Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Javier CortesMario Campone

Abstract

There is no standard treatment after progression on second-line chemotherapy for metastatic breast cancer (MBC). We compared vinflunine with physician's choice of alkylating agent (AA) for patients with heavily pretreated MBC. In this open-label phase III trial, patients with MBC were included if they had received at least two prior chemotherapy regimens for MBC and had received anthracycline, taxane, antimetabolite and vinca alkaloid therapy. Patients were no longer candidates for these chemotherapies because of resistance and/or intolerance. Patients were randomised to either vinflunine 280 mg/m2 intravenously every 3 weeks (q3w) or AA monotherapy q3w. Stratification factors were performance status, number of prior chemotherapy lines for MBC, disease measurability and study site. The primary end point was overall survival (OS). A total of 594 patients were randomised (298 to vinflunine, 296 to AA). There was no difference between treatment arms in OS (hazard ratio 1.04, P = 0.67; median 9.1 months for vinflunine versus 9.3 months for AA), progression-free survival (hazard ratio 0.94, P = 0.49; median 2.5 versus 1.9 months, respectively) or overall response rate (6% versus 4%, respectively). However, the disease control rate w...Continue Reading

References

Feb 1, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kathy D MillerHope S Rugo
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Oct 23, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·H Roché, L T Vahdat
Mar 8, 2011·Lancet·Javier CortesUNKNOWN EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators
Jul 17, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John P CrownGilles Romieu
Jan 22, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Peter A KaufmanJavier Cortes

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Citations

Jan 16, 2019·Clinical and Translational Medicine·Burak Uzunparmak, Ibrahim Halil Sahin
Dec 15, 2020·Journal of Oncology·Vito LorussoFrancesco Giotta

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