PMID- 27101934
OWN - NLM
STAT- MEDLINE
DCOM- 20170602
LR  - 20191210
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 174
IP  - 4
DP  - 2016 Aug
TI  - A phase 2 study of inotuzumab ozogamicin in patients with indolent B-cell 
      non-Hodgkin lymphoma refractory to rituximab alone, rituximab and chemotherapy, 
      or radioimmunotherapy.
PG  - 571-81
LID - 10.1111/bjh.14094 [doi]
AB  - This phase 2 study evaluated the efficacy and safety of inotuzumab ozogamicin 
      (InO) in patients with indolent B-cell non-Hodgkin lymphoma (NHL) refractory to 
      rituximab alone, rituximab plus chemotherapy or anti-CD20 radioimmunotherapy. 
      Patients received InO 1.8 mg/m(2) intravenously on a 28-d cycle for a planned 4-8 
      cycles. The initial InO dose and schedule could be adjusted for tolerability and 
      patients were allowed to receive 2 additional cycles (up to 8 total) after 
      achieving a complete response (CR). The primary endpoint was overall response. 
      Eighty-one patients were enrolled, among whom 48 (59%) received >/=3 InO cycles and 
      13 (16%) completed the treatment phase. The overall response rate was 67% (CR, 
      31%). Median (95% confidence interval) progression-free survival was 12.7 
      (8.9-26.9) months; median overall survival was not reached. Haematological 
      adverse events (AEs) were common, particularly thrombocytopenia (74%) and 
      neutropenia (56%). These were also the most common AEs leading to treatment 
      discontinuation (37% and 11%, respectively); 58% of patients reported AEs leading 
      to treatment discontinuation. InO demonstrated robust activity in these heavily 
      pretreated patients, although treatment duration was limited by haematological 
      toxicities. Additional studies may determine dosing regimens that allow for 
      reduced toxicity.
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Goy, Andre
AU  - Goy A
AD  - John Theurer Cancer Center, HUMC, Hackensack, NJ, USA.
FAU - Forero, Andres
AU  - Forero A
AD  - University of Alabama at Birmingham, Birmingham, AL, USA.
FAU - Wagner-Johnston, Nina
AU  - Wagner-Johnston N
AD  - Washington University School of Medicine, St. Louis, MO, USA.
FAU - Christopher Ehmann, W
AU  - Christopher Ehmann W
AD  - Penn State Hershey Cancer Institute, Hershey, PA, USA.
FAU - Tsai, Michaela
AU  - Tsai M
AD  - Minnesota Oncology, Minneapolis, MN, USA.
FAU - Hatake, Kiyohiko
AU  - Hatake K
AD  - Cancer Institute Hospital, Tokyo, Japan.
FAU - Ananthakrishnan, Revathi
AU  - Ananthakrishnan R
AD  - Inventiv Health, Cambridge, MA, USA.
FAU - Volkert, Angela
AU  - Volkert A
AD  - Pfizer Inc, New York, NY, USA.
FAU - Vandendries, Erik
AU  - Vandendries E
AD  - Pfizer Inc, Cambridge, MA, USA.
FAU - Ogura, Michinori
AU  - Ogura M
AD  - Nagoya Daini Red Cross Hospital, Nagoya, Japan.
AD  - Tokai Central Hospital, Kakamigahara, Gifu, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20160422
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - P93RUU11P7 (Inotuzumab Ozogamicin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Inotuzumab Ozogamicin
MH  - Lymphoma, B-Cell/complications/*drug therapy/mortality/radiotherapy
MH  - Male
MH  - Middle Aged
MH  - Neutropenia/chemically induced/etiology
MH  - Radioimmunotherapy/adverse effects
MH  - Remission Induction
MH  - Salvage Therapy/adverse effects/*methods
MH  - Survival Rate
MH  - Thrombocytopenia/chemically induced/etiology
MH  - Treatment Outcome
OTO - NOTNLM
OT  - chemotherapy
OT  - inotuzumab ozogamicin
OT  - non-Hodgkin lymphoma
OT  - radioimmunotherapy
OT  - rituximab
EDAT- 2016/04/23 06:00
MHDA- 2017/06/03 06:00
CRDT- 2016/04/23 06:00
PHST- 2015/11/16 00:00 [received]
PHST- 2016/01/12 00:00 [accepted]
PHST- 2016/04/23 06:00 [entrez]
PHST- 2016/04/23 06:00 [pubmed]
PHST- 2017/06/03 06:00 [medline]
AID - 10.1111/bjh.14094 [doi]
PST - ppublish
SO  - Br J Haematol. 2016 Aug;174(4):571-81. doi: 10.1111/bjh.14094. Epub 2016 Apr 22.