e17525 Background: Outcomes of pediatric and adult cancer pts have improved more than outcomes of AYA pts. Reduced access of AYA pts to clinical trials may partially account for this. Methods: The 10 cancers of highest annual incidence for pts ages 15-29 were identified using the 2005-09 SEER data base and searched on ClinicalTrials.gov (2012/OCT/27) using restriction terms “recruiting”, “intervention studies”, “Canada-Ontario”, and “Adult (18-65)”. Among trials identified, variables compared were sponsor (industry; not industry), intent (curative; palliative; other), endpoints (survival; disease control-adverse event; other), previous therapy (none; other), age (max < 29; max>29 but <50; max>50), intervention (drug; RT+/-drug; other) and randomized design (yes; no). Comparisons used a 2-tailed Fisher’s exact test. Results: We identified 139 trials, including (incidence rank order in bracket): breast-41 (8), non Hodgkin’s lymphoma-36 (4), CNS-30 (6) and acute lymphoblastic leukemia (ALL)-21[10]. There were 45 trials available for the other 6 indications; some trials permitted multiple indications. Most common features were non-industry sponsorship (58%), palliative intent (65%), disease control-adverse event primary endpoint (82%), not restricted to 1st line therapy (76%), max age>50 (69%), drug-only intervention (78%) and non-randomized design (56%). Among all trials, those with an age restriction did not significantly differ from trials with an age maximum of >50. Industry sponsorship was associated with fewer non-drug-only trials (2% vs. 36%; p<0.0001), curative trials (12% vs. 41%; p=0.0002) and age-restricted trials (10% vs. 48%; p<0.0001). CNS and ALL trials were more likely to restrict age eligibility (60% vs. 13%; p<0.0001 for CNS; 52% vs. 18%; p<0.0001 for ALL) and have non-industry sponsorship (90% vs. 49%; p<0.0001 for CNS; 76% vs. 24%; p=0.09 for ALL). Conclusions: Availability of clinical trials for Ontario AYA pts is very heterogeneous and no correlation is seen between AYA cancer-type incidence and number of trials. While CNS cancers and ALL appear unique, access and characteristics of trials for other AYA pts appear to relate to determinants associated with older patients.
Industry sponsorship and selection of comparators in randomized clinical trials