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Clinical Trial
. 2013 Mar 1;119(5):1042-9.
doi: 10.1002/cncr.27859. Epub 2012 Nov 6.

Phase 2 trial of concurrent bevacizumab and transhepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma

Manon Buijs  1 , Diane K Reyes, Timothy M Pawlik, Amanda L Blackford, Riad Salem, Wells A Messersmith, Colin D Weekes, Mary Mulcahy, Ihab R Kamel, Jean-Francois H Geschwind
Affiliations
Clinical Trial

Phase 2 trial of concurrent bevacizumab and transhepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma

Manon Buijs et al. Cancer. .

Abstract

Background: Vascular endothelial growth factor is up-regulated in hepatocellular carcinoma (HCC) and is further up-regulated after transhepatic arterial chemoembolization. The authors of this report conducted a phase 2 trial to evaluate the safety and efficacy of bevacizumab combined with chemoembolization in patients with unresectable HCC.

Methods: Patients who had an Eastern Cooperative Oncology Group performance of status 0 to 2, a Child-Pugh score of A or B, and Barcelona Clinic Liver Cancer stage B or C HCC were eligible. Treatment consisted of bevacizumab every 2 weeks and chemoembolization during the third week of a 6-week cycle for up to 3 cycles over 6 months. The primary endpoints were safety and efficacy.

Results: Twenty-five patients received chemoembolization and bevacizumab. The most common grade 3 and 4 events after the first treatment cycle were leukocytopenia (12%), fatigue (12%), and hyponatremia (12%). Serious toxicities that had a known association with bevacizumab were observed in 4 patients. Thirty-day mortality was 0%. The median time to tumor progression for the targeted lesions was not reached, and overall survival was 10.8 months. The objective response rate was 60% using enhancement response evaluation criteria, and the disease control rate was 100%.

Conclusions: Concurrent treatment with bevacizumab and chemoembolization was safe in carefully selected patients and demonstrated antitumor activity in patients with unresectable HCC. These results support the further development of bevacizumab combined with chemoembolization as a treatment for unresectable HCC.

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Figures

Figure 1
Figure 1
Treatment protocol before (a) and after (b) protocol amendment.
Figure 2
Figure 2
(a) Time to tumor progression of the targeted lesion, stratified by imaging response. (b) Overall survival stratified by imaging response.
Figure 2
Figure 2
(a) Time to tumor progression of the targeted lesion, stratified by imaging response. (b) Overall survival stratified by imaging response.
See this image and copyright information in PMC

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