Impact of Hepatitis Virus on the Feasibility and Efficacy of Anticancer Agents in Patients With Hepatocellular Carcinoma in Phase I Clinical Trials

This study was approved by the NCCH institutional review board and performed in compliance with our institutional guidelines. Patients positive for anti-HCV antibody or HBV antigen (HBsAg) were considered to have HCC due to chronic viral hepatitis, whereas those without anti-HCV antibody nor HBsAg were considered to have HCC by another etiology (non-B/non-C). All medical records were reviewed to summarize the patients' clinical characteristics, treatments, and outcomes based on the status of chronic viral hepatitis. The baseline clinical characteristics included age, gender, ECOG-performance status (PS), treatment history, spread from the primary site, number of metastatic sites and their locations, laboratory tests, and the C-P classification. The outcomes consisted of the date of P-I enrolment and progression, the date of death or loss to follow-up, the best response to therapy based on Response Evaluation Criteria in Solid Tumors (RECIST), and adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) ver.4. Endpoints and Statistical Methods The primary outcome of interest was the effect of chronic viral hepatitis on the efficacy and feasibility of the drugs on patients with HCC who enrolled in P-Is. We assessed the effectiveness through time to failure (TTF), OS, and the best response, and the feasibility through toxicity. TTF was defined as the time from the start of P-I enrolment to discontinuation (as judged by the P-I investigators), b...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research