Abstract :
Purpoe: To report initial mortality finding from the Collaborative Ocular Melanoma tudy (COM) randomized clinical trial of pre-enucleation radiation of large choroidal melanoma.
Method: Patient were evaluated for eligibility at one of 43 participating center in the United tate and Canada. Eligible conenting patient were aigned randomly at the time of enrollment to tandard enucleation or to external radiation of the orbit and globe prior to enucleation. Eligibility wa confirmed at the COM Coordinating Center, Echography Center, and Photograph Reading Center. Adherence to the radiotherapy protocol wa monitored at the Radiological Phyic Center. The diagnoi of choroidal melanoma wa confirmed following enucleation by a three-member Pathology Review Committee. Patient accrual began in November 1986 and wa completed in December 1994; 1,003 patient enrolled. Patient have been followed at annual clinical examination. Caue of death wa coded by a Mortality Coding Committee whoe member were not involved in the care of COM patient; the clinical trial wa monitored by an independent Data and afety Monitoring Committee.
Reult: A total of 1,003 patient were enrolled; 506 were aigned to enucleation alone and 497 to pre-enucleation radiation. Treatment group were well balanced on baeline characteritic. Only nine patient were found to be ineligible after enrollment, even in the interval between randomization and enucleation and two after enucleation baed on hitopathology. All but nine patient were treated a aigned; in only ix of 491 eye treated with pre-enucleation radiation wa there a major deviation from the radiotherapy protocol. With 5-year outcome known for 801 patient enrolled (80%), the etimated 5-year urvival rate and 95% confidence interval (CI) were 57% (95% CI, 52% to 62%) for enucleation alone and 62% (95% CI, 57% to 66%) for pre-enucleation radiation. Among the baeline covariate evaluated, only age and longet baal diameter of the melanoma affected the prognoi for urvival to a tatitically ignificant degree. The rik of death among patient treated with pre-enucleation radiation relative to thoe treated with enucleation alone after adjutment for baeline characteritic of patient, eye, and tumor wa 1.03 (95% CI, 0.85 to 1.25). Of 435 death claified by the Mortality Coding Committee, 269 patient had hitologically confirmed melanoma metatae at the time of death. Etimated 5-year urvival rate for thi econdary outcome were 72% (95% CI, 68% to 76%) for enucleation alone and 74% (95% CI, 69% to 78%) for pre-enucleation radiation.
Concluion: No urvival difference attributable to pre-enucleation radiation of large choroidal melanoma, uing the COM fractionation chedule, ha been demontrated to date in thi randomized trial. The trial had tatitical power of 90% to detect a relative difference in mortality rate between the two treatment arm of 20% or larger. A maller difference i poible, but a clinically meaningful difference in mortality rate, whether from all caue or from metatatic melanoma, i unlikely.
