Gefitinib in advanced unresectable hepatocellular carcinoma: Results from the Eastern Cooperative Oncology Group’s Study E1203
| Autor: | Peter O'Dwyer, D. B. Fitzgerald, Al B. Benson, John S. Kauh, D. E. Levy, Bruce J. Giantonio |
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| Rok vydání: | 2006 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 24:4143-4143 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2006.24.18_suppl.4143 |
| Popis: | 4143 Background: Worldwide, hepatocellular carcinoma (HCC) is the most common cause of cancer death. Chemotherapy yields no survival benefit, and median survival is < 6 months. Up to 47% of HCCs express the epidermal growth factor receptor (EGFR), which predicts survival. Also, EGFR signaling activates c-Met, the hepatocyte growth factor receptor. Gefitinib is an oral selective EGFR inhibitor that has shown growth inhibition of HCC cell lines. Methods: E1203 was a single arm phase II study of gefitinib in advanced HCC. Eligibility requirements: unresectable measurable (by RECIST) HCC (diagnosed by histology or alpha-fetoprotein criteria); PS ≤ 2; total bilirubin ≤ 2× ULN; SGOT ≤ 5× ULN; INR ≤ 2.3; albumin ≥ 2.8 g/dl; Child Pugh Class < C; no prior systemic therapy. Gefitinib 250 mg taken daily. 1 cycle = 3 weeks. Tumor assessments done every 6 weeks. Objectives: 4.5 month PFS of 63%, OS, RR, toxicity. A two-stage design was used. Results: Thirty-one patients were accrued to the first stage. Median follow-up is 13.2 months. Med age = 64.8 yrs (46–86). M:F 87%:10%. PS 0/1/2: 39%/42%/16%. Med PFS = 2.8 months (95%CI: 1.5, 3.9). Med OS = 6.5 months (95% CI: 4.4, 8.9). Response #s (CR/PR/SD): 0/1/7. Selected grade 3 adverse events: neutropenia ×2; rash ×2; diarrhea ×1. There was only 1 grade 4 AE (neutropenia). The criterion for second-stage accrual was not met. Conclusion: Gefitinib as a single agent is not active in advanced HCC. No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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