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Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience

Nivolumab and ipilimumab combination became the first-line standard in advanced melanoma. We assessed its efficacy in a real-life study in Poland. In a one-year follow-up, we evaluated the medical records of 50 melanoma patients treated with that modality in five oncology centers. We recorded therap...

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Autores principales: Pacholczak-Madej, Renata, Grela-Wojewoda, Aleksandra, Puskulluoglu, Mirosława, Lompart, Joanna, Las-Jankowska, Manuela, Krawczak, Katarzyna, Wrona, Ewa, Zaręba, Lech, Żubrowska, Justyna, Walocha, Jerzy, Bazan-Socha, Stanisława, Ziobro, Marek
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9598919/
https://www.ncbi.nlm.nih.gov/pubmed/36289790
http://dx.doi.org/10.3390/biomedicines10102528
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author Pacholczak-Madej, Renata
Grela-Wojewoda, Aleksandra
Puskulluoglu, Mirosława
Lompart, Joanna
Las-Jankowska, Manuela
Krawczak, Katarzyna
Wrona, Ewa
Zaręba, Lech
Żubrowska, Justyna
Walocha, Jerzy
Bazan-Socha, Stanisława
Ziobro, Marek
author_facet Pacholczak-Madej, Renata
Grela-Wojewoda, Aleksandra
Puskulluoglu, Mirosława
Lompart, Joanna
Las-Jankowska, Manuela
Krawczak, Katarzyna
Wrona, Ewa
Zaręba, Lech
Żubrowska, Justyna
Walocha, Jerzy
Bazan-Socha, Stanisława
Ziobro, Marek
author_sort Pacholczak-Madej, Renata
collection PubMed
description Nivolumab and ipilimumab combination became the first-line standard in advanced melanoma. We assessed its efficacy in a real-life study in Poland. In a one-year follow-up, we evaluated the medical records of 50 melanoma patients treated with that modality in five oncology centers. We recorded therapy outcomes and adverse events (AEs) after 3 and 12 months of therapy. At the first checkpoint, the disease control rate (DCR) was recorded in 58% (n = 29) of patients, but the same number of patients (n = 29, 58%) stopped immunotherapy due to disease progression (PD, n = 14, 48.3%), toxicity (n = 11, 37.9%) or death (n = 4, 13.8%). Among patients with DCR after the induction phase, 8 (27.6%) terminated due to toxicity, and 21 (72.4%) continued. However, at the 12-month checkpoint, only 14 patients (27% of all) were still receiving immunotherapy. In 7 (33.3%) it was discontinued due to PD (n = 2), toxicity (n = 2, 28.6% each), or death (n = 3, 42.9%). AEs occurred in 66.7% (n = 34) of patients; severe (grade 3 or 4) in half of them. Interestingly, those with AEs had an 80% lower risk of death (hazard ratio [HR] 0.2, 95% confidence interval [CI] 0.07–0.57, p = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, p < 0.0001). In the entire group of patients, after a 12-month follow-up, the median overall survival was not reached (NR, range: 6.8 months-NR) and progression-free survival was 6.3 (range: 3-NR) months. Our results demonstrate that combined immunotherapy is less effective in real-life than in pivotal trials. However, early responders will likely continue the therapy after a one-year follow-up. AEs occurrence might be a predictor of clinical effectiveness.
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spelling pubmed-95989192022-10-27 Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience Pacholczak-Madej, Renata Grela-Wojewoda, Aleksandra Puskulluoglu, Mirosława Lompart, Joanna Las-Jankowska, Manuela Krawczak, Katarzyna Wrona, Ewa Zaręba, Lech Żubrowska, Justyna Walocha, Jerzy Bazan-Socha, Stanisława Ziobro, Marek Biomedicines Article Nivolumab and ipilimumab combination became the first-line standard in advanced melanoma. We assessed its efficacy in a real-life study in Poland. In a one-year follow-up, we evaluated the medical records of 50 melanoma patients treated with that modality in five oncology centers. We recorded therapy outcomes and adverse events (AEs) after 3 and 12 months of therapy. At the first checkpoint, the disease control rate (DCR) was recorded in 58% (n = 29) of patients, but the same number of patients (n = 29, 58%) stopped immunotherapy due to disease progression (PD, n = 14, 48.3%), toxicity (n = 11, 37.9%) or death (n = 4, 13.8%). Among patients with DCR after the induction phase, 8 (27.6%) terminated due to toxicity, and 21 (72.4%) continued. However, at the 12-month checkpoint, only 14 patients (27% of all) were still receiving immunotherapy. In 7 (33.3%) it was discontinued due to PD (n = 2), toxicity (n = 2, 28.6% each), or death (n = 3, 42.9%). AEs occurred in 66.7% (n = 34) of patients; severe (grade 3 or 4) in half of them. Interestingly, those with AEs had an 80% lower risk of death (hazard ratio [HR] 0.2, 95% confidence interval [CI] 0.07–0.57, p = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, p < 0.0001). In the entire group of patients, after a 12-month follow-up, the median overall survival was not reached (NR, range: 6.8 months-NR) and progression-free survival was 6.3 (range: 3-NR) months. Our results demonstrate that combined immunotherapy is less effective in real-life than in pivotal trials. However, early responders will likely continue the therapy after a one-year follow-up. AEs occurrence might be a predictor of clinical effectiveness. MDPI 2022-10-10 /pmc/articles/PMC9598919/ /pubmed/36289790 http://dx.doi.org/10.3390/biomedicines10102528 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Pacholczak-Madej, Renata
Grela-Wojewoda, Aleksandra
Puskulluoglu, Mirosława
Lompart, Joanna
Las-Jankowska, Manuela
Krawczak, Katarzyna
Wrona, Ewa
Zaręba, Lech
Żubrowska, Justyna
Walocha, Jerzy
Bazan-Socha, Stanisława
Ziobro, Marek
Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title_full Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title_fullStr Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title_full_unstemmed Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title_short Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
title_sort early effects of nivolumab and ipilimumab combined immunotherapy in the treatment of metastatic melanoma in poland: a multicenter experience
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9598919/
https://www.ncbi.nlm.nih.gov/pubmed/36289790
http://dx.doi.org/10.3390/biomedicines10102528
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