TY - JOUR
T1 - 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
T2 - A real-world data study
AU - Fink, Morten
AU - Vittrup, Anders Schwartz
AU - Bastholt, Lars
AU - Svane, Inge Marie
AU - Donia, Marco
AU - Luczak, Adam A.
AU - Ruhlmann, Christina H.
AU - Guldbrandt, Louise Mahncke
AU - Koehler, Ulrich Heide
AU - Winther, Mette Lerche
AU - Ellebaek, Eva
AU - Haslund, Charlotte Aaquist
AU - Schmidt, Henrik
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/11/5
Y1 - 2021/11/5
N2 - 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.
AB - 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.
KW - DAMMED
KW - Immune-related adverse events
KW - Immunotherapy
KW - Ipilimumab
KW - Melanoma
KW - Nivolumab
UR - http://www.scopus.com/inward/record.url?scp=85118493580&partnerID=8YFLogxK
U2 - 10.3390/cancers13215550
DO - 10.3390/cancers13215550
M3 - Journal article
AN - SCOPUS:85118493580
SN - 2072-6694
VL - 13
JO - Cancers
JF - Cancers
IS - 21
M1 - 5550
ER -