Phase II trial of bevacizumab and erlotinib as a second-line therapy for advanced hepatocellular carcinoma.
Onco Targets Ther
; 9: 773-80, 2016.
Article
em En
| MEDLINE
| ID: mdl-26929648
ABSTRACT
TRIAL REGISTRY Clinicaltrials.gov #NCT01180959. BACKGROUND:
Early clinical studies of bevacizumab and erlotinib in advanced hepatocellular carcinoma (HCC) have a tolerable toxicity and a promising clinical outcome. We evaluated the efficacy and tolerability of this combination as a second-line therapy for HCC refractory to sorafenib.METHODS:
For this single-arm, Phase II study, we recruited patients with Child-Pugh class A or B liver disease, Eastern Cooperative Oncology Group performance status 0-2, and advanced HCC that was not amenable to surgical or regional therapies and treatment with sorafenib had failed (disease progressed or patient could not tolerate sorafenib). Patients received 10 mg/kg intravenous bevacizumab every 14 days and 150 mg oral erlotinib daily for 28-day cycles until progression. Tumor response was evaluated every two cycles using Response Evaluation Criteria in Solid Tumors. The primary end point was the 16-week progression-free survival rate. Secondary end points included time to progression and overall survival.RESULTS:
A total of 44 patients were enrolled and had a median follow-up time of 33.8 months (95% confidence interval [CI] 23.5 months - not defined). The 16-week progression-free survival rate was 43% (95% CI 28%-59%), median time to progression was 3.9 months (95% CI 2.0-8.3 months), and median overall survival duration was 9.9 months (95% CI 8.3-15.5 months). Grade 3-4 adverse events included fatigue (13%), acne (11%), diarrhea (9%), anemia (7%), and upper gastrointestinal hemorrhage (7%).CONCLUSION:
Bevacizumab plus erlotinib was tolerable and showed a signal of survival benefit in the second-line setting for patients with advanced HCC. Because standard-of-care options are lacking in this setting, further studies to identify predictors of response to this regimen are warranted.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
3_ND
Base de dados:
MEDLINE
Tipo de estudo:
Prognostic_studies
Idioma:
En
Revista:
Onco Targets Ther
Ano de publicação:
2016
Tipo de documento:
Article