THE COLLABORATIVE OCULAR MELANOMA STUDY (COMS) RANDOMIZED TRIAL OF PREENUCLEATION RADIATION OF LARGE CHOROIDAL MELANOMA III - LOCAL COMPLICATIONS AND OBSERVATIONS FOLLOWING ENUCLEATION COMS REPORT NO. 11

PURPOSE: To summarize local complications and observations following e nucleation of eyes with large choroidal melanoma that were reported pr ospectively at scheduled examinations of patients enrolled in the Coll aborative Ocular Melanoma Study (COMS) randomized trial of pre enuclea tion radiation. METHODS: Of 1,003 patients with large choroidal melano ma who were assigned randomly at time of enrollment to enucleation alo ne or to preenucleation radiation, 994 were treated as assigned. Compl ications and observations were reported to the Coordinating Center on standard forms completed at the time of enucleation surgery and during the immediate 24-hour postsurgery period, 1 to 6 weeks following surg ery, 6 and 12 months after enucleation, and at examinations scheduled at 12-month intervals thereafter. RESULTS: The most common perioperati ve complication was pain that prolonged hospital stay, which was repor ted for six patients (1%) who had standard enucleation and eight patie nts (2%) who had pre-enucleation radiation. Patients treated with pre enucleation radiation had somewhat more complications reported at the examination 1 to 6 weeks after surgery than did patients treated with enucleation alone, 36 (8%) and 21 (4%), respectively (P = .03, XZ test ), but all complications were minor. During follow up, fewer biopsy-co nfirmed tumor recurrences in the orbit were observed among patients tr eated with pre enucleation radiation than with enucleation alone (0 vs 5, respectively; P = .03, Fisher exact test). Patients treated with p re-enucleation radiation also had a lower incidence of severe ptosis t han did patients treated with enucleation alone (P = .007, log rank te st). Among 307 patients examined 5 years after enucleation, the most f requent complication reported at the 5-year examination was poor prost hetic motility for 24 patients (16%) treated with enucleation alone an d 30 patients (19%) treated with pre enucleation radiation. CONCLUSION S: Complications were infrequent during the 5-year period following en ucleation surgery. Five-year incidence rates and prevalence at the 5-y ear examination of most complications were similar in the two treatmen t arms. There was no indication that pre-enucleation radiation had res ulted in more serious complications. (C) 1998 by Elsevier Science Inc. All rights reserved.