Mortality after deferral of treatment or no treatment for choroidal melanoma

For The Collaborative Ocular Melanoma Study Group

Research output: Contribution to journalArticle

Abstract

Purpose: To report mortality of patients who were eligible for enrollment in the Collaborative Ocular Melanoma Study (COMS) clinical trials of medium-sized choroidal melanoma or large-sized choroidal melanoma but chose to defer treatment or receive no melanoma treatment. Design: Prospective nonrandomized multicenter cohort study as an adjunct to COMS randomized clinical trials. Methods: Patient follow-up procedures included examinations, correspondence, telephone contacts, and National Death Index searches. Primary outcome was patient death measured by all-cause mortality. Secondary outcomes were melanoma treatment and melanoma metastasis. Results: Of 77 patients eligible for COMS clinical trials who chose to defer or receive no melanoma treatment, 61 were appropriate candidates and 45 (74%) enrolled in the natural history study (NHS). In all, 42 patients (42 eyes) had medium melanoma, and the median follow-up was 5.3 years (range, 4-10.7 years). In all, 22 patients (52%) had subsequent melanoma treatment, and 20 (48%) had no melanoma treatment. For the 42 patients, Kaplan-Meier estimate of 5-year mortality was approximately 30% [95% confidence interval (CI), 18%-47%]. For COMS medium melanoma trial, 5-year mortality was 18% (95% CI, 16%-20%), not statistically significantly different from the NHS patients. After adjusting for differences in age and longest basal diameter, the 5-year risk of death for NHS patients versus COMS trial patients was 1.54 (95% CI, 0.93-2.56). Three patients had large melanoma. Melanoma metastasis was confirmed or suspected in 8 (42%) of 19 deaths. Conclusion: Greater mortality and higher risk of death for NHS patients are probative but not conclusive evidence of a beneficial, life-extending effect of medium melanoma treatment.

Original languageEnglish (US)
Pages (from-to)1395-1400
Number of pages6
JournalIndian Journal of Ophthalmology
Volume66
Issue number10
DOIs
StatePublished - Oct 1 2018

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Melanoma
Mortality
Therapeutics
Natural History
Confidence Intervals
Clinical Trials
Neoplasm Metastasis
Kaplan-Meier Estimate
Telephone
Multicenter Studies
Cohort Studies
Randomized Controlled Trials

Keywords

  • Choroidal melanoma
  • COMS
  • melanoma
  • mortality
  • uveal melanoma

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Mortality after deferral of treatment or no treatment for choroidal melanoma. / For The Collaborative Ocular Melanoma Study Group.

In: Indian Journal of Ophthalmology, Vol. 66, No. 10, 01.10.2018, p. 1395-1400.

Research output: Contribution to journalArticle

For The Collaborative Ocular Melanoma Study Group. / Mortality after deferral of treatment or no treatment for choroidal melanoma. In: Indian Journal of Ophthalmology. 2018 ; Vol. 66, No. 10. pp. 1395-1400.
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abstract = "Purpose: To report mortality of patients who were eligible for enrollment in the Collaborative Ocular Melanoma Study (COMS) clinical trials of medium-sized choroidal melanoma or large-sized choroidal melanoma but chose to defer treatment or receive no melanoma treatment. Design: Prospective nonrandomized multicenter cohort study as an adjunct to COMS randomized clinical trials. Methods: Patient follow-up procedures included examinations, correspondence, telephone contacts, and National Death Index searches. Primary outcome was patient death measured by all-cause mortality. Secondary outcomes were melanoma treatment and melanoma metastasis. Results: Of 77 patients eligible for COMS clinical trials who chose to defer or receive no melanoma treatment, 61 were appropriate candidates and 45 (74{\%}) enrolled in the natural history study (NHS). In all, 42 patients (42 eyes) had medium melanoma, and the median follow-up was 5.3 years (range, 4-10.7 years). In all, 22 patients (52{\%}) had subsequent melanoma treatment, and 20 (48{\%}) had no melanoma treatment. For the 42 patients, Kaplan-Meier estimate of 5-year mortality was approximately 30{\%} [95{\%} confidence interval (CI), 18{\%}-47{\%}]. For COMS medium melanoma trial, 5-year mortality was 18{\%} (95{\%} CI, 16{\%}-20{\%}), not statistically significantly different from the NHS patients. After adjusting for differences in age and longest basal diameter, the 5-year risk of death for NHS patients versus COMS trial patients was 1.54 (95{\%} CI, 0.93-2.56). Three patients had large melanoma. Melanoma metastasis was confirmed or suspected in 8 (42{\%}) of 19 deaths. Conclusion: Greater mortality and higher risk of death for NHS patients are probative but not conclusive evidence of a beneficial, life-extending effect of medium melanoma treatment.",
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