May 2002

The COMS: Why Was It Not Stopped Sooner?

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

Arch Ophthalmol. 2002;120(5):672. doi:

Fifteen years ago, the potential value of the Collaborative Ocular Melanoma Study (COMS) was questioned. First, millions of scarce health care dollars were to be spent on a problem that was not nationally significant.1 Second, reasonable, but admittedly not totally conclusive, evidence indicated that the COMS would be unlikely to reveal a differential effect of the compared treatments for medium-sized melanomas that was substantial both clinically and statistically, with regard to mortality.2,3 Third, prior to the inception of the COMS, there was very little data that suggested a lower mortality rate after enucleation than after eye-retaining radiotherapy. In fact, Zimmerman et al4 suggested that enucleation caused a higher death rate. Leading ocular oncologists around the United States refused to participate in the COMS because they questioned the ethics of removing eyes with medium-sized melanomas and 20/20 visual acuity.2,3,5

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