Lipoplatin monotherapy: A phase II trial in second line treatment of metastatic non-small cell lung cancer

Abstract

18160 Background: 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 II trial in pre-treated patients with advanced non-small cell lung cancer (NSCLC). Methods: Nineteen patients with stage IV NSCLC pre-treated with first line chemotherapy were enrolled in our study. Patient selection criteria included: histologically confirmed malignancy type or cytological confirmation of advanced NSCLC, at least one measurable bi-dimensional lesion outside an irradiation field, stage IV disease, a life expectancy of more than 3 months, previous chemotherapy regimens, PS 0–2, age between 18 and 75, good bone marrow function (peripheral absolute granulocyte count of > 2,000/mm3 and platelet count of 100,000/mm3) and liver function (bilirubine less or equal to 1,5 mg/dl). Patients with symptomatic brain metastases or other severe illnesses were excluded from the study. Written informed consent was required from each patient prior to inclusion. The protocol was approved by the Local Ethical Commitee. We administered lipoplatin at the dose of 100 mg/m2 every fourteen days as second line chemotherapy. Primary endpoint was response rate. Results: We enrolled 19 patients, median age 64, with stage IV NSCLC. This was an open label single-arm trial. Statistical analysis was performed with the SPSS statistical program (version 11.0). Survival curves were estimated by the Kaplan-Meier method. All of the patients completed at least 6 cycles and were evaluated for response and toxicity. After 19 patients were treated we obtained only one partial response (5.2%) and three stable diseases (15.9%) and the study was stopped. Median time to progression was four months and median survival time was 7 months. Conclusions: In this study lipoplatin as second line drug demonstrated a lower activity in comparison to other drugs used in second line treatment. Nevertheless at the light of the excellent safety profile shown we think that the possibility to increase the dose in a new phase I-II study with escalation of the dosage should be considered. No significant financial relationships to disclose.