title: Phase 2 study of arsenic trioxide followed by autologous hematopoietic cell transplantation for relapsed acute promyelocytic leukemia.
abstract: The optimal treatments for relapsed acute promyelocytic leukemia (APL) remain equivocal. We conducted a phase 2 study to evaluate the efficacy and feasibility of a sequential treatment consisting of induction and consolidation with arsenic trioxide (ATO), peripheral blood stem cell (PBSC) harvest after high-dose cytarabine chemotherapy, and autologous hematopoietic cell transplantation (HCT). Between 2005 and 2009, 35 patients (26 with hematologic and 9 with molecular relapse) were enrolled. Induction therapy resulted in complete remission in 81% of those with hematologic relapse, and most patients became negative for PML-RARα after the first ATO consolidation course, but 4 remained positive. Administration of the second ATO consolidation course further decreased the transcript levels in 3 patients. In total, 25 patients proceeded to PBSC harvest, all of whom successfully achieved the target CD34+ cell doses, and 23 underwent autologous HCT with PML-RARα-negative PBSC graft. Posttransplant relapse occurred in 3 patients, and there was no transplant-related mortality. With a median follow-up of 4.9 years, the 5-year event-free and overall survival rates were 65% and 77%, respectively. These findings demonstrate the outstanding efficacy and feasibility of the sequential treatment featuring ATO and autologous HCT for relapsed APL. This study was registered at http://www.umin.ac.jp/ctr/ as #C000000302.
authors: Fujita Health University School of Medicine, Toyoake 470-1192, Japan. myanada@fujita-hu.ac.jp
authors: Masamitsu
authors: M
authors: Yanada
authors: Motohiro
authors: M
authors: Tsuzuki
authors: Hiroyuki
authors: H
authors: Fujita
authors: Katsumichi
authors: K
authors: Fujimaki
authors: Shin
authors: S
authors: Fujisawa
authors: Kazutaka
authors: K
authors: Sunami
authors: Masafumi
authors: M
authors: Taniwaki
authors: Akira
authors: A
authors: Ohwada
authors: Kosuke
authors: K
authors: Tsuboi
authors: Akio
authors: A
authors: Maeda
authors: Akihiro
authors: A
authors: Takeshita
authors: Shigeki
authors: S
authors: Ohtake
authors: Yasushi
authors: Y
authors: Miyazaki
authors: Yoshiko
authors: Y
authors: Atsuta
authors: Yukio
authors: Y
authors: Kobayashi
authors: Tomoki
authors: T
authors: Naoe
authors: Nobuhiko
authors: N
authors: Emi
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000627:therapeutic use*; D003561:Cytarabine / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000235:genetics / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000235:genetics / Q000601:surgery*; D015514:Oncogene Proteins, Fusion / Q000235:genetics; D010087:Oxides / Q000627:therapeutic use*; D012074:Remission Induction; D014158:Transcription, Genetic; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001152:Arsenicals; D015514:Oncogene Proteins, Fusion; D010087:Oxides; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein; D003561:Cytarabine; D000077237:Arsenic Trioxide