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We conducted a multi-institutional randomized study to determine whether highdose daunorubicin would be as effective as standard-dose idarubicin in remissioninduction therapy for newly diagnosed adult patients younger than 65 years of age with acute myeloid leukemia. Of 1064 patients registered, 1057 were evaluable. They were randomly assigned to receive either daunorubicin (

Adult T-cell leukemia/lymphoma (ATLL) is a distinct peripheral T-cell neoplasm that is highly resistant to chemotherapy. Several groups, including ours, have reported encouraging results of allogeneic hematopoietic stem cell transplantation (allo-HSCT) for patients with ATLL. To confirm our previous report and to establish the basis for a phase II clinical study, we analyzed 40 allo-HSCT for acute and lymphoma types of ATLL in seven institutions in Japan between 1997 and 2002. All evaluable cases entered complete remission (CR) after allo-HSCT and the median survival time was 9.6 months for all patients. The estimated 3-year overall and relapse-free survival, and disease relapse were 45.3, 33.8 and 39.3%, respectively. Among 10 cases with ATLL relapse, five cases achieved CR again: three by the reduction or cessation of immunosuppressive agents, which suggested a graft-versus-ATLL (GvATLL) effect. However, univariate or multivariate analysis did not show any benefit of graft-versus-host disease (GVHD) on the prevention of relapse. These results suggested that allo-HSCT was effective for some patients with aggressive ATLL, and that the GvATLL effect could be achieved even without GVHD. A new phase II trial to test the efficacy of allo-HSCT for ATLL is warranted.

We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m 2 twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study. Five-year disease-free survival was 43% for the HiDAC group and 39% for the multiagent CT group (P ‫؍‬ .724), and 5-year overall survival was 58% and 56%, respectively (P ‫؍‬ .954). Among the favorable cytogenetic risk group (n ‫؍‬ 218), 5-year diseasefree survival was 57% for HiDAC and 39% for multiagent CT (P ‫؍‬ .050), and 5-year overall survival was 75% and 66%, respectively (P ‫؍‬ .174). In the HiDAC group, the nadir of leukocyte counts was lower, and the duration of leukocyte less than 1.0 ؋ 10 9 /L longer, and the frequency of documented infections higher. The present study demonstrated that the multiagent CT regimen is as effective as our HiDAC regimen for consolidation. Our HiDAC regimen resulted in a beneficial effect on disease-free survival only in the favorable cytogenetic leukemia group. This trial was registered at www.umin.ac.jp/ ctr/ as #C000000157. IntroductionApproximately 70% to 80% of the newly diagnosed younger adult patients with acute myeloid leukemia (AML) achieve complete remission (CR) when treated with an anthracycline, usually daunorubicin (DNR) or idarubicin (IDR), and cytarabine (Ara-C); however, only approximately one-third of these patients remain free of disease for more than 5 years. [1][2][3][4][5] If CR patients are left untreated, almost all of them will relapse and die. 6 Therefore, postremission therapy is indispensable. Postremission therapy is divided into consolidation and maintenance therapy. In the previous studies of Japan Adult Leukemia Study Group (JALSG) for adult AML (AML87, 89, 92, and 95), 1-3,5 we administered 3 courses of consolidation therapy and 6 courses of intensified maintenance therapy. In the AML97 study, 7 we conducted a randomized study to compare the conventional 3-course consolidation and 6-course maintenance therapies with 4 courses of intensive consolidation therapy without maintenance and demonstrated no difference in overall survival (OS) and disease-free survival (DFS). Therefore, the 4 courses of conventional standard-dose multiagent chemotherapy (CT) became the standard regimen in Japan. On the other hand, multiple cycles of high-dose cytarabine (HiDAC) have been commonly used as consolidation therapy in the United States and other countries. However, our national medical insurance system did not allow us to use HiDAC until 2001, and thus we could not use HiDAC in the previous treatment regimens for leukemia. We therefore conducted this prospective, multicenter cooperative An Inside Blood analysis of this article appears at the front of this issu...

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