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

Abstract Lipoplatin™ 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 end-point 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/m2 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 un-derstand the real therapeutic activity of lipoplatin.