THE COLLABORATIVE OCULAR MELANOMA STUDY (COMS) RANDOMIZED TRIAL OF PREENUCLEATION RADIATION OF LARGE CHOROIDAL MELANOMA - I - CHARACTERISTICS OF PATIENTS ENROLLED AND NOT ENROLLED COMS REPORT NO. 9

PURPOSE: To describe the baseline characteristics and status of patien ts enrolled in the Collaborative Ocular Melanoma Study (COMS) randomiz ed clinical trial of pre-enucleation radiation of large choroidal mela noma conducted in the United States and Canada, and to compare charact eristics of patients enrolled with those of patients with tumors of el igible size who were not enrolled in order to assess the generalizabil ity of findings from the clinical trial. METHODS: For all patients eva luated for the clinical trial at COMS centers from November 1986 throu gh December 15, 1994, selected data were transmitted to the COMS Coord inating Center. For patients who enrolled in the clinical trial, ophth almic and medical history, examination findings, and visual acuity mea surements were recorded prior to enrollment. Standardized A-scan and c ontact B-scan echographic examinations were performed prior to enrollm ent, and photo echograms were submitted for central review for consist ency with the diagnosis, independent measurement of the apical height of the tumor, and description of tumor configuration and internal refl ectivity for each patient enrolled. Until January 1992, wide-angle fun dus photographs and fluorescein angiograms taken prior to enrollment a lso were submitted for central review to confirm consistency with the diagnosis. All data were integrated and analyzed at the COMS Coordinat ing Center. RESULTS: Of 6,078 patients with choroidal melanoma evaluat ed in COMS centers, 1,860 had tumors of eligible size; of these, 1,302 (70%) were eligible for the clinical trial, and 1,003 (77% of eligibl e patients) enrolled. The two principal reasons for ineligibility were other primary cancer and predominantly ciliary body melanoma. Ineligi ble patients were older than eligible patients, had larger choroidal m elanoma, and had poorer visual acuity at the time of evaluation for th e COMS (P < .01, Wilcoxon rank sum tests). Patients eligible for the c linical trial had a mean age of 60 years; 56% were male; almost all (9 7%) were non Hispanic whites, Among eligible patients, mean tumor apic al height was 9.5 mm and mean longest basal diameter was 17.2 mm, Elig ible patients who enrolled in the trial were similar to eligible patie nts who did not enroll with respect to most factors considered, Those who enrolled had longer tumor basal diameter and better visual acuity in the fellow eye, more often had their primary residence in Canada, a nd less often had education beyond high school, than did eligible pati ents who did not enroll (P < .05, Wilcoxon rank sum tests and chi(2) t ests, respectively). CONCLUSIONS: The COMS clinical trial of preenucle ation radiation was designed to yield internally valid treatment compa risons through random treatment assignment at time of enrollment. Find ings also have high external validity because a majority (54%) of all patients with tumors of eligible size, and a large majority (77%) of a ll eligible patients, were enrolled, Furthermore, patient characterist ics are similar to those of patients included in other evaluations of this method of treating large choroidal melanoma. Thus, findings from this clinical trial apply to all patients who have large choroidal mel anoma and satisfy COMS eligibility criteria. (C) 1998 by Elsevier Scie nce Inc. All rights reserved.).