Is Lipoplatinum Monotherapy An Active Alternative In Second Line Treatment Of Metastatic Non-Small Cell Lung Cancer? A Phase Ii Trial

Lipoplatin is a liposome encapsulated form of cisplatin, Phase I studies on Lipoplatin showed an excellent toxicity profile of the compound. Therefore we performed a phase It trial in heavily pre-treated patients with advanced non-small cell lung cancer (NSCLC).This was an open label single-arm trial in patients with NSCLC with stage IV disease already pre-treated with first line chemotherapy. 63% of these patients were pre-treated with platinum containing regimens. Statistical analysis was performed with the SPSS statistical program (version 11.0). Survival curves were estimated by the Kaplan Meyer method. We administered Lipoplatin at the dose of 100mg/m(2) every 14 days as second line chemotherapy. The primary endpoint was the response rate. The secondary endpoints were safety, time to progression and overall Survival.Nineteen patients with stage IV NSCLC, the median age being 64 were treated. Fifteen patients completed at least six cycles and were evaluated for response and toxicity. Four patients completed one cycle of therapy and were evaluated only for toxicity. We obtained one partial response (5.2%) and three stable diseases (15.9%)). Median time to progression was 4 months and median survival time was 7.2 months.In this study lipoplatin as second line treatment showed a lower activity in comparison to other drugs, but the same overall survival. New phase H studies with escalation of the dosage should be considered.