Vinflunine noninferior to docetaxel for refractory NSCLC

The use of vinflunine, a novel microtubule inhibitor, may be a new treatment option for patients with non–small cell lung cancer who had treatment failure on platinum-based first-line chemotherapy. The results of a phase-3 trial indicate that the drug is noninferior to docetaxel in this patient population.

Researchers conducted a randomized, multicenter trial to compare vinflunine 320 mg/m² (n=274) to 75 mg/m² (n=277) in patients with locally advanced or metastatic NSCLC who have failed treatment on a platinum-based regimen. Patients received treatment every 21 days until disease progression or serious toxicity.

Results indicated that vinflunine is noninferior to docetaxel. Median PFS, the primary endpoint, was 2.3 months in both arms of the study. In addition, there were no significant differences between vinflunine and docetaxel for overall response rate (4.4% vs. 5.5%), OS (6.7 months vs. 7.2 months), or stable disease (36% vs. 39.6%).

Researchers also examined quality of life among patients in the study. Again, no significant difference was found between treatment arms using the eight Functional Assessment of Cancer Therapy-Lung quality-of-life scoring items.

Differences were found between vinflunine and docetaxel for treatment toxicity. More patients assigned vinflunine had drug-related injection site reaction (31.9% vs. 0.7%), abdominal pain (20.1% vs. 3.6%), neutropenia (49.3% vs. 39%), and leucopenia (48.9% vs. 38.2%). The researchers wrote, “While patients on vinflunine may have had more gastrointestinal events, such as vomiting, of note, all docetaxel-treated patients received premedication with dexamethesone over three days starting one day before treatment administration while in the vinflunine arm, administration of corticosteroids was not allowed except for antiemetic purposes on the day of drug administration.”

Krzakowski M. J Clin Oncol. 2010:doi:10.1200/JCO.2009.23.4146.