IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype
Jacques Cadranel, Elisabeth Quoix, Laurence Baudrin, Pierre Mourlanette, Denis Moro-Sibilot, Jean-François Morere, Pierre-Jean Souquet, Jean-Charles Soria, Franck Morin, Bernard Milleron, IFCT-0401 Trial Group, J Cadranel, P Mourlanette, E Quoix, D Moro-Sibilot, J-F Morére, P-J Souquet, J-C Soria, S Friard, B Lebeau, H Janicot, I Monnet, M Pérol, E Dansin, G Zalcman, A Vergnenégre, D Coëtmeur, A Depierre, G Oliviero, A Le Groumellec, P David, G Fraboulet, E Lemarié, J Le Treut, Y Le Guen, S Chouabe, P Masson, G Robinet, L Thiberville, D Paillotin, J-Y Douillard, R Gervais, Martine Antoine, M-P Lebitasy, S Poulain, E Amour, R Rouveau, N Establier, Jacques Cadranel, Elisabeth Quoix, Laurence Baudrin, Pierre Mourlanette, Denis Moro-Sibilot, Jean-François Morere, Pierre-Jean Souquet, Jean-Charles Soria, Franck Morin, Bernard Milleron, IFCT-0401 Trial Group, J Cadranel, P Mourlanette, E Quoix, D Moro-Sibilot, J-F Morére, P-J Souquet, J-C Soria, S Friard, B Lebeau, H Janicot, I Monnet, M Pérol, E Dansin, G Zalcman, A Vergnenégre, D Coëtmeur, A Depierre, G Oliviero, A Le Groumellec, P David, G Fraboulet, E Lemarié, J Le Treut, Y Le Guen, S Chouabe, P Masson, G Robinet, L Thiberville, D Paillotin, J-Y Douillard, R Gervais, Martine Antoine, M-P Lebitasy, S Poulain, E Amour, R Rouveau, N Establier
Abstract
Purpose: Intergroupe Francophone de Cancérologie Thoracique-0401 phase II trial aimed to evaluate the efficacy and safety of gefitinib as a first-line treatment for patients with adenocarcinoma with bronchioloalveolar carcinoma subtype (ADC-BAC).
Methods: Chemotherapy-naive patients (n = 88) with advanced ADC-BAC were treated with 250 mg/d of gefitinib. The primary objective was assessment of disease control rate (DCR [objective response + stable disease]) at 3 months using World Health Organization criteria. A disease control rate of 25% or greater would be of interest in this patient population. Progression-free survival (PFS), overall survival (OS), and toxicity were the secondary criteria. Clinical and disease characteristics that conferred a favorable prognosis under gefitinib were also analyzed.
Results: Disease control was achieved in 25 patients (29.4%); 11 patients (12.9%) had partial response and 14 (16.4%) had stable disease. Median PFS was 2.9 months (95% confidence interval [CI], 2.3-3.2) and median OS was 13.2 months (95% CI, 10.2-17.3). Never smokers, patients with low respiratory symptoms score, occurrence of cutaneous rash, and nonmucinous ADC-BAC subtype were associated with increased probability of disease control. Nonmucinous ADC-BAC was associated with increased PFS and OS at 3 years. Patients with nonmucinous BAC had longer OS and PFS compared with patients with other ADC-BAC variants; median PFS for nonmucinous BAC was 11.3 months (95% CI, 3.2-14.7), whereas it was 2.6 months (95% CI, 2.1-3) for mucinous BAC. As expected, toxicity was low, with dermatological problems, diarrhea, and nausea being the most common adverse events.
Conclusion: Results from the Intergroupe Francophone de Cancérologie Thoracique-0401 trial demonstrate that gefitinib combines efficacy with low toxicity and is, therefore, suitable as a first-line treatment of advanced ADC-BAC, particularly in patients with nonmucinous BAC subtype.
Source: PubMed