American Journal of Ophthalmology
Volume 125, Issue 6 , Pages 779-796 , June 1998

The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings COMS report no. 10

  • Collaborative Ocular Melanoma Study Group

      Affiliations

    • Corresponding Author InformationReprint requests to Barbara S. Hawkins, PhD, COMS Coordinating Center, 550 N Broadway, 9th Fl, Baltimore, MD 21205-2010; fax: (410) 955-0569

,Accepted 4 March 1998.

References 

  1. Scotto J, Fraumeni FJ, Lee JAH. Melanomas of the eye and other noncutaneous sites (epidemiologic aspects). J Natl Cancer Inst. 1976;56:489–491
  2. Zimmerman LE, McLean IW, Foster WD. Does enucleation of the eye containing a malignant melanoma prevent or accelerate the dissemination of tumour cells?. Br J Ophthalmol. 1978;62:420–425
  3. Zimmerman LE, McLean IW. An evaluation of enucleation in the management of uveal melanomas. Am J Ophthalmol. 1979;87:741–760
  4. Zimmerman LE, McLean IW, Foster WD. Statistical analysis of follow-up data concerning uveal melanomas, and the influence of enucleation. Ophthalmology. 1980;87:557–564
  5. Zimmerman LE. Metastatic disease from uveal melanoma. A review of current concepts with comments concerning future research and prevention. Trans Ophthalmol Soc UK. 1980;100:34–54
  6. McLean IW, Foster WD, Zimmerman LE, Martin DG. Inferred natural history of uveal melanoma. Invest Ophthalmol Vis Sci. 1980;19:760–770
  7. Seigel D, Myers M, Ferris F, Steinhorn SC. Survival rates after enucleation of eyes with malignant melanoma. Am J Ophthalmol. 1979;87:760–765
  8. Jakobiec FA. A moratorium on enucleation for choroidal melanoma?. Am J Ophthalmol. 1979;87:842–846
  9. Maumenee AE. An evaluation of enucleation in the management of uveal melanomas. Am J Ophthalmol. 1979;87:846–847
  10. Manschot WA, van Peperzeel HA. Choroidal melanoma: enucleation or observation? A new approach. Arch Ophthalmol. 1980;98:71–77
  11. Lommatzsch P, Dietrich B. The effect of orbital irradiation on the survival rate in patients with choroidal melanoma. Ophthalmologica. 1976;173:49–52
  12. Char DH, Phillips TL. The potential for adjuvant radiotherapy in choroidal melanoma. Arch Ophthalmol. 1982;100:247–248
  13. Char DH, Phillips TL. Pre-enucleation irradiation of uveal melanoma. Br J Ophthalmol. 1985;69:177–179
  14. Benediktsdóttir K, Edenholm M, Lindholm Å, Mårtensson B, Ståhl L, Zetterlund B. Preoperative irradiation of malignant melanoma (a multifactorial statistical analysis of survival). Acta Radiol Oncol. 1984;23:315–320
  15. Bornfeld N, Alberti W, Foerster MH, Gerke E, Wessing A, Meyer-Schwickerath G. External beam therapy of choroidal melanomata (preliminary report). Trans Ophthalmol Soc U K. 1983;103:68–71
  16. Fournier GA, Saulenas AM, Seddon JM, et al.  The effects of pre-enucleation irradiation on the development of metastases from intraocular Greene melanoma in hamsters. Am J Ophthalmol. 1985;100:669–677
  17. Rousseau A, Boudreault G, Deschênes J, Pelletier G, Tardif Y. Malignant melanoma (radiation treatment prior to enucleation). In:  Henkind P editors. ACTA (XXIV International Congress of Ophthalmology). Philadelphia: Lippincott; 1983;p. 983–987
  18. Sanborn GE, Ngyuen P, Gamel J, Niederkorn JY. Reduction of enucleation-induced metastasis in intraocular melanoma by periorbital irradiation. Arch Ophthalmol. 1987;105:1260–1264
  19. Augsburger JJ, Eagle RC, Chiu M, Shields JA. The effect of pre-enucleation radiotherapy on mitotic activity of choroidal and ciliary body melanomas. Ophthalmology. 1987;94:1627–1630
  20. Burch FE, Camp WF. Results of irradiation of malignant melanomas of the uveal tract. Trans Am Acad Ophthalmol Ototlaryngol. 1943;47:335–353
  21. Sobanski J, Zeydler-Grzedzielewska L, Szusterowska-Martinowa E. Decreased mortality of patients with intranuclear malignant melanoma after enucleation of the eyeball followed by orbit X-ray irradiation. Polish Med J. 1972;11:1512–1516
  22. Fraunfelder FT, Boozman FW, Wilson RS, Thomas AH. No-touch technique for intraocular malignant melanomas. Arch Ophthalmol. 1977;95:1616–1620
  23. McCubbin JA, Spratt JS. The value of no-touch isolation technique for resection of cancer (the eye as a model). Arch Surg. 1980;115:224–228
  24. Char DH. Current treatments and trials in uveal melanoma. Oncology. 1989;3:113–121
  25. McLean IW, Berd D, Mastrangelo MJ, et al.  A randomized study of methanol-extraction residue of bacille Calmette-Guérin as postsurgical adjuvant therapy of uveal melanoma. Am J Ophthalmol. 1990;110:522–526
  26. Cummings BJ. A critical review of adjuvant preoperative irradiation for adenocarcinoma of the rectum. Br J Surg. 1986;73:332–338
  27. Hoye RC, Smith RR. The effectiveness of small amounts of pre-operative irradiation in preventing the growth of tumor cells disseminated at surgery (an experimental study). Cancer. 1961;14:284–295
  28. Miller LS. Bladder cancer (superiority of preoperative irradiation and cystectomy in clinical stages B2 and C). Cancer. 1977;39:973–980
  29. Gérard A, Buyse M, Nordlinger B, et al.  Preoperative radiotherapy as adjuvant treatment in rectal cancer (final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC)). Ann Surg. 1988;208:606–614
  30. Rider WD, Palmer JA, Mahoney LJ, Robertson CT. Preoperative irradiation in operable cancer of the rectum (report of the Toronto trial). Can J Surg. 1977;20:335–338
  31. Roswit B, Higgins GA, Humphrey EW, Robinette CD. Preoperative irradiation of operable adenocarcinoma of the rectum and rectosigmoid colon (report of a randomized study). Ther Radiol. 1973;108:389–395
  32. Stearns MW, Deddish MR, Quan SHQ, Leaming RH. Preoperative roentgen therapy for cancer of the rectum and rectosigmoid. Surg Gynecol Obstet. 1974;138:584–586
  33. Stevens KR, Allen CV, Fletcher WS. Preoperative radiotherapy for adenocarcinoma of the rectosigmoid. Cancer. 1976;37:2866–2874
  34. Lawrence W, Terz JJ, Rogers C, King RE, Wolf JS, King ER. Preoperative irradiation for head and neck cancer (a prospective study). Cancer. 1974;33:318–323
  35. Snow JB, Gelber RD, Kramer S, Davis LW, Marcial VA, Lowry LD. Evaluation of randomized preoperative and postoperative radiation therapy for supraglottic carcinoma (preliminary report). Ann Otol. 1978;87:686–691
  36. Augsburger JJ, Lauritzen K, Gamel JW, Lowry JC, Brady LW. Matched group study of preenucleation radiotherapy versus enucleation alone for primary malignant melanoma of the choroid and ciliary body. Am J Clin Oncol. 1990;13:372–387
  37. Char DH, Phillips TL, Andejeski Y, Crawford JB, Kroll S. Failure of preenucleation radiation to decrease uveal melanoma mortality. Am J Ophthalmol. 1988;106:21–26
  38. Luyten GPM, Mooy CM, Eijkenboom WMH, et al.  No demonstrated effect of pre-enucleation irradiation on survival of patients with uveal melanoma. Am J Ophthalmol. 1995;119:786–791
  39. Bornfeld N, Huser U, Sauerwein W, Wessing A, Sack H. Präoperative Bestrahlung vor Enukleation bei malignem Melanom der Uvea. Literaturübersicht und erste eigene Erfahrungen. Klin Monatsbl Augenheilkd. 1989;194:252–260
  40. Kreissig I, Rohrbach M, Lincoff H. Irradiation of choroidal melanomas before enucleation?. Retina. 1989;9:101–104
  41. Collaborative Ocular Melanoma Study Group . Design and methods of a clinical trial for a rare condition: the Collaborative Ocular Melanoma Study. COMS report no. 3. Controlled Clin Trials. 1993;14:362–391
  42. Collaborative Ocular Melanoma Study Group . The Collaborative Ocular Melanoma Study (COMS) trial of pre-enucleation radiation of large choroidal melanoma, I: characteristics of patients enrolled and not enrolled. COMS report no. 9. Am J Ophthalmol. 1998;125:767–778
  43. Collaborative Ocular Melanoma Study Group . Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS report no. 1. Arch Ophthalmol. 1990;108:1268–1273
  44. Collaborative Ocular Melanoma Study Research Group Straatsma BR, Fine SL, Earle JD, Hawkins BS, Diener-West M, McLaughlin JA. Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology. 1988;95:1000–1004
  45. Collaborative Ocular Melanoma Study Group . Collaborative Ocular Melanoma Study Group. Complications of enucleation surgery (COMS report no. 2). In:  Franklin RM editors. Proceedings of the New Orleans Academy of Ophthalmology Symposium on Retina and Vitreous. New York: Kugler; 1993;p. 181–190
  46. Collaborative Ocular Melanoma Study Group . COMS manual of procedures. Accession no. PB95-179693. Springfield, Virginia: National Technical Information Service; 1995;
  47. Collaborative Ocular Melanoma Study Group . COMS forms book. Accession no. PB91-217315. Springfield, Virginia: National Technical Information Service; 1991;
