P-114 - A phase II trial of bevacizumab and erlotinib as second line therapy for advanced hepatocellular carcinoma

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Cytotoxic agents
Hepatobiliary Cancers
Biological therapy
Presenter A. Kaseb
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors A. Kaseb, H. Al-Shamsi, J. Morris, M. Iwasaki, L. Xiao, R. Abdelwahab, K. Raghav, M. Hassan, H. Hassabo, R. Wolff
  • Houston/US



The objective of the study was to evaluate the efficacy and tolerability of bevacizumab (B) and erlotinib (E) combination as second line therapy for advanced hepatocellular carcinoma (HCC)


Patients who had advanced HCC that was not amenable to surgical or regional therapies, had shown progression with sorafenib therapy; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received bevacizumab 10 mg/kg every 14 days and erlotinib 150 mg orally daily, continuously, for 28-day cycles. The tumor response was evaluated every 2 cycles by using Response Evaluation Criteria in Solid Tumors Group criteria. The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy. The secondary objective will be to assess time to progression (TTP) and overall survival (OS)


A total of 44 patients were included. PFS at 16 weeks was 43% (95% CI 28% -59%), the Median TTP was 3.9 months (95% CI 2.0-8.3) and median overall survival (OS) was 9.9 months (95% CI, 8.3-15.5). Grade 3-4 adverse events included fatigue (13.3%), acne (11.1%), diarrhea (8.8%), anemia (6.6%), and upper gastrointestinal hemorrhage (6.6%)


Bevacizumab and Erlotinib combination showed promising activity in this first US study in the second line setting. Validation studies are warranted