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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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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.
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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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