  48. Bailey IL, Lovie JE. New design principles for visual acuity letter charts. Am J Optom Physiol Opt. 1976;53:740–745
  49. Ferris FL, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982;94:91–96
  50. Diener-West M, Hawkins BS, Markowitz JA, Schachat AP. A review of mortality from choroidal melanoma, II (a meta-analysis of mortality rates following enucleation, 1966 through 1988). Arch Ophthalmol. 1992;110:245–250
  51. Collaborative Ocular Melanoma Study Group . Histopathologic characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma Study. COMS report no. 6. Am J Ophthalmol. 1998;125:745–766
  52. Melia BM, Diener-West M. Modeling interrater agreement for pathologic features of choroidal melanoma. In:  Lange N,  Ryan L,  Billard L,  Brillinger D,  Conquest L,  Greenhouse J editor. Case studies in biometry. New York: Wiley & Sons; 1994;p. 323–338
  53. McLean IW, Foster WD, Zimmerman LE, Gamel JW. Modification of Callender’s classification of uveal melanoma at the Armed Forces Institute of Pathology. Am J Ophthalmol. 1983;96:502–509
  54. Snedecor GW, Cochran WG. In: Statistical methods. 7th ed. Ames, Iowa: Iowa State University Press; 1980;p. 144–145
  55. Armitage P, Berry G. In: Statistical methods in medical research. 2nd ed. Boston, Massachusetts: Blackwell Scientific; 1987;p. 372–374
  56. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–481
  57. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep. 1966;50:163–170
  58. Peto R, Peto J. Asymptotically efficient rank invariant procedures. J R Stat Soc A. 1972;135(pt 2):185–206
  59. Simon R. Confidence intervals for reporting results of clinical trials. Ann Intern Med. 1986;105:429–435
  60. Cox DR. Regression models and life-tables. J R Stat Soc B. 1972;134(pt 2):187–220
  61. Collaborative Ocular Melanoma Study Group. The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma, III: local complications with and without pre-enucleation radiation. COMS report no. 11. Am J Ophthalmol. Forthcoming.
  62. Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR, for the Collaborative Ocular Melanoma Study Group. Clear cell differentiation in choroidal melanoma. COMS report no. 8. Arch Ophthalmol 1997;115:894–898.
  63. Glicksman AS, Reinstein LE, Laurie F. Quality assurance of radiotherapy in clinical trials. Cancer Treat Rep. 1985;69:1199–1205
  64. Reinstein LE, Peachey S, Laurie F, Glicksman AS. Impact of a dosimetry review program on radiotherapy in group trials. Int J Radiation Oncol Biol Physics. 1985;11:1179–1184
  65. Seegenschmiedt MH, Sauerbrei W, Sauer R, et al.  Quality control review for radiotherapy of small breast cancer (analysis of 708 patients in the GBSG I trial). Strahlenther Onkol. 1993;169:339–350
  66. Albert DM, Niffenegger AS, Willson JKV. Treatment of metastatic uveal melanoma (review and recommendations). Surv Ophthalmol. 1992;36:429–438
  67. Curb JD, Babcock C, Pressel S, Tung B, Remington RD, Hawkins CM. Nosological coding of cause of death. Am J Epidemiol. 1983;118:122–128
  68. Remington RD. Who should code cause of death in a clinical trial?. Controlled Clin Trials. 1984;5:241–244
  69. Bangdiwala SI, Cohn R, Hazard C, Davis CE, Prineas RJ. Comparisons of cause of death verification methods and costs in the Lipid Research Clinics Program Mortality Follow-up Study. Controlled Clin Trials. 1989;10:167–187
  70. Percy C, Muir C. The international comparability of cancer mortality data (results of an international death certificate study). Am J Epidemiol. 1989;129:934–946
  71. Hayman JA, Fairclough DL, Harris JR, Weeks JC. Patient preferences concerning the trade-off between the risks and benefits of routine radiation therapy after conservative surgery for early-stage breast cancer. J Clin Oncol. 1997;15:1252–1260

 The COMS has received support from the National Eye Institute and the National Cancer Institute through cooperative agreements EY06253, EY06257, EY06258, EY06259, EY06260, EY06264, EY06265, EY06266, EY06268, EY06269, EY06270, EY06274, EY06275, EY06276, EY06279, EY06280, EY06282, EY06283, EY06284, EY06287, EY06288, EY06289, EY06291, EY06839, EY06843, EY06844, EY06848, EY06858, and EY06899 with the National Institutes of Health, Bethesda, Maryland.

PII: S0002-9394(98)00039-7

American Journal of Ophthalmology
Volume 125, Issue 6 , Pages 779-796 , June 1998