Isabelle Monnet1, Clarisse Audigier-Valette2, Nicolas Girard3, Alain Vergnenègre4, Olivier Molinier5, Pierre Jean Souquet6, François Blanchon7, Franck Bonnetain8, Naila Taguieva-Pioger9, Corinne Lamour10, Marie Wislez11. 1. Centre Hospitalier Intercommunal de Créteil, Créteil, France. Electronic address: isabelle.monnet@chicreteil.fr. 2. Centre Hospitalier Sainte Musse, Toulon, France. 3. Hôpital Louis Pradel, Institut de Cancérologie des Hospices Civils de Lyon, Bron, France. 4. Centre Hospitalier Universitaire Dupuytren, Limoges, France. 5. Centre Hospitalier du Mans, Le Mans, Cedex 9 France, France. 6. Centre Hospitalier Lyon-Sud, Pierre Bénite, France. 7. Centre Hospitalier de Meaux, Meaux, France. 8. Centre Hospitalier Régional Universitaire, Besançon, France. 9. Roche France S.A.S, Boulogne-Billancourt, France. 10. Centre Hospitalier Universitaire de Poitiers, Poitiers, France. 11. Service de Pneumologie Hôpital Tenon, 4 Rue de la Chine, 75020 Paris, France.
Abstract
OBJECTIVES: Erlotinib, an inhibitor of tyrosine kinase activity of the epidermal growth factor receptor, is effective in non-small cell lung cancer (NSCLC). Data on erlotinib use in squamous NSCLC are limited. This observational study aimed at evaluating the efficacy and safety of second-line erlotinib in patients with stage IIIB/IV squamous NSCLC in a real-life setting. MATERIAL AND METHODS: Patients with predominantly squamous stage IIIB/IV NSCLC, who failed first-line platinum-based therapy, were recruited and followed-up for 12 months. Patients underwent visits each trimester. Data were derived from case report forms, and functional assessment of cancer therapy-lung (FACT-L) questionnaires. RESULTS: A total of 152 patients were enrolled; the majority were males (90%) and mean age was 67.7 years. All patients had squamous (97%) or predominantly squamous (3%) NSCLC, of stage IIIB (21%) or IV (79%). Median progression free survival (PFS) and overall survival were 3 and 5.8 months, respectively. Disease progression was observed in the majority of the patients, mostly due to progression of primary tumour and/or metastatic sites, and led to death in 91/107 of patients. Of the 107 deaths reported, none were due to erlotinib. FACT-L questionnaires were interpretable up to the first visit and were in line with PFS data, showing a relatively good quality of life up to Month 3 (mean total score=78.8). No new or unexpected safety issues were reported. CONCLUSIONS: The results of this real-life cohort study like those of previous phase III/IV subgroups study analyses indicate that erlotinib is a valuable option for second-line treatment of stage IIIB/IV squamous NSCLC.
OBJECTIVES:Erlotinib, an inhibitor of tyrosine kinase activity of the epidermal growth factor receptor, is effective in non-small cell lung cancer (NSCLC). Data on erlotinib use in squamous NSCLC are limited. This observational study aimed at evaluating the efficacy and safety of second-line erlotinib in patients with stage IIIB/IV squamous NSCLC in a real-life setting. MATERIAL AND METHODS:Patients with predominantly squamous stage IIIB/IV NSCLC, who failed first-line platinum-based therapy, were recruited and followed-up for 12 months. Patients underwent visits each trimester. Data were derived from case report forms, and functional assessment of cancer therapy-lung (FACT-L) questionnaires. RESULTS: A total of 152 patients were enrolled; the majority were males (90%) and mean age was 67.7 years. All patients had squamous (97%) or predominantly squamous (3%) NSCLC, of stage IIIB (21%) or IV (79%). Median progression free survival (PFS) and overall survival were 3 and 5.8 months, respectively. Disease progression was observed in the majority of the patients, mostly due to progression of primary tumour and/or metastatic sites, and led to death in 91/107 of patients. Of the 107 deaths reported, none were due to erlotinib. FACT-L questionnaires were interpretable up to the first visit and were in line with PFS data, showing a relatively good quality of life up to Month 3 (mean total score=78.8). No new or unexpected safety issues were reported. CONCLUSIONS: The results of this real-life cohort study like those of previous phase III/IV subgroups study analyses indicate that erlotinib is a valuable option for second-line treatment of stage IIIB/IV squamous NSCLC.