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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.
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Submitted August 28, 2006
Accepted March 18, 2007
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 Asou*, Yuji Kishimoto, Hitoshi Kiyoi, Masaya Okada, Yasukazu Kawai, Motohiro Tsuzuki, Kentaro Horikawa, Mitsuhiro Matsuda, Katsuji Shinagawa, Tohru Kobayashi, Shigeki Ohtake, Miki Nishimura, Masatomo Takahashi, Fumiharu Yagasaki, Akihiro Takeshita, Yukihiko Kimura, Masako Iwanaga, Tomoki Naoe, and Ryuzo Ohno
Department of Hematology, Kumamoto University School of Medicine, Kumamoto, Japan
First Department of Internal Medicine, Kansai Medical University, Moriguchi, Japan
Department of Hematology/Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan
Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
First Department of Internal Medicine, University of Fukui, Fukui, Japan
Department of Medicine, Fujita Health University School of Medicine, Toyoake, Japan
Department of Hematology, Kinki University School of Medicine, Osaka-Sayama, Japan
Department of Hematology and Oncology, Okayama University Graduate School, Okayama, Japan
Department of Hematology, Mie University Graduate School of Medicine, Tsu, Japan
Department of Hematology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan
Department of Hematology, Chiba University Hospital, Chiba, Japan
Division of Hematology and Oncology, St. Marianna University School of Medicine, Kawasaki, Japan
Department of Internal Medicine (Hematology), Saitama Medical University, Saitama, Japan
Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan
First Department of Internal Medicine, Tokyo Medical University, Tokyo, Japan
Department Molecular Medicine, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Aichi Cancer Center, Nagoya, Japan
* Corresponding author; email: ktcnasou{at}gpo.kumamoto-u.ac.jp.
To examine the efficacy of intensified maintenance chemotherapy, we conducted a prospective multicenter trial in adult patients with newly diagnosed acute promyelocytic leukemia (APL) treated with all-trans retinoic acid and chemotherapy. Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission (CR). Predicted 6-year overall survival in all assessable patients and disease-free survival (DFS) in patients who achieved CR 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 DFS was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the two groups (P = 0.20). 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 = 0.014). These results indicate that the intensified maintenance chemotherapy did not improved DFS, but rather conferred a significant poor survival in APL patients who have become negative for the PML-RAR fusion transcript after 3 courses of intensive consolidation therapy.

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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]
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