PMID- 27143254
OWN - NLM
STAT- MEDLINE
DCOM- 20170518
LR  - 20180309
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
VI  - 122
IP  - 14
DP  - 2016 Jul 15
TI  - Blinatumomab treatment of older adults with relapsed/refractory B-precursor acute 
      lymphoblastic leukemia: Results from 2 phase 2 studies.
PG  - 2178-85
LID - 10.1002/cncr.30031 [doi]
AB  - BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. (c) 2016 
      American Cancer Society.
CI  - (c) 2016 American Cancer Society.
FAU - Kantarjian, Hagop M
AU  - Kantarjian HM
AD  - Department of Leukemia, The University of Texas MD Anderson Cancer Center, 
      Houston, Texas.
FAU - Stein, Anthony S
AU  - Stein AS
AD  - Gehr Leukemia Center, City of Hope, Duarte, California.
FAU - Bargou, Ralf C
AU  - Bargou RC
AD  - Department of Internal Medicine II, Hematology/Oncology, Comprehensive Cancer 
      Center Mainfranken, University Hospital of Wurzburg, Wurzburg, Germany.
FAU - Grande Garcia, Carlos
AU  - Grande Garcia C
AD  - Department of Medicine, Hematology, University Hospital "12 de Octubre", Madrid, 
      Spain.
FAU - Larson, Richard A
AU  - Larson RA
AD  - Department of Medicine, Hematology/Oncology, University of Chicago, Chicago, 
      Illinois.
FAU - Stelljes, Matthias
AU  - Stelljes M
AD  - Department of Medicine, University of Muenster, Muenster, Germany.
FAU - Gokbuget, Nicola
AU  - Gokbuget N
AD  - Department of Medicine II, University Hospital, Frankfurt, Germany.
FAU - Zugmaier, Gerhard
AU  - Zugmaier G
AD  - Amgen Research Munich GmbH, Munich, Germany.
FAU - Benjamin, Jonathan E
AU  - Benjamin JE
AD  - Amgen, Thousand Oaks, California.
FAU - Zhang, Alicia
AU  - Zhang A
AD  - Amgen, Thousand Oaks, California.
FAU - Jia, Catherine
AU  - Jia C
AD  - Amgen South San Francisco, South San Francisco, California.
FAU - Topp, Max S
AU  - Topp MS
AD  - Medical Clinic and Polyclinic II, University Hospital of Wurzburg, Wurzburg, 
      Germany.
LA  - eng
GR  - P30 CA016672/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160503
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antibodies, Bispecific)
RN  - 0 (Antineoplastic Agents)
RN  - 4FR53SIF3A (blinatumomab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Bispecific/*therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Clinical Trials, Phase II as Topic
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Molecular Targeted Therapy
MH  - Multicenter Studies as Topic
MH  - Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/*drug 
      therapy/mortality/*pathology
MH  - Recurrence
MH  - Retreatment
MH  - Transplantation, Homologous
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - acute lymphoblastic leukemia
OT  - bispecific antibodies
OT  - blinatumomab
OT  - elderly
OT  - relapsed/refractory
EDAT- 2016/05/05 06:00
MHDA- 2017/05/19 06:00
CRDT- 2016/05/05 06:00
PHST- 2015/12/18 00:00 [received]
PHST- 2016/02/12 00:00 [revised]
PHST- 2016/03/09 00:00 [accepted]
PHST- 2016/05/05 06:00 [entrez]
PHST- 2016/05/05 06:00 [pubmed]
PHST- 2017/05/19 06:00 [medline]
AID - 10.1002/cncr.30031 [doi]
PST - ppublish
SO  - Cancer. 2016 Jul 15;122(14):2178-85. doi: 10.1002/cncr.30031. Epub 2016 May 3.