title: Prognostic factors for outcome in patients with refractory and relapsed acute lymphocytic leukemia treated with inotuzumab ozogamicin, a CD22 monoclonal antibody.
abstract: Inotuzumab ozogamicin was found to be highly active in patients with refractory-relapsed acute lymphocytic leukemia (ALL), with an overall response rate of 58% and a median survival of 6.3 months. Identifying factors associated with different outcomes on inotuzumab therapy may help select patients for this treatment and advice of prognosis. A total of 89 patients treated with inotuzumab on previous studies were analyzed. Inotuzumab was given at 1.3-1.8 mg/m(2) intravenously (IV) × 1 every 3-4 weeks or weekly (0.8 mg/m(2) day 1, 0.5 mg/m(2) days 8 and 15) every 3-4 weeks. Pretreatment factors associated with achieving marrow complete response (CR) and with survival were analyzed using standard statistical methods. The median survival of patients with at least marrow CR was 9.2 months versus 3.4 months for those without marrow CR (P < 0.001). By multivariate analysis, a high peripheral blood absolute blast count and low platelet count were independently associated with a lower likelihood of achieving at least marrow CR. Baseline characteristics independently associated with worse survival included adverse cytogenetics [complex karyotype, translocation (4;11), translocation (9;22), abnormal chromosome 17], disease beyond first salvage, and high peripheral blood absolute count. Patients with 0, 1-2, or 3 adverse factors had a median survival of 39+, 7.5, and 2.4 months, respectively. Our current analyses identified a subset of adult patients with ALL in whom outcome of therapy with inotuzumab ozogamicin can be differentially predicted.
authors.affiliation: Department of Leukemia, U.T. M.D. Anderson Cancer Center, Houston, Texas.
authors.forename: Elias
authors.initials: E
authors.lastname: Jabbour
authors.forename: Susan
authors.initials: S
authors.lastname: O'Brien
authors.forename: Xuelin
authors.initials: X
authors.lastname: Huang
authors.forename: Deborah
authors.initials: D
authors.lastname: Thomas
authors.forename: Michael
authors.initials: M
authors.lastname: Rytting
authors.forename: Koji
authors.initials: K
authors.lastname: Sasaki
authors.forename: Jorge
authors.initials: J
authors.lastname: Cortes
authors.forename: Guillermo
authors.initials: G
authors.lastname: Garcia-Manero
authors.forename: Tapan
authors.initials: T
authors.lastname: Kadia
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi
authors.forename: Sherry
authors.initials: S
authors.lastname: Pierce
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001792:Blood Platelets / Q000473:pathology; D001853:Bone Marrow / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D000080045:Inotuzumab Ozogamicin; D008214:Lymphocytes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000175:diagnosis* / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D012008:Recurrence; D016019:Survival Analysis; D014178:Translocation, Genetic
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000080045:Inotuzumab Ozogamicin