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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| 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.
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| Authors | K Zaman, X Durando, J-F Baurain, Y Humblet, F Mazzeo, M Bostnavaron, N Meheust, S Monnoyer-Favrel, J-P Machiels, J Bauer |
| Journal | Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 127 Issue 3 Pg. 689-96 (Jun 2011) ISSN: 1573-7217 [Electronic] Netherlands |
| PMID | 21442199 (Publication Type: Clinical Trial, Phase I, Journal Article) |
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