Pral VP-16 and tamoxifen as a palliative treatment in patiens with advanced hepatocellular carcinoma

ABSTRACT

This is a prospective single arm study including 20 patients with hepatocellular carcinoma [HCC] aiming to evaluate the therapeutic efficacy of prolonged use of oral VP-16 plus tamoxifen [a potential multidrug resistant reversing agent] in patients with an advanced HCC. Eligibility criteria were unresectable objectively measurable tumors, adequate hemogram, renal functions and karnofsky PS of greater than or equal to 50%. The treatment protocol included VP-16 50 mg/m2/day orally and tamoxifen 40 mg/day, day 1-21 repeated every five weeks. Male to female ratio was 9 1 with a median age of 46 years, the patients received an average of 3.1 [range 1-6 cycles] courses. GIII and IV leucopenia was developed in 25% and 10% of patients, while thrombocytopenia was developed in 5%, respectively. The dose was reduced in six patients. Hematologic toxicity was moderate and tolerable in the majority of patients and five patients achieved PR. The median survival of responders was eight months and three for the non-responders. The median Karnofsky PS of responders was improved from 70% to 80%. It was concluded that the use of oral VP-16 plus tamoxifen for 21 days had a modest activity and an acceptable toxicity in patients with an advanced HCC and it was useful as a palliative treatment in 25% of the patients