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June 15, 1998
Researchers found that patients with large eye melanomas had similar five-year survival rates regardless of whether they were treated with radiation prior to removal of the eye or had their eye removed without prior radiation therapy. These findings appear in a scientific paper published in the June 1998 issue of the American Journal of Ophthalmology.
In the clinical trial, the Collaborative Ocular Melanoma Study (COMS), two groups of patients with tumors large enough to require removal of the eye were studied. One group received radiation treatment to the affected eye before it was removed. The other group had the eye removed without the radiation treatment. Researchers found that, after five years of follow-up study, the radiation treatment had no effect on patients' survival rates. The COMS trial was supported by the 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 from treating ocular melanoma patients with radiation before removal of the eye," said Dr. Carl Kupfer, director of the NEI. "Radiation therapy is costly and has the potential for side effects. Unless a survival benefit is shown with further follow-up, it is unlikely doctors will advise it for their patients with large melanoma eye tumors."
The type of ocular melanoma studied by researchers was choroidal melanoma, a tumor of the eye that forms from pigmented cells of the choroid, a layer of tissue in the back of the eye. Although it is a rare cancer, choroidal melanoma is the most common primary eye cancer in adults. Many choroidal melanomas enlarge over time and can lead to loss of vision. More importantly, tumors also can spread to other parts of the body and eventually cause death. Researchers estimate that between 1680 and 2240 new cases of ocular melanoma are diagnosed annually in the US and Canada, a rate of about six-to-eight new cases per million people each year. Ocular melanoma occurs in all ethnic groups, although it is more common in whites of northern European descent.
There had been uncertainty in the medical community about the value of giving radiation treatments prior to removal of the eye of patients with large ocular melanoma. In cancers occurring elsewhere in the body, prior radiation has reduced the rate of tumor recurrence after surgery. The COMS is the first controlled, randomized, multicenter clinical trial large enough to measure the survival rate of patients who had received radiation treatment prior to eye removal.
"Patients in the trial will continue to be followed so that we can learn more about the risks and long-term effects of both treatments," said Dr. Stuart Fine, chairman of the Department of Ophthalmology at the University of Pennsylvania's Scheie Eye Institute in Philadelphia and chairman of the COMS clinical trial. "Based on data from previously published reports, patients in this study have lived longer than expected. About 60 percent of participants are alive after five years, whereas only 50 percent had been expected to live that long when the study was planned."
According to Dr. Fine, "The findings from this study are the initial results only. By continuing to follow study participants for a number of years, researchers will obtain important new information to help doctors advise their patients about appropriate therapy."
A separate trial comparing two different treatments for medium sized eye melanomas will finish enrolling patients this year, but survival data from that study are not expected soon.
The COMS trial was conducted at over 50 institutions, including medical schools, hospitals, and doctors' offices, throughout the US and Canada.
A list of current study centers is attached.
Choroidal melanoma is a tumor of the eye that forms from pigmented cells of the choroid, a layer of tissue in the back of the eye. Many choroidal melanomas enlarge over time and can lead to loss of vision. Tumors can also spread to other parts of the body and may cause death. Although it is a rare cancer, choroidal melanoma is the most common 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 the cancer may grow before the problem becomes noticeable. Choroidal melanoma is usually detected during a dilated eye exam, when an eye care professional dilates the pupils and examines the back of the eye.
Since the late 19th century, removal of the eye has been the standard treatment for choroidal melanoma of all sizes. Since World War II, radiation has been used to treat choroidal melanomas; during the past 20 years, interest in radiation therapy has increased because of the potential for saving eyes with small to medium-sized tumors. In the case of large tumors requiring removal of the eye, it was speculated that treating patients with radiation prior to eye removal may inactivate the tumor cells and reduce the chance these cells will divide and grow if they escape from the eye during the eye removal operation. The dose of radiation given is not enough to kill the tumor.
Treating large tumors with radiation before eye removal raised the question in the medical community of whether the radiation treatment prolonged the life of these patients as compared with patients whose eyes were removed without prior radiation treatment. The best data from smaller studies suggested that there was no difference between the two treatments. Researchers concluded that the only way to answer this question conclusively was to conduct a clinical trial in which a large number of choroidal melanoma patients would receive the two different treatments and be followed for many years. The survival rates of the two treatments could then be compared.
The Collaborative Ocular Melanoma Study (COMS) includes two separate, long-term, multicenter, randomized controlled trials that compare treatments and track the survival rate of patients with ocular melanoma. Collectively, the two COMS clinical trials are designed to:
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.
Leonard Joffe, M.D., F.R., C.S.
Retina Associates Southwest
Bradley R. Straatsma, M.D.
Jules Stein Eye Institute
University of California at Los Angeles Los Angeles, CA
A. Linn Murphree, M.D.
Doheny Eye Institute
University of Southern California
Los Angeles, CA
Man M. Singh Hayreh, M.D.
Southern California Permanente Group
Panorama City, CA
Schatz, McDonald, Johnson, and Ai
San Francisco, CA
Kenneth R. Hovland, M.D.
Timothy G. Murray, M.D.
Bascom Palmer Eye Institute
University of Miami School of
W. Sanderson Grizzard, M.D.
Retina Associates of Florida, P.A.
South Tampa Medical Center
Paul Steinberg, Jr., M.D.
Emory Eye Center
Eye Consultants of Atlanta, P.C.
Lee M. Jampol, M.D.
Northwestern University Medical School
Norman P. Blair, M.D.
University of Illinois
John T. Minturn, M.D.
Midwest Eye Institute
Thomas A. Weingeist, M.D., Ph.D.
University of Iowa Hospitals and Clinics
Iowa City, IA
Gerald Cohen, M.D
New Orleans, LA
Andrew P. Schachat, M.D.
Wilmer Ophthalmological Institute
The Johns Hopkins Medical Institutions
Clement L. Trempe, M.D.
Schepens Retina Associates
Andrew K. Vine, M.D.
W. K. Kellogg Eye Center
University of Michigan
Ann Arbor, MI
Raymond R. Margherio, M.D.
Associated Retinal Consultants, P.C.
Royal Oak, MI
Dennis M. Robertson, M.D.
Washington University School of Medicine
St. Louis, MO
David H. Abramson, M.D.
Cornell University Medical Center
New York, NY
Paul T. Finger, M.D.
New York Eye and Ear Infirmary
North Shore University Hospital
Great Neck, NY
Jonathan J. Dutton, M.D., Ph.D.
Duke University Eye Center
Z. Nicholas Zakov, M.D.
Retina Associates of Cleveland/Case Western Reserve University
Francie A. Gutman, M.D.
Cleveland Clinic Foundation
Frederick H. Davidorf, M.D.
Ohio State University College of Medicine
Reagan H. Bradford, Jr. M.D.
Dean A. McGee Eye Institute
Oklahoma City, OK
David J. Wilson, M.D.
Casey Eye Institute
Oregon Health Sciences University
Karl R. Olsen, M.D.
Dwain G. Fuller, M.D.
Texas Retina Associates
Richard S. Ruiz, M.D.
Hermann Eye Center
Wichard A. Van Heuven, M.D.
University of Texas
Health Science Center
San Antonio, TX
J. Paul Dieckert, M.D.
Scott and White Memorial Hospital
Brian P. Conway, M.D.
University of Virginia
Health Sciences Center
Edward B. McLean, M.D.
Ophthalmic Consultants Northwest, Inc.
Craig G. Wells, M.D.
University of Washington
School of Medicine
Suresh R. Chandra, M.D.
University of Wisconsin
William F. Mieler, M.D.
Medical College of Wisconsin
E. Rand Simpson, M.D.
Ontario Cancer Institute/Princess
Toronto, Ontario, Canada
Christina Corriveau, M.D.
Notre Dame Hospital
Montreal, Quebec, Canada
Stuart L. Fine, M.D.
Scheie Eye Institute
University of Pennsylvania
51 North 39th Street
Philadelphia, PA 19104
Telephone: (215) 662-9679
Barbara S. Hawkins, Ph.D.
Clinical Trials and Biometry Division
Wilmer Ophthalmological Institute
The Johns Hopkins Medical Institutions
Baltimore, MD 21205-2010
Telephone: (800) 553-9114
Natalie Kurinij, Ph.D.
National Eye Institute
National Institutes of Health
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