title: Phase II study of imatinib-based chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia.
abstract: This study investigated the efficacy of imatinib based therapy with intensified consolidation therapy in patients with Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) to prevent early relapse. We conducted a phase II trial of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive ALL in adults. Sixty-eight patients were included in the trial between October 2008 and December 2010. The median age was 49 years, with 28 patients >55 years of age. Sixty-five patients achieved CR (95.6%). The estimated 2-year event-free survival (EFS) and overall survival (OS) were 62.3% and 67.4%, respectively. Allogeneic stem cell transplantation (allo-SCT) at initial CR was performed in 43 patients. Thirty-five of 39 patients <55 years and 8 of 26 patients >55 years underwent allo-SCT at first CR. The 3-year OS in patients <55 years receiving allo-SCT at first CR, patients >55 years receiving allo-SCT at first CR, patients <55 years not receiving allo-SCT at first CR, and patients >55 years not receiving allo-SCT at first CR were 80.4%, 41.1%, 32.5%, and 52.0%, respectively (P = 0.058). The three-year EFS in each group was 76.7%, 53.6%, not reached, and 26.4%, respectively (P = 0.150). A high CR rate was observed with imatinib-based chemotherapy allowing allo-SCT in a high proportion of patients, particularly those <55 years. Moreover, intensified consolidation therapy reduced early relapse rates following induction therapy and resulted in improved OS and EFS rates following allo-SCT. This trial was registered with the UMIN (000001226).
authors.affiliation: Department of Hematology, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Shin
authors.identifier: http://orcid.org/0000-0003-2028-0209
authors.initials: S
authors.lastname: Fujisawa
authors.affiliation: Department of Hematology, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Mizuta
authors.affiliation: Tokyo Metropolitan Health and Medical Treatment Corporation Tama-Hokubu Medical Center, Tokyo, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Akiyama
authors.affiliation: Department of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Ueda
authors.affiliation: Department of Hematology, Seichokai Fuchu Hospital, Osaka, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Aoyama
authors.affiliation: Department of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Hatta
authors.affiliation: Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kakihana
authors.affiliation: Division of Clinical Oncology and Hematology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Dobashi
authors.affiliation: Division of Hematology and Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan.
authors.forename: Isamu
authors.initials: I
authors.lastname: Sugiura
authors.affiliation: Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Onishi
authors.affiliation: Department of Hemato-Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Maeda
authors.affiliation: Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
authors.forename: Kiyotoshi
authors.initials: K
authors.lastname: Imai
authors.affiliation: Institute of Liberal Arts and Science, Kanazawa University, Kanazawa, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Ohtake
authors.affiliation: Department of Hematology, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Oncology Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ohnishi
authors.affiliation: Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan.
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.affiliation: National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: Tomoki
authors.initials: T
authors.lastname: Naoe
mesh_terms: D000293:Adolescent; D000328:Adult; D060830:Consolidation Chemotherapy / Q000379:methods; D005260:Female; D016044:Fusion Proteins, bcr-abl; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006801:Humans; D000068877:Imatinib Mesylate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy*; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016019:Survival Analysis; D015996:Survival Rate; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl