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 language | English (US) |
|---|---|
| Pages (from-to) | 1395-1400 |
| Number of pages | 6 |
| Journal | Indian Journal of Ophthalmology |
| Volume | 66 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2018 |
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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 journal › Article
}
TY - JOUR
T1 - Mortality after deferral of treatment or no treatment for choroidal melanoma
AU - For The Collaborative Ocular Melanoma Study Group
AU - Straatsma, Bradley R.
AU - Diener-West, Marie
AU - Caldwell, Robert
AU - Engstrom, Robert E.
PY - 2018/10/1
Y1 - 2018/10/1
N2 - 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.
AB - 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.
KW - Choroidal melanoma
KW - COMS
KW - melanoma
KW - mortality
KW - uveal melanoma
UR - http://www.scopus.com/inward/record.url?scp=85054023852&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85054023852&partnerID=8YFLogxK
U2 - 10.4103/ijo.IJO_1499_18
DO - 10.4103/ijo.IJO_1499_18
M3 - Article
C2 - 30249822
AN - SCOPUS:85054023852
VL - 66
SP - 1395
EP - 1400
JO - Indian Journal of Ophthalmology
JF - Indian Journal of Ophthalmology
SN - 0301-4738
IS - 10
ER -