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.
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.
Authors: Suresh S Ramalingam; Ju-Whei Lee; Chandra P Belani; Seena C Aisner; Jill Kolesar; Craig Howe; Mario R Velasco; Joan H Schiller Journal: J Clin Oncol Date: 2011-03-21 Impact factor: 44.544
Authors: Suresh S Ramalingam; Angela M Davies; Jeffrey Longmate; Martin J Edelman; Primo N Lara; Everett E Vokes; Miguel Villalona-Calero; Barbara Gitlitz; Karen Reckamp; Ravi Salgia; John J Wright; Chandra P Belani; David R Gandara Journal: J Thorac Oncol Date: 2011-10 Impact factor: 15.609
Authors: Dirk Van Raemdonck; Robin Vos; Jonas Yserbyt; Herbert Decaluwe; Paul De Leyn; Geert M Verleden Journal: J Thorac Dis Date: 2016-11 Impact factor: 2.895