NATIONAL INSTITUTES OF HEALTH |
National Eye Institute |
FOR RELEASE Monday, June 15, 1998 |
Judith Stein or Michael Coogan 301-496-5248 jas@nei.nih.gov mjc@.nei.nih.gov |
The two COMS clinical trials are:
Randomized Trial of Pre-Enucleation Radiation for Large Choroidal Melanoma
Patient enrollment in the COMS' Randomized Trial of Pre-Enucleation Radiation for Large Choroidal Melanoma began in November 1986 and was completed in December 1994. A total of 1003 patients enrolled on the trial and were assigned to one of two treatment groups, and of this number, 994 were treated as assigned. Eligible patients were at least 21 years old, had no other primary tumor, and had no other disease that threatened their lives within five years. Previous treatment for choroidal cancer or secondary treatment related to the eye cancer rendered a patient ineligible. Nearly two-thirds of all patients enrolled had at least one blood relative who had cancer.
Patients were divided into two groups by randomization. The mean age of patients in both groups was approximately 60 years. One group - 506 patients - were assigned to have the affected eye removed without the radiation treatment. The other group - 497 patients - were assigned radiation treatment to the eye before it was removed. The dosage of external beam radiation given to patients was 2000 rads in five fractions (A total dose of 2000 rads is as large a dose as radiation oncologists believe reasonable to treat preoperatively for this tumor). The eye was removed as soon as possible after the last radiation treatment, on the same day whenever possible but no more than 80 hours later.
By July 1997, researchers knew the five-year survival status of 80 percent (801) of all 1003 patients enrolled. About 38 percent (181) of the patients assigned to the radiation treatment died within five years after treatment, compared with 43 percent (202) of those patients who did not have radiation treatment. Scientists found that the radiation treatment had no effect on patients' survival rates for up to eight years after treatment. There is no evidence to date of radiation damage to the other eye.
The two randomly assigned groups of patients will be followed for at least 10 years or until death, and will be compared on the basis of length of remaining life. Following study participants over a longer period of time will provide important information about the risks and long-term effects of both treatments. For example, at this time it is too early to know whether the long-term incidence of second primary tumors, malignant or nonmalignant, differs between treatment strategies.