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Researchers found that patients with large eye melanomas had similarfive-year survival rates regardless of whether they were treated withradiation prior to removal of the eye or had their eye removed withoutprior radiation therapy. These findings appear in a scientific paperpublished in the June 1998 issue of the American Journal ofOphthalmology.
In the clinical trial, the Collaborative Ocular Melanoma Study(COMS), two groups of patients with tumors large enough to requireremoval of the eye were studied. One group received radiationtreatment to the affected eye before it was removed. The other grouphad the eye removed without the radiation treatment. Researchers foundthat, after five years of follow-up study, the radiation treatment hadno effect on patients’ survival rates. The COMS trial was supported bythe National Eye Institute (NEI) and the National Cancer Institute(NCI), two of the Federal government’s National Institutes of Health.
“This clinical trial found neither benefit nor harm fromtreating ocular melanoma patients with radiation before removal of theeye,” said Dr. Carl Kupfer, director of the NEI. “Radiationtherapy is costly and has the potential for side effects. Unless asurvival benefit is shown with further follow-up, it is unlikelydoctors will advise it for their patients with large melanoma eyetumors.”
The type of ocular melanoma studied by researchers was choroidalmelanoma, a tumor of the eye that forms from pigmented cells of thechoroid, a layer of tissue in the back of the eye. Although it is arare cancer, choroidal melanoma is the most common primary eye cancerin adults. Many choroidal melanomas enlarge over time and can lead toloss of vision. More importantly, tumors also can spread to otherparts of the body and eventually cause death. Researchers estimatethat between 1680 and 2240 new cases of ocular melanoma are diagnosedannually in the US and Canada, a rate of about six-to-eight new casesper million people each year. Ocular melanoma occurs in all ethnicgroups, although it is more common in whites of northern Europeandescent.
There had been uncertainty in the medical community about the valueof giving radiation treatments prior to removal of the eye of patientswith large ocular melanoma. In cancers occurring elsewhere in thebody, prior radiation has reduced the rate of tumor recurrence aftersurgery. The COMS is the first controlled, randomized, multicenterclinical trial large enough to measure the survival rate of patientswho had received radiation treatment prior to eye removal.
“Patients in the trial will continue to be followed so that wecan learn more about the risks and long-term effects of bothtreatments,” said Dr. Stuart Fine, chairman of the Department ofOphthalmology at the University of Pennsylvania’s Scheie Eye Institutein Philadelphia and chairman of the COMS clinical trial. “Basedon data from previously published reports, patients in this study havelived longer than expected. About 60 percent of participants are aliveafter five years, whereas only 50 percent had been expected to livethat long when the study was planned.”
According to Dr. Fine, “The findings from this study are theinitial results only. By continuing to follow study participants for anumber of years, researchers will obtain important new information tohelp doctors advise their patients about appropriate therapy.”
A separate trial comparing two different treatments for medium sizedeye melanomas will finish enrolling patients this year, but survivaldata from that study are not expected soon.
The COMS trial was conducted at over 50 institutions, includingmedical schools, hospitals, and doctors’ offices, throughout the USand Canada.
A list of current study centers is attached.
Choroidal melanoma is a tumor of the eye that forms frompigmented cells of the choroid, a layer of tissue in the back of theeye. Many choroidal melanomas enlarge over time and can lead to loss ofvision. Tumors can also spread to other parts of the body and may causedeath. Although it is a rare cancer, choroidal melanoma is the mostcommon primary eye cancer in adults.
Choroidal melanoma may produce symptoms of blurry vision. However,there are often no symptoms in the disease’s early stages, and thecancer may grow before the problem becomes noticeable. Choroidalmelanoma is usually detected during a dilated eye exam, when an eye careprofessional dilates the pupils and examines the back of the eye.
Since the late 19th century, removal of the eye has been the standardtreatment for choroidal melanoma of all sizes. Since World War II,radiation has been used to treat choroidal melanomas; during the past 20years, interest in radiation therapy has increased because of thepotential for saving eyes with small to medium-sized tumors. In the caseof large tumors requiring removal of the eye, it was speculated thattreating patients with radiation prior to eye removal may inactivate thetumor cells and reduce the chance these cells will divide and grow ifthey escape from the eye during the eye removal operation. The dose ofradiation given is not enough to kill the tumor.
Treating large tumors with radiation before eye removal raised thequestion in the medical community of whether the radiation treatmentprolonged the life of these patients as compared with patients whoseeyes were removed without prior radiation treatment. The best data fromsmaller studies suggested that there was no difference between the twotreatments. Researchers concluded that the only way to answer thisquestion conclusively was to conduct a clinical trial in which a largenumber of choroidal melanoma patients would receive the two differenttreatments and be followed for many years. The survival rates of the twotreatments could then be compared.
The Collaborative Ocular Melanoma Study (COMS)
The Collaborative Ocular Melanoma Study (COMS) includes two separate,long-term, multicenter, randomized controlled trials that comparetreatments and track the survival rate of patients with ocular melanoma.Collectively, the two COMS clinical trials are designed to:
- Evaluate therapeutic interventions for patients who have choroidalmelanoma
- Assess the potential life-preserving as well as sight-preservingrole of radiation therapy
- Determine which of two standard treatments, removal of the eye orradiation therapy, is more likely to prolong survival of eligiblepatients with medium-sized tumors
- Determine whether preoperative radiation treatment prolongs lifefor patients whose tumors are large enough to require removal of theeye
The two COMS clinical trials are:
- The Randomized Trial of Pre-Enucleation Radiation for LargeChoroidal Melanoma. This trial was designed to determine whether atype of preoperative radiation therapy, called external beamradiation, prolongs life for patients whose tumors are large enough torequire removal of the eye. It is the results of this trial that arereported in the June 1998 issue of the American Journal ofOphthalmology.
- The Randomized Trial of I-125 Brachytherapy for MediumChoroidal Melanoma. This trial will determine which of twostandard treatments—removal of the eye or therapy with smallradiation pellets placed over the tumor (brachytherapy)—is morelikely to prolong survival of eligible patients with medium-sizedtumors. This clinical trial is ongoing; survival data from that studyare not expected soon.
Randomized Trial of Pre-Enucleation Radiation for Large ChoroidalMelanoma
Patient enrollment in the COMS’ Randomized Trial of Pre-EnucleationRadiation for Large Choroidal Melanoma began in November 1986 and wascompleted in December 1994. A total of 1003 patients enrolled on thetrial and were assigned to one of two treatment groups, and of thisnumber, 994 were treated as assigned. Eligible patients were at least 21years old, had no other primary tumor, and had no other disease thatthreatened their lives within five years. Previous treatment forchoroidal cancer or secondary treatment related to the eye cancerrendered a patient ineligible. Nearly two-thirds of all patientsenrolled had at least one blood relative who had cancer.
Patients were divided into two groups by randomization. The mean ageof patients in both groups was approximately 60 years. One group—506patients—were assigned to have the affected eye removed without theradiation treatment. The other group—497 patients—were assignedradiation treatment to the eye before it was removed. The dosage ofexternal beam radiation given to patients was 2000 rads in fivefractions (A total dose of 2000 rads is as large a dose as radiationoncologists believe reasonable to treat preoperatively for this tumor).The eye was removed as soon as possible after the last radiationtreatment, on the same day whenever possible but no more than 80 hourslater.
By July 1997, researchers knew the five-year survival status of 80percent (801) of all 1003 patients enrolled. About 38 percent (181) ofthe patients assigned to the radiation treatment died within five yearsafter treatment, compared with 43 percent (202) of those patients whodid not have radiation treatment. Scientists found that the radiationtreatment had no effect on patients’ survival rates for up to eightyears after treatment. There is no evidence to date of radiation damageto the other eye.
The two randomly assigned groups of patients will be followed for atleast 10 years or until death, and will be compared on the basis oflength of remaining life. Following study participants over a longerperiod of time will provide important information about the risks andlong-term effects of both treatments. For example, at this time it istoo early to know whether the long-term incidence of second primarytumors, malignant or nonmalignant, differs between treatment strategies.
Study Centers for the COMS Clinical Trial
Leonard Joffe, M.D., F.R., C.S.
Retina Associates Southwest
A. Linn Murphree, M.D.
Man M. Singh Hayreh, M.D.
W. Sanderson Grizzard, M.D.
Norman P. Blair, M.D.
Raymond R. Margherio, M.D.
Paul T. Finger, M.D.
Jonathan J. Dutton, M.D., Ph.D.
Duke University Eye Center
Francie A. Gutman, M.D.
Frederick H. Davidorf, M.D.
Richard S. Ruiz, M.D.
Wichard A. Van Heuven, M.D.
J. Paul Dieckert, M.D.
Craig G. Wells, M.D.
William F. Mieler, M.D.
Christina Corriveau, M.D.
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- Histopathologic Characteristics of Uveal Melanomas in Eyes Enucleated from The Collaborative Ocular Melanoma Study. COMS Report no. 6. Am J Ophthalmol. 1998 Jun. PubMed
- The Collaborative Ocular Melanoma Study (COMS) Randomized Trial of Pre-Enucleation Radiation of Large Choroidal Melanoma I: Characteristics of Patients Enrolled and Not Enrolled. COMS Report No. 9. Am J Ophthalmol. 1998 Jun. PubMed
- The Collaborative Ocular Melanoma Study (COMS) Randomized Trial of Pre-Enucleation Radiation of Large Choroidal Melanoma II: Initial Mortality Findings. COMS Report No. 10. Am J Ophthalmol. 1998 Jun. PubMed