title: Durable molecular remissions with a single cycle of timed sequential consolidation chemotherapy in acute promyelocytic leukemia.
abstract: In a pilot study to reduce the duration of treatment and potential long-term toxicities, 39 patients with acute promyelocytic leukemia in remission received a single cycle of intensive consolidation therapy, followed by intermittent ATRA maintenance. Consolidation therapy required prolonged hospitalization and was associated with a high incidence of mucositis (43% grade II or greater) and documented infection (45%). No deaths occurred during consolidation. Seven patients have relapsed; all other patients are in molecular remission (median follow-up, 2.75 years). Kaplan-Meier estimate of 3 year disease-free survival is 73% (95% confidence interval 55-91%). The relapse rate (0.06 relapses/patient-year of follow-up) is well within the range of larger published series that administer more prolonged consolidation. One patient has developed secondary myelodysplastic syndrome. These pilot data suggest that decreasing the total duration of consolidation chemotherapy did not compromise disease-free survival for APL patients induced with ATRA/anthracycline and given intermittent ATRA maintenance. However, the toxicity of the consolidation module and the development of secondary myelodysplasia despite decreased total therapy emphasize the need to further improve and refine curative therapy for APL.
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, USA. Steven.Gore@jhu.edu
authors.forename: Steven D
authors.initials: SD
authors.lastname: Gore
authors.forename: B Douglas
authors.initials: BD
authors.lastname: Smith
authors.forename: Ivana
authors.initials: I
authors.lastname: Gojo
authors.forename: Michael
authors.initials: M
authors.lastname: Grever
authors.forename: Scott H
authors.initials: SH
authors.lastname: Kaufmann
authors.forename: Louis
authors.initials: L
authors.lastname: Letendre
authors.forename: Debra G B
authors.initials: DG
authors.lastname: Leonard
authors.forename: Guido
authors.initials: G
authors.lastname: Marcucci
authors.forename: Carole B
authors.initials: CB
authors.lastname: Miller
authors.forename: Lawrence
authors.initials: L
authors.lastname: Morris
authors.forename: Steven
authors.initials: S
authors.lastname: Piantadosi
authors.forename: Thomas
authors.initials: T
authors.lastname: Prior
authors.forename: Wendy
authors.initials: W
authors.lastname: Stock
authors.forename: Judith E
authors.initials: JE
authors.lastname: Karp
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000378:metabolism; D006801:Humans; D015994:Incidence; D007239:Infections / Q000139:chemically induced / Q000453:epidemiology; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000378:metabolism; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D010865:Pilot Projects; D018168:Receptors, Retinoic Acid / Q000378:metabolism; D012074:Remission Induction; D000072482:Retinoic Acid Receptor alpha; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013280:Stomatitis / Q000139:chemically induced / Q000453:epidemiology; D016019:Survival Analysis; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C000607071:RARA protein, human; D018168:Receptors, Retinoic Acid; D000072482:Retinoic Acid Receptor alpha; D014212:Tretinoin