Vinflunine -- an active chemotherapy for treatment of advanced non-small-cell lung cancer previously treated with a platinum-based regimen: results of a phase II study.

Abstract

A multicentre, single-arm, phase II trial designed to determine the efficacy of single-agent vinflunine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with a platinum-based regimen. The objectives were to assess efficacy in terms of tumour response rate (primary end point), duration of response, progression-free survival (PFS) and overall survival (OS), and to evaluate the toxicity associated with this treatment. Patients with advanced NSCLC with progressive disease having failed prior platinum-based first-line treatment for advanced disease. Five responses out of the 63 treated patients were documented by WHO criteria and validated by an independent panel review (IRP), yielding a response rate of 7.9% (95% CI: 2.6-17.6) in the intent-to-treat analysis and 8.3% (95% CI: 2.8-18.4) in the evaluable population. Disease control was achieved in 35 out of 60 evaluable patients (58.3%). The median duration of response (complete response+partial response), according to modified WHO criteria was 7.8 months (95% CI: 4.6-NR). Median PFS was 2.6 months (95% CI: 1.4-3.8), and the median survival was 7.0 months (95% CI: 5.8-9.2). Grades 3-4 neutropenia was reported in 50% of patients; febrile neutropenia was observed in two patients (3.2%); grades 3-4 myalgia and grade 3 constipation were experienced by 10 (15.9%) and six (9.5%) of patients, respectively. Constipation was manageable, non-cumulative and could be prevented with laxative prophylaxis. The encouraging results from this phase II study with vinflunine warrant further investigations in phase III trials as second- or first-line treatment of advanced non-small-cell lung carcinoma, as a single agent or in combination with other active drugs.

• Authors: J Bennouna, J-L Breton, J-M Tourani, C Ottensmeier, M O'Brien, P Kosmidis, T E Huat, M-C Pinel, C Colin, J-Y Douillard
• Journal: British journal of cancer (Br J Cancer) Vol. 94 Issue 10 Pg. 1383-8 (May 22 2006) ISSN: 0007-0920 [Print] England
• PMID: 16641911 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• vinflunine
• Vinblastine
• Carboplatin
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic (therapeutic use)
• Carboplatin (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Cisplatin (therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Salvage Therapy
• Survival Rate
• Vinblastine (analogs & derivatives, therapeutic use)