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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Autor*in:	Renata Pacholczak-Madej [verfasserIn] Aleksandra Grela-Wojewoda [verfasserIn] Mirosława Puskulluoglu [verfasserIn] Joanna Lompart [verfasserIn] Manuela Las-Jankowska [verfasserIn] Katarzyna Krawczak [verfasserIn] Ewa Wrona [verfasserIn] Lech Zaręba [verfasserIn] Justyna Żubrowska [verfasserIn] Jerzy Walocha [verfasserIn] Stanisława Bazan-Socha [verfasserIn] Marek Ziobro [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events

Übergeordnetes Werk:	In: Biomedicines - MDPI AG, 2014, 10(2022), 10, p 2528
Übergeordnetes Werk:	volume:10 ; year:2022 ; number:10, p 2528

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/biomedicines10102528

Katalog-ID:	DOAJ086811924

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allfields	10.3390/biomedicines10102528 doi (DE-627)DOAJ086811924 (DE-599)DOAJb5cf9ecd12f24219ba5cbad3ce0cc533 DE-627 ger DE-627 rakwb eng QH301-705.5 Renata Pacholczak-Madej verfasserin aut Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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. melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General) Aleksandra Grela-Wojewoda verfasserin aut Mirosława Puskulluoglu verfasserin aut Joanna Lompart verfasserin aut Manuela Las-Jankowska verfasserin aut Katarzyna Krawczak verfasserin aut Ewa Wrona verfasserin aut Lech Zaręba verfasserin aut Justyna Żubrowska verfasserin aut Jerzy Walocha verfasserin aut Stanisława Bazan-Socha verfasserin aut Marek Ziobro verfasserin aut In Biomedicines MDPI AG, 2014 10(2022), 10, p 2528 (DE-627)750370483 (DE-600)2720867-9 22279059 nnns volume:10 year:2022 number:10, p 2528 https://doi.org/10.3390/biomedicines10102528 kostenfrei https://doaj.org/article/b5cf9ecd12f24219ba5cbad3ce0cc533 kostenfrei https://www.mdpi.com/2227-9059/10/10/2528 kostenfrei https://doaj.org/toc/2227-9059 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022 10, p 2528
spelling	10.3390/biomedicines10102528 doi (DE-627)DOAJ086811924 (DE-599)DOAJb5cf9ecd12f24219ba5cbad3ce0cc533 DE-627 ger DE-627 rakwb eng QH301-705.5 Renata Pacholczak-Madej verfasserin aut Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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. melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General) Aleksandra Grela-Wojewoda verfasserin aut Mirosława Puskulluoglu verfasserin aut Joanna Lompart verfasserin aut Manuela Las-Jankowska verfasserin aut Katarzyna Krawczak verfasserin aut Ewa Wrona verfasserin aut Lech Zaręba verfasserin aut Justyna Żubrowska verfasserin aut Jerzy Walocha verfasserin aut Stanisława Bazan-Socha verfasserin aut Marek Ziobro verfasserin aut In Biomedicines MDPI AG, 2014 10(2022), 10, p 2528 (DE-627)750370483 (DE-600)2720867-9 22279059 nnns volume:10 year:2022 number:10, p 2528 https://doi.org/10.3390/biomedicines10102528 kostenfrei https://doaj.org/article/b5cf9ecd12f24219ba5cbad3ce0cc533 kostenfrei https://www.mdpi.com/2227-9059/10/10/2528 kostenfrei https://doaj.org/toc/2227-9059 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022 10, p 2528
allfields_unstemmed	10.3390/biomedicines10102528 doi (DE-627)DOAJ086811924 (DE-599)DOAJb5cf9ecd12f24219ba5cbad3ce0cc533 DE-627 ger DE-627 rakwb eng QH301-705.5 Renata Pacholczak-Madej verfasserin aut Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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. melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General) Aleksandra Grela-Wojewoda verfasserin aut Mirosława Puskulluoglu verfasserin aut Joanna Lompart verfasserin aut Manuela Las-Jankowska verfasserin aut Katarzyna Krawczak verfasserin aut Ewa Wrona verfasserin aut Lech Zaręba verfasserin aut Justyna Żubrowska verfasserin aut Jerzy Walocha verfasserin aut Stanisława Bazan-Socha verfasserin aut Marek Ziobro verfasserin aut In Biomedicines MDPI AG, 2014 10(2022), 10, p 2528 (DE-627)750370483 (DE-600)2720867-9 22279059 nnns volume:10 year:2022 number:10, p 2528 https://doi.org/10.3390/biomedicines10102528 kostenfrei https://doaj.org/article/b5cf9ecd12f24219ba5cbad3ce0cc533 kostenfrei https://www.mdpi.com/2227-9059/10/10/2528 kostenfrei https://doaj.org/toc/2227-9059 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022 10, p 2528
