Radiation, enucleation have comparable mortality rates in choroidal melanoma

COMS (the Collaborative Ocular Melanoma Study) discovered about 80% 5-year survival rates with both treatment methods.

Issue: October 1, 2001

ByBob Kronemyer

BALTIMORE — Mortality rates for patients with choroidal melanoma are comparable for both iodine 125 brachytherapy and enucleation, according to the Collaborative Ocular Melanoma Study (COMS). The unadjusted 5-year survival rates were 81% with enucleation and 82% with radiation treatment delivered via an iodine 125 episcleral plaque.

“The overall results were better in both groups than we expected,” said Andrew P. Schachat, MD, a member of the COMS Group and the Karl Hagen Professor of Ophthalmology at Johns Hopkins University here.

“I honestly believed there would be an occasional plaqued eye where the tumor is not radiosensitive or there would be a ‘miss’ with plaque localization,” he said. “In other words, I thought that plaque outcomes would be slightly less encouraging.”

Entry criteria

Of the 8,712 patients evaluated for the COMS, 5,046 had tumors of eligible size (medium) and 2,882 were eligible for enrollment, of which 1,317 actually enrolled. Articles on enrollment characteristics and initial mortality findings appeared in the July issue of Archives of Ophthalmology.

“The entry criteria were broad, so the study applies to a large fraction of adults with choroidal melanoma,” Dr. Schachat told Ocular Surgery News. “For the medium-tumor trial, patients with predominantly ciliary body tumors and patients with tumors touching two or more clock hours of the disc were excluded.” In addition, systemic inclusion/exclusion criteria were such that most patients with existing non-ocular cancers were excluded.

“Patients also needed to likely survive 5 years, exclusive of their ocular melanoma diagnosis,” Dr. Schachat said. Consequently, the results are “somewhat skewed in that by excluding patients likely to die from other disease over the next few years, our patients were a tad healthier,” he said.

Practitioner advice

Based on the study results and assuming that a choroidal melanoma patient meets the study entry criteria, “I would tell the patient that it appears the eye can be preserved and some vision retained in about 90% of cases with plaque, and that survival rates with plaque or enucleation are similar,” Dr. Schachat said.

However, he said, “some patients view their blurred vision as an aggravation, and the post-plaque follow-up is more complex, so they may prefer the simpler enucleation. But most patients view their residual partial vision as a benefit, and some may even keep good vision, so most patients who would meet entry criteria will likely select plaque.”

Generally, enucleation is less expensive and simpler to perform and requires only one surgery vs. two for radiation.

The patient needs to rely on the physician to tell him or her the size and location of the tumor, Dr. Schachat said. Only by assessing those factors can radiation be considered.

“If plaque is possible — or another radiation modality — then the patient can choose. Otherwise, the doctor would advise enucleation,” he said.

Well-executed study

Paul A. Sieving, MD, PhD, director of the National Eye Institute in Bethesda, Md., said he is “absolutely, totally delighted with the way the study was conducted and some of the important spin-offs.”

When the study was initiated in 1987, he said, “it was thought that within 5 years after diagnosis, about 30% of patients would have died as a result of their ocular tumors. But the outcomes showed a 5-year mortality of only 20% died. The attention focused on these intraocular melanomas improved the medical care and resulted in a higher survival rate.”

In an editorial on the two articles that appeared in the same issue of Archives of Ophthalmology, Dr. Sieving noted that only two of the 660 eyes enucleated were found histologically not to have melanoma. “This is a testament to the remarkable improvements in diagnostic acumen,” he said. The study “is a major health answer for people who end up with these tumors through no fault of their own.”

Whether to enucleate or treat choroidal melanoma with radiation “has been a very perplexing quandary for the patient and physician over the years,” said Dr. Sieving. “It has been perplexing because there has been suspicion or a question raised that enucleation might in fact make things worse because you manipulate the eye and spread the tumor. The comforting result of the study is that the patients’ overall health was not jeopardized if the affected eye was removed.”

Reasons for enucleation

As to why a patient would choose enucleation over radiation, “the patient is faced with the problem of having eye cancer,” Dr. Sieving told Ocular Surgery News. “It is a frightening idea to have cancer in the body and to leave it there, as opposed to having that cancer removed from the body. Choosing enucleation is a very personal decision. Some people are going to feel medically much safer just to be done with it by having the cancer removed. Emotionally and psychologically, this is the best route for some people.”

Dr. Sieving continued: “The patients who participated in the study rendered a great service to all of us. Now, when a person walks into a doctor’s office in this country or abroad with choroidal melanoma, he or she has some answers because of the diligence and generosity of all the patients who participated in the study. Either modality has the best interest of the patient at heart.

“Although the results are obviously directly and specifically applicable to the population that was studied, the results can also be well extended to melanoma tumors that are in a similar close-by location.”

For Your Information:

Andrew P. Schachat, MD, can be reached at Johns Hopkins Hospital, 600 N. Wolfe St., Maumenee 713, Baltimore, MD 21287-9275; (410) 955-7411; fax: (410) 614-1683; e-mail: aschachat@jhmi.edu.

Paul A. Sieving, MD, PhD, can be reached at National Eye Institute, Building 31, 6th Floor, 31 Center Drive, MSC 2510, Bethesda, MD 20892-2510; (301) 496-2234; fax (301) 496-9970; e-mail: paulsieving@nei.nih.gov.

Reference:

The 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;119:951-965.

The 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;119:969-982.

Sieving PA. Fifteen years of work: the COMS outcomes for medium-sized choroidal melanoma. Editorial. Arch Ophthalmol. 2001;119:1067-1068.