PMID- 26179770
OWN - NLM
STAT- MEDLINE
DCOM- 20151215
LR  - 20181113
IS  - 1349-7006 (Electronic)
IS  - 1347-9032 (Print)
IS  - 1347-9032 (Linking)
VI  - 106
IP  - 9
DP  - 2015 Sep
TI  - A phase II study of bortezomib in patients with relapsed or refractory aggressive 
      adult T-cell leukemia/lymphoma.
PG  - 1219-23
LID - 10.1111/cas.12735 [doi]
AB  - Adult T-cell leukemia/lymphoma (ATL) is a malignancy of peripheral T-lymphocytes 
      with a poor prognosis. This multicenter, two-stage, single-arm, phase II study 
      assessed the efficacy and safety of bortezomib in patients with 
      relapsed/refractory ATL who received at least one regimen of chemotherapy. The 
      primary endpoint was the best overall response rate (ORR), and secondary 
      endpoints included safety, the best response by lesions, and progression-free 
      survival (PFS). Fifteen patients were enrolled in the first stage of this study. 
      One partial remission (PR) and five stable disease (SD) were observed as the best 
      overall responses, and ORR was 6.7% (95% confidence interval (C.I.) 0.17-31.95%). 
      Responses according to disease sites were one complete remission (CR) in 
      peripheral blood, two PR in measurable targeted lesions, and two PR in skin 
      lesions. Progression-free survival (PFS) was 38 (95% CI; 18-106) days. All 
      patients developed >/=1 adverse events (AEs), and 80% of patients had >/=1 grade 3/4 
      AEs; however, no new safety findings were obtained. Although these results 
      fulfilled the planned settings to proceed to the second stage, the coordinating 
      committee decided to terminate this study because single agent activity did not 
      appear to be very promising for this cohort of patients.
CI  - (c) 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on 
      behalf of Japanese Cancer Association.
FAU - Ishitsuka, Kenji
AU  - Ishitsuka K
AD  - Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, 
      Fukuoka, Japan.
FAU - Utsunomiya, Atae
AU  - Utsunomiya A
AD  - Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
FAU - Katsuya, Hiroo
AU  - Katsuya H
AD  - Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, 
      Fukuoka, Japan.
FAU - Takeuchi, Shogo
AU  - Takeuchi S
AD  - Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
FAU - Takatsuka, Yoshifusa
AU  - Takatsuka Y
AD  - Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
FAU - Hidaka, Michihiro
AU  - Hidaka M
AD  - Department of Hematology, National Hospital Organization Kumamoto Medical Center, 
      Kumamoto, Japan.
FAU - Sakai, Tatsunori
AU  - Sakai T
AD  - Department of Hematology, National Hospital Organization Kumamoto Medical Center, 
      Kumamoto, Japan.
FAU - Yoshimitsu, Makoto
AU  - Yoshimitsu M
AD  - Division of Hematology and Immunology, Center for Chronic Viral Diseases, 
      Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, 
      Japan.
FAU - Ishida, Takashi
AU  - Ishida T
AD  - Department of Hematology and Oncology, Nagoya City University Graduate School of 
      Medical Sciences, Nagoya, Japan.
FAU - Tamura, Kazuo
AU  - Tamura K
AD  - Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, 
      Fukuoka, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Cancer Sci
JT  - Cancer science
JID - 101168776
RN  - 0 (Antineoplastic Agents)
RN  - 69G8BD63PP (Bortezomib)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Bortezomib/adverse effects/*therapeutic use
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Leukemia-Lymphoma, Adult T-Cell/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Remission Induction/methods
PMC - PMC4582992
OTO - NOTNLM
OT  - Adult T-cell leukemia/lymphoma
OT  - bortezomib
OT  - nuclear factor-kappaB
OT  - proteasome inhibitor
OT  - salvage treatment
EDAT- 2015/07/17 06:00
MHDA- 2015/12/17 06:00
PMCR- 2015/09/01
CRDT- 2015/07/17 06:00
PHST- 2015/04/22 00:00 [received]
PHST- 2015/06/23 00:00 [revised]
PHST- 2015/07/04 00:00 [accepted]
PHST- 2015/07/17 06:00 [entrez]
PHST- 2015/07/17 06:00 [pubmed]
PHST- 2015/12/17 06:00 [medline]
PHST- 2015/09/01 00:00 [pmc-release]
AID - 10.1111/cas.12735 [doi]
PST - ppublish
SO  - Cancer Sci. 2015 Sep;106(9):1219-23. doi: 10.1111/cas.12735.