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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...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9598919 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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