Lipoplatin ™ Monotherapy: A Phase II Trial of Second-Line Treatment of Metastatic Non-Small-Cell Lung Cancer

Lipoplatin (TM) is a liposome encapsulated form of cisplatin. Phase I studies on Lipoplatin have demonstrated that the compound has an excellent toxicity profile. Therefore we performed a phase II trial in heavily pre-treated patients with advanced non-small-cell lung cancer (NSCLC), performance status 0-2 in which the primary endpoint was response rate and secondary endpoints were safety and overall survival. Nineteen patients, average age 64 years old, with stage IV NSCLC, were treated with Lipoplatin 100 mg/m(2) every two weeks, as second line chemotherapy. We observed 1 partial remission (5.2%) and 3 stable diseases (15.9%). Time to progression (TTP) was 16 weeks and median overall survival (OS) was 31 weeks (7.2 months). We observed G1-G2 toxicity during chemotherapy, mainly gastrointestinal with nausea and vomiting (4 patients), asthenia (3 patients), mucositis (2 patients) and anemia (4 patients). Our phase II study does not support a more extensive use of Lipoplatin in phase III studies. An increase of dosage and a better selection of patients are mandatory to understand the real therapeutic activity of Lipoplatin.