Centrum Onkologii Instytut, Warsaw; Regional Lung Disease Hospital, Poznan; Medical Academy Radiotherapy Clinic, Gdansk; Samodzielmy Wojewodzki Zaklad Opieki Zdrowotnej, Otwock, Poland; Klinika Pneumologie e Brudni Chir, Praha, Czech Republic; Asklepios Fachkliniken München-Gauting, Gauting, Germany; Hôpital André Boulloche, Montbéliard; Centre René Gauducheau, Saint-Herblain; Institut de Recherche Pierre Fabre, Boulogne; Hôpital Lyautey, Strasbourg; Centre René Gauducheau, Saint-Herblain, France; Instituto Clinico Humanitas, Rozzano, Italy; Jeroen Boch Ziekenhuis, Hertogenbosch, Netherlands; Odense Univesitetshospital, Odense, Denmark; National Cancer Centre, Singapore, Singapore; and Hospital Ramón y Cajal, Madrid, Spain.
J Clin Oncol. 2010 Mar 29.
To compare vinflunine (VFL) to docetaxel in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC) who have experienced treatment failure with first-line platinum-based chemotherapy.
Randomized, multicenter, phase III study, 551 patients received either vinflunine 320 mg/m(2) or docetaxel 75 mg/m(2) every 21 days until disease progression or serious toxicity. The primary end point was progression-free survival (PFS). The noninferiority analysis was based on a 10% difference (types I/II error rates: 5%/20%). Secondary end points included response rate (ORR), response duration, overall survival (OS), clinical benefit, quality of life (QOL), and safety.
Median PFS was 2.3 months for each arm (HR, 1.004; 95% CI, 0.841 to 1.199). ORR, stable disease, median OS, were 4.4% versus 5.5%, 36.0% versus 39.6%, 6.7 versus 7.2 months (HR, 0.973; 95% CI, 0.805 to 1.176), respectively. No significant difference in patient benefit and QOL (Functional Assessment of Cancer Therapy-Lung). No unexpected adverse events were observed. Grade higher than 0 (vinflunine v docetaxel) anemia (82.1% v 79.8%), neutropenia (49.3 v 39.02%), thrombocytopenia (30.6% v 14.3%), febrile neutropenia (3.3% v 4.7%), constipation (39.2% v 11.7%), fatigue (36.6% v 33.9%), injection site reaction (31.9% v 0.7%), nausea (26.7% v 23.7%), vomiting (23.8% v 14.2%), alopecia (19.8% v 35.4%), stomatis (19.4% v 12.4%), abdominal pain (20.1% v 3.6%), myalgia (14.7% v 6.6%), peripheral neuropathy (10.7% v 15.0%), arthralgia (7.0% v 7.7%), diarrhea (6.2% v 12.4%), edema (1.5% v 5.4%), and nail disorders (1.1% v 5;1%) were observed.
This noninferiority phase III study showed similar efficacy end points for vinflunine and docetaxel. Despite higher rates of some adverse effects (anemia, abdominal pain, constipation, fatigue) the overall toxicity profile of vinflunine was manageable. Therefore, VFL may be another option in the second-line treatment of patients with advanced NSCLC.
PMID: 20351334 [PubMed - as supplied by publisher] Source: National Library of Medicine.
