title: Blinatumomab treatment of older adults with relapsed/refractory B-precursor acute lymphoblastic leukemia: Results from 2 phase 2 studies.
abstract: Older adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL) are reported to have a poor prognosis and few therapeutic options. In the current study, the authors evaluated treatment with single-agent blinatumomab in adults aged ≥65 years with r/r ALL.
  
  
  
  A total of 261 adults with r/r ALL who were examined across two phase 2 studies received blinatumomab in cycles of 4-week continuous infusion and 2-week treatment-free intervals. The primary endpoint in each study was complete remission (CR) or CR with partial hematologic recovery (CRh) during the first 2 cycles. Data were pooled and analyzed according to patient age at screening (aged ≥65 years vs aged <65 years).
  
  
  
  Of 36 older adults, 56% (95% confidence interval [95% CI], 38%-72%) achieved CR/CRh during the first 2 cycles compared with 46% (225 patients) (95% CI, 40%-53%) of younger adults. Complete minimal residual disease responses were 60% in older and 70% in younger responders. Three older responders (15%) and 61 younger responders (59%) proceeded to allogeneic hematopoietic stem cell transplantation. Kaplan-Meier curves overlapped for relapse-free and overall survival for both age groups. Older adults were found to have a similar incidence of grade ≥3 adverse events (AEs) as younger adults (86% vs 80%) but more grade ≥3 neurologic events (28% vs 13%). Cytokine release syndrome occurred in 7 older (19%) (1 case of grade 3) and 23 younger (10%) (4 cases of grade ≥3) adults. There were no treatment-related fatal AEs reported.
  
  
  
  Older adults with r/r ALL who were treated with single-agent blinatumomab were found to have similar hematologic response rates and incidence of grade ≥3 AEs compared with younger adults but had more neurologic events, which were reversible and primarily resolved with treatment interruption. Cancer 2016;122:2178-85. © 2016 American Cancer Society.
authors.affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Hagop M
authors.initials: HM
authors.lastname: Kantarjian
authors.affiliation: Gehr Leukemia Center, City of Hope, Duarte, California.
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Stein
authors.affiliation: Department of Internal Medicine II, Hematology/Oncology, Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg, Wurzburg, Germany.
authors.forename: Ralf C
authors.initials: RC
authors.lastname: Bargou
authors.affiliation: Department of Medicine, Hematology, University Hospital "12 de Octubre", Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Grande Garcia
authors.affiliation: Department of Medicine, Hematology/Oncology, University of Chicago, Chicago, Illinois.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.affiliation: Department of Medicine, University of Muenster, Muenster, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Stelljes
authors.affiliation: Department of Medicine II, University Hospital, Frankfurt, Germany.
authors.forename: Nicola
authors.initials: N
authors.lastname: Gökbuget
authors.affiliation: Amgen Research Munich GmbH, Munich, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Zugmaier
authors.affiliation: Amgen, Thousand Oaks, California.
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Benjamin
authors.affiliation: Amgen, Thousand Oaks, California.
authors.forename: Alicia
authors.initials: A
authors.lastname: Zhang
authors.affiliation: Amgen South San Francisco, South San Francisco, California.
authors.forename: Catherine
authors.initials: C
authors.lastname: Jia
authors.affiliation: Medical Clinic and Polyclinic II, University Hospital of Würzburg, Wurzburg, Germany.
authors.forename: Max S
authors.initials: MS
authors.lastname: Topp
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018033:Antibodies, Bispecific / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D019008:Drug Resistance, Neoplasm; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D015337:Multicenter Studies as Topic; D015452:Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D012008:Recurrence; D019233:Retreatment; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018033:Antibodies, Bispecific; D000970:Antineoplastic Agents; C510808:blinatumomab
keywords: acute lymphoblastic leukemia; bispecific antibodies; blinatumomab; elderly; relapsed/refractory