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

Hawkins, Barbara S.; Vine, Andrew K.; Willis, J. R.; Frueh, Béatrice E.; Kurtz, Ronald M.; Elner, Susan G.; Johnson, Mark W.; Sneed, Scott R.; Hayman, James A.; Lichter, Allen S.; McGinn, Cornelius J.; Robertson, Jeanne M.; Schoeppel, Sonja L.; Haken, R. Ten; Thompson, A. V.; Meyer, Karsten; Mártonyi, Csaba L.; Stanley, Sarah A.; Elner, Victor M.; Kincaid, Marilyn C.; Wolter, R. J.; Sternberg, Paul; Brown, J. M.; Aaberg, Thomas M.; Capone, Antonio; Wojno, Ted H.; Lim, Jennifer I.; Keller, James W.; Landry, Jace P.; Crocker, Ian; McLaren, Jay W.; Aguilera, C. A.; Butker, Elizabeth; Klee, Katharina; Strongosky, D.; Gibbs, Danielle; Curtis, Luke; Fremstad, A.; Waldron, Rhonda; Ward, Aaron D.; Gilman, James; Myles, Richard A.; Swords, R.; Grossniklaus, Hans E.; Calhoun, F. Phinizy; Campbell, William; Jarrett, William H.; Hagler, William S.; Halpern, Robert L.; Jones, N.; Schwaibold, Frederick P.; Wynn, K. J.; Mondalek, Peter M.; Degenhardt, G. A.; Hulsey, E. K.; Lee, D. H.; Aaron, Joann; Bolerjak, D.; McCart, S.; McCoy, Georgia A.; Thompson, Kimberly D.; Baxter, B. Timothy; Robinson, Barry; Wilson, K.; Schachat, Andrew P.; Doll, W T Jr; Greenberg, E. F.; Alexander, Marguerite F.; Sackett, C. S.; Goldberg, Morton F.; Hammer, Liat; Iliff, Nicholas T.; Lee, D. J.; Chun, Melissa W.; Jackson, J. F.; Iannito, J.; Lam, Wai Ching; Pollack, L.; DiBernardo, Cathy; Cain, Dennis; Emmert, David; George, Timothy; Zakov, Z. N.; Rice, Thomas A.; Hartnett, M. Elizabeth; Lichterman, Susan; Dempsey, Karen; Preseren, D.; Niffenegger, John H.; Novák, Michael; Pendergast, Scott D.; Singermann, L. J.; Weidenthal, Daniel T.; Zegarra, Hernando; Antoszyk, James H.; Shina, DC; Pillai, Kumar; Knight, D.; Coreno, K.

doi:10.1016/s0002-9394(98)00039-7

Cited by 211 publications

(16 citation statements)

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“…Tumor size (largest basal diameter and thickness) is one of the most important clinical prognostic features of uveal melanoma. 4,[31][32][33] Due to the short followup period and small sample size, the prognostic factors could not be assessed with the current study database. The current study has no sufficient power for evaluating the type of regression pattern.…”

Section: Discussionmentioning

confidence: 99%

<p>Comparison of Iodide-125 and Ruthenium-106 Brachytherapy in the Treatment of Choroidal Melanomas</p>

Ghassemi¹,

Sheibani²,

Arjmand³

et al. 2020

OPTH

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Background: To compare iodine-125 ( 125 I) with ruthenium-106 ( 106 Ru) episcleral plaque radiation therapy in terms of the effectiveness and non-inferiority for choroidal melanoma treatment.Objective: To report the non-inferiority of new made iodine-125 ( 125 I) compared with ruthenium-106 ( 106 Ru) episcleral plaque radiation. Patients and Methods: A retrospective, non-randomized comparative case series. In this series the patients treated with 125 I and 106 Ru episcleral plaques for choroidal melanoma between September 2013 and August 2017 at Farabi Hospital are compared. Local control of choroidal melanomas after 125 I and 106 Ru plaques implantation and vision changes are the main outcome measures. Results: A total of 35 patients were identified ( 125 I = 15, 106 Ru = 20). No significant difference between two groups in visual acuity, diameter and thickness changes were observed after treatment. Multivariate linear regression (MLR) analysis showed that final diameter was only, independently and significantly, correlated with the pre-treatment diameter of the tumor (β = 0.59, 95% confidence interval [CI]: 0.29, 1.34, P = 0.003). The same MLR analysis for the final thickness and visual acuity, after adjusting for age and sex showed no significant difference between two groups. A single patient treated with 106 Ru had local tumor recurrence with no one in the 125 I group. No statistical difference in the rate of ocular complications was observed. Conclusion: The treatment with our 125 I plaques is as effective as 106 Ru plaques in controlling choroidal melanoma tumor and preserving the vision during the two and half year of follow-up. The complication rates are alike. It means that the effectiveness of 125 I is not only comparable to 106 Ru but also superior when the outcome of the interest is the thickness of the tumors.

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Section: Discussionmentioning

confidence: 99%

<p>Comparison of Iodide-125 and Ruthenium-106 Brachytherapy in the Treatment of Choroidal Melanomas</p>

Ghassemi¹,

Sheibani²,

Arjmand³

et al. 2020

OPTH

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“…Melanoma was primarily located in the choroid (58.7%) and ciliary body (32.2%). Collaborative Ocular Melanoma Study (COMS) disclosed that melanoma-related mortality at 10 years was 17% to 18% for medium melanoma, and the patients underwent I-125 plaque brachytherapy, and 40% to 45% for large melanoma, wherein the patients underwent pre-enucleation radiation (15)(16)(17)(18). In our previous study, we found the 5, 10-year UM metastasis rate and metastasis-related death (95% CI) in 1151 Asian UM patients were 15.5% (12.3%-19.5%), 24.5% (17.6% -33.6%); and 7.5% (5.3%-10.7%), 11.9% (8.1%-17.2%), respectively.…”

Section: Discussionmentioning

confidence: 99%

Surgical Resection of Intraocular Tumors (Partial Transscleral Sclerouvectomy Combined With Mircoinvasive Vitrectomy and Reconstruction of the Eyeball) in Asian Patients: Twenty-Five Years Results

Zhou

Wang

et al. 2022

Front. Oncol.

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ObjectiveTo describe the outcome of intraocular tumor resection by partial transscleral sclerouvectomy (PTSU) combined with micro-invasive vitrectomy and reconstruction of the eyeball (MVRE) in Asian patients.Design, Methods and ParticipantsThis retrospective, interventional cohort study included 366 patients who underwent PTSU combined with MVRE for intraocular tumors both in adult and pediatric age groups. The medical records of these patients were reviewed for clinical, operative, and histopathological features.Main Outcome MeasuresGlobe salvage, best corrected visual acuity (BCVA), surgical side effects, tumor control, and tumor-related metastasis and death.ResultsThe mean follow-up duration was 87 months (median, 66; range, 1-303 months). Among the 366 patients, the mean age was 8.5 years (median, 7; range, 1-19 years) in the 37 pediatric patients, and was 43 years (median, 42; range, 20-51) in 329 adult patients. The tumor mainly involved the ciliary body (n=136; 37.2%) and choroid (n=86; 23.5%). The common pathologic diagnosis of the 366 patients was as follows. In the pediatric age group, histopathologic examination revealed positive tumor margins in 37 patients mainly including ciliary body medulloepithelioma (8/37), ciliary body melanocytoma (13/37) and uveal melanoma (5/37). In the adult group, the pathological diagnosis mainly included melanoma (195/329), RPE adenoma (21/329), amelanotic melanoma (13/329), ciliary body adenoma of nonpigmented epithelium (19/329), schwannoma/neurilemmoma (11/329), melanocytoma (24/329), and leiomyoma (9/329). The globe salvage rate was 81.1% in the pediatric age groups (<20 years), and 93.6% in the adult group (≥20 years), respectively. Of the 338 salvaged eyes, final BCVA was 20/20 to 20/40 in 16 (4.7%), 20/40 to 20/80 in 58 (17.2%), 20/80 to 20/200 in 160 (47.3%), and ≤ 20/200 in 104 (30.8%). Early side effects included corneal edema in 28 (7.7%) patients, hyphema in 46 (12.6%), and vitreous hemorrhage in 76 (21%) patients. Postoperative side effects included proliferative vitreoretinopathy (PVR) in 67 (18.3%), late cataract in 42 (11.5%), and glaucoma in 18 (5%) patients. Local tumor recurrence was detected in 20 patients (5.5%) at a mean interval of 23.6 months, including melanoma (n=19) and medulloepithelioma (n=1). Enucleation was necessary in 28 (7.7%) cases owing to recurrence in 15 (53.6%), eye prophylaxis with high-grade malignancy in 5 (17.8%), and blind painful eye in 8 (28.6%) cases. Kaplan-Meier estimated for 5, 10-year metastasis rate and metastasis-related death rate (95%CI) in 213 UM patients were 3.2% (1.4%-7.0%), 6.9% (3.8%-12.3%); and 3.5% (1.6%-7.6%), 7.6% (4.2%-13.5%), respectively.ConclusionsAs a surgically challenging procedure, PTSU combined with MVRE offers several theoretical advantages over enucleation and radiotherapy. It can achieve control of most intraocular tumors, preserve useful vision, and maintain a cosmetically normal eye.

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“…I 125 brachytherapy was applied to medium-sized (2.5–10 mm in apical height and ≤ 16 mm in LBD) [ 13 ]tumors and large tumors (> 10 mm in apical height or > 16 mm in LBD) [ 13 , 14 ] that refused enucleation. The dose to be delivered to the tumor apex was 100 Gy.…”

Section: Methodsmentioning

confidence: 99%

Retrospective analysis of secondary enucleation for uveal melanoma after plaque radiotherapy

et al. 2022

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Background Uveal melanoma (UM) is the most common primary intraocular malignancy in adults. Plaque brachytherapy (PRT) is widely accepted as an effective globe-conserving treatment modality for UM. However, local treatment failure and complications lead to the enucleation of irradiated eyes. We conducted this study to explore the causes and long-term prognosis for UM patients who accepted secondary enucleation after plaque radiotherapy. Methods This was a retrospective cohort study. Data of patients who underwent secondary enucleation for UM after plaque radiotherapy, from July 2007 to July 2019, at Beijing Tongren Hospital were analyzed. Kaplan–Meier analysis was performed to assess the probability of indications, metastasis, and metastasis-related death. Cox regression analysis was used to analyze associations of the prognostic factors. Results Eight hundred and eighty patients were clinically diagnosed with uveal melanoma and initially treated by iodine-125 plaque radiotherapy, 132 of whom underwent secondary enucleation and pathological examination in the same hospital. Fifty-two (39.4%) eyes were enucleated simply because of uncontrollable neovascular glaucoma (NVG). Forty-four (33.3%) patients suffered from tumor recurrence. Tumor non-response occurred in 18 (13.6%) cases. Ten (7.6%) eyes received enucleation entirely due to other types of glaucoma. Failure to preserve the eyes for other reasons occurred in eight (6.1%) patients. At a median follow-up of 58.1 [IQR: 40.9–90.5] months, the systemic spread was detected in 45 (34.1%) patients, and 38 of them died. On multivariate analysis, tumor largest basal diameter (HR 1.15 [95% CI: 1.01, 1.31]), tumor non-response (HR 7.22 [95% CI: 2.63, 19.82]), and recurrence (HR 3.29 [95% CI: 1.54, 7.07]) were risk factors for metastasis. Increased age (HR 1.54 [95% CI: 1.07, 2.23]), tumor non-response (HR 7.91 [95% CI: 2.79, 22.48]), and recurrence (HR 3.08 [95% CI: 1.13, 7.23]) were risk factors for metastasis-related death. Conclusions NVG was the major reason for secondary enucleation for Chinese UM patients after PRT. Tumor non-response and recurrence were associated with a significantly higher risk of long-term metastasis and metastasis-related death.

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

Cited by 211 publications

References 51 publications

<p>Comparison of Iodide-125 and Ruthenium-106 Brachytherapy in the Treatment of Choroidal Melanomas</p>

<p>Comparison of Iodide-125 and Ruthenium-106 Brachytherapy in the Treatment of Choroidal Melanomas</p>

Surgical Resection of Intraocular Tumors (Partial Transscleral Sclerouvectomy Combined With Mircoinvasive Vitrectomy and Reconstruction of the Eyeball) in Asian Patients: Twenty-Five Years Results

Retrospective analysis of secondary enucleation for uveal melanoma after plaque radiotherapy

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