PMID- 30239252
OWN - NLM
STAT- MEDLINE
DCOM- 20190917
LR  - 20190917
IS  - 2156-535X (Electronic)
IS  - 2156-5333 (Linking)
VI  - 7
IP  - 5
DP  - 2018 Oct
TI  - High-Dose Vincristine Sulfate Liposome Injection, for Advanced, Relapsed, or 
      Refractory Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in an 
      Adolescent and Young Adult Subgroup of a Phase 2 Clinical Trial.
PG  - 546-552
LID - 10.1089/jayao.2018.0041 [doi]
AB  - PURPOSE: A study of vincristine sulfate (VCR) liposome injection (VSLI) was 
      conducted in patients with advanced, relapsed, or refractory, Philadelphia 
      chromosome-negative acute lymphoblastic/lymphocytic leukemia (ALL). A 
      retrospective subgroup analysis of the results was performed to evaluate the 
      safety and efficacy of VSLI in the adolescent and young adult (AYA) patients. 
      METHODS: Of the 65 patients treated in the pivotal Phase 2 Study HBS407 
      (NCT00495079), 44 patients were aged </=39 years (median 27 [range 19-39] years) 
      and were included in this analysis. Patients received VSLI (2.25 mg/m(2) 
      intravenously every 7 +/- 3 days) without dose capping or concurrent steroid 
      administration in continuous 28-day cycles. RESULTS: VSLI was well tolerated in 
      the AYA patients over a median of 5 (range 1-15) doses administered. One-third of 
      patients (36%) experienced treatment-related serious adverse events (AEs) with 
      peripheral neuropathy (7%), tumor lysis syndrome (7%), and febrile neutropenia 
      (5%) in >1 patient. Neuropathy-associated AEs occurred in 82% patients; no 
      neuropathy-related deaths occurred. The rate of complete remission (CR) (with or 
      without complete blood count recovery) by investigator assessment was 25% in AYA 
      patients, and the overall response rate was 39%. Median leukemia-free survival in 
      AYA patients attaining CR was 135 (range 32-463) days, and median overall 
      survival was 141 (range 13-620) days. CONCLUSION: VSLI provided a meaningful 
      clinical benefit to AYA patients with ALL, and its safety profile was comparable 
      to that of VCR despite the delivery of higher doses (individual and cumulative).
FAU - Schiller, Gary J
AU  - Schiller GJ
AD  - 1 Department of Hematology, Oncology, David Geffen School of Medicine at 
      University of California Los Angeles , Los Angeles, California.
FAU - Damon, Lloyd E
AU  - Damon LE
AD  - 2 Department of Hematology and Blood and Marrow Transplant, University of 
      California San Francisco , San Francisco, California.
FAU - Coutre, Steven E
AU  - Coutre SE
AD  - 3 Department of Hematology, Stanford Cancer Institute, Stanford University School 
      of Medicine , Stanford, California.
FAU - Hsu, Pamela
AU  - Hsu P
AD  - 4 Department of Clinical Science, Spectrum Pharmaceuticals , Irvine, California.
FAU - Bhat, Gajanan
AU  - Bhat G
AD  - 4 Department of Clinical Science, Spectrum Pharmaceuticals , Irvine, California.
FAU - Douer, Dan
AU  - Douer D
AD  - 5 Division of Hematology, University of Southern California , Los Angeles, 
      California.
LA  - eng
SI  - ClinicalTrials.gov/NCT00495079
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180921
PL  - United States
TA  - J Adolesc Young Adult Oncol
JT  - Journal of adolescent and young adult oncology
JID - 101543508
RN  - 0 (Liposomes)
RN  - 5J49Q6B70F (Vincristine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Injections/*methods
MH  - Liposomes/pharmacology/*therapeutic use
MH  - Male
MH  - Philadelphia Chromosome/*drug effects
MH  - Precursor Cell Lymphoblastic Leukemia-Lymphoma/*drug therapy/pathology
MH  - Recurrence
MH  - Treatment Outcome
MH  - Vincristine/pharmacology/*therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - acute lymphoblastic leukemia
OT  - vincristine sulfate liposome injection
EDAT- 2018/09/22 06:00
MHDA- 2019/09/19 06:00
CRDT- 2018/09/22 06:00
PHST- 2018/09/22 06:00 [pubmed]
PHST- 2019/09/19 06:00 [medline]
PHST- 2018/09/22 06:00 [entrez]
AID - 10.1089/jayao.2018.0041 [doi]
PST - ppublish
SO  - J Adolesc Young Adult Oncol. 2018 Oct;7(5):546-552. doi: 10.1089/jayao.2018.0041. 
      Epub 2018 Sep 21.