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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MDPI AG
2021-11-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/13/21/5550 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-10T06:04:44Z |
| format | Article |
| id | doaj.art-8adceece5386472fa24368dcbcd508ec |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T06:04:44Z |
| publishDate | 2021-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-8adceece5386472fa24368dcbcd508ec2023-11-22T20:36:54ZengMDPI AGCancers2072-66942021-11-011321555010.3390/cancers13215550Comparison 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 StudyMorten Fink0Anders Schwartz Vittrup1Lars Bastholt2Inge Marie Svane3Marco Donia4Adam A. Luczak5Christina H. Ruhlmann6Louise Mahncke Guldbrandt7Ulrich Heide Koehler8Mette Lerche Winther9Eva Ellebaek10Charlotte Aaquist Haslund11Henrik Schmidt12Department of Oncology, Aarhus University Hospital, 8200 Aarhus, DenmarkDepartment of Oncology, Aarhus University Hospital, 8200 Aarhus, DenmarkDepartment of Oncology, Odense University Hospital, 5000 Odense, DenmarkNational Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, DenmarkNational Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Oncology, Aalborg University Hospital, 9100 Aalborg, DenmarkDepartment of Clinical Research, University of Southern Denmark, 5230 Odense, DenmarkDepartment of Oncology, Aarhus University Hospital, 8200 Aarhus, DenmarkDepartment of Oncology, Aarhus University Hospital, 8200 Aarhus, DenmarkDepartment of Oncology, Odense University Hospital, 5000 Odense, DenmarkNational Center for Cancer Immuno Therapy, CCIT-DK, Department of Oncology, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Oncology, Aalborg University Hospital, 9100 Aalborg, DenmarkDepartment of Oncology, Aarhus University Hospital, 8200 Aarhus, DenmarkImmune-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.https://www.mdpi.com/2072-6694/13/21/5550ipilimumabnivolumabmelanomaimmune-related adverse eventsDAMMEDimmunotherapy |
| spellingShingle | 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 Cancers ipilimumab nivolumab melanoma immune-related adverse events DAMMED immunotherapy |
| 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_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_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_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 |
| topic | ipilimumab nivolumab melanoma immune-related adverse events DAMMED immunotherapy |
| url | https://www.mdpi.com/2072-6694/13/21/5550 |
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