allfieldsGer	10.3390/biomedicines10102528 doi (DE-627)DOAJ086811924 (DE-599)DOAJb5cf9ecd12f24219ba5cbad3ce0cc533 DE-627 ger DE-627 rakwb eng QH301-705.5 Renata Pacholczak-Madej verfasserin aut Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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. melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General) Aleksandra Grela-Wojewoda verfasserin aut Mirosława Puskulluoglu verfasserin aut Joanna Lompart verfasserin aut Manuela Las-Jankowska verfasserin aut Katarzyna Krawczak verfasserin aut Ewa Wrona verfasserin aut Lech Zaręba verfasserin aut Justyna Żubrowska verfasserin aut Jerzy Walocha verfasserin aut Stanisława Bazan-Socha verfasserin aut Marek Ziobro verfasserin aut In Biomedicines MDPI AG, 2014 10(2022), 10, p 2528 (DE-627)750370483 (DE-600)2720867-9 22279059 nnns volume:10 year:2022 number:10, p 2528 https://doi.org/10.3390/biomedicines10102528 kostenfrei https://doaj.org/article/b5cf9ecd12f24219ba5cbad3ce0cc533 kostenfrei https://www.mdpi.com/2227-9059/10/10/2528 kostenfrei https://doaj.org/toc/2227-9059 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022 10, p 2528
allfieldsSound	10.3390/biomedicines10102528 doi (DE-627)DOAJ086811924 (DE-599)DOAJb5cf9ecd12f24219ba5cbad3ce0cc533 DE-627 ger DE-627 rakwb eng QH301-705.5 Renata Pacholczak-Madej verfasserin aut Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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. melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General) Aleksandra Grela-Wojewoda verfasserin aut Mirosława Puskulluoglu verfasserin aut Joanna Lompart verfasserin aut Manuela Las-Jankowska verfasserin aut Katarzyna Krawczak verfasserin aut Ewa Wrona verfasserin aut Lech Zaręba verfasserin aut Justyna Żubrowska verfasserin aut Jerzy Walocha verfasserin aut Stanisława Bazan-Socha verfasserin aut Marek Ziobro verfasserin aut In Biomedicines MDPI AG, 2014 10(2022), 10, p 2528 (DE-627)750370483 (DE-600)2720867-9 22279059 nnns volume:10 year:2022 number:10, p 2528 https://doi.org/10.3390/biomedicines10102528 kostenfrei https://doaj.org/article/b5cf9ecd12f24219ba5cbad3ce0cc533 kostenfrei https://www.mdpi.com/2227-9059/10/10/2528 kostenfrei https://doaj.org/toc/2227-9059 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022 10, p 2528
language	English
source	In Biomedicines 10(2022), 10, p 2528 volume:10 year:2022 number:10, p 2528
sourceStr	In Biomedicines 10(2022), 10, p 2528 volume:10 year:2022 number:10, p 2528
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events Biology (General)
isfreeaccess_bool	true
container_title	Biomedicines
authorswithroles_txt_mv	Renata Pacholczak-Madej @@aut@@ Aleksandra Grela-Wojewoda @@aut@@ Mirosława Puskulluoglu @@aut@@ Joanna Lompart @@aut@@ Manuela Las-Jankowska @@aut@@ Katarzyna Krawczak @@aut@@ Ewa Wrona @@aut@@ Lech Zaręba @@aut@@ Justyna Żubrowska @@aut@@ Jerzy Walocha @@aut@@ Stanisława Bazan-Socha @@aut@@ Marek Ziobro @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	750370483
id	DOAJ086811924
language_de	englisch
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callnumber-first	Q - Science
author	Renata Pacholczak-Madej
spellingShingle	Renata Pacholczak-Madej misc QH301-705.5 misc melanoma misc immunotherapy misc real-life data misc nivolumab and ipilimumab misc adverse events misc Biology (General) Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
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topic_title	QH301-705.5 Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience melanoma immunotherapy real-life data nivolumab and ipilimumab adverse events
topic	misc QH301-705.5 misc melanoma misc immunotherapy misc real-life data misc nivolumab and ipilimumab misc adverse events misc Biology (General)
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title	Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
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title_full	Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
author_sort	Renata Pacholczak-Madej
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author_browse	Renata Pacholczak-Madej Aleksandra Grela-Wojewoda Mirosława Puskulluoglu Joanna Lompart Manuela Las-Jankowska Katarzyna Krawczak Ewa Wrona Lech Zaręba Justyna Żubrowska Jerzy Walocha Stanisława Bazan-Socha Marek Ziobro
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title_sort	early effects of nivolumab and ipilimumab combined immunotherapy in the treatment of metastatic melanoma in poland: a multicenter experience
callnumber	QH301-705.5
title_auth	Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
abstract	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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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.
abstractGer	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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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.
abstract_unstemmed	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, <i<p</i< = 