Multicenter observational study of erlotinib therapy (OBSTAR) for non small-cell lung cancer: A GFPC study

Abstract Context Erlotinib therapy for non small-cell lung cancer (NSCLC) has mainly been evaluated in randomized trials. Method OBSTAR was a multicenter, retrospective, observational study involving all patients treated with erlotinib in 18 French centers between June 2005 and September 2007. The analyses focused on the patients’ characteristics, previous treatments, and treatment efficacy during a three-year follow-up period. Results 534 patients were included in this study. The median survival times were respectively 5.2 [3.7–7.4] and 4.7 [4.1–5.7] months, depending to whether erlotinib was used as second- ( n = 190), or ≥third-line treatment ( n = 305). The disease control rate were 39.1% [30.2–48.7] and 29.9% [29.6–36.9] according to the line of treatment. Factors predictive of an objective response were gender, age, and smoking status. Factors predictive of progression were age, sex, smoking status, the line of treatment, and the number of metastases. Treatment had to be interrupted for toxicity in 8.5% of cases. Conclusion This study of erlotinib therapy in 2005–2007 confirms, in the general NSCLC patient population, the results of pivotal trials.