Mitoxantrone is superior to doxorubicin in a multiagent weekly regimen forpatients older than 60 with high-grade lymphoma: results of a BNLI randomized trial of PAdfiaCEBO versus PMitCEBO

A prospective, multicenter, randomized trial was undertaken to compare the efficacy and toxicity of adriamycin with mitoxantrone within a 6-drug combi nation chemotherapy regimen for elderly patients (older than 60 years) with high-grade non-Hodgkin lymphoma (HGL) given for a minimum of 8 weeks. A to tal of 516 previously untreated patients aged older than 60 years were rand omized to receive 1 of 2 anthracycline-containing regimens: adriamycin, 35 mg/m(2) intravenously (IV) on day 1 (n = 259), or mitoxantrone, 7 mg/m(2) I V on day 1 (n = 257); with prednisolone, 50 mg orally on days 1 to 14; cycl ophosphamide, 300 mg/m(2) IV on day 1; etoposide, 150 mg/m(2) IV on day 1; vincristine, 1.4 mg/m(2) IV on day 8; and bleomycin, 10 mg/m(2) IV on day 8 . Each 2-week cycle was administered for a minimum of 8 weeks in the absenc e of progression. Forty-three patients were ineligible for analysis. The ov erall and complete remission rates were 78% and 60% for patients receiving PMitCEBO and 69% and 52% for patients receiving PAdriaCEBO (P =.05, P =.12, respectively). Overall survival was significantly better with PMitCEBO tha n PAdriaCEBO (P =.0067). However, relapse-free survival was not significant ly different (P =.16). At 4 years, 28% of PAdrlaCEBO patients and 50% of PM itCEBO patients were alive (P =.0001). Ann Arbor stage III/IV, World Health Organization performance status 2-4, and elevated lactate dehydrogenase ne gatively influenced overall survival from diagnosis. In conclusion, the PMi tCEBO 8-week combination chemotherapy regimen offers high response rates, d urable remissions, and acceptable toxicity in elderly patients with HGL. (B lood. 2001;97.-2991-2997) (C) 2001 by The American Society of Hematology.