Phase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory diseaseReport as inadecuate




Phase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory disease - Download this document for free, or read online. Document in PDF available to download.

Investigational New Drugs

, Volume 30, Issue 6, pp 2384–2390

First Online: 09 March 2012Received: 01 January 2012Accepted: 26 February 2012 Summary

Background The combination of bevacizumab B and erlotinib E has shown promising clinical outcomes as the first-line treatment of advanced HCC patients. We aimed to evaluate the efficacy and safety of using combination of B + E in treating advanced HCC patients who had failed prior sorafenib treatment. Methods Eligible advanced HCC patients with documented radiological evidence of disease progression with sorafenib treatment were recruited. All patients received bevacizumabB at 10 mg-kg every 2 weeks with erlotinibE at 150 mg daily for a maximum of 6 cycles. Response assessments using both RECIST and modified RECIST criteria were performed after every 6 weeks. The primary endpoint was clinical benefit CB rate and a Simon two-stage design was employed. Results The trial was halted in the first stage according to the pre-set statistical criteria with 10 patients recruited. The median age was 47 years range, 28–61 and all patients were in ECOG performance status 1. Eighty percent of patients were chronic hepatitis B carriers and all patients had Child A cirrhosis. Among these 10 patients, none of the enrolled patients achieved response or stable disease. The median time-to-progression was 1.81 months 95 % confidence interval C.I., 1.08–1.74 months and overall survival was 4.37 months 95 % C.I., 1.08–11.66 months. Rash 70 %, diarrhea 50 % and malaise 40 % were the most commonly encountered toxicities. Conclusion The combination of B + E was well tolerated but had no activity in an unselected sorafenib-refractory advanced HCC population. Condensed abstract The combination of bevacizumab and erlotinib had no clinical activity in sorafenib-refractory HCC population.

KeywordsBevacizumab Erlotinib Advanced HCC Sorafenib-refractory  Download fulltext PDF



Author: Thomas Yau - Hilda Wong - Pierre Chan - T. J. Yao - R. Pang - T. T. Cheung - S. T. Fan - Ronnie T. Poon

Source: https://link.springer.com/







Related documents