High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial

摘要: In the Asia-Pacific region and elsewhere, almost 85% of patients with hepatocellular carcinoma (HCC) are inoperable at diagnosis have a dismal prognosis. Tamoxifen (TMX) is believed to inhibit HCC positive for estrogen receptor (ER), but most HCCs ER negative. Results previous phase 3 trials in been conflicting inconclusive. At higher doses, however, TMX inhibits through ER-independent mechanisms. A multicenter randomized controlled trial was performed assess role high-dose versus placebo (P) treatment respect survival quality life (QoL). total 329 from 10 centers 9 countries enrolled double-blind 120 mg/d (TMX120) against P as control arm an intermediate dosage 60 (TMX60) possible dose response. An independent data monitoring committee reviewed all aspects trial. QoL assessed using European Organization Research Treatment Cancer QLQ-C30 questionnaire. Three-month rates P, TMX60, TMX120 groups were 44%, 41%, 35%, respectively, statistically significant trend difference across regimens (P = .011). There significantly risk death group compared (hazard ratio, 1.39; 95% confidence interval, 1.07-1.81). Adverse drug reactions reported 3% (9 patients), 8 lost follow-up. conclusion, does not prolong has increasingly negative impact increasing dose. No appreciable advantage observed.