCT, Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Morin
authors.affiliation: Dept of Pneumology, APHP Hôpital Tenon and Pierre et Marie Curie Université Paris 6, Paris, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Wislez
authors.affiliation: Dept of Pneumology and Thoracic Oncology, CHU Caen, Côte de Nacre, Caen, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Zalcman
mesh_terms: D002282:Adenocarcinoma, Bronchiolo-Alveolar / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D015415:Biomarkers / Q000032:analysis; D016190:Carboplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D016190:Carboplatin; D000069347:Erlotinib Hydrochloride; D017239:Paclitaxel