Phase III comparative trial (m-BACOD v m-BNCOD) in the treatment of stage II to IV non-Hodgkin's lymphomas with intermediate- or high-grade histology.

From September 1984 to July 1986, 70 previously untreated patients with Stage II to IV intermediate- or high-grade non-Hodgkin's lymphoma (according to the International Working Formulation) were enrolled in a phase III comparative trial. The objectives of the study were to compare the efficacy and safety of using mitoxantrone instead of doxorubicin in the combination chemotherapeutic regimen m-BACOD (intermediate-dose methotrexate, bleomycin, Adriamycin [doxorubicin, Adria Laboratories], cyclophosphamide, Oncovin [vincristine, Eli Lilly and Company], and dexamethasone). Seventy patients were randomly assigned to receive either m-BN (Novantrone; mitoxantrone, American Cyanamid Company) COD or m-BACOD. The complete-response rate was 57% in both treatment groups, and no significant differences in overall or relapse-free survival were recorded between the two groups. Patients treated with m-BACOD experienced severe alopecia more frequently (P less than .001) and reported six adverse cardiac events of grade greater than 1 whereas neither was observed among those receiving m-BNCOD. The mitoxantrone-containing regimen was found to have an equivalent efficacy and reduced clinical toxicity in comparison to the standard doxorubicin-containing regimen in patients with poor-prognosis non-Hodgkin's lymphomas.