Abstract
Chronic viral hepatitis is a risk factor for liver fibrosis and hepatocellular carcinoma (HCC). Patients with advanced HCC have limited effective therapeutic options and are considered potential candidates for early phase clinical trials of anti-cancer agents. The impact of chronic viral hepatitis on the efficacy of anticancer agents for patients with HCC in phase I trials (P-Is) still remains unclear and has not been reported. We retrospectively analyzed the outcomes of consecutive HCC patients in P-Is conducted in a single institute, focusing on chronic viral hepatitis. Of 85 patients enrolled in P-Is, 46 (54%) patients positive and 39 (46%) patients negative for chronic viral hepatitis showed no significant difference in clinical and laboratory variables and on the point of the best response based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria; moreover, the frequency of Grade ≥3 adverse events (AE) was not significantly different. The median time to treatment failure (TTF) and overall survival (OS) from the P-I enrolment were 2.0 and 13.7 months, respectively. No patient experienced reactivation of hepatitis B virus (HBV) or treatment-related death. Chronic viral hepatitis does not independently affect the outcomes of anticancer drugs. Advanced HCC patients with chronic viral hepatitis could be feasible for P-Is.
Highlights
Hepatocellular carcinoma (HCC) is one of the most commonly found solid tumors and the fourth leading cause of cancer-related death worldwide [1]
The outcomes consisted of the date of phase I trials (P-Is) 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
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
Summary
Hepatocellular carcinoma (HCC) is one of the most commonly found solid tumors and the fourth leading cause of cancer-related death worldwide [1]. Virus on treatment response and adverse events to investigational new drugs in phase I clinical trials (P-I) for advanced HCC patients. The A-P study showed that HCC patients with HBV infection who received sorafenib tended to have longer overall survival (OS) than patients who received a placebo (HR0.68) [14]. Increasing data from subgroup analyses in phase III clinical trials suggested that patients with chronic hepatitis C as the etiology of their cirrhosis might show a better response to sorafenib than those with other underlying causes of cirrhosis [8, 15, 16]. The present study was designed to examine the feasibility and efficacy of new anticancer drugs in patients with HCC who enrolled in P-I, from the perspective of HBV or HCV infection
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