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Blood, 1 July 2007, Vol. 110, No. 1, pp. 59-66. Prepublished online as a Blood First Edition Paper on March 20, 2007; DOI 10.1182/blood-2006-08-043992. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2006-08-043992v1 110/1/59    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Asou, N. Articles by Ohno, R. Search for Related Content PubMed PubMed Citation Articles by Asou, N. Articles by Ohno, R. Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RAR transcript after consolidation therapy: The Japan Adult Leukemia Study Group (JALSG) APL97 study Norio Asou1, Yuji Kishimoto2, Hitoshi Kiyoi3, Masaya Okada4, Yasukazu Kawai5, Motohiro Tsuzuki6, Kentaro Horikawa1, Mitsuhiro Matsuda7, Katsuji Shinagawa8, Tohru Kobayashi9, Shigeki Ohtake10, Miki Nishimura11, Masatomo Takahashi12, Fumiharu Yagasaki13, Akihiro Takeshita14, Yukihiko Kimura15, Masako Iwanaga16, Tomoki Naoe3, Ryuzo Ohno17, and for the Japan Adult Leukemia Study Group 1 Department of Hematology, Kumamoto University School of Medicine, Japan; 2 First Department of Internal Medicine, Kansai Medical University, Moriguchi, Japan; 3 Department of Hematology/Oncology, Nagoya University Graduate School of Medicine, Japan; 4 Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan; 5 First Department of Internal Medicine, University of Fukui, Japan; 6 Department of Medicine, Fujita Health University School of Medicine, Toyoake, Japan; 7 Department of Hematology, Kinki University School of Medicine, Osaka-Sayama, Japan; 8 Department of Hematology and Oncology, Okayama University Graduate School, Japan; 9 Department of Hematology, Mie University Graduate School of Medicine, Tsu, Japan; 10 Department of Hematology, Kanazawa University Graduate School of Medical Science, Japan; 11 Department of Hematology, Chiba University Hospital, Japan; 12 Division of Hematology and Oncology, St. Marianna University School of Medicine, Kawasaki, Japan; 13 Department of Internal Medicine (Hematology), Saitama Medical University, Japan; 14 Department of Internal Medicine, Hamamatsu University School of Medicine, Japan; 15 First Department of Internal Medicine, Tokyo Medical University, Japan; 16 Department of Molecular Medicine, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Japan; 17 Aichi Cancer Center, Nagoya, Japan To examine the efficacy of intensified maintenance chemotherapy, we conducted a prospective multicenter trial in adult patients with newly diagnosed acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy. Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission. Predicted 6-year overall survival in all assessable patients and disease-free survival in patients who achieved complete remission were 83.9% and 68.5%, respectively. A total of 175 patients negative for PML-RAR at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). Predicted 6-year disease-free survival was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the 2 groups (P = .20). Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = .014). These results indicate that the intensified maintenance chemotherapy did not improve disease-free survival, but rather conferred a significantly poorer chance of survival in acute promyelocytic leukemia patients who have become negative for the PML-RAR fusion transcript after 3 courses of intensive consolidation therapy. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: M. A. Sanz, D. Grimwade, M. S. Tallman, B. Lowenberg, P. Fenaux, E. H. Estey, T. Naoe, E. Lengfelder, T. Buchner, H. Dohner, et al. Management of acute promyelocytic leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet Blood, February 26, 2009; 113(9): 1875 - 1891. [Abstract] [Full Text] [PDF] F. Ravandi, E. Estey, D. Jones, S. Faderl, S. O'Brien, J. Fiorentino, S. Pierce, D. Blamble, Z. Estrov, W. Wierda, et al. Effective Treatment of Acute Promyelocytic Leukemia With All-Trans-Retinoic Acid, Arsenic Trioxide, and Gemtuzumab Ozogamicin J. Clin. Oncol., February 1, 2009; 27(4): 504 - 510. [Abstract] [Full Text] [PDF] Z.-Y. Wang and Z. Chen Acute promyelocytic leukemia: from highly fatal to highly curable Blood, March 1, 2008; 111(5): 2505 - 2515. [Abstract] [Full Text] [PDF] M. S. Tallman and J. K. Altman Curative Strategies in Acute Promyelocytic Leukemia Hematology, January 1, 2008; 2008(1): 391 - 399. [Abstract] [Full Text] [PDF]

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