title: 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.affiliation: Centre René Gauducheau, Boulevard Jacques Monod, Saint-Herblain 44805, France. j-bennouna@nantes.fnclcc.fr
authors.forename: J
authors.initials: J
authors.lastname: Bennouna
authors.forename: J-L
authors.initials: JL
authors.lastname: Breton
authors.forename: J-M
authors.initials: JM
authors.lastname: Tourani
authors.forename: C
authors.initials: C
authors.lastname: Ottensmeier
authors.forename: M
authors.initials: M
authors.lastname: O'Brien
authors.forename: P
authors.initials: P
authors.lastname: Kosmidis
authors.forename: T E
authors.initials: TE
authors.lastname: Huat
authors.forename: M-C
authors.initials: MC
authors.lastname: Pinel
authors.forename: C
authors.initials: C
authors.lastname: Colin
authors.forename: J-Y
authors.initials: JY
authors.lastname: Douillard
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D016879:Salvage Therapy; D015996:Survival Rate; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; C111217:vinflunine; D014747:Vinblastine; D016190:Carboplatin; D002945:Cisplatin