The University of Texas MD Anderson Cancer Center, Houston, TX
Ishwaria Mohan Subbiah , Aman Buzdar , Ecaterina Elena Ileana Dumbrava , Siqing Fu , Filip Janku , Daniel D. Karp , Aung Naing , Shubham Pant , Jordi Rodon , Apostolia Maria Tsimberidou , Timothy A Yap , Vivek Subbiah , Funda Meric-Bernstam , David S. Hong
Background: While safety and dose-finding remain the primary objective of Phase 1 trials, the potential for clinical benefit has taken a greater meaning in the last decade with the novel therapies. With data from phase I trials being submitted for regulatory approval, the finer details of these studies are under even more scrutiny: in particular, do the trial participants reflect the general patient population for whom the drug may be indicated? To that end, we investigated age-based enrollment on phase I clinical trials over time. Methods: We queried a prospectively maintained database at a major phase I trials center to identify eligible patients and demographic + clinical variables including phase I trial characteristics, age at date of enrollment into 3 age-based cohorts: AYA ages 15-39y, mid-age 40-64y, older adults aged 65y+. We calculated descriptive statistics, and explored correlations (Pearson/Spearman) and associations (linear regression) between age and independent variables. Results: Over a 3-year period (1/1/17 to 12/31/19), we identified 6267 pts enrolled on 338 phase I trials. Median overall age 58.4y (range 15.5-95.1y). 729 (12%, median age 34.8y) were AYA, 3652 (58%, median age 55.4y) mid-age and 1886 (30%, median 70y) older adults, of whom 870 pts were aged 70-79y and 76 pts aged 80y+ (18 being >85y). There was no association b/w senior participation and year of enrollment (2017 31%, 2018 29%, 2019 30%, b/w age and type of therapy (i.e. targeted vs immunotherapy, etc.) or b/w age and # of drugs given on trial (single agent vs combo) (all p > 0.05). Conclusions: Older adults remain underrepresented on phase I trials esp. when compared to incidence of cancer in that age group (30% enrollment vs 60% incidence), a discordance more staggering in the oldest old pts (85y+; only 18 pts enrolled over 3 yrs when compared to 140,690 pts 85y+ w a new cancer dx in just 2019). Once enrolled, older adults received similar types of phase I therapies with comparable number of drugs as compared to middle age patients, i.e. older adults were just as likely to get immunotherapy or targeted therapy as well mono- vs combo therapy as mid-age pts.
Types of Therapy | Older adult | % | Midage | % |
---|---|---|---|---|
Immunotherapy agent(s) | 662 | 35% | 1292 | 35% |
Single Agent IO | 286 | 43% | 585 | 45% |
Combo IO | 376 | 57% | 707 | 55% |
Chemotherapy | 49 | 3% | 79 | 2% |
Single Agent | 47 | 96% | 77 | 97% |
Combo | 2 | 4% | 2 | 3% |
Targeted | 801 | 42% | 1566 | 43% |
Single Agent | 633 | 79% | 1260 | 80% |
Combo | 168 | 21% | 306 | 20% |
Immuno+Targeted | 259 | 14% | 463 | 13% |
Targeted+Chemo | 85 | 5% | 171 | 5% |
Other (biologics, combo) | 30 | 2% | 81 | 2% |
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Abstract Disclosures
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Giovanni Trovato
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Takahito Awatsu
2016 ASCO Annual Meeting
First Author: Ishwaria Mohan Subbiah
2023 ASCO Annual Meeting
First Author: Funda Meric-Bernstam