title: Survival advantage from imatinib compared with the combination interferon-alpha plus cytarabine in chronic-phase chronic myelogenous leukemia: historical comparison between two phase 3 trials.
abstract: In the multinational IRIS study comparing imatinib with interferon plus cytarabine (IFN/Ara-C) in patients with newly diagnosed chronic-phase chronic myelogenous leukemia (CP CML), imatinib demonstrated significantly higher rates of complete cytogenetic responses (CCyRs) and improved progression-free survival (PFS). However, because of a high early crossover rate to imatinib, survival benefit was not assessable. Here, we report the result of a study comparing long-term outcome of patients included in 2 prospective randomized trials: 551 patients assigned to imatinib in the IRIS trial from 2000 to 2001 and 325 patients who received the combination IFN/Ara-C in the CML91 trial between 1991 and 1996 before imatinib was available. With a follow-up of 42 months for both groups of patients, estimated CCyR, survival free of transformation, and overall survival were significantly higher with imatinib compared with IFN/Ara-C (P < .001, P = .004, and P < .001, respectively). Improved overall survival was also confirmed within different Sokal prognostic risk groups. Of interest, among all patients who achieved major cytogenetic response or CCyR at 12 months, the survival rate was similar irrespective of their treatment. In conclusion, within the limitation of this historical comparison, there is a survival advantage from first-line therapy with imatinib over IFN/Ara-C.
authors.affiliation: Department of Oncology-Hematology and Cell Therapy, EA 3805, CHU La Milétrie, 2 Rue de la Milétrie, 86021 POITIERS CEDEX, France.
authors.forename: Lydia
authors.initials: L
authors.lastname: Roy
authors.forename: Joëlle
authors.initials: J
authors.lastname: Guilhot
authors.forename: Tillmann
authors.initials: T
authors.lastname: Krahnke
authors.forename: Agnès
authors.initials: A
authors.lastname: Guerci-Bresler
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Druker
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.forename: Steve
authors.initials: S
authors.lastname: O'Brien
authors.forename: Charlene
authors.initials: C
authors.lastname: So
authors.forename: Giorgio
authors.initials: G
authors.lastname: Massimini
authors.forename: François
authors.initials: F
authors.lastname: Guilhot
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001549:Benzamides; D016026:Bone Marrow Transplantation; D017326:Clinical Trials, Phase III as Topic; D003561:Cytarabine / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D016898:Interferon-alpha / Q000627:therapeutic use*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D012189:Retrospective Studies; D013163:Splenomegaly / Q000453:epidemiology; D016019:Survival Analysis; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D016898:Interferon-alpha; D010879:Piperazines; D011743:Pyrimidines; D003561:Cytarabine; D000068877:Imatinib Mesylate