No beneficial effect from addition of etoposide to daunorubicin, cytarabine, and 6-mercaptopurine in individualized induction therapy of adult acute myeloid leukemia: the JALSG-AML92 study

To assess the efficacy of etoposide added to the standard remission inducti on therapy for acute myeloid leukemia (AML). newly diagnosed adult AML pati ents were randomized to receive either daunorubicin (40 mg/m(2)/day x 4 or more), behenoyl cytarabine (200 mg/m(2)/day x 10 or more), and 6-mercaptopu rine (70 mg/m(2)/day x 10 or more) (BHAC-DM), or the same three drugs plus etoposide (100 mg/m(2)/day x 5) (BHAC-EDM) for response-oriented individual ized induction therapy. The patients achieving complete remission (CR) rece ived the same 3 courses of consolidation therapy followed by 6 courses of m aintenance/intensification therapy. M3 patients were excluded because all-t rans retinoic acid was used. Of 667 patients registered, 655 were evaluable. The median age was 49 (rang e 15 to 85). CR rates were 77% in the BHAC-DM group and 75% in the BHAC-EDM group. In 173 M4 patients, CR rates were 86% and 69% (P = 1.009), and in 3 2 M5 patients, 80% and 77% (P = 0.810) in the BHAC-DM and the BHAC-EDM grou ps, respectively. The: predicted 6-year overall survival rates were 30% and 38% (P = 0.925) for the BHAC-DM and BHAC-EDM groups. and the disease-free survival rates of CR patients were 25% and 35% (P = 0.352), respectively No nhematological toxicities after the fil st course of induction therapy were almost equal among the two groups. with the exception of a greater loss of hair (P = 0.024) and more frequent diarrhea (P = 0.013) in the BHAC-EDM gr oup. We concluded that in the present study, the addition of etoposide to t he standard individualized induction therapy showed no advantage in adult A ML, even among M4 and M5 patients. (C) 1999 The Japanese Society of Hematol ogy.