BACKGROUND:Bevacizumab is associated with an increased risk of arterial thromboembolism (ATE); however, its effect on venous thromboembolism (VTE) remains controversial. Scant data exist on the factors that increase the risk of ATE/VTE in patients with prostate cancer. The authors investigated the association of bevacizumab treatment and clinical factors with ATE/VTE risk in patients who were treated on Cancer and Leukemia Group B (CALGB) trial 90401. METHODS:Patients with metastatic, castration-resistant prostate cancer were randomized to receive docetaxel and prednisone with or without bevacizumab once every 21 days. Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade 3 or greater (≥ 3) ATE and VTE. Age, prior ATE/VTE, baseline antiplatelet/anticoagulant use, and VTE risk score (based on leukocyte count, hemoglobin, platelet count, body mass index, and tumor location) were evaluated in univariate and multivariable analyses. RESULTS: Of 1008 randomized patients, the odds of experiencing grade ≥ 3 ATE were significantly greater in those who received bevacizumab compared with those who received placebo (odds ratio, 2.79; P = .02), whereas an opposite trend was noted for grade ≥ 3 VTE (odds ratio, 0.60; P = .08). In the multivariable analysis, bevacizumab treatment (hazard ratio [HR], 3.00; P = .01) and age (HR, 1.06; P = .02) were significantly associated with the risk of ATE; whereas age (HR, 1.05; P = .01) and VTE risk score (HR, 1.83; P = .03) were significantly associated with the risk of VTE. CONCLUSIONS:Bevacizumab was significantly associated with a greater risk of ATE in patients with metastatic, castration-resistant prostate cancer, but it was not significantly associated with the risk of VTE. Understanding clinical factors that increase the risk for experiencing ATE/VTE is essential to mitigate the risks and reduce the burden of these prevalent complications in cancer care.
RCT Entities:
BACKGROUND:Bevacizumab is associated with an increased risk of arterial thromboembolism (ATE); however, its effect on venous thromboembolism (VTE) remains controversial. Scant data exist on the factors that increase the risk of ATE/VTE in patients with prostate cancer. The authors investigated the association of bevacizumab treatment and clinical factors with ATE/VTE risk in patients who were treated on Cancer and Leukemia Group B (CALGB) trial 90401. METHODS:Patients with metastatic, castration-resistant prostate cancer were randomized to receive docetaxel and prednisone with or without bevacizumab once every 21 days. Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade 3 or greater (≥ 3) ATE and VTE. Age, prior ATE/VTE, baseline antiplatelet/anticoagulant use, and VTE risk score (based on leukocyte count, hemoglobin, platelet count, body mass index, and tumor location) were evaluated in univariate and multivariable analyses. RESULTS: Of 1008 randomized patients, the odds of experiencing grade ≥ 3 ATE were significantly greater in those who received bevacizumab compared with those who received placebo (odds ratio, 2.79; P = .02), whereas an opposite trend was noted for grade ≥ 3 VTE (odds ratio, 0.60; P = .08). In the multivariable analysis, bevacizumab treatment (hazard ratio [HR], 3.00; P = .01) and age (HR, 1.06; P = .02) were significantly associated with the risk of ATE; whereas age (HR, 1.05; P = .01) and VTE risk score (HR, 1.83; P = .03) were significantly associated with the risk of VTE. CONCLUSIONS:Bevacizumab was significantly associated with a greater risk of ATE in patients with metastatic, castration-resistant prostate cancer, but it was not significantly associated with the risk of VTE. Understanding clinical factors that increase the risk for experiencing ATE/VTE is essential to mitigate the risks and reduce the burden of these prevalent complications in cancer care.
Authors: William Kevin Kelly; Susan Halabi; Michael Carducci; Daniel George; John F Mahoney; Walter M Stadler; Michael Morris; Philip Kantoff; J Paul Monk; Ellen Kaplan; Nicholas J Vogelzang; Eric J Small Journal: J Clin Oncol Date: 2012-03-26 Impact factor: 44.544
Authors: Herbert I Hurwitz; Leonard B Saltz; Eric Van Cutsem; James Cassidy; Jonas Wiedemann; Florin Sirzén; Gary H Lyman; Ulrich-Peter Rohr Journal: J Clin Oncol Date: 2011-03-21 Impact factor: 44.544
Authors: Alan Sandler; Robert Gray; Michael C Perry; Julie Brahmer; Joan H Schiller; Afshin Dowlati; Rogerio Lilenbaum; David H Johnson Journal: N Engl J Med Date: 2006-12-14 Impact factor: 91.245
Authors: E Van Cutsem; F Rivera; S Berry; A Kretzschmar; M Michael; M DiBartolomeo; M-A Mazier; J-L Canon; V Georgoulias; M Peeters; J Bridgewater; D Cunningham Journal: Ann Oncol Date: 2009-04-30 Impact factor: 32.976
Authors: Leonard B Saltz; Stephen Clarke; Eduardo Díaz-Rubio; Werner Scheithauer; Arie Figer; Ralph Wong; Sheryl Koski; Mikhail Lichinitser; Tsai-Shen Yang; Fernando Rivera; Felix Couture; Florin Sirzén; Jim Cassidy Journal: J Clin Oncol Date: 2008-04-20 Impact factor: 44.544
Authors: Frank A Scappaticci; Jamey R Skillings; Scott N Holden; Hans-Peter Gerber; Kathy Miller; Fairooz Kabbinavar; Emily Bergsland; James Ngai; Eric Holmgren; Jiuzhou Wang; Herbert Hurwitz Journal: J Natl Cancer Inst Date: 2007-08-08 Impact factor: 13.506
Authors: Přemysl Mladěnka; Lenka Applová; Jiří Patočka; Vera Marisa Costa; Fernando Remiao; Jana Pourová; Aleš Mladěnka; Jana Karlíčková; Luděk Jahodář; Marie Vopršalová; Kurt J Varner; Martin Štěrba Journal: Med Res Rev Date: 2018-01-05 Impact factor: 12.944
Authors: Jeffrey G Gross; Adam R Glassman; Margaret J Klein; Lee M Jampol; Frederick L Ferris; Neil M Bressler; Roy W Beck Journal: JAMA Ophthalmol Date: 2017-06-01 Impact factor: 7.389
Authors: Stephen J H Dobbin; Mark C Petrie; Rachel C Myles; Rhian M Touyz; Ninian N Lang Journal: Clin Sci (Lond) Date: 2021-01-15 Impact factor: 6.124
Authors: Frits I Mulder; Matteo Candeloro; Pieter W Kamphuisen; Marcello Di Nisio; Patrick M Bossuyt; Noori Guman; Kirsten Smit; Harry R Büller; Nick van Es Journal: Haematologica Date: 2019-01-03 Impact factor: 11.047