title: Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia.
abstract: We report a study of an alternative treatment schedule of imatinib (IM) in chronic myeloid leukemia (CML). Seventy-six Philadelphia-positive (Ph+), BCR-ABL-positive patients aged 65 years or older who had been treated with IM for more than 2 years and who were in stable complete cytogenetic response (CCgR) and major molecular response (MMR) were enrolled in a single-arm study to test the effects of a policy of intermittent IM (INTERIM) therapy for 1 month on and 1 month off. With a minimum follow-up of 4 years, 13 patients (17%) lost CCgR and MMR and 14 (18%) lost MMR only. All these patients resumed continuous IM and all but one (lost to follow-up) regained CCgR and MMR. No patients progressed to accelerated or blastic phase or developed clonal chromosomal abnormalities in Ph+ cells or BCR-ABL mutations. In elderly Ph+ CML patients carefully selected for a stable CCgR (lasting >2 years), the policy of INTERIM treatment affected the markers of residual disease, but not the clinical outcomes (overall and progression-free survival). This trial was registered at www.clinicaltrials.gov as NCT 00858806.
authors.affiliation: Unit of Blood Diseases and Stem Cell Transplantation, University of Brescia, Brescia, Italy. russo@med.unibs.it
authors.forename: Domenico
authors.initials: D
authors.lastname: Russo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Michele
authors.initials: M
authors.lastname: Malagola
authors.forename: Cristina
authors.initials: C
authors.lastname: Skert
authors.forename: Simona
authors.initials: S
authors.lastname: Soverini
authors.forename: Ilaria
authors.initials: I
authors.lastname: Iacobucci
authors.forename: Antonio
authors.initials: A
authors.lastname: De Vivo
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Testoni
authors.forename: Fausto
authors.initials: F
authors.lastname: Castagnetti
authors.forename: Gabriele
authors.initials: G
authors.lastname: Gugliotta
authors.forename: Diamante
authors.initials: D
authors.lastname: Turri
authors.forename: Micaela
authors.initials: M
authors.lastname: Bergamaschi
authors.forename: Michela
authors.initials: M
authors.lastname: Bergamaschi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Pregno
authors.forename: Ester
authors.initials: E
authors.lastname: Pungolino
authors.forename: Fabio
authors.initials: F
authors.lastname: Stagno
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Bruno
authors.initials: B
authors.lastname: Martino
authors.forename: Tamara
authors.initials: T
authors.lastname: Intermesoli
authors.forename: Carmen
authors.initials: C
authors.lastname: Fava
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Abruzzese
authors.forename: Mario
authors.initials: M
authors.lastname: Tiribelli
authors.forename: Catia
authors.initials: C
authors.lastname: Bigazzi
authors.forename: Bruno Mario
authors.initials: BM
authors.lastname: Cesana
authors.forename: Gianantonio
authors.initials: G
authors.lastname: Rosti
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001549:Benzamides / Q000627:therapeutic use*; D020732:Cytogenetic Analysis; D005260:Female; D005500:Follow-Up Studies; D016044:Fusion Proteins, bcr-abl / Q000235:genetics; D006291:Health Policy; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl