Isabelle L Ray-Coquard1, Julien Domont1, Emmanuelle Tresch-Bruneel1, Emmanuelle Bompas1, Philippe A Cassier1, Olivier Mir1, Sophie Piperno-Neumann1, Antoine Italiano1, Christine Chevreau1, Didier Cupissol1, François Bertucci1, Jacques-Olivier Bay1, Olivier Collard1, Esma Saada-Bouzid1, Nicolas Isambert1, Corinne Delcambre1, Stéphanie Clisant1, Axel Le Cesne1, Jean-Yves Blay1, Nicolas Penel2. 1. Isabelle L. Ray-Coquard, Philippe A. Cassier, and Jean-Yves Blay, Centre Léon Bérard and Claude Bernard University, Lyon; Julien Domont, Olivier Mir, and Axel Le Cesne, Gustave Roussy, Villejuif; Emmanuelle Tresch-Bruneel and Stéphanie Clisant, Centre Oscar Lambret; Nicolas Penel, Centre Oscar Lambret and Lille-Nord-de-France Medical School, Lille; Emmanuelle Bompas, Centre René Gauducheau, Nantes; Sophie Piperno-Neumann, Institut Curie, Paris; Antoine Italiano, Institut Bergonié, Bordeaux; Christine Chevreau, Institut Claudius Regaud, Toulouse; Didier Cupissol, Institut de Cancérologie de Montpellier, Val d'Aurelle, Montpellier; François Bertucci, Institut Paoli Calmette, Marseille; Jacques-Olivier Bay, Centre Jean Perrin, Clermont-Ferrand; Olivier Collard, Institut de Cancérologie de la Loire Lucien Neuwirth, Saint Priest en Jarez; Esma Saada-Bouzid, Centre Antoine Lacassagne, Nice; Nicolas Isambert, Centre Georges-François Leclerc, Dijon; and Corinne Delcambre, Centre François Baclesse, Caen, France. 2. Isabelle L. Ray-Coquard, Philippe A. Cassier, and Jean-Yves Blay, Centre Léon Bérard and Claude Bernard University, Lyon; Julien Domont, Olivier Mir, and Axel Le Cesne, Gustave Roussy, Villejuif; Emmanuelle Tresch-Bruneel and Stéphanie Clisant, Centre Oscar Lambret; Nicolas Penel, Centre Oscar Lambret and Lille-Nord-de-France Medical School, Lille; Emmanuelle Bompas, Centre René Gauducheau, Nantes; Sophie Piperno-Neumann, Institut Curie, Paris; Antoine Italiano, Institut Bergonié, Bordeaux; Christine Chevreau, Institut Claudius Regaud, Toulouse; Didier Cupissol, Institut de Cancérologie de Montpellier, Val d'Aurelle, Montpellier; François Bertucci, Institut Paoli Calmette, Marseille; Jacques-Olivier Bay, Centre Jean Perrin, Clermont-Ferrand; Olivier Collard, Institut de Cancérologie de la Loire Lucien Neuwirth, Saint Priest en Jarez; Esma Saada-Bouzid, Centre Antoine Lacassagne, Nice; Nicolas Isambert, Centre Georges-François Leclerc, Dijon; and Corinne Delcambre, Centre François Baclesse, Caen, France. n-penel@o-lambret.fr.
Abstract
PURPOSE: 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). CONCLUSION: 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.
RCT Entities:
PURPOSE: 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). CONCLUSION: 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.
Authors: Choi-Fong Cho; Lihai Yu; Tienabe K Nsiama; Alisha N Kadam; Arun Raturi; Sourabh Shukla; Giulio A Amadei; Nicole F Steinmetz; Leonard G Luyt; John D Lewis Journal: Nanoscale Date: 2017-08-24 Impact factor: 7.790
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