EPIDOXORUBICIN VS IDARUBICIN CONTAINING REGIMENS IN INTERMEDIATE AND HIGH-GRADE NON-HODGKINS-LYMPHOMA - PRELIMINARY-RESULTS OF A MULTICENTRIC RANDOMIZED TRIAL

Background. In recent years many therapeutic regimens have been design ed in order to improve response rate and response duration in non-Hodg kin's lymphoma (NHL). In 1991 the Italian Lymphoma Study Group (GISL) started a prospective randomized trial on treatment of aggressive and advanced NHL, focused on the efficacy of two Pro-MACE-CytaBom (P-C) de rived protocols. Methods. From April 1991 to March 1993, 243 cases of intermediate and high grade NHL (Groups D-H according to the Working F ormulation) in stage I bulky, II-IV have been registered from 19 insti tutions and randomized to receive 6 courses of either epidoxorubicin, 30 Mg/M2 (P-E) or idarubicin, 6 mg/m2 (P-I) containing P-C. The presen t study deals with the results of an interim analysis of the first 96 cases enrolled up to December 1991 (median follow up of surviving case s 19 months, range 15-23), in terms of overall response rate, toxicity and dose intensity of the two schedules, and overall survival. Result s. The overall response rate was: 55 CR (64.0%), 15 PR (17.4%), 5 NR ( 5.8%) and 11 PG (12.8%). The actuarial survival rate was 61% at 24 mon ths. Hematological and non-hematological toxicity was comparable in th e two arms. Dose intensity was high and similar for the two schedules (90% vs 89%). Conclusion. This interim analysis demonstrates that in a ggressive NHL both P-C derived schedules with epidoxorubicin or idarub icin are effective, safe and well tolerated, also when used in a large multicentric setting.