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Research Also Increases Nationwide Availability of Treatments
Researchers have found that the survival rates for two alternative treatments for primary eye cancer–radiation therapy and removal of the eye–are about the same. Prior to this finding, there was a question in the medical community as to whether either treatment might result in lower mortality. Also, as a consequence of this research, the capability of doctors nationwide to provide more accurate diagnoses and state-of-the-art treatments for eye cancer has been greatly expanded. Mortality data are compared in the July 2001 issue of Archives of Ophthalmology.
“These findings are reassuring to patients with medium-sized eye tumors who have to choose between the option of radiation therapy vs. removal of the eye,” said Paul A. Sieving, M.D., Ph.D., director of the National Eye Institute (NEI). “Patients now know that their choice will not impact their survival. Equally important, more information is now available about how each treatment will affect a patient’s life, so patients and their doctors can make informed treatment decisions.”
The clinical trial–called the Collaborative Ocular Melanoma Study (COMS)–was supported by the NEI and the National Cancer Institute (NCI), components of the Federal government’s National Institutes of Health.
“The COMS findings are a striking example of the role that clinical trials play in improving patient care,” said Richard Klausner, M.D., director of the NCI. “Without thisimportant trial, patients would not have known that they have a choice betweenradiation and surgery for treatment of their ocular melanoma, with the same opportunity for long-term survival.”
With the data showing similar survival rates for radiation therapy vs. removal of the eye, quality of life issues become important factors when deciding which of the two treatment options is better for the individual patient. “Most patients who received the radiation therapy had some vision loss, and some eyes receiving radiation therapy were later removed because of tumor regrowth or other complications,” said Stuart Fine, M.D., chairman of the Department of Ophthalmology at the University of Pennsylvania in Philadelphia and chair of the COMS clinical trial. “However, many people diagnosed with primary eye cancer may consider these problems worth risking in comparison to immediate loss of the eye.
“COMS researchers have initiated a parallel study to assess the quality of life for patients enrolled in this clinical trial,” Dr. Fine said. “The findings of this study–when released in a few years–should provide more information on which to base a treatment decision.”
For more than a century, removal of the eye has been the standard treatment for primary eye cancer, also known as ocular melanoma. During the past 25 years, interest in radiation therapy has increased because of the potential for saving the eye–and with it, some vision. In the COMS, patients with medium-sized tumors were studied in a randomized clinical trial to determine which of two treatments–radiation therapy or removal of the eye–is more likely to prolong survival. The affected eyes of one group received a form of radiation therapy called I-125 brachytherapy (pronounced BRAK-e-ther-a-pe), in which a small plaque containing radioactive iodine pellets is placed over the tumor. The other group had the eye removed. Approximately one-third of the patients have been followed for 10 years; over 80 percent were followed for five years. Researchers found that the survival rates were essentially the same in the two groups.
In the COMS clinical trial, researchers also found that the five-year survival rate of patients who were treated with either radiation therapy or eye removal was 82 percent, considerably better than the 70 percent five-year survival rate that had been projected when the study was designed in 1985. Moreover, there is no evidence that eithertreatment causes harm to the other eye. All patients in the study will continue to be followed for up to 15 years.
The type of eye cancer studied by COMS researchers is choroidal melanoma, a tumor of the eye that arises from pigmented cells of the choroid, a layer of tissue in the back of the eye. Although it is rare, choroidal melanoma is the most common primary eye cancer in adults. These tumors enlarge over time and may lead to vision loss. More importantly, these tumors can spread, or metastasize, to other parts of the body; once metastasis is clinically detected, death typically occurs within months. Because there is no cure for metastatic melanoma, treatment is aimed at keeping the cancer confined tothe eye. Researchers estimate that between 1600 and 2400 new cases of ocularmelanoma are diagnosed annually in the United States and Canada, a rate of about six-to-eight new cases per million people each year. Choroidal melanoma is much more common in whites of northern European descent.
In June 1998, in a separate but related COMS clinical trial, researchers released results concerning whether a type of preoperative radiation therapy, called external beam radiation, prolonged life for patients whose ocular melanoma tumors were so large that removal of the eye was a medical necessity. Researchers reported that patients had similar survival rates regardless of whether their eyes were treated with external beam radiation prior to removal of the eye, or had their eyes removed without prior radiation therapy.
The COMS trials were conducted at 43 institutions, including medical schools, hospitals, and doctors’ offices, throughout the United States and Canada. A list of current study centers and principal investigators is attached.
