PMID- 32926420
OWN - NLM
STAT- MEDLINE
DCOM- 20210730
LR  - 20240210
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 193
IP  - 1
DP  - 2021 Apr
TI  - Results of a UK National Cancer Research Institute Phase II study of brentuximab 
      vedotin using a response-adapted design in the first-line treatment of patients 
      with classical Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty 
      or comorbidity (BREVITY).
PG  - 63-71
LID - 10.1111/bjh.17073 [doi]
AB  - Standard treatment for classical Hodgkin lymphoma (cHL) is poorly tolerated in 
      older patients and results disappointing. We assessed safety and efficacy of 
      brentuximab vedotin (BV), in previously untreated patients with cHL unfit for 
      standard treatment due to age, frailty or comorbidity. The primary outcome was 
      complete metabolic response (CMR) by positron emission tomography/computed 
      tomography after four BV cycles (PET4). The secondary outcomes included 
      progression-free survival (PFS), overall survival (OS), and toxicity. In all, 35 
      patients with a median age of 77 years and median total Cumulative Illness Rating 
      Scale for Geriatrics (CIRS-G) score of 6 were evaluable for toxicity and 31 for 
      response. A median of four cycles were given (range one-16). In all, 14 patients 
      required dose reduction due to toxicity and 11 patients stopped treatment due to 
      adverse events (AEs). A total of 716 AEs were reported, of which 626 (88%) were 
      Grade 1/2 and 27 (77%) patients had at least one AE Grade >/=3. At PET4, CMR was 
      25.8% [95% confidence interval (CI) 13.7-42.2%] and objective response rate 83.9% 
      (95% CI 63.7-90.8%). Median PFS was 7.3 months (95% CI 5.2-9.0), and OS 19.5 
      months. Our results suggest that BV monotherapy is tolerable but suboptimal in 
      the front-line therapy of elderly or comorbid patients with cHL. Combining BV 
      with other agents may be more effective. Trial Registration: Clinicaltrials.gov 
      identifier: NCT02567851.
CI  - (c) 2020 The Authors. British Journal of Haematology published by British Society 
      for Haematology and John Wiley & Sons Ltd.
FAU - Gibb, Adam
AU  - Gibb A
AD  - National Institute for Health Research (NIHR) Manchester Clinical Research 
      Facility, The Christie NHS Foundation Trust, Manchester, UK.
FAU - Pirrie, Sarah J
AU  - Pirrie SJ
AUID- ORCID: 0000-0002-2894-2230
AD  - Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, 
      Birmingham, UK.
FAU - Linton, Kim
AU  - Linton K
AUID- ORCID: 0000-0002-3294-1548
AD  - National Institute for Health Research (NIHR) Manchester Clinical Research 
      Facility, The Christie NHS Foundation Trust, Manchester, UK.
AD  - University of Manchester, Manchester, UK.
FAU - Warbey, Victoria
AU  - Warbey V
AD  - King's College London and Guy's and St Thomas' PET Centre, School of Biomedical 
      Engineering and Imaging Sciences, King's College London, King's Health Partners, 
      London, UK.
FAU - Paterson, Kathryn
AU  - Paterson K
AD  - Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, 
      Birmingham, UK.
FAU - Davies, Andrew J
AU  - Davies AJ
AUID- ORCID: 0000-0002-7517-6938
AD  - Cancer Research UK Centre, Cancer Sciences Unit, Faculty of Medicine, University 
      of Southampton, Southampton, UK.
FAU - Collins, Graham P
AU  - Collins GP
AUID- ORCID: 0000-0002-8803-4234
AD  - Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.
FAU - Menne, Tobias
AU  - Menne T
AUID- ORCID: 0000-0002-3289-2344
AD  - Freeman Hospital, Newcastle, UK.
FAU - McKay, Pamela
AU  - McKay P
AUID- ORCID: 0000-0002-3959-9730
AD  - The Beatson West of Scotland Cancer Centre, Glasgow, UK.
FAU - Fields, Paul A
AU  - Fields PA
AD  - Guy's Hospital, London, UK.
FAU - Miall, Fiona M
AU  - Miall FM
AD  - University Hospitals Leicester, Leicester, UK.
FAU - Nagy, Eszter
AU  - Nagy E
AD  - Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, 
      Birmingham, UK.
FAU - Wheatley, Keith
AU  - Wheatley K
AUID- ORCID: 0000-0003-0792-580X
AD  - Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, 
      Birmingham, UK.
FAU - Reed, Rachel
AU  - Reed R
AD  - Stoller Biomarker Discovery Centre, University of Manchester, Manchester, UK.
FAU - Baricevic-Jones, Ivona
AU  - Baricevic-Jones I
AD  - Stoller Biomarker Discovery Centre, University of Manchester, Manchester, UK.
FAU - Barrington, Sally
AU  - Barrington S
AUID- ORCID: 0000-0002-2516-5288
AD  - King's College London and Guy's and St Thomas' PET Centre, School of Biomedical 
      Engineering and Imaging Sciences, King's College London, King's Health Partners, 
      London, UK.
FAU - Radford, John
AU  - Radford J
AUID- ORCID: 0000-0001-7898-2786
AD  - National Institute for Health Research (NIHR) Manchester Clinical Research 
      Facility, The Christie NHS Foundation Trust, Manchester, UK.
AD  - University of Manchester, Manchester, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT02567851
GR  - 25354/CRUK_/Cancer Research UK/United Kingdom
GR  - RP-2016-07-001/DH_/Department of Health/United Kingdom
GR  - MR/M008959/1/MRC_/Medical Research Council/United Kingdom
GR  - MR/N00583X/1/MRC_/Medical Research Council/United Kingdom
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200914
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Biomarkers, Tumor)
RN  - 7XL5ISS668 (Brentuximab Vedotin)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Immunological/administration & dosage/adverse 
      effects/*therapeutic use/toxicity
MH  - Biomarkers, Tumor/metabolism
MH  - Brentuximab Vedotin/administration & dosage/adverse effects/*therapeutic 
      use/toxicity
MH  - Comorbidity
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy/ethics/*standards
MH  - Female
MH  - Frailty/*epidemiology
MH  - Hodgkin Disease/*drug therapy/metabolism/pathology
MH  - Humans
MH  - Male
MH  - Neoplasm Staging/methods
MH  - Positron Emission Tomography Computed Tomography/methods
MH  - Progression-Free Survival
MH  - Safety
MH  - Treatment Outcome
MH  - United Kingdom/epidemiology
OTO - NOTNLM
OT  - Hodgkin lymphoma
OT  - brentuximab Vedotin
OT  - elderly
EDAT- 2020/09/15 06:00
MHDA- 2021/07/31 06:00
CRDT- 2020/09/14 15:49
PHST- 2020/03/06 00:00 [received]
PHST- 2020/08/04 00:00 [accepted]
PHST- 2020/09/15 06:00 [pubmed]
PHST- 2021/07/31 06:00 [medline]
PHST- 2020/09/14 15:49 [entrez]
AID - 10.1111/bjh.17073 [doi]
PST - ppublish
SO  - Br J Haematol. 2021 Apr;193(1):63-71. doi: 10.1111/bjh.17073. Epub 2020 Sep 14.