Phase II study of liposomal cisplatin (Lipoplatin) plus gemcitabine versus cisplatin plus gemcitabine as first line treatment in inoperable (stage IIIB/IV) non-small cell lung cancer.

Abstract

BACKGROUND:

Lipoplatin is a new liposomal cisplatin designed to reduce cisplatin toxicities without reducing efficacy. In the present randomized phase II study, we examined the efficacy and safety of a Lipoplatin-gemcitabine versus a cisplatin-gemcitabine combination as first line treatment in advanced NSCLC.

PATIENTS AND METHODS:

Patients with advanced (stages IIIB-IV) NSCLC received up to six 21-day cycles of Lipoplatin 120 mg/m(2) (days 1, 8, 15) and gemcitabine 1000 mg/m(2) (days 1+8) (arm A; LipoGem) versus cisplatin 100mg/m(2) (day 1) and gemcitabine 1000 mg/m(2) (days 1+8) (arm B; CisGem). The primary objective was objective response rate (ORR). Secondary objectives were disease control rate (DCR), progression-free survival (PFS), duration of response and overall survival (OS). Another secondary objective was safety and tolerability of the LipoGem combination.

RESULTS:

Eighty-eight patients (n=88) entered the study; 47 patients were treated with LipoGem versus 41 patients treated with CisGem. Efficacy was assessed in patients who completed at least 1 cycle of treatment; ORR was 31.7% in arm A versus 25.6% in arm B and DCR was 70.7% versus 56.4%, respectively. A preliminary efficacy of LipoGem versus CisGem in the adenocarcinoma histological subtype of NSCLC showed 16.7% versus 45.8% PD. Treatment in arm A was better tolerated with myelotoxicity and a transient mild elevation of serum creatinine as the dominant side effects; the only grade 4 adverse event was neutropenia noted in 2% of the patients. There was a significant reduction in nephrotoxicity in the LipoGem arm (0% versus 5% grade III, p-value<0.001) as well as in nausea vomiting (2% versus 12% grade III, p-value<0.001). In addition, less antiemetics and G-CSF were administered in arm A.

CONCLUSION:

Overall, Lipoplatin appears to have lower toxicity, mainly renal toxicity as well as higher efficacy than cisplatin when combined with gemcitabine in advanced NSCLC.

• Authors: N Mylonakis, A Athanasiou, N Ziras, J Angel, A Rapti, S Lampaki, N Politis, C Karanikas, C Kosmas
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 68 Issue 2 Pg. 240-7 (May 2010) ISSN: 1872-8332 [Electronic] Ireland
• PMID: 19628292 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• lipoplatin
• Deoxycytidine
• Creatinine
• Cisplatin
• Gemcitabine

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (blood, drug therapy, pathology, physiopathology)
• Cisplatin (administration & dosage, adverse effects)
• Creatinine (blood)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Humans
• Lung Neoplasms (blood, drug therapy, pathology, physiopathology)
• Male
• Middle Aged
• Neoplasm Staging
• Neutropenia (etiology)
• Gemcitabine