Phase II study of vinflunine in patients with metastatic renal cell carcinoma |
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Authors: | D Goldstein S P Ackland D R Bell I N Olver I D Davis M A Rosenthal G C Toner M C Pinel M Byrne |
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Institution: | (1) Prince of Wales Hospital, Randwick, Australia;(2) Mater Misericordiae Hospital, Waratah, Australia;(3) Royal North Shore Hospital, St. Leonards, Australia;(4) Royal Adelaide Hospital, Adelaide, Australia;(5) Austin Health, Heidelberg, Australia;(6) Royal Melbourne Hospital, Parkville, Australia;(7) Peter Mac Callum Cancer Centre, East Melbourne, Australia;(8) Institut de Recherche Pierre Fabre, Boulogne Billancourt, France;(9) Sir Charles Gairdner Hospital, Nedlands, Australia |
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Abstract: | Summary Purpose: An open-label, multicentre, non-comparative phase II trial to determine the response rate of intravenous vinflunine as first
line chemotherapy in patients with metastatic renal cell carcinoma (RCC). Patients and methods: Patients with metastatic RCC were treated with vinflunine 350 mg/m2 (n = 11) or 320 mg/m2 (n = 22) administered intravenously every 21 days. Results: Out of 33 patients included in this study, one partial response was observed in the group treated at 350 mg/m2 and none in the group receiving 320 mg/m2 resulting in a response rate in this population of 9.1% (95% CI: 0.2–41.3). Median progression free survival was 5.6 months
(95% CI: 2.8–14.4) for patients treated at 350 mg/m2, and 3.3 months (95% CI: 1.6–6.4) for those treated at 320 mg/m2.The median survival time was 10.4 months (95% CI: 6.8–12.4) for the whole study population. The principal toxicities were
grade 3/4 neutropaenia —90.9% at 350 mg/m2 and 68.1% at 320 mg/m2, febrile neutropaenia was recorded in 3 patients (27.3%) at 350 mg/m2 and in 5 patients (22.7%) at 320 mg/m2. One episode of thromboembolic event was reported in 1 patient at each dose level. Conclusion: Vinflunine given intravenously once every 3 weeks has not shown any clinically relevant activity in the management of patients
with metastatic renal cell carcinoma; tolerance of the treatment was better at a dose of 320 mg/m2 than at 350 mg/m2.
Supported by Institute de Recherche Pierre Fabre Oncologie, Boulogne-Billancourt, France. |
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Keywords: | Vinflunine Renal cell carcinoma |
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