Phase III trial comparing vinflunine with docetaxel in second-line advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy

Maciej Krzakowski, Rodryg Ramlau, Jacek Jassem, Aleksandra Szczesna, Petr Zatloukal, Joachim Von Pawel, Xushan Sun, Jaafar Bennouna, Armando Santoro, Bonne Biesma, François M. Delgado, Yacine Salhi, Nathalie Vaissiere, Olfred Hansen, Eng Huat Tan, Elisabeth Quoix, Pilar Garrido, Jean Yves Douillard

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Abstract

Purpose: 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. Patients and Methods: Randomized, multicenter, phase III study, 551 patients received either vinflunine 320 mg/m2 or docetaxel 75 mg/m2 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. Results: 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)2167-2173
Number of pages7
JournalJournal of Clinical Oncology
Volume28
Issue number13
DOIs
Publication statusPublished - May 1 2010

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ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Krzakowski, M., Ramlau, R., Jassem, J., Szczesna, A., Zatloukal, P., Von Pawel, J., Sun, X., Bennouna, J., Santoro, A., Biesma, B., Delgado, F. M., Salhi, Y., Vaissiere, N., Hansen, O., Tan, E. H., Quoix, E., Garrido, P., & Douillard, J. Y. (2010). Phase III trial comparing vinflunine with docetaxel in second-line advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy. Journal of Clinical Oncology, 28(13), 2167-2173. https://doi.org/10.1200/JCO.2009.23.4146