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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 Bennouna J; Breton JL; Tourani JM; Ottensmeier C; O'Brien M; Kosmidis P; Huat TE; Pinel MC; Colin C; Douillard JYBr J Cancer 2006[May]; 94 (10): 1383-8A 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.|Adult[MESH]|Aged[MESH]|Antineoplastic Agents, Phytogenic/*therapeutic use[MESH]|Carboplatin/therapeutic use[MESH]|Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology[MESH]|Cisplatin/therapeutic use[MESH]|Dose-Response Relationship, Drug[MESH]|Female[MESH]|Humans[MESH]|Lung Neoplasms/*drug therapy/pathology[MESH]|Male[MESH]|Maximum Tolerated Dose[MESH]|Middle Aged[MESH]|Neoplasm Staging[MESH]|Salvage Therapy[MESH]|Survival Rate[MESH]|Vinblastine/*analogs & derivatives/therapeutic use[MESH] |
