The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: Characteristics of patients enrolled and not enrolled: COMS report no. 17

Barbara S Hawkins, A. K. Vine, J. M. Willis, B. Frueh, K. Itani, R. M. Kurtz, S. R. Sneed, J. A. Hayman, C. J. McGinn, R. Diaz, A. S. Lichter, J. M. Robertson, S. Schoeppel, R. T. Haken, A. V. Thompson, K. A. Meyer, S. A. Stanley, C. Martonyi, V. Elner, M. KincaidR. J. Wolter, P. Sternberg, T. A. Meredith, J. M. Brown, Jr Aaberg T.M., Sr Aaberg T.M., T. H. Wojno, J. W. Keller, J. Landry, I. R. Crocker, J. McLaren, C. A. Aguilera, E. Butker, K. A. Klee, D. Strongosky, D. K. Gibbs, L. T. Curtis, A. Fremstad, R. G. Waldron, A. Ward, J. Gilman, R. A. Myles, C. Snipes, R. Swords, H. E. Grossniklaus, Jr Calhoun F.P., W. Campbell, J. H. Frank, W. H. Jarrett, R. L. Halpern, W. S. Hagler, N. Jones, F. P. Schwaibold, M. Jones, P. Mondalek, K. J. Wynn, G. A. Degenhardt, A. R. Muncey, J. Aaron, D. S. Bolerjack, C. E. Cooper, E. K. Hulsey, L. Kailey, D. H. Lee, S. N. McCart, G. A. McCoy, M. E. Clark, B. Baxter, B. P. Robinson, K. D. Thompson, K. K. Wilson, A. P. Schachat, Jr Doll W.T., E. F. Greenberg, M. Hartnett, M. Alexander, S. Kaiser, C. S. Sackett, N. T. Iliff, D. J. Lee, J. F. Jackson, J. Ianitto, W. C. Lam, L. T. Pollack, C. DiBernardo, D. Cain, D. Emmert, T. George, Z. N. Zakov, T. A. Rice, K. Dempsey, G. Daley, D. Preseren, S. D. Pendergast, H. Zegarra, D. Shina, N. Began, K. Pillai, K. A. DuBois

Research output: Contribution to journalArticle

Abstract

Objectives: To describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients. Methods: For all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A- and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms. Results: Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of eligible patients, 26% of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48%) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40% of eligible patients not enrolled and 29% of ineligible patients. Conclusions: This trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.

Original languageEnglish (US)
Pages (from-to)951-965
Number of pages15
JournalArchives of Ophthalmology
Volume119
Issue number7
StatePublished - 2001

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Brachytherapy
Iodine
Melanoma
Neoplasms
Clinical Trials
Baltimore
Fluorescein

ASJC Scopus subject areas

  • Ophthalmology

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The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II : Characteristics of patients enrolled and not enrolled: COMS report no. 17. / Hawkins, Barbara S; Vine, A. K.; Willis, J. M.; Frueh, B.; Itani, K.; Kurtz, R. M.; Sneed, S. R.; Hayman, J. A.; McGinn, C. J.; Diaz, R.; Lichter, A. S.; Robertson, J. M.; Schoeppel, S.; Haken, R. T.; Thompson, A. V.; Meyer, K. A.; Stanley, S. A.; Martonyi, C.; Elner, V.; Kincaid, M.; Wolter, R. J.; Sternberg, P.; Meredith, T. A.; Brown, J. M.; Aaberg T.M., Jr; Aaberg T.M., Sr; Wojno, T. H.; Keller, J. W.; Landry, J.; Crocker, I. R.; McLaren, J.; Aguilera, C. A.; Butker, E.; Klee, K. A.; Strongosky, D.; Gibbs, D. K.; Curtis, L. T.; Fremstad, A.; Waldron, R. G.; Ward, A.; Gilman, J.; Myles, R. A.; Snipes, C.; Swords, R.; Grossniklaus, H. E.; Calhoun F.P., Jr; Campbell, W.; Frank, J. H.; Jarrett, W. H.; Halpern, R. L.; Hagler, W. S.; Jones, N.; Schwaibold, F. P.; Jones, M.; Mondalek, P.; Wynn, K. J.; Degenhardt, G. A.; Muncey, A. R.; Aaron, J.; Bolerjack, D. S.; Cooper, C. E.; Hulsey, E. K.; Kailey, L.; Lee, D. H.; McCart, S. N.; McCoy, G. A.; Clark, M. E.; Baxter, B.; Robinson, B. P.; Thompson, K. D.; Wilson, K. K.; Schachat, A. P.; Doll W.T., Jr; Greenberg, E. F.; Hartnett, M.; Alexander, M.; Kaiser, S.; Sackett, C. S.; Iliff, N. T.; Lee, D. J.; Jackson, J. F.; Ianitto, J.; Lam, W. C.; Pollack, L. T.; DiBernardo, C.; Cain, D.; Emmert, D.; George, T.; Zakov, Z. N.; Rice, T. A.; Dempsey, K.; Daley, G.; Preseren, D.; Pendergast, S. D.; Zegarra, H.; Shina, D.; Began, N.; Pillai, K.; DuBois, K. A.

In: Archives of Ophthalmology, Vol. 119, No. 7, 2001, p. 951-965.

Research output: Contribution to journalArticle

Hawkins, BS, Vine, AK, Willis, JM, Frueh, B, Itani, K, Kurtz, RM, Sneed, SR, Hayman, JA, McGinn, CJ, Diaz, R, Lichter, AS, Robertson, JM, Schoeppel, S, Haken, RT, Thompson, AV, Meyer, KA, Stanley, SA, Martonyi, C, Elner, V, Kincaid, M, Wolter, RJ, Sternberg, P, Meredith, TA, Brown, JM, Aaberg T.M., J, Aaberg T.M., S, Wojno, TH, Keller, JW, Landry, J, Crocker, IR, McLaren, J, Aguilera, CA, Butker, E, Klee, KA, Strongosky, D, Gibbs, DK, Curtis, LT, Fremstad, A, Waldron, RG, Ward, A, Gilman, J, Myles, RA, Snipes, C, Swords, R, Grossniklaus, HE, Calhoun F.P., J, Campbell, W, Frank, JH, Jarrett, WH, Halpern, RL, Hagler, WS, Jones, N, Schwaibold, FP, Jones, M, Mondalek, P, Wynn, KJ, Degenhardt, GA, Muncey, AR, Aaron, J, Bolerjack, DS, Cooper, CE, Hulsey, EK, Kailey, L, Lee, DH, McCart, SN, McCoy, GA, Clark, ME, Baxter, B, Robinson, BP, Thompson, KD, Wilson, KK, Schachat, AP, Doll W.T., J, Greenberg, EF, Hartnett, M, Alexander, M, Kaiser, S, Sackett, CS, Iliff, NT, Lee, DJ, Jackson, JF, Ianitto, J, Lam, WC, Pollack, LT, DiBernardo, C, Cain, D, Emmert, D, George, T, Zakov, ZN, Rice, TA, Dempsey, K, Daley, G, Preseren, D, Pendergast, SD, Zegarra, H, Shina, D, Began, N, Pillai, K & DuBois, KA 2001, 'The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: Characteristics of patients enrolled and not enrolled: COMS report no. 17', Archives of Ophthalmology, vol. 119, no. 7, pp. 951-965.
Hawkins, Barbara S ; Vine, A. K. ; Willis, J. M. ; Frueh, B. ; Itani, K. ; Kurtz, R. M. ; Sneed, S. R. ; Hayman, J. A. ; McGinn, C. J. ; Diaz, R. ; Lichter, A. S. ; Robertson, J. M. ; Schoeppel, S. ; Haken, R. T. ; Thompson, A. V. ; Meyer, K. A. ; Stanley, S. A. ; Martonyi, C. ; Elner, V. ; Kincaid, M. ; Wolter, R. J. ; Sternberg, P. ; Meredith, T. A. ; Brown, J. M. ; Aaberg T.M., Jr ; Aaberg T.M., Sr ; Wojno, T. H. ; Keller, J. W. ; Landry, J. ; Crocker, I. R. ; McLaren, J. ; Aguilera, C. A. ; Butker, E. ; Klee, K. A. ; Strongosky, D. ; Gibbs, D. K. ; Curtis, L. T. ; Fremstad, A. ; Waldron, R. G. ; Ward, A. ; Gilman, J. ; Myles, R. A. ; Snipes, C. ; Swords, R. ; Grossniklaus, H. E. ; Calhoun F.P., Jr ; Campbell, W. ; Frank, J. H. ; Jarrett, W. H. ; Halpern, R. L. ; Hagler, W. S. ; Jones, N. ; Schwaibold, F. P. ; Jones, M. ; Mondalek, P. ; Wynn, K. J. ; Degenhardt, G. A. ; Muncey, A. R. ; Aaron, J. ; Bolerjack, D. S. ; Cooper, C. E. ; Hulsey, E. K. ; Kailey, L. ; Lee, D. H. ; McCart, S. N. ; McCoy, G. A. ; Clark, M. E. ; Baxter, B. ; Robinson, B. P. ; Thompson, K. D. ; Wilson, K. K. ; Schachat, A. P. ; Doll W.T., Jr ; Greenberg, E. F. ; Hartnett, M. ; Alexander, M. ; Kaiser, S. ; Sackett, C. S. ; Iliff, N. T. ; Lee, D. J. ; Jackson, J. F. ; Ianitto, J. ; Lam, W. C. ; Pollack, L. T. ; DiBernardo, C. ; Cain, D. ; Emmert, D. ; George, T. ; Zakov, Z. N. ; Rice, T. A. ; Dempsey, K. ; Daley, G. ; Preseren, D. ; Pendergast, S. D. ; Zegarra, H. ; Shina, D. ; Began, N. ; Pillai, K. ; DuBois, K. A. / The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II : Characteristics of patients enrolled and not enrolled: COMS report no. 17. In: Archives of Ophthalmology. 2001 ; Vol. 119, No. 7. pp. 951-965.
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title = "The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: Characteristics of patients enrolled and not enrolled: COMS report no. 17",
abstract = "Objectives: To describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients. Methods: For all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A- and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms. Results: Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57{\%}) were eligible for enrollment, and 1317 (46{\%} of eligible patients, 26{\%} of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48{\%}) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40{\%} of eligible patients not enrolled and 29{\%} of ineligible patients. Conclusions: This trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.",
author = "Hawkins, {Barbara S} and Vine, {A. K.} and Willis, {J. M.} and B. Frueh and K. Itani and Kurtz, {R. M.} and Sneed, {S. R.} and Hayman, {J. A.} and McGinn, {C. J.} and R. Diaz and Lichter, {A. S.} and Robertson, {J. M.} and S. Schoeppel and Haken, {R. T.} and Thompson, {A. V.} and Meyer, {K. A.} and Stanley, {S. A.} and C. Martonyi and V. Elner and M. Kincaid and Wolter, {R. J.} and P. Sternberg and Meredith, {T. A.} and Brown, {J. M.} and {Aaberg T.M.}, Jr and {Aaberg T.M.}, Sr and Wojno, {T. H.} and Keller, {J. W.} and J. Landry and Crocker, {I. R.} and J. McLaren and Aguilera, {C. A.} and E. Butker and Klee, {K. A.} and D. Strongosky and Gibbs, {D. K.} and Curtis, {L. T.} and A. Fremstad and Waldron, {R. G.} and A. Ward and J. Gilman and Myles, {R. A.} and C. Snipes and R. Swords and Grossniklaus, {H. E.} and {Calhoun F.P.}, Jr and W. Campbell and Frank, {J. H.} and Jarrett, {W. H.} and Halpern, {R. L.} and Hagler, {W. S.} and N. Jones and Schwaibold, {F. P.} and M. Jones and P. Mondalek and Wynn, {K. J.} and Degenhardt, {G. A.} and Muncey, {A. R.} and J. Aaron and Bolerjack, {D. S.} and Cooper, {C. E.} and Hulsey, {E. K.} and L. Kailey and Lee, {D. H.} and McCart, {S. N.} and McCoy, {G. A.} and Clark, {M. E.} and B. Baxter and Robinson, {B. P.} and Thompson, {K. D.} and Wilson, {K. K.} and Schachat, {A. P.} and {Doll W.T.}, Jr and Greenberg, {E. F.} and M. Hartnett and M. Alexander and S. Kaiser and Sackett, {C. S.} and Iliff, {N. T.} and Lee, {D. J.} and Jackson, {J. F.} and J. Ianitto and Lam, {W. C.} and Pollack, {L. T.} and C. DiBernardo and D. Cain and D. Emmert and T. George and Zakov, {Z. N.} and Rice, {T. A.} and K. Dempsey and G. Daley and D. Preseren and Pendergast, {S. D.} and H. Zegarra and D. Shina and N. Began and K. Pillai and DuBois, {K. A.}",
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language = "English (US)",
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pages = "951--965",
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TY - JOUR

T1 - The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II

T2 - Characteristics of patients enrolled and not enrolled: COMS report no. 17

AU - Hawkins, Barbara S

AU - Vine, A. K.

AU - Willis, J. M.

AU - Frueh, B.

AU - Itani, K.

AU - Kurtz, R. M.

AU - Sneed, S. R.

AU - Hayman, J. A.

AU - McGinn, C. J.

AU - Diaz, R.

AU - Lichter, A. S.

AU - Robertson, J. M.

AU - Schoeppel, S.

AU - Haken, R. T.

AU - Thompson, A. V.

AU - Meyer, K. A.

AU - Stanley, S. A.

AU - Martonyi, C.

AU - Elner, V.

AU - Kincaid, M.

AU - Wolter, R. J.

AU - Sternberg, P.

AU - Meredith, T. A.

AU - Brown, J. M.

AU - Aaberg T.M., Jr

AU - Aaberg T.M., Sr

AU - Wojno, T. H.

AU - Keller, J. W.

AU - Landry, J.

AU - Crocker, I. R.

AU - McLaren, J.

AU - Aguilera, C. A.

AU - Butker, E.

AU - Klee, K. A.

AU - Strongosky, D.

AU - Gibbs, D. K.

AU - Curtis, L. T.

AU - Fremstad, A.

AU - Waldron, R. G.

AU - Ward, A.

AU - Gilman, J.

AU - Myles, R. A.

AU - Snipes, C.

AU - Swords, R.

AU - Grossniklaus, H. E.

AU - Calhoun F.P., Jr

AU - Campbell, W.

AU - Frank, J. H.

AU - Jarrett, W. H.

AU - Halpern, R. L.

AU - Hagler, W. S.

AU - Jones, N.

AU - Schwaibold, F. P.

AU - Jones, M.

AU - Mondalek, P.

AU - Wynn, K. J.

AU - Degenhardt, G. A.

AU - Muncey, A. R.

AU - Aaron, J.

AU - Bolerjack, D. S.

AU - Cooper, C. E.

AU - Hulsey, E. K.

AU - Kailey, L.

AU - Lee, D. H.

AU - McCart, S. N.

AU - McCoy, G. A.

AU - Clark, M. E.

AU - Baxter, B.

AU - Robinson, B. P.

AU - Thompson, K. D.

AU - Wilson, K. K.

AU - Schachat, A. P.

AU - Doll W.T., Jr

AU - Greenberg, E. F.

AU - Hartnett, M.

AU - Alexander, M.

AU - Kaiser, S.

AU - Sackett, C. S.

AU - Iliff, N. T.

AU - Lee, D. J.

AU - Jackson, J. F.

AU - Ianitto, J.

AU - Lam, W. C.

AU - Pollack, L. T.

AU - DiBernardo, C.

AU - Cain, D.

AU - Emmert, D.

AU - George, T.

AU - Zakov, Z. N.

AU - Rice, T. A.

AU - Dempsey, K.

AU - Daley, G.

AU - Preseren, D.

AU - Pendergast, S. D.

AU - Zegarra, H.

AU - Shina, D.

AU - Began, N.

AU - Pillai, K.

AU - DuBois, K. A.

PY - 2001

Y1 - 2001

N2 - Objectives: To describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients. Methods: For all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A- and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms. Results: Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of eligible patients, 26% of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48%) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40% of eligible patients not enrolled and 29% of ineligible patients. Conclusions: This trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.

AB - Objectives: To describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients. Methods: For all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A- and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms. Results: Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of eligible patients, 26% of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48%) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40% of eligible patients not enrolled and 29% of ineligible patients. Conclusions: This trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.

UR - http://www.scopus.com/inward/record.url?scp=0034937991&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034937991&partnerID=8YFLogxK

M3 - Article

C2 - 11448318

AN - SCOPUS:0034937991

VL - 119

SP - 951

EP - 965

JO - JAMA Ophthalmology

JF - JAMA Ophthalmology

SN - 2168-6165

IS - 7

ER -