Liposomal cisplatin and paclitaxel versus cisplatin and paclitaxel in advanced NSCLC

Abstract

7684 Background: A new liposomal formulation of Cisplatin has been tested in a phase I and phase II trial in advanced solid tumors as a single agent or in combination with Gemcitabine or paclitaxel. It is a non-myelotoxic and non-nephrotoxic agent. Effectiveness has been shown, in particular when it is combined with a second agent. Objectives, comparison of toxicity, efficacy of liposomal cisplatin (lipoplatin) versus cisplatin both combined with paclitaxel for non-small cell lung cancer patients. It is a preliminary report of the study which is on-going. Methods: From April 2006 till December 2006, 61 patients were recruited. 54 are evaluable for response and toxicity. Were all untreated. Median age 65 (42–80). They were randomized in two arms A and B. Arm A patients -27- were treated with lipoplatin-paclitaxel and Arm B patients -27- with cisplatin-paclitaxel. Arm A: 24 male, 3 female, histology: 10 squamous, 10 adenocarcinomas, 7 undifferentiated. Stage: IIIa 4 patients, IIIb 11 pat., IV 12 pat. Arm B: 25 males, 2 female, histology: 11 squamous, 11 adenocarcinomas, 5 undifferentiated, stage IIIa 2 pat., IIIb 14 pat., IV 11 pat. Arm A Chemotherapy: Lipoplatin 200 mg/m2 Paclitaxel 135 mg/m2 administered on day 1 repeated every 2 weeks. Lipoplatin infused for 8 hours in 5% dextrose 1 lt. Arm B: cisplatin 75 mg/m2 (hydration of 2 lt) and paclitaxel 135 mg/m2, every two weeks. Each day treatment was 1 cycle and the plan was to give 9 cycles per patient unless disease progression was detected before 9th cycle. Results: Response: Arm A: PR: 48.15% SD: 37.03% PD: 3.7% and clinical benefit 11.11%. Arm B: PR 44.44% SD 44.44% PD: 3.7% and clinical benefit 7.41%. Toxicity: Arm A: Renal toxicity in 1 pat. (3.70%) neurotoxicity grade I-II in 7 pat. (25.92%) Nausea-vomit in 5 patients (18.52%) Myelotoxicity Grade I-II in 10 pat. (37.04%). Arm B: Renal toxicity in 7 pat. (25.92%), Neurotoxicity Grade I-III in 12 pat. (44.44%) Nausea-vomit in 7 pat. (25.92%) Myelotoxicity Grade I-III in 17 pat. (62.96%). Conclusions: Preliminary results showed liposomal cisplatin compared with cisplatin each one combined with paclitaxel, the response rate was similar but toxicity and in particular nephrotoxicity, neurotoxicity, and myelotoxicity was significantly lower in liposomal cisplatin arm. No significant financial relationships to disclose.