PMID- 34107012
OWN - NLM
STAT- MEDLINE
DCOM- 20210923
LR  - 20220531
IS  - 1468-2834 (Electronic)
IS  - 0002-0729 (Linking)
VI  - 50
IP  - 5
DP  - 2021 Sep 11
TI  - Enrolment of older adults with cancer in early phase clinical trials-an 
      observational study on the experience in the north west of England.
PG  - 1736-1743
LID - 10.1093/ageing/afab091 [doi]
AB  - INTRODUCTION: older patients represent the majority of cancer patients but are 
      under-represented in trials, particularly early phase clinical trials (EPCTs). 
      MATERIAL AND METHODS: observational retrospective study of patients referred for 
      EPCTs (January-December 2018) at a specialist cancer centre in the UK. The 
      primary aim was to analyse the successful enrolment into EPCTs according to age 
      (<65/65+). The secondary aims were to identify enrolment obstacles and the 
      outcomes of enrolled patients. Patient data were analysed at: referral; in-clinic 
      assessment and after successful enrolment. Among patients assessed in clinic, a 
      sample was defined by randomly matching the older cohort with the younger cohort 
      (1:1) by tumour type. RESULTS: 555 patients were referred for EPCTs with a median 
      age of 60 years, of whom 471 were assessed in new patient clinics (38% were 65+). 
      From those assessed, a randomly tumour-matched sample of 318 patients (159 per 
      age cohort) was selected. Older patients had a significantly higher comorbidity 
      score measured by ACE-27 (P < 0.0001), lived closer to the hospital (P = 0.045) 
      and were referred at a later point in their cancer management (P = 0.002). There 
      was no difference in suitability for EPCTs according to age with overall 84% 
      deemed suitable. For patients successfully enrolled into EPCTs, there was no 
      difference between age cohorts (20.1 vs. 22.6% for younger and older, 
      respectively; P = 0.675) and no significant differences in their safety and 
      efficacy outcomes. DISCUSSION: older age did not affect the enrolment into EPCTs. 
      However, the selected minority referred for EPCTs suggests a pre-selection 
      upstream by primary oncologists.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of the 
      British Geriatrics Society. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Gomes, Fabio
AU  - Gomes F
AD  - The Christie NHS Foundation Trust, Manchester, UK.
FAU - Descamps, Tine
AU  - Descamps T
AD  - Cancer Research UK Manchester Institute, Manchester, UK.
FAU - Lowe, Jessica
AU  - Lowe J
AD  - The Christie NHS Foundation Trust, Manchester, UK.
FAU - Little, Martin
AU  - Little M
AD  - The Christie NHS Foundation Trust, Manchester, UK.
FAU - Lauste, Rosie
AU  - Lauste R
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
FAU - Krebs, Matthew G
AU  - Krebs MG
AD  - The Christie NHS Foundation Trust, Manchester, UK.
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
FAU - Graham, Donna
AU  - Graham D
AD  - The Christie NHS Foundation Trust, Manchester, UK.
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
FAU - Thistlethwaite, Fiona
AU  - Thistlethwaite F
AD  - The Christie NHS Foundation Trust, Manchester, UK.
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
FAU - Carter, Louise
AU  - Carter L
AD  - The Christie NHS Foundation Trust, Manchester, UK.
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
FAU - Cook, Natalie
AU  - Cook N
AD  - The Christie NHS Foundation Trust, Manchester, UK.
AD  - Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The 
      University of Manchester, Manchester, UK.
LA  - eng
GR  - DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Age Ageing
JT  - Age and ageing
JID - 0375655
SB  - IM
MH  - Aged
MH  - Cohort Studies
MH  - England/epidemiology
MH  - Humans
MH  - Middle Aged
MH  - *Neoplasms/diagnosis/epidemiology/therapy
MH  - Referral and Consultation
MH  - Retrospective Studies
OTO - NOTNLM
OT  - early phase
OT  - experimental therapies
OT  - older cancer patients
OT  - phase 1 trials
EDAT- 2021/06/10 06:00
MHDA- 2021/09/24 06:00
CRDT- 2021/06/09 17:29
PHST- 2020/10/29 00:00 [received]
PHST- 2021/06/10 06:00 [pubmed]
PHST- 2021/09/24 06:00 [medline]
PHST- 2021/06/09 17:29 [entrez]
AID - 6295382 [pii]
AID - 10.1093/ageing/afab091 [doi]
PST - ppublish
SO  - Age Ageing. 2021 Sep 11;50(5):1736-1743. doi: 10.1093/ageing/afab091.