Phase II study of erlotinib plus gemcitabine in first-line treatment of poor prognosis, advanced non-small cell lung cancer patients

Purpose: The purpose of the present trial was to investigate whether clinical benefit can be obtained by concurrent administration of erlotinib with gemcitabine as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) and ECOG performance status (PS) 2. Methods: Included were chemotherapy-naive patients with histologically/cytologically documented unresectable advanced and/or metastatic (stage IIIB/IV) NSCLC and ECOG PS 2. In this phase II, single-arm study, all patients received first-line gemcitabine plus erlotinib for 6 cycles or until disease progression, unacceptable toxicity or patient withdrawal due to any reason. The primary study objectives were the evaluation of disease response and the time to progression. Secondary objectives included evaluation of overall survival and the safety profile of gemcitabine plus erlotinib. Results: Nineteen eligible patients were studied. The overall response rate (complete response/CR and partial response/PR) was 15.8% and the clinical benefit rate (CR+PR+stable disease/SD) 36.84%. The median overall survival for the whole study group was 39 weeks (95% CI 27-51) and the median time to disease progression for 19 evaluable patients was 15 weeks (95% CI 7-36). The safety profile of the combination was acceptable with only 2 serious adverse events. Conclusion: Taking into account similar published clinical studies we conclude that gemcitabine plus erlotinib achieve superior response rate and comparable overall survival with acceptable toxicity compared to mono-chemotherapy with gemcitabine. This combination represents a treatment option for patients with advanced NSCLC and ECOG PS 2.