Evaluation of older patients in early phase clinical trials


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Jessica Lowe1,Rosie Lauste2,Tine Descamps3,Matthew Krebs1,Donna Graham1,Fiona Thistlethwaite1,Louise Carter1,Natalie Cook1
1The Christie NHS Foundation Trust, Manchester, UK,2University of Manchester, Manchester, UK,3Cancer Research UK, London, UK

Abstract

Background

Older patients (pts) make up two thirds of cancer pts but only one third of the cancer trial population. It is unknown whether older pts have poorer outcomes in early phase clinical trials (EPCTs). The aim of this research was to understand if EPCTs at a large specialist cancer centre represented older pts (aged ≥65 years (yrs)) and to understand their clinical outcomes compared to younger (<65yrs) pts.

Method

Retrospective data analysis was undertaken for new EPCT pts seen at the Christie NHS Foundation Trust (period covered 1st January 2018 to 31st December 2018). Demographic data was collected, including toxicity and response data from those that received an investigational medicinal product (IMP). Statistical analysis was conducted using cross-tabulation and Fisher Exact Test.

Results

A total of 436 pts were seen, including 130 pts ≥65yrs (30%). A random selection of 131 pts <65yrs were assessed as controls. In the older pt group, 101/130 (78%) were deemed to be eligible for a phase 1 clinical trial and 29/101 (29%) were subsequently enrolled on to a trial with an IMP. In the <65yr group 97/131 (74%) of pts were deemed suitable and 21/97 (22%) subsequently went on to an IMP trial. There were no significant differences between these groups (p-value 0.663). Despite older pts having significantly more co-morbidity than younger pts (p-value = 0.0127), they were no more likely to suffer ≥ Grade 3 toxicity (p-value = 0.170), require dose reduction ((p-value = 0.671) or drop out of study than the control group (p-value = 0.982). There was no difference in response to treatment between the two groups (p-value 0.762).

Conclusion

Despite there being a significant difference in comorbidities between older and younger pts, we did not find any significant differences between pt outcomes or bias of pt selection within our EPCTs.