A Randomized Phase II Open-Label Multi-Institution Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma.
Oncology
; 94(6): 329-339, 2018.
Article
in En
| MEDLINE
| ID: mdl-29719302
ABSTRACT
OBJECTIVES:
To investigate the clinical efficacy and tolerability of the combination of bevacizumab (B) and erlotinib (E) compared to sorafenib (S) as first-line treatment for patients with advanced hepatocellular carcinoma (HCC).METHODS:
A total of 90 patients with advanced HCC, Child-Pugh class A-B7 cirrhosis, and no prior systemic therapy were randomly assigned (1 1) to receive either 10 mg/kg B intravenously every 14 days and 150 mg E orally daily (n = 47) (B+E) or 400 mg S orally twice daily (n = 43). The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), time to progression, and safety and tolerability.RESULTS:
The median OS was 8.55 months (95% CI 7.00-13.9) for patients treated with B+E and 8.55 months (95% CI 5.69-12.2) for patients receiving S. The hazard ratio (HR) for OS was 0.92 (95% CI 0.57-1.47). The median EFS was 4.37 months (95% CI 2.99-7.36) for patients receiving B+E and 2.76 months (95% CI 1.84-4.80) for patients receiving S. The HR for EFS was 0.67 (95% CI 0.42-1.07; p = 0.09), favoring B+E over S. When OS was assessed among patients who were Child-Pugh class A, the median OS was 11.4 months (95% CI 7.5-15.7) for patients treated with B+E (n = 39) and 10.26 months (95% CI 5.9-13.0) for patients treated with S (n = 38) (HR = 0.88; 95% CI 0.53-1.46).CONCLUSIONS:
There was no difference in efficacy between the B+E and S arms, although the safety and tolerability profile tended to favor B+E over S based on competing risk analysis.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Phenylurea Compounds
/
Antineoplastic Combined Chemotherapy Protocols
/
Niacinamide
/
Carcinoma, Hepatocellular
/
Erlotinib Hydrochloride
/
Bevacizumab
/
Liver Neoplasms
Type of study:
Clinical_trials
Limits:
Adult
/
Aged
/
Aged80
/
Humans
/
Middle aged
Language:
En
Journal:
Oncology
Year:
2018
Document type:
Article
Affiliation country:
Estados Unidos