Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 19024
© 2008 American Society of Clinical Oncology

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Abstract

Liposomally-encapsulated cisplatin (Lipoplatin) plus gemcitabine in NSCLC: Preliminary results of a phase II trial and its antiangiogenesis potential

Rapt; Regulon AE, Alimos Athens, Greece

19024

Background: Liposomally-encapsulated cisplatin (Lipoplatin) nanoparticles evade immune surveillance, target tumor cells in mouse xenografts, primary human tumors and metastases in patients as well as endothelial cells of tumor vasculature. Thus, Lipoplatin may enjoy the cytotoxic properties of cisplatin while additionally exerting antiangiogenic effects. Lipoplatin-gemcitabine is less toxic yet at least as efficacious as cisplatin-gemcitabine in Phase III trials. Lipoplatin has an orphan drug status for pancreatic cancer in the EU. This is the first report of a multicenter, phase II Lipoplatin study in NSCLC. Methods: Eligibility criteria included confirmed diagnosis of inoperable/metastatic NSCLC, no previous chemotherapy, WHO PS 0–1, adequate end-organ function. Patients received Lipoplatin 120 mg/m² D1,8,15 combined with gemcitabine 1 g/m² D1,8, in 3-week cycles, with disease evaluation after 3 and 6 cycles. Primary endpoints were Response Rates and Toxicity; OS PFS and QOL are also being evaluated. Results: 47 patients (pts) were treated; 41 were evaluable. There were 15 (36.6%) pts. with PR, 14 (34.1%) pts. with SD and 12 (29.3%) pts. with PD. Thus, Lipoplatin may be superior to historical platinum-gemcitabine combinations in NSCLC. Observed Toxicities were: grade 1–2 myelotoxicity; mild gastrointestinal toxicity in 50% of the pts. (easily controllable with antiemetics); hypersensitivity reactions in 7 pts (yet without hospitalization needs or any life threatening events); grade 1 nephrotoxicity in 18 (38.3%) pts (mostly in single infusions); of the 3 pts developing grade 2 nephrotoxicity, 2 did so after the first treatment, to recover with adequate hydration shortly after (no Grade 3 or 4 nephrotoxicity was seen; Neurotoxicity, a major side effect of cisplatin, was observed in 6 (12.8%) pts. and was mild (grade 1). None of the cases required treatment discontinuation. There were no associated deaths, or life-threatening adverse events. Conclusion: Lipoplatin may have lower toxicity as well as higher efficacy than cisplatin, when combined with gemcitabine in advanced NSCLC. Particularly relevant is that Lipoplatin is administered without pre- or post-hydration or on an outpatients basis.

No significant financial relationships to disclose.