A phase I clinical and pharmacological study evaluating vinflunine in combination with doxorubicin as first line treatment in metastatic breast cancer.

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Serval ID
serval:BIB_4302E1982FFA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A phase I clinical and pharmacological study evaluating vinflunine in combination with doxorubicin as first line treatment in metastatic breast cancer.
Journal
Breast Cancer Research and Treatment
Author(s)
Zaman K., Durando X., Baurain J.F., Humblet Y., Mazzeo F., Bostnavaron M., Meheust N., Monnoyer-Favrel S., Machiels J.P., Bauer J.
ISSN
1573-7217 (Electronic)
ISSN-L
0167-6806
Publication state
Published
Issued date
2011
Volume
127
Number
3
Pages
689-696
Language
english
Abstract
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.
Pubmed
Web of science
Open Access
Yes
Create date
08/06/2011 10:14
Last modification date
01/10/2019 7:17
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