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Tytuł:
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Comparison of efficacy and toxicity of intravitreal melphalan formulations for retinoblastoma.
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Autorzy:
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Hsieh T; Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.; Ophthalmic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.
Liao A; Ophthalmic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.; Emory Eye Center, Emory University School of Medicine, Atlanta, GA, United States of America.
Francis JH; Ophthalmic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.; Department of Ophthalmology, Weill-Cornell Medical Center, New York, NY, United States of America.
Lavery JA; Department of Epidemiology & Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.
Mauguen A; Department of Epidemiology & Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.
Brodie SE; Department of Ophthalmology, NYU Langone Health, New York, NY, United States of America.
Abramson DH; Ophthalmic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States of America.; Department of Ophthalmology, Weill-Cornell Medical Center, New York, NY, United States of America.
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Źródło:
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PloS one [PLoS One] 2020 Jul 01; Vol. 15 (7), pp. e0235016. Date of Electronic Publication: 2020 Jul 01 (Print Publication: 2020).
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Typ publikacji:
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Comparative Study; Journal Article
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Język:
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English
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Imprint Name(s):
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Original Publication: San Francisco, CA : Public Library of Science
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MeSH Terms:
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Antineoplastic Agents, Alkylating/*therapeutic use
Melphalan/*therapeutic use
Retinal Neoplasms/*drug therapy
Retinoblastoma/*drug therapy
Adolescent ; Antineoplastic Agents, Alkylating/administration & dosage ; Antineoplastic Agents, Alkylating/adverse effects ; Child ; Child, Preschool ; Humans ; Infant ; Intravitreal Injections ; Melphalan/administration & dosage ; Melphalan/adverse effects ; Retina/drug effects ; Treatment Outcome
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References:
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Br J Ophthalmol. 2012 Aug;96(8):1078-83. (PMID: 22694968)
Retina. 2016 Jun;36(6):1184-90. (PMID: 26630319)
JAMA Ophthalmol. 2015 Dec;133(12):1459-63. (PMID: 26378741)
Ophthalmology. 2017 Apr;124(4):488-495. (PMID: 28089679)
Pharm Dev Technol. 2018 Dec;23(10):1024-1029. (PMID: 27973975)
PLoS One. 2016 Jul 28;11(7):e0160094. (PMID: 27467588)
Ophthalmology. 2014 Sep;121(9):1810-7. (PMID: 24819859)
Semin Dial. 2007 May-Jun;20(3):217-9. (PMID: 17555487)
JAMA Ophthalmol. 2014 Nov;132(11):1372-3. (PMID: 25078631)
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Grant Information:
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P30 CA008748 United States CA NCI NIH HHS
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Substance Nomenclature:
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0 (Antineoplastic Agents, Alkylating)
Q41OR9510P (Melphalan)
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Entry Date(s):
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Date Created: 20200702 Date Completed: 20200907 Latest Revision: 20200907
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Update Code:
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20240105
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PubMed Central ID:
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PMC7329086
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DOI:
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10.1371/journal.pone.0235016
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PMID:
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32609726
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Objective: Intravitreal melphalan injections are commonly used in the treatment for intraocular retinoblastoma. This study compares retinal toxicity and ocular survival between two formulations, with and without propylene glycol (Alkeran vs. Evomela, respectively).
Methods: A retrospective cohort study of retinoblastoma patients who received intravitreal injections of Alkeran and Evomela at 30 μg from September 2012 to January 2019 at a single tertiary care center were enrolled. Retinal toxicity was measured using electroretinogram (ERG) and compared using a multivariate analysis of 338 injections in 101 eyes of 96 patients. Ocular survival of 163 eyes in 150 patients was compared across formulations using Cox proportional hazards model. Eyes were censored at the time a patient received a dose other than 30 μg.
Results: Overall, ERG decline (mean, 95% CI) for each injection was -5.58 μV (-7.17, -3.99). No significant differences in ERG decrement were found between Alkeran (with alcohol) -5.52uV (-6.99, -4.05). and Evomela (without alcohol) -5.65uV (-8.31 to -2.98) formulations (p = 0.93). Ocular survival at 24 months was 93.6% (95% CI 86.2, 97.1) with alcohol and 91.7% (95% CI 53.9, 98.8) without alcohol. The hazard ratio (HR) for without vs with alcohol was 0.50 (95% CI 0.06 to 4.07); no significant difference in ocular survival was found between formulations (p = 0.52).
Conclusions and Relevance: No differences were found in retinal toxicity and ocular survival between 30 μg intravitreal injections of Alkeran or Evomela for intraocular retinoblastoma. Given the increased stability of Evomela, intravitreal treatment could be expanded to centers without the ability to supply Alkeran due to its shorter safety window; however, Alkeran is less expensive. For those with existing infrastructure, Alkeran is a comparable, cost-effective alternative.
Competing Interests: The authors have declared that no competing interests exist.
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