HEPATOCELLULAR-CARCINOMA - AN ECOG RANDOMIZED PHASE-II STUDY OF INTERFERON-BETA AND MENAGORIL

This study was undertaken to investigate the response rate, time to tr eatment failure and survival time of patients with hepatocellular canc er (HCC) treated with beta-interferon or menogaril. Sixty-nine patient s with histologically confirmed, advanced, measurable hepatocellular c arcinoma were randomized to receive beta-interferon or menogaril. Elig ibility criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, as well as adequate kidney and l iver function and hematologic reserve. The number of patients with let hal, life-threatening, and severe toxicities on beta-interferon were 1 , 3, and 12 and on menogaril 2, 5, and 10, respectively. No objective responses were documented among the 61 patients who had HCC, histologi cally reviewed and confirmed. The time to treatment failure was 6.7 we eks on beta-interferon and 8.6 weeks on menogaril. The median survival time was 11.1 weeks on beta-interferon and 23.1 weeks on menogaril (S outh African patients 10.1 weeks). The difference is not significant. Poor prognostic factors were jaundice, age, and associated hepatitis. After controlling for other covariates, beta-interferon appears to inc rease the relative risk of dying by 2.7. This trial reconfirms the imp ortance, previously reported by ECOG of jaundice and age in the progno sis of patients with HCC. It shows that further trials with neither be ta-interferon nor menogaril are warranted.