A phase II trial of lipoplatin and gemcitabine in patients with NSCLC previously treated with platinum-based chemotherapy

Background: A phase I trial 1 of lipoplatin and gemcitabine (1000 mg/m 2 D 1,8) in pretreated NSCLC patients has established the maximum tolerated dose (MTD) of lipoplatin at 120mg/m 2 on D 1,8. The purpose of this phase II study was to determine the efficacy and safety of the same combination when administered in patients with advanced NSCLC after platinum-based 1st line treatment. Methods: Forty-five patients with advanced NSCLC, after first line platinum-based treatment, were treated with lipoplatin 120mg/m 2 and gemcitabine 1000mg/m 2 on D 1 and 8 repeated every 3 weeks. All were assessable for response and toxicity according to the WHO criteria. Results: Overall disease control was achieved in 13 patients (28.9%): 9 patients (20%) showed partial response and 4 (8.9%) stable disease. Median overall survival (OS) was 22 weeks ( range: 3-72) and median time to tumor progression (TTP) was 10 weeks (range: 3-50). There was a significant difference in OS (p=0.0048) and TTP (p=0.0009) between responders and non-responders. Grade 4 neutropenia was observed in 3 patients (6.6%), vomiting in 3, thrombocytopenia in 1 (2.2%) and another 1 developed severe allergic reaction. We concluded that this combination of lipoplatin and gemcitabine showed interesting results and therefore needs to be studied further in phase III trials, considering that our NSCLC patients were previously treated with platinum combinations. 1. Froudarakis M, Pataka A, Pappas P et al: Cancer 2008;113:2752-60.