Biweekly docetaxel and gemcitabine as first line chemotherapy in advanced non-small cell lung cancer (NSCLC)

Abstract

18147 Background: The activity and tolerability of third-generation agents led many investigators to evaluate doublet combinations in the hope that platinum analogues could be eliminated from the treatment of advanced NSCLC. To improve the therapeutic index of this combination, we performed a study with biweekly gemcitabine and docetaxel. Primary objective was determination of objective response rate (ORR). Secondary objectives were time to progression, tolerability and overall survival. Methods: Patients histologically confirmed of non-small cell lung cancer, aged ≥ 18, ECOG PS 0–2, measurable lesion according RECIST criteria, adequate bone marrow, renal and hepatic function were included. Prior chemotherapy was not allowed. Patients received treatment with a combination of Docetaxel 50 mg/m2 and gemcitabine 20,00 mg/m2 each 15 days for a maximum of 8 cycles. Results: Fifty patients were included between July 2005 and October 2006.Now we present the results of the first 32 patients: 88% were male, median age was 62.7 years old, 69% had ECOG 0–1 and 81% of patients had stage IV. Histology was squamous cell carcinoma (53%) adenocarcinoma (31%) and large cell carcinoma (16%). A total 221 cycles were administrated . Over 30 patients evaluable for response, none achieved CR, 11 PR (36%), 7 SD (23%) and 12 PD, with an overall response rate of 36%. Median follow up of patients is 16 months, with a median overall survival of 9 months. Grade 3–4 toxicity per patient was: neutropenia (6%).Grade 1–2 toxicity per patient asthenia (75%), and nauseas (30%). Conclusions: These results suggest that biweekly schedule of gemcitabine / docetaxel is a safe and active regimen in first line advanced NSCLC patients.Updated results will be presented. No significant financial relationships to disclose.