XXXX : A Phase II Randomized Controlled Double-Blind Trial of Transarterial Chemoembolization in Combination with Biweekly Intravenous Administration of Bevacizumab or a Placebo.

@entity1 @entity632 @entity82 @entity96 @entity5 @entity157 @entity285 @entity1349
UNASSIGNED: Purpose To investigate the efficacy and safety of conventional transarterial chemoembolization (TACE) (cTACE) in combination with bevacizumab or a placebo in @entity1 with @entity157 ( @entity157 ) in a randomized controlled double-blind phase II trial. Materials and Methods This study was approved by the institutional review board, and written informed consent was obtained prior to inclusion. A total of 40 @entity1 (20 @entity1 per group, all 18 years or older) with histologically confirmed early- or intermediate-stage @entity157 and @entity1 -Pugh class A or B @entity82 were scheduled for inclusion. The primary endpoint was radiologic progression at 12 months according to European Association for the Study of the Liver criteria. Secondary endpoints were safety and @entity1349 ( @entity1349 ). @entity1 underwent cTACE with @entity632 and intravenous administration of a placebo (cTACE-C) or bevacizumab (cTACE-B) (5 mg per kilogram of body weight) every 2 weeks for 52 weeks. After the first TACE procedure, TACE was repeated twice in 4-week intervals if indicated and technically feasible and on demand thereafter. Statistical analyses were performed with statistical software. P < .05 indicated a significant difference. Results Thirty-two @entity1 were recruited between January 2006 and December 2009 (29 male, three female; mean age, 61 years    8 [standard deviation]; Barcelona Clinic @entity96 stage A, n = 4; Barcelona Clinic @entity96 stage B, n = 28; predominant cause, @entity285 [n = 15]; @entity1 -Pugh class A disease, n = 22; @entity1 -Pugh class B disease, n = 10; 16 @entity1 received bevacizumab; 16 @entity1 received a placebo). @entity1 underwent a median of three TACE cycles and received 13 infusions of bevacizumab versus 11 infusions of the placebo before the trial was stopped prematurely for safety reasons. Severe (grade 3-5) septic (n = 8 vs n = 3) and vascular (n = 9 vs n = 0) side effects were observed almost exclusively in the cTACE-B group. Median survival was worse in the cTACE-B group than in the cTACE-C group (5.3 vs 13.7 months; hazard ratio [HR], 1.7; 95% confidence interval [CI]: 0.8, 3.6; P = .195) and reached significance in @entity1 with @entity1 -Pugh class A @entity82 (7.3 vs 26.5 months; HR, 2.6; 95% CI: 1.0, 6.6; P = .049). The primary endpoint was not met, since there was no difference in radiologic response between the groups at 3, 6, or 12 months. Conclusion No improvement in radiologic @entity5 response or @entity1349 was observed in @entity1 with @entity157 who received cTACE and bevacizumab, but severe and even lethal septic and vascular side effects occurred. Thus, bevacizumab cannot be recommended as an adjuvant treatment to cTACE. (  ) RSNA, 2015 Online supplemental material is available for this article.
