IDARUBICIN IN PATIENTS WITH DIFFUSE LARGE-CELL LYMPHOMAS - A RANDOMIZED TRIAL COMPARING VACOP-B (A=DOXORUBICIN) VS VICOP-B (I=IDARUBICIN)

Background and Objective. Idarubicin is an effective drug in acute leu kemia but its use in nonHodgkin lymphomas (NHLs) is not yet well estab lished. We evaluated its efficacy in patients with diffuse large cell lymphoma (DLCL) by means of a randomized trial comparing two 12-week r egimens (VACOP-B and VICOP-B) which differed only in the anthracycline drug used (doxorubicin vs idarubicin). Methods. From January 1992 to December 1994, 104 patients aged less than 65 years with de novo advan ced stage DLCL were enrolled. Fifty-two patients were treated with VAC OP-B (doxorubicin 50 mg/sqm) and 52 with VICOP-B (idarubicin initially 8 mg/sqm and thereafter 10 mg/sqm). Results. Clinical characteristics of the two groups were not significantly different. One HBsAg(+) pati ent died of hepatic necrosis in the VICOP-B arm, and severe (WHO grade > 2) toxicities occurred in 7 patients treated with VACOP-B and in 5 treated with VICOP-B; the only significant difference was for mucositi s (p=0.02). Complete remission (CR) was obtained in 79% of patients re ceiving VACOP-B and in 56% (idarubicin 8 mg/sqm) and 75% (idarubicin 1 0 mg/sqm) of those in the VICOP-B group (p=n.s.). Prognostic factors t hat negatively affected CR were advanced stage in VACOP, bone marrow i nfiltration in both schedules. At a median follow-up of two years, ove rall survival (67% VACOP and 61% VICOP) and disease-free survival (65% and 67%, respectively) were not significantly different. Interpretati on and Conclusions. Idarubicin is slightly less toxic than doxorubicin ; at a dose of 10 mg/sqm the former is easily tolerated and shows the same efficacy as doxorubicin in the treatment of DLCL. (C) 1997, Ferra ta Storti Foundation.