Therapeutic clinical trial enrollment among young adults diagnosed with cancer.

Abstract

6096 Background: Young adults (YA) with cancer have poor enrollment in therapeutic clinical trials. This study compares trial participation among young and older adults (OA) at a tertiary cancer care center, with a view to identifying and removing barriers. Methods: Trial enrollment data was compared between YA (age ≤39 years) and OA (age >39 years) followed at Princess Margaret Hospital (PMH), Toronto, from 2006-2008. Trials open to active accrual were: 1) therapeutic: systemic therapy, radiation, or surgery; 2) Phase I, II or III; 3) investigator initiated, industry or cooperative group. Number of trials activated and accrual data were collected through the Clinical Trial Support Unit at PMH. Number of patients with cancer were identified through the PMH Cancer Registry. Proportions of patients enrolled in clinical trials were compared between groups using a chi-square test. Results: A total of 25,958 patients (YA: 2,699; OA: 23,259) and 318 clinical trials were identified. The table reports the number of patients, trial availability and enrollment rate for the top 5 most common diagnoses for YA and OA. YA had significantly lower enrollment rates as compared to older adults (7.0% vs. 11.9%; p<0.001) including early phase trials (4.6% vs. 7.5%; p<0.001) and phase III trials (2.4 vs. 4.4%; p<0.001). Conclusions: Trial enrollment rates were significantly lower among YA patients compared to OA across the spectrum of tumor types. Further study is underway to understand differences in trial participation between YA with different primary tumours and identify barriers to enrollment among YA. Trial availability (phase I, II, III) and enrollment among the top five most common YA and OA cancers at PMH (2006-2008). Cancer site No. of patients Percent of cancer diagnoses No. of clinical trials Ratio of clinical trials: Patients No. of patients enrolled Percent enrollment Young adults Breast 338 13% 22 1:15 18 5% CNS 298 11% 11 1:27 20 7% Testicular 250 9% 0 0:250 0 0% Sarcoma 241 9% 3 1:80 1 <1% Hodgkin lymphoma 213 8% 3 1:71 15 7% Total 1,340 50% 39 1:34 54 4%† Older Adults Prostate 3,855 17% 30 1:129 494 13% Breast 3,811 16% 22 1:173 237 6% Lung 2,534 11% 37 1:68 345 14% Colorectal 1,987 9% 20 1:99 183 9% Head and neck 1,893 8% 16 1:118 85 4% Total 14,080 61% 125 1:112 1,344 10%† † p <0.001