Enrolment of older cancer patients in early phase clinical trials – an observational study on the experience in the north west of England

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 United Kingdom. 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 was analysed at: referral; in-clinic assessment; and after successful enrolment. Amongst 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.