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5-Year Results From the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3

Collaborative Ocular Melanoma Study–Quality of Life Study Group^*

Arch Ophthalmol. 2006;124:226-238.

Objective  To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial.

Main Outcome Measures  Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression.

Participants  Two hundred nine patients who enrolled in the Collaborative Ocular Melanoma Study trial for medium-sized tumors between March 1995 and July 1998 and gave informed consent prior to randomization to participation in an ancillary study of quality of life.

Methods  Patients were interviewed by telephone by a trained interviewer from the Collaborative Ocular Melanoma Study Coordinating Center at baseline (prior to randomization), at 6 months, and on annual anniversaries of enrollment. The questionnaire battery included the Medical Outcomes Study Short Form 36, the Activities of Daily Vision Scale, the National Eye Institute Visual Function Questionnaire, and the Hospital Anxiety and Depression Scale. Additional questions concerning satisfaction with posttreatment appearance and concerns about cancer recurrence also were included in posttreatment interviews.

Results  There was a significant increase in both treatment groups in levels of reported difficulty for most vision-oriented activities, and in bodily and ocular pain, 6 months following treatment. Differences in visual function between treatment groups reported during follow-up were relatively small, but significant differences favoring brachytherapy-treated patients were observed for driving during the first year of follow-up and for peripheral vision during the first 2 years of follow-up. Anxiety levels in both groups decreased significantly following treatment, but patients treated with brachytherapy with symptoms of anxiety were less likely to report later resolution of symptoms than patients with symptoms of anxiety who were treated with enucleation. This study was unable to assess impact of treatment on satisfaction with appearance and concern about cancer recurrence during the first year after treatment, but no treatment-related differences were found on these measures at 2 years and later follow-up times.

Conclusions  Patients treated with brachytherapy reported significantly better visual function than patients treated with enucleation with respect to driving and peripheral vision for up to 2 years following treatment. Differences between treatments in visual function diminished by 3 to 5 years posttreatment, paralleling decline in visual acuity in brachytherapy-treated eyes. Patients treated with brachytherapy were more likely to have symptoms of anxiety during follow-up than patients treated with enucleation.

Application to Clinical Practice  Given that no significant differences in survival between enucleation and brachytherapy have been found, the differences demonstrated here for driving and anxiety will allow the individual patient and physician to make informed choices regarding treatment based on personal preferences.

*Authors: Members of the writing team who signed authorship responsibility, financial disclosure, and copyright transfer statements for the group are listed below.
Collaborative Ocular Melanoma Study–Quality of Life Study Group Authors: Michele Melia, ScM; Claudia S. Moy, PhD; and Sandra M. Reynolds, MA, Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, Md; James A. Hayman, MD, Department of Radiation Oncology, University of Michigan, Ann Arbor; Timothy G. Murray, MD, Bascom Palmer Eye Institute, University of Miami, Miami, Fla; Kenneth R. Hovland, MD, Porter Adventist Hospital, Denver, Colo; John D. Earle, MD, Department of Radiation Oncology, Mayo Clinic, Jacksonville, Fla; Natalie Kurinij, PhD, National Eye Institute, Bethesda, Md; Li Ming Dong, PhD, and Päivi H. Miskala, PhD, Wilmer Ophthalmological Institute; Connie Fountain, COT, Department of Ophthalmology, University of Iowa Hospitals and Clinic, Iowa City; David Cella, PhD, Center on Outcomes Research and Education, Evanston Northwestern Healthcare, Evanston, Ill; and Carol M. Mangione, MD, MSPH, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles.
Dr Moy is currently with the National Institute of Neurological Disorders and Stroke, Bethesda.

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