Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma

Background The relationship between immune related adverse events (irAEs) and efficacy is not definitively proven, and data on the relationship between irAE and treatment efficacy are contradictory. Material and methods Five hundred ninety-three consecutive patients with unresectable or metastatic m...

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Main Authors: Bożena Cybulska-Stopa, Marcin Ziętek, Anna M. Czarnecka, Karolina Piejko, Robert Dziura, Łukasz Galus, Barbara Ziółkowska, Stanisław Kieszko, Natasza Kempa-Kamińska, Jacek Calik, Joanna Seredyńska, Kamila Gądek, Tomasz Zemełka, Paweł Teterycz, Tomasz Kubiatowski, Rafał Suwiński, Jacek Mackiewicz, Piotr Rutkowski
Format: Article
Language:English
Published: Taylor & Francis Group 2022-05-01
Series:Journal of Dermatological Treatment
Subjects:
Online Access:http://dx.doi.org/10.1080/09546634.2021.1937477
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author Bożena Cybulska-Stopa
Marcin Ziętek
Anna M. Czarnecka
Karolina Piejko
Robert Dziura
Łukasz Galus
Barbara Ziółkowska
Stanisław Kieszko
Natasza Kempa-Kamińska
Jacek Calik
Joanna Seredyńska
Kamila Gądek
Tomasz Zemełka
Paweł Teterycz
Tomasz Kubiatowski
Rafał Suwiński
Jacek Mackiewicz
Piotr Rutkowski
author_facet Bożena Cybulska-Stopa
Marcin Ziętek
Anna M. Czarnecka
Karolina Piejko
Robert Dziura
Łukasz Galus
Barbara Ziółkowska
Stanisław Kieszko
Natasza Kempa-Kamińska
Jacek Calik
Joanna Seredyńska
Kamila Gądek
Tomasz Zemełka
Paweł Teterycz
Tomasz Kubiatowski
Rafał Suwiński
Jacek Mackiewicz
Piotr Rutkowski
author_sort Bożena Cybulska-Stopa
collection DOAJ
description Background The relationship between immune related adverse events (irAEs) and efficacy is not definitively proven, and data on the relationship between irAE and treatment efficacy are contradictory. Material and methods Five hundred ninety-three consecutive patients with unresectable or metastatic melanoma treated in the first line with anti-PD-1 (nivolumab or pembrolizumab) between January 2016 and December 2019 were enrolled in the study. Results Statistically significant differences were demonstrated between the group of patients without and with irAE in median OS and PFS (p < .0001 both) and also in OS between the group of patients without irAE and patients with irAE within 3, 6, and 9 months from the start of anti-PD-1 therapy (p = .0121, p = .0014, p < .0001; respectively) and PFS (p = .0369, p = .0052, p = .0001; respectively). A statistically significant relationship was demonstrated between the occurrence of irAE and the location of the primary tumor (skin vs. mucosa vs. unknown; p = .0183), brain metastasis (present vs. absent; p = .0032), other locations (present vs. absent, p = .0032), LDH (normal vs. elevated; p = .0046) and stage according to TNM (p = .0093). Conclusion The occurrence of irAE was associated with longer OS, PFS, and more frequent response to treatment. IrAE occurred statistically significantly more often in patients with mucosa primary tumor, with normal LDH levels, without brain metastases, stages III, M1a, and M1b.
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spelling doaj.art-030c6b06bfb5401d9e96d4bb224825ca2023-09-15T14:28:50ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532022-05-013342168217410.1080/09546634.2021.19374771937477Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanomaBożena Cybulska-Stopa0Marcin Ziętek1Anna M. Czarnecka2Karolina Piejko3Robert Dziura4Łukasz Galus5Barbara Ziółkowska6Stanisław Kieszko7Natasza Kempa-Kamińska8Jacek Calik9Joanna Seredyńska10Kamila Gądek11Tomasz Zemełka12Paweł Teterycz13Tomasz Kubiatowski14Rafał Suwiński15Jacek Mackiewicz16Piotr Rutkowski17Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Oncology, Wrocław Medical UniversityDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyClinical Oncology Department, Holy Cross Cancer CenterDepartment of Medical and Experimental Oncology, University of Medical SciencesII Clinic of Radiotherapy and Chemotherapy, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Saint Jan of Dukla Oncology Centre of the Lublin RegionDepartment of Clinical Oncology, Wrocław Comprehensive Cancer CenterDepartment of Clinical Oncology, Wrocław Comprehensive Cancer CenterDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Clinical Oncology, Saint Jan of Dukla Oncology Centre of the Lublin RegionII Clinic of Radiotherapy and Chemotherapy, Maria Sklodowska-Curie National Research Institute of OncologyDepartment of Medical and Experimental Oncology, University of Medical SciencesDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of OncologyBackground The relationship between immune related adverse events (irAEs) and efficacy is not definitively proven, and data on the relationship between irAE and treatment efficacy are contradictory. Material and methods Five hundred ninety-three consecutive patients with unresectable or metastatic melanoma treated in the first line with anti-PD-1 (nivolumab or pembrolizumab) between January 2016 and December 2019 were enrolled in the study. Results Statistically significant differences were demonstrated between the group of patients without and with irAE in median OS and PFS (p < .0001 both) and also in OS between the group of patients without irAE and patients with irAE within 3, 6, and 9 months from the start of anti-PD-1 therapy (p = .0121, p = .0014, p < .0001; respectively) and PFS (p = .0369, p = .0052, p = .0001; respectively). A statistically significant relationship was demonstrated between the occurrence of irAE and the location of the primary tumor (skin vs. mucosa vs. unknown; p = .0183), brain metastasis (present vs. absent; p = .0032), other locations (present vs. absent, p = .0032), LDH (normal vs. elevated; p = .0046) and stage according to TNM (p = .0093). Conclusion The occurrence of irAE was associated with longer OS, PFS, and more frequent response to treatment. IrAE occurred statistically significantly more often in patients with mucosa primary tumor, with normal LDH levels, without brain metastases, stages III, M1a, and M1b.http://dx.doi.org/10.1080/09546634.2021.1937477melanomairaeimmunotherapyanti-pd-1 therapyimmune-related adverse events
spellingShingle Bożena Cybulska-Stopa
Marcin Ziętek
Anna M. Czarnecka
Karolina Piejko
Robert Dziura
Łukasz Galus
Barbara Ziółkowska
Stanisław Kieszko
Natasza Kempa-Kamińska
Jacek Calik
Joanna Seredyńska
Kamila Gądek
Tomasz Zemełka
Paweł Teterycz
Tomasz Kubiatowski
Rafał Suwiński
Jacek Mackiewicz
Piotr Rutkowski
Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
Journal of Dermatological Treatment
melanoma
irae
immunotherapy
anti-pd-1 therapy
immune-related adverse events
title Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
title_full Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
title_fullStr Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
title_full_unstemmed Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
title_short Development of immunity-related adverse events correlates with baseline clinical factors, survival and response to anti-PD-1 treatment in patients with inoperable or metastatic melanoma
title_sort development of immunity related adverse events correlates with baseline clinical factors survival and response to anti pd 1 treatment in patients with inoperable or metastatic melanoma
topic melanoma
irae
immunotherapy
anti-pd-1 therapy
immune-related adverse events
url http://dx.doi.org/10.1080/09546634.2021.1937477
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