A RANDOMIZED COMPARISON OF THE EFFICACY AND TOXICITY OF EPIRUBICIN AND DOXORUBICIN IN THE TREATMENT OF PATIENTS WITH NON-HODGKINS-LYMPHOMA

BACKGROUND. Combination chemotherapy consisting of methotrexate, doxor ubicin, cyclophosphamide, vincristine, prednisolone, and bleomycin (MA COP-B) has been frequently used for the treatment of non-Hodgkin's lym phoma. This randomized study was undertaken to assess the efficacy and toxicity of this regimen when either doxorubicin or epirubicin was us ed as the anthracycline drug. METHODS. Between April 1989 and December 1993, 211 previously untreated patients with intermediate grade and h igh grade non-Hodgkin's lymphoma were randomized to receive either dox orubicin (n = 106) or epirubicin (n = 105) with the MACOP-B regimen. T hese patients were followed through December 1996. Numerous clinical f eatures predictive of response and survival were analyzed. Cardiac and noncardiac toxicity in the two treatment arms were compared. RESULTS. The median age of the patients was 48 years. Complete remission was e xperienced by 122 patients (58.3%); 62 patients (58.5%) achieved compl ete remission in the doxorubicin arm and 60 (58.1%) in the epirubicin arm. Response rates, time to treatment failure, relapse data, and over all survival were comparable between the two arms. Morbidity due to mu cositis, vomiting, peripheral neuropathy, and cardiotoxicity were also comparable. The overall mortality was 10%. Mortality due to neutropen ic sepsis was considerably higher among patients who received epirubic in (10 patients) than among those who received doxorubicin (5 patients ). Cardiac evaluation revealed no difference in toxicity between the t wo arms. CONCLUSIONS. Epirubicin was as effective as doxorubicin in te rms of patients' responses to therapy. There was no difference in card iotoxicity between the two treatment arms. However, in this study, the mortality due to neutropenic sepsis was significantly higher among pa tients treated with epirubicin. (C) 1998 American Cancer Society.