A phase I clinical and pharmacological study evaluating vinflunine in combination with doxorubicin as first line treatment in metastatic breast cancer.
- Zaman K Breast Center (CePO), University Hospital CHUV, Rue du Bugnon 46, 1011 Lausanne, Switzerland. Khalil.Zaman@chuv.ch
- Durando X
- Baurain JF
- Humblet Y
- Mazzeo F
- Bostnavaron M
- Meheust N
- Monnoyer-Favrel S
- Machiels JP
- Bauer J
- 2011-03-29
Published in:
- Breast cancer research and treatment. - 2011
Adolescent
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Breast Neoplasms
Doxorubicin
Drug Administration Schedule
Female
Humans
Middle Aged
Vinblastine
English
Vinfunine (VFL) is a novel bifluorinated tubulin-targeted agent of the vinca alkaloids class active in advanced stage breast cancer. We conducted a phase I study combining VFL with doxorubicin (DXR) to define the recommended dose (RD), safety, pharmacokinetic (PK) interaction and efficacy. Two schedules (day 1 every 3 weeks; days 1 and 8 every 3 weeks) were investigated as first line chemotherapy in metastatic breast cancer patients. Thirty-two patients received a total of 162 cycles of the VFL-DXR combination (median 6). The RDs were VFL 250 mg/m(2)/DXR 40 mg/m(2) every 3 weeks for schedule 1 and VFL 120 mg/m(2)/DXR 25 mg/m(2) days 1 and 8 every 3 weeks for schedule 2. The main dose-limiting toxicity was neutropenia. The most frequent non-hematological adverse events were nausea, fatigue, constipation, vomiting, anorexia, stomatitis and dyspnea. Objective response rate was reached in 47.1% of the patients. No PK interaction was observed. VFL-DXR combination is feasible with manageable toxicity. The antitumor activity was promising and supports further evaluation.
- Language
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- English
- Open access status
- green
- Identifiers
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- DOI 10.1007/s10549-011-1446-x
- PMID 21442199
- Persistent URL
- https://folia.unifr.ch/global/documents/125966
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