title: A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RARalpha transcript after consolidation therapy: the Japan Adult Leukemia Study Group (JALSG) APL97 study.
abstract: 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-RARalpha 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-RARalpha fusion transcript after 3 courses of intensive consolidation therapy.
authors: Department of Hematology, Kumamoto University School of Medicine, Kumamoto, Japan. ktcnasou@gpo.kumamoto-u.ac.jp
authors: Norio
authors: N
authors: Asou
authors: Yuji
authors: Y
authors: Kishimoto
authors: Hitoshi
authors: H
authors: Kiyoi
authors: Masaya
authors: M
authors: Okada
authors: Yasukazu
authors: Y
authors: Kawai
authors: Motohiro
authors: M
authors: Tsuzuki
authors: Kentaro
authors: K
authors: Horikawa
authors: Mitsuhiro
authors: M
authors: Matsuda
authors: Katsuji
authors: K
authors: Shinagawa
authors: Tohru
authors: T
authors: Kobayashi
authors: Shigeki
authors: S
authors: Ohtake
authors: Miki
authors: M
authors: Nishimura
authors: Masatomo
authors: M
authors: Takahashi
authors: Fumiharu
authors: F
authors: Yagasaki
authors: Akihiro
authors: A
authors: Takeshita
authors: Yukihiko
authors: Y
authors: Kimura
authors: Masako
authors: M
authors: Iwanaga
authors: Tomoki
authors: T
authors: Naoe
authors: Ryuzo
authors: R
authors: Ohno
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000032:analysis* / Q000235:genetics; D012334:RNA, Neoplasm / Q000032:analysis; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome; D014212:Tretinoin / Q000627:therapeutic use
chemical_list: D015514:Oncogene Proteins, Fusion; D012334:RNA, Neoplasm; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein; D014212:Tretinoin