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Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma
Uveal melanoma (UM) is the most common intraocular malignancy in adults and shows a high rate of metastatic spread. As randomized clinical trials with immune checkpoint inhibitors (ICI) have not been performed in patients with metastatic UM, we analyzed the real-world outcomes in a nationwide popula...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6826482/ https://www.ncbi.nlm.nih.gov/pubmed/31623302 http://dx.doi.org/10.3390/cancers11101489 |
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author | Bol, Kalijn Fredrike Ellebaek, Eva Hoejberg, Lise Bagger, Mette Marie Larsen, Mathilde Skaarup Klausen, Tobias Wirenfeldt Køhler, Ulrich Heide Schmidt, Henrik Bastholt, Lars Kiilgaard, Jens Folke Donia, Marco Svane, Inge Marie |
author_facet | Bol, Kalijn Fredrike Ellebaek, Eva Hoejberg, Lise Bagger, Mette Marie Larsen, Mathilde Skaarup Klausen, Tobias Wirenfeldt Køhler, Ulrich Heide Schmidt, Henrik Bastholt, Lars Kiilgaard, Jens Folke Donia, Marco Svane, Inge Marie |
author_sort | Bol, Kalijn Fredrike |
collection | PubMed |
description | Uveal melanoma (UM) is the most common intraocular malignancy in adults and shows a high rate of metastatic spread. As randomized clinical trials with immune checkpoint inhibitors (ICI) have not been performed in patients with metastatic UM, we analyzed the real-world outcomes in a nationwide population-based study. Clinical data of patients with UM were extracted from the Danish Metastatic Melanoma database, a nationwide database containing unselected records of patients diagnosed with metastatic melanoma in Denmark. Survival before (pre-ICI, n = 32) and after (post-ICI, n = 94) the approval of first-line treatment with ICI was analyzed. A partial response to first-line treatment was observed in 7% of patients treated with anti-programmed cell death protein (PD)-1 monotherapy and in 21% with combined anti-cytotoxic T lymphocyte antigen (CTLA)-4 plus anti-PD-1 therapy. Median progression-free survival was 2.5 months for patients treated in the pre-ICI era compared to 3.5 months in the post-ICI era (hazard ratio (HR) 0.43; 95% confidence interval (CI) 0.28–0.67; p < 0.001). The estimated one-year overall survival rate increased from 25.0% to 41.9% and the median overall survival improved from 7.8 months to 10.0 months, respectively (HR 0.52; 95% CI 0.34–0.79; p = 0.003). Thus, the introduction of ICI as first-line treatment appears to have significantly improved the real-world survival of patients with metastatic UM, despite relatively low response rates compared to cutaneous melanoma. With the lack of therapies proven effective in randomized trials, these data support the current treatment with ICI in patients with metastatic UM. |
format | Online Article Text |
id | pubmed-6826482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-68264822019-11-18 Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma Bol, Kalijn Fredrike Ellebaek, Eva Hoejberg, Lise Bagger, Mette Marie Larsen, Mathilde Skaarup Klausen, Tobias Wirenfeldt Køhler, Ulrich Heide Schmidt, Henrik Bastholt, Lars Kiilgaard, Jens Folke Donia, Marco Svane, Inge Marie Cancers (Basel) Article Uveal melanoma (UM) is the most common intraocular malignancy in adults and shows a high rate of metastatic spread. As randomized clinical trials with immune checkpoint inhibitors (ICI) have not been performed in patients with metastatic UM, we analyzed the real-world outcomes in a nationwide population-based study. Clinical data of patients with UM were extracted from the Danish Metastatic Melanoma database, a nationwide database containing unselected records of patients diagnosed with metastatic melanoma in Denmark. Survival before (pre-ICI, n = 32) and after (post-ICI, n = 94) the approval of first-line treatment with ICI was analyzed. A partial response to first-line treatment was observed in 7% of patients treated with anti-programmed cell death protein (PD)-1 monotherapy and in 21% with combined anti-cytotoxic T lymphocyte antigen (CTLA)-4 plus anti-PD-1 therapy. Median progression-free survival was 2.5 months for patients treated in the pre-ICI era compared to 3.5 months in the post-ICI era (hazard ratio (HR) 0.43; 95% confidence interval (CI) 0.28–0.67; p < 0.001). The estimated one-year overall survival rate increased from 25.0% to 41.9% and the median overall survival improved from 7.8 months to 10.0 months, respectively (HR 0.52; 95% CI 0.34–0.79; p = 0.003). Thus, the introduction of ICI as first-line treatment appears to have significantly improved the real-world survival of patients with metastatic UM, despite relatively low response rates compared to cutaneous melanoma. With the lack of therapies proven effective in randomized trials, these data support the current treatment with ICI in patients with metastatic UM. MDPI 2019-10-03 /pmc/articles/PMC6826482/ /pubmed/31623302 http://dx.doi.org/10.3390/cancers11101489 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Bol, Kalijn Fredrike Ellebaek, Eva Hoejberg, Lise Bagger, Mette Marie Larsen, Mathilde Skaarup Klausen, Tobias Wirenfeldt Køhler, Ulrich Heide Schmidt, Henrik Bastholt, Lars Kiilgaard, Jens Folke Donia, Marco Svane, Inge Marie Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title | Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title_full | Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title_fullStr | Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title_full_unstemmed | Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title_short | Real-World Impact of Immune Checkpoint Inhibitors in Metastatic Uveal Melanoma |
title_sort | real-world impact of immune checkpoint inhibitors in metastatic uveal melanoma |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6826482/ https://www.ncbi.nlm.nih.gov/pubmed/31623302 http://dx.doi.org/10.3390/cancers11101489 |
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