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The National Eye Institute (NEI) and the National Cancer Institute (NCI) are both part of the National Institutes of Health (NIH). The NEI is the Federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. The NCI is the Federal government’s primary agency for cancer research. The NIH is an agency of the US Department of Health and Human Services.
The Collaborative Ocular Melanoma Study (COMS) Randomized Trialof I-125 Brachytherapy for Medium Choroidal Melanoma
Choroidal melanoma is a tumor of the eye that forms from pigmented cells of the choroid, a layer of vascular tissue in the back of the eye. These tumors enlarge over time and can lead to loss of vision. Melanoma cells also can 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; radiation has been used experimentally to treat choroidal melanoma since World War II. During the past 20 years, interest in different methods of radiation therapy has increased because of the potential for saving eyes with small to medium-sized tumors. However, many in the medical community questioned whether patients treated with eye-conserving radiation therapy experienced higher death rates than those whose eyes were removed. Researchers concluded that the only way to determine this conclusively was to conduct a clinical trial in which a large number of choroidal melanoma patients would randomly 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)
The Collaborative Ocular Melanoma Study (COMS) includes two separate, long-term, multicenter, randomized controlled trials that compare treatments with respect to survival rates of patients with choroidal melanoma.
The two COMS clinical trials are:
1. The Randomized Trial of Pre-Enucleation Radiation for Large Choroidal Melanoma. This trial determined whether a type of preoperative radiation therapy, called external beam radiation, prolongs life for patients whose tumors are so large as to require removal of the eye. Researchers found that for at least five years after diagnosis and treatment, patients with large choroidal melanoma had similar 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. Previous to this clinical trial, there had been uncertainty in the medical community about the value of irradiating the eye prior to eye removal in patients with large choroidal melanoma. These results were reported in the June 1998 issue of the American Journal of Ophthalmology.
2. The Randomized Trial of I-125 Brachytherapy for Medium Choroidal Melanoma. This trial was designed to determine which of two standard treatments–removal of the eye or therapy with small radioactive iodine pellets placed over the tumor (brachytherapy)–is more likely to prolong survival of eligible patients with medium-sized tumors. It is the results of this trial that are reported in the July 2001 issue of the Archives of Ophthalmology.
The Randomized Trial of I-125 Brachytherapy for Medium Choroidal Melanoma
Patient enrollment in the COMS’ Randomized Trial of I-125 Brachytherapy for Medium Choroidal Melanoma began in February 1987 and was completed in July 1998. To be eligible for this trial, a patient had to have choroidal melanoma from 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal diameter. Eligible patients were at least 21 years old, had no other primary tumor, and had no other disease that threatened their lives within the next five years. Previous treatment related to the eye cancer rendered a patient ineligible. Eligible patients enrolled and received treatment at 43 clinical centers located in major population areas of the United States and Canada.
The study enrolled 1317 patients with medium-sized choroidal melanoma. About 98 percent were non-Hispanic whites. The group was evenly divided by gender, and the mean age was approximately 60 years. Patients were assigned to one of two treatment groups by randomization. One group–660 patients–was assigned to have the affected eye removed. The other group–657 patients–was assigned to radiation treatment.
The radiation treatment was delivered via an iodine-125 episcleral plaque. Prior to the treatment, the dimensions of the tumor were measured. A gold plaque with a plastic seed carrier containing the proper dosage and configuration of radioactive iodine seeds was sutured to the outside of the eye over the base of the tumor. This procedure delivered a high dose of radiation to the tumor. The plaque typically was removed from the eye after three-to-five days.
COMS Clinical Trial
Current Principal Investigators & Study Centers
Current Principal Investigators & Study Centers
A. Linn Murphree, M.D.
Man M. Singh Hayreh, M.D.
Robert N. Johnson, M.D.
W. Sanderson Grizzard, M.D.
James H. Frank, M.D.
Norman P. Blair, M.D.
Antonio Capone, M.D.
Paul T. Finger, M.D.
Froncie 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.
Judith E. Kim, M.D.
Christina Corriveau, M.D.
Photograph Reading Center
Radiological Physics Center
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- Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR, Collaborative Ocular Melanoma Study Group. The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma, II: Characteristics of Patients Enrolled and Not Enrolled. COMS Report No. 17. Arch Ophthalmol. 2001 Jul. PubMed
- Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR, Collaborative Ocular Melanoma Study Group. The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma, III: Initial Mortality Findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul. PubMed