Randomized study comparing 4'-epi-doxorubicin (epirubicin) versus doxorubicin as a part of induction treatment in adult acute lymphoblastic leukemia.

Doxorubicin or daunorubicin are routinely used to induce remission in acute lymphoblastic leukemia (ALL). Efficacy of epirubicin (an analog of doxorubicin), however, has not been adequately evaluated in ALL management. This randomized study was undertaken to compare the relative efficacy of epirubicin vs. doxorubicin as part of induction chemotherapy in adult ALL. Between January 1990 and June 1998, 79 previously untreated adult ALL patients (age 11-55 years, median 20 years) were randomized to receive either doxorubicin (Group A, n = 39) or epirubicin (Group B, n = 40) as a part of induction therapy. Vincristine and prednisolone were common in each group. The induction treatment was followed by identical consolidation and maintenance therapy. The two groups were compared as regards pretherapy clinical and laboratory parameters, dose intensity of therapy, therapeutic efficacy, myelotoxicity, and survival. Epirubicin was as effective as doxorubicin in terms of complete remission rate (80% vs. 78.3%; P = 0.87) and relapse rate (57.1% vs. 51.7%; P = 0.68). Five-year overall survival (30% vs. 30%, P = 0.98) and disease-free survival (40% vs. 39%, P = 0.92) at median follow-up of 68 months was also similar in the two groups. The incidence of Grade 4 myelotoxicity was comparable in the two groups. Patients 20 years of age or less had better CR rates (90% vs. 65%; P = 0.011) and median overall survival (39 vs. 11 months; P = 0.008) compared to those who were older. From this study epirubicin appears as effective as doxorubicin as part of induction therapy for adult ALL. However, the results need to be validated on the basis of immunophenotype and cytogenetic prognostic characterization.