Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer

摘要: This phase II study evaluated the response rate and tolerability of gemcitabine–oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage IIIB or IV NSCLC received gemcitabine 1000 mg m−2 on days 1 8, followed by oxaliplatin 130 mg m−2 day 1. Cycles were repeated every 21 for up to six cycles. From February 2002 May 2004, 60 enrolled into seven Italian institutions. We observed one complete (1.7%) 14 partial responses (23.3%), an overall 25.0% (95% confidence interval, 14.7–37.9%). The median duration was 5.9 months (range 1.5–17.1 months). With a follow-up 6.7 months, time progressive disease survival 2.7 1.9–3.4 months) 7.3 7.2–8.6 months), respectively. main grade 3–4 haematological toxicities transient neutropenia 11.7% thrombocytopenia 8.3% Nausea/vomiting nonhaematological toxicity, occurring 10.0% Two (3.3%) developed 3 neurotoxicity. Our results show that is active well tolerated advanced NSCLC, deserving further study, especially not eligible receive cisplatin.