Abstract
Purpose :
The purpose of the COOG2 study was to conduct a large, multicenter study to prospectively evaluate and optimize the established biomarker gene expression profile (GEP), along with emerging biomarkers PRAME and prognostic driver mutations BAP1, SF3B1 and EIF1AX using a novel next generation sequencing (NGS) panel.
Methods :
Institutional Review Board (IRB)/Ethics Committee approval was prospectively obtained. Subjects who met the following inclusion criteria were enrolled prospectively: 18 years and older; diagnosed with a uveal melanoma; undergoing a fine needle aspiration biopsy with treatment of enucleation, I-125 plaque therapy, proton beam therapy, or close observation; able to consent to baseline/ongoing metastatic screening; no previous treatment for UM.
Results :
1756 patients were enrolled from 26 sites across the U.S. and Canada. Mean age at time of enrollment was 62 years. 793 patients were women and 963 were men. 1434 patients identified as non-Hispanic white, 57 self-identified as Hispanic, and the remainder declined to answer. 824 eyes enrolled in the study were right and 932 were left. 587 eyes were identified as blue/green, 240 as brown, and the remainder as mixed/intermediate. 98 (6%), 1356 (83%), 302 (17%), and tumors involved the iris, choroid, and ciliary body primarily, respectively. 83 (5%) had associated congenital ocular melanocytosis. The largest base dimension of the tumors in the study ranged from 1.9 mm to 34 mm (mean, 11.8 mm). The thickness of the tumors ranged from 0.5 to 18 mm (mean, 4.9 mm).
171 (10%) were treated with enucleation, and 1296 (74%) with radioactive plaque therapy with biopsy, 120 (7%) with proton beam therapy with biopsy, and 169 (10%) with biopsy then observation. GEP/Prame status was: 1A/Prame– for 577 (33%), 1A/Prame+ for 157 (9%), 1B/Prame– in 302 (17%), 1B/Prame+ in 104 (6%), 2/Prame– in 287 (16%), and 2/Prame+ in 234 (13%). The remaining 6% had a pending GEP analysis from recent enrollment. NGS results are in process.
Conclusions :
The COOG network has prospectively collected clinical, molecular, and outcomes data in a 26-center study resulting in the largest database of information ever collected for this cancer. Forthcoming analyses will define a new, more accurate classification system for metastatic prognostication as well as the gold standard synthetic control arm for future adjuvant therapeutic trials.
This is a 2021 ARVO Annual Meeting abstract.