A phase III comparative trial of m-BACOD vs m-BNCOD in the treatment of stage II-IV diffuse non-Hodgkin's lymphomas

From September, 1984 to July, 1986 seventy previously untreated adult patients with advanced non-Hodgkin's lymphoma of intermediate or high grade histology were enrolled in an open phase III multicenter, comparative chemotherapeutic trial. The objectives were to compare, by means of response rate, duration of response and survival time, the efficacy and safety of substituting mitoxantrone for doxorubicin in the combination chemotherapy regimen m-BACOD (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine and dexamethasone). Thirty-five patients were randomly assigned to receive m-B-NOVANTRONE TM (mitoxantrone)-COD (m-BNCOD) and 35 m-B-ADRIAMYCIN TM (doxorubicin)-COD. The complete response rate was 57% for both treatment groups, and no significant disease-free survival and survival differences were found between the two groups of patients. Patients treated with m-BACOD experienced severe alopecia more frequently (p less than 0.001) and, after 10 cycles, six adverse cardiac event of WHO grade greater than 1, as opposed to none among those who received m-BNCOD. The mitoxantrone-containing regimen (m-BNCOD) has equivalent efficacy and reduced toxicity compared to the standard doxorubicin-containing regimen (m-BACOD) in patients with poor prognosis NHL.