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The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma, II: Characteristics of Patients Enrolled and Not Enrolled
COMS Report No. 17
The Collaborative Ocular Melanoma Study Group
Arch Ophthalmol. 2001;119:951-965.
Objectives To describe characteristics of patients evaluated for the Collaborative
Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy
for choroidal melanoma by enrollment status, and to compare characteristics
of patients enrolled with those of patients with tumors of eligible size who
did not enroll in order to assess the extent to which findings from the clinical
trial can be generalized to future patients.
Methods For all patients diagnosed with choroidal melanoma and evaluated for
the clinical trial at COMS centers from November 1986 through July 31, 1998,
selected data were transmitted to the COMS Coordinating Center, Baltimore,
Md, where they were integrated and analyzed. Data included ophthalmic and
medical history, examination findings, and visual acuity measurements recorded
prior to enrollment; standardized A- and B-scan echographic examination findings;
and wide-angle fundus photographs and fluorescein angiograms.
Results Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible
size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of
eligible patients, 26% of patients with tumors of eligible size) enrolled.
Most differences between eligible and ineligible patients corresponded to
eligibility and exclusion criteria. However, ineligible patients were older
and had thicker tumors than eligible patients. Eligible patients who enrolled
were slightly older and had larger tumors than those who did not enroll. Nearly
half (48%) of enrolled patients had choroidal melanoma with the apex located
temporal to the fovea, compared with 40% of eligible patients not enrolled
and 29% of ineligible patients.
Conclusions This trial was designed to yield internally valid treatment comparisons
through random assignment to treatment at time of enrollment. Information
from this and other studies document that enrolled patients were similar to
other patients with choroidal melanoma who were treated with 125I
brachytherapy. These findings support the external validity of the trial and
applicability of treatment findings to all patients who meet the criteria
used to judge eligibility for the trial.
Members of the writing team who signed authorship responsibility, financial
disclosure, and copyright transfer statements for the group are as follows:
Marie Diener-West, PhD; John D. Earle, MD; Stuart L. Fine, MD; Barbara S.
Hawkins, PhD; Claudia S. Moy, PhD; Sandra M. Reynolds, MS; Andrew P. Schachat,
MD; Bradley R. Straatsma, MD.
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