Abstract 505P
Background
Although 45% of GI cancer pts are aged ≥70 yrs, they are underrepresented in clinical trials. Older-age-selected studies are desirable, but their characteristics and performance are unknown. We conducted a SR to fill this gap.
Methods
We searched Embase and PubMed with the keywords “older adults”, “cancer” and “clinical trials”, from inception to March 1, 2023. We included phase (Ph) I-III trials testing systemic therapies in GI cancer pts aged ≥70 yrs. For each of the selected studies, we carried out an ad-hoc search for age-unselected trials testing the same interventions. We followed the PRISMA guidelines for SR and registered the study with PROSPERO (CRD42023465089).
Results
We screened 25,868 records, and identified 76 eligible trials (47 colorectal, 27 oesophago-gastric, 2 pancreatic). 3 studies were published in 1992-2001, 24 in 2002-2011, and 49 in 2012-2023. The majority were Ph II (88%), while 3% were Ph I and 9% Ph III. Most trials (80%) were run in the palliative setting, and chemotherapy was the most frequently tested treatment (95%), followed by targeted therapy (34%). Only 9% of trials were dedicated to frail pts. Geriatric assessments (GA) and quality of life (QoL) analyses were carried out in 46% and 24%, respectively. Toxicity or QoL were primary endpoints in 7% of Ph II-III. 84% of trials enrolled ≥90% of the required pts. The median accrual time was 28 (IQR 18-40) and 43 months (IQR 31.5-64) for Ph II and III, respectively. Premature study discontinuation occurred in 9 studies (Ph II 11%, Ph III 29%), the major reason being slow accrual. 73% of trials met the primary endpoint, including 75% of Ph II and 57% of Ph III. Corresponding age-unselected trials were available for 33 older-patient studies. Compared with those, similar proportions of age-unselected studies enrolled ≥90% of the required pts (100% vs 93%, p>0.99) and met the primary endpoint (75% vs 74%, p>0.99).
Conclusions
The interest in GI cancer trials for older pts has increased over time. Ph II trials appear feasible, while Ph I are few and a substantial proportion of Ph III suffer from slow accrual and premature discontinuation. Interventions to tackle recruitment barriers should be implemented, and efforts should be made to systematically include GA and QoL analyses.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
F. Sclafani: Financial Interests, Personal, Advisory Board: AMAL Therapeutics, Bayer, BMS, Dragonfly Therapeutics, GSK, Nordic Pharma, Roche; Financial Interests, Personal, Invited Speaker: Amgen, Merck, Servier; Financial Interests, Institutional, Research Grant: Amgen, Astellas, AstraZeneca, Bayer, BMS, Merck, MSD, Pierre Fabre, Roche, Sanofi; Non-Financial Interests, Leadership Role, Secretary of the EORTC Gastrointestinal Tract Cancer Group: EORTC Gastrointestinal Tract Cancer Group; Other, Travel grants: Amgen, Bayer, Lilly, Merck, Roche, Servier. All other authors have declared no conflicts of interest.