Abstract
Aim
The percentage of adolescents and young adults with sarcoma enrolled in multicenter clinical trials is reportedly much lower than that of younger children. We intended to determine if this remained true despite the availability of a study open to patients up to the age of 40 years
Method
Review of interim recruitment and randomization rates in a large randomized multinational trial for resectable osteosarcoma, EURAMOS-1, jointly performed by COG, COSS, EOI, and SSG, within ECT-EUROCORES. Randomization scheduled after preoperative chemotherapy and definitive surgery of the primary tumour.
Results
Between Apr-2005 and Jan-2010, 1,682 patients were recruited (870 COG, 390 COSS, 338 EOI, 85 SSG). To date, 979 have been randomized. When normalizing for population-based, age-dependent osteosarcoma incidence rates according to SEER data (Mirabello et al., Cancer 2009;115:1531–43) and arbitrarily defining observed/expected recruitment at age 10-14 years as 1, there was age-appropriate recruitment at age 5-9 (1.06 patients recruited per patient expected), but under recruiting for patients aged 15 and above, particularly above the age of 19 (15-19yr: 0.88, 20-24yr: 0.52; 25-29yr: 0.17, 30-34yr: 0.09, 35-39yr: 0.22 patients recruited per patient expected) (Fig. 1). If age groups 15yr and above had recruited with the same incidence-based ratio as younger ages, up to 592 additional patients might have been recruited, an increment of 35%. Uptake of randomization was similar across all age groups.
Fig. 1: EURAMOS recruitment in comparison to epidemiological data (SEER). Recruitment ratio at age 10-14 arbitrarily defined as 1.
Conclusion
Recruitment and randomization into large, multinational osteosarcoma trials might be increased by approximately one third if older adolescents and young adults were recruited at similar incidence-related rates as younger pediatric patients. Supported by the European Science Foundation (ESF), under the EUROCORES Program European Clinical Trials (ECT), through contract number ERASCT-2003-980409 of the European Commission, DG Research, FP6.
