Phase II study of intravenous vinflunine after failure of first-line vinorelbine based regimen for advanced breast cancer

Abstract Purpose This open label phase II study evaluated the safety and efficacy of vinflunine in patients with breast cancer previously treated with a vinorelbine-based regimen and who progressed during or within 6 months of completing this chemotherapy. Patients and methods Thirty eight patients...

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Bibliographic Details
Published in:Breast (Edinburgh) 2013-02, Vol.22 (1), p.58-63
Main Authors: Blasinska-Morawiec, Maria, Tubiana-Mathieu, Nicole, Fougeray, Ronan, Pinel, Marie-Claire, Bougnoux, Philippe
Format: Article
Language:English
Subjects:
Adult
Advanced breast cancer
Aged
Antineoplastic Agents, Phytogenic - adverse effects
Antineoplastic Agents, Phytogenic - therapeutic use
Breast Neoplasms - drug therapy
Breast Neoplasms - mortality
Disease-Free Survival
Drug Administration Schedule
Female
Hematology, Oncology and Palliative Medicine
Humans
Infusions, Intravenous
Kaplan-Meier Estimate
Middle Aged
Phase II
Prospective Studies
Single agent
Survival Rate
Treatment Failure
Treatment Outcome
Vinblastine - adverse effects
Vinblastine - analogs & derivatives
Vinblastine - therapeutic use
Vinflunine
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Summary:Abstract Purpose This open label phase II study evaluated the safety and efficacy of vinflunine in patients with breast cancer previously treated with a vinorelbine-based regimen and who progressed during or within 6 months of completing this chemotherapy. Patients and methods Thirty eight patients received vinflunine 320 mg/m2 once every 3 weeks. The primary efficacy endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results ORR was 8.3% (95% CI: 1.75–22.4) and DCR was 75% (95% CI: 57.8–87.9). PFS was 4.0 months (95% CI: 2.5–6.1) and OS was 13.6 months (95% CI: 8.7–18.9). Toxicities not hampering dose intensity were as expected neutropenia (75.6% of patients), fatigue (44.7%), constipation (28.9%) and abdominal pain (26.3%). Conclusion Vinflunine demonstrated antitumour activity and can be safely administered in breast cancer patients refractory/resistant to vinorelbine.
ISSN:0960-9776
1532-3080
DOI:10.1016/j.breast.2012.10.007