Erlotinib For First Line Treatment In Unselected Patients (P) With Advanced Or Metastatic Non-Small Cell Lung Carcinoma (Nsclc)

7639 Background: Erlotinib is an orally available selective EGFR tyrosine-kinase inhibitor. Erlotinib is approved for the treatment of patients (p) with advanced or metastatic NSCL that have progressed at least to one prior chemotherapy regimen. In certain subgroups erlotinib has demonstrated to be active when administered as first line treatment. We retrospectively analysed efficacy and safety of patients treated with erlotinib as first line included in the Target Study. Methods: The TargeT trial is a multicentric, open-label, non-randomized, phase II study carried out in 101 Spanish institutions. Eligibility criteria included chemonaive p with stage IIIB-IV NSCLC. Subjects were treated with 150 mg/day po until disease progression or unacceptable toxicity. Dose reductions were allowed. Primary end-point was survival. Results: By the time of this interim analysis, data from 437 p treated with erlotinib as first line were available. Median age 72 y (range 26–90). Demographics (%): M/F 59/41; PS0/1/2 19/51/30; pathology adeno 53; current or former smoker 63. In the evaluable population for efficacy best response was: 6 CR, 68 PR, 93 SD, 69 PD (RR 31.35%). Time to progression was 6.6 mo (95% CI 4.8–8.6/ OS 7.1). Overall survival was 7.1 mo (95% CI 5.9–9.1). Most common erlotinib-related adverse events were skin rash (61%) and diarrhea (31.2%) with no unexpected toxicities having been observed. Conclusions: Although at this moment clinical trials are ongoing trying to find the best predicitive factor of response, erlotinib first line was active and well tolerated in this analysis in an unselected population. No significant financial relationships to disclose.