Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since...

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Autores principales:	Morten Fink, Anders Schwartz Vittrup, Lars Bastholt, Inge Marie Svane, Marco Donia, Adam A. Luczak, Christina H. Ruhlmann, Louise Mahncke Guldbrandt, Ulrich Heide Koehler, Mette Lerche Winther, Eva Ellebaek, Charlotte Aaquist Haslund, Henrik Schmidt
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	ipilimumab nivolumab melanoma immune-related adverse events DAMMED immunotherapy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/8adceece5386472fa24368dcbcd508ec
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spelling	oai:doaj.org-article:8adceece5386472fa24368dcbcd508ec2021-11-11T15:34:38ZComparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study10.3390/cancers132155502072-6694https://doaj.org/article/8adceece5386472fa24368dcbcd508ec2021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/21/5550https://doaj.org/toc/2072-6694Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.Morten FinkAnders Schwartz VittrupLars BastholtInge Marie SvaneMarco DoniaAdam A. LuczakChristina H. RuhlmannLouise Mahncke GuldbrandtUlrich Heide KoehlerMette Lerche WintherEva EllebaekCharlotte Aaquist HaslundHenrik SchmidtMDPI AGarticleipilimumabnivolumabmelanomaimmune-related adverse eventsDAMMEDimmunotherapyNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5550, p 5550 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	ipilimumab nivolumab melanoma immune-related adverse events DAMMED immunotherapy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	ipilimumab nivolumab melanoma immune-related adverse events DAMMED immunotherapy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Morten Fink Anders Schwartz Vittrup Lars Bastholt Inge Marie Svane Marco Donia Adam A. Luczak Christina H. Ruhlmann Louise Mahncke Guldbrandt Ulrich Heide Koehler Mette Lerche Winther Eva Ellebaek Charlotte Aaquist Haslund Henrik Schmidt Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
description	Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.
format	article
author	Morten Fink Anders Schwartz Vittrup Lars Bastholt Inge Marie Svane Marco Donia Adam A. Luczak Christina H. Ruhlmann Louise Mahncke Guldbrandt Ulrich Heide Koehler Mette Lerche Winther Eva Ellebaek Charlotte Aaquist Haslund Henrik Schmidt
author_facet	Morten Fink Anders Schwartz Vittrup Lars Bastholt Inge Marie Svane Marco Donia Adam A. Luczak Christina H. Ruhlmann Louise Mahncke Guldbrandt Ulrich Heide Koehler Mette Lerche Winther Eva Ellebaek Charlotte Aaquist Haslund Henrik Schmidt
author_sort	Morten Fink
title	Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
title_short	Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
title_full	Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
title_fullStr	Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
title_full_unstemmed	Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study
title_sort	comparison of efficacy in patients with metastatic melanoma treated with ipilimumab and nivolumab who did or did not discontinue treatment due to immune-related adverse events: a real-world data study
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/8adceece5386472fa24368dcbcd508ec
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Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

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