Title :

Paclitaxel given once per week with or without bevacizumab in patients with advanced angiosarcoma: a randomized phase ii trial

Author(s) :

Ray-Coquard, Isabelle [Auteur]
Domont, Julien [Auteur]
Tresch-Bruneel, Emmanuelle [Auteur]
Bompas, Emmanuelle [Auteur]
Cassier, Philippe Alexandre [Auteur]
Mir, Olivier [Auteur]
Piperno-Neumann, Sophie [Auteur]
Italiano, Antoine [Auteur]
Chevreau, Christine [Auteur]
Cupissol, Didier [Auteur]
Bertucci, François [Auteur]
Bay, Jacques-Olivier [Auteur]
Collard, Olivier [Auteur]
Saada-Bouzid, Esma [Auteur]
Isambert, Nicolas [Auteur]
Delcambre, Corinne [Auteur]
Clisant-Delaine, Stephanie [Auteur]
Le Cesne, Axel [Auteur]
Blay, Jean-Yves [Auteur]
Penel, Nicolas [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]

Journal title :

Journal of clinical oncology . official journal of the American Society of Clinical Oncology

Abbreviated title :

J. Clin. Oncol.

Volume number :

33

Pages :

2797-U116

Publication date :

2015-09-01

ISSN :

0732-183X

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: The aim of this randomized, phase II trial was to explore the activity and safety of adding bevacizumab to paclitaxel once per week in treatment of angiosarcomas (AS). METHODS: Patients were treated with paclitaxel ...
Show more >OBJECTIVE: The aim of this randomized, phase II trial was to explore the activity and safety of adding bevacizumab to paclitaxel once per week in treatment of angiosarcomas (AS). METHODS: Patients were treated with paclitaxel alone (90 mg/m(2) per week for six cycles of 28 days each; arm A) or with paclitaxel combined with bevacizumab (10 mg/kg once every 2 weeks; arm B). In the combination treatment arm, bevacizumab was administered after the six cycles of chemotherapy as maintenance therapy (15 mg/kg once every 3 weeks) until intolerance or progression occurred. Stratification factors were superficial versus visceral AS and de novo versus radiation-induced AS. The primary end point was the 6-month progression-free survival (PFS) rate, which was based on RECIST, version 1.1. Statistical assumptions were P0 = 20%, P1 = 40%, a = 10%, and b = 20%. P0 was the PFS rate at 6 months defining inactive drug, and P1 was the PFS rate at 6 months defining promising drug. RESULTS: A total of 52 patients were enrolled, and 50 were randomly assigned in 14 centers. The most common primary sites were the breast (49%) and skin (12%). There were 17 (34%) visceral and 24 (49%) radiation-induced AS. The performance status was 0 in 24 patients (49%) and 1 in the remaining 25 patients (51%). The median follow-up time was 14.5 months. Both treatment regimens were considered active, with 6-month PFS rates of 54% (14 of 26) in arm A and 57% (14 of 24) in arm B. The median overall survival rates were 19.5 months in arm A and 15.9 months in arm B. Toxicity was higher with the combination arm and included one fatal drug-related toxicity (intestinal occlusion). CONCLUSIONS: The primary objective was met in both treatment arms. However, the present data do not support additional clinical investigation of combined paclitaxel/bevacizumab for the treatment of advanced AS.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Université de Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2019-12-09T16:52:24Z