Bevacizumab with Erlotinib as First-line Therapy in Asian Patients with Advanced Hepatocellular Carcinoma: A Multicenter Phase II Study
| Autor: | Chiun Hsu, Tzeon Jye Chiou, Jennifer Sandoval-Tan, Yu-Yun Shao, Kate Jin, Chia-Tung Shun, Ann-Lii Cheng, Chih-Hung Hsu, Wu Chou Su, Yoon-Koo Kang, Tsai Shen Yang |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male Vascular Endothelial Growth Factor A Oncology Cancer Research medicine.medical_specialty Carcinoma Hepatocellular genetic structures Bevacizumab Phases of clinical research Antibodies Monoclonal Humanized Disease-Free Survival Erlotinib Hydrochloride Asian People Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans neoplasms Aged Aged 80 and over business.industry Liver Neoplasms General Medicine Middle Aged medicine.disease digestive system diseases respiratory tract diseases ErbB Receptors Clinical trial Treatment Outcome Hepatocellular carcinoma Monoclonal Quinazolines Female Erlotinib business Proto-Oncogene Proteins c-akt medicine.drug |
| Zdroj: | Oncology. 85:44-52 |
| ISSN: | 1423-0232 0030-2414 |
| Popis: | Objectives: The bevacizumab/erlotinib combination was reported with high clinical activity for advanced hepatocellular carcinoma (HCC) by a phase II study conducted in the USA. This multicenter study across several Asian countries was to evaluate the safety and efficacy of the combination in this population. Methods: Patients with histology-proven HCC, advanced disease and Child-Pugh class A liver function received bevacizumab 5 mg/kg intravenously every 2 weeks and erlotinib 150 mg/day orally as first-line therapy. The primary end point was progression-free survival at 16 weeks (PFS-16W). The expression of epidermal growth factor receptor (EGFR), phospho-AKT and vascular endothelial growth factor, the microvessel density and the EGFR gene copy number in HCC tissues were correlated with treatment efficacy. Results: Fifty-one patients were enrolled. The PFS-16W was 35.3% (95% CI 22.4-49.9), the median PFS was 2.9 months (95% CI, 1.3-4.4) and the median overall survival was 10.7 months (95% CI, 6.2-15.2). Grade 3/4 toxicities were uncommon, including rash, acne (10% each), diarrhea (6%) and gastrointestinal bleeding (4%). None of the evaluated biomarkers correlated with disease control or PFS. Conclusions: Bevacizumab plus erlotinib showed good tolerability and modest activity in this Asian cohort. Further studies are warranted to identify the predictive biomarkers of this combination. |
| Databáze: | OpenAIRE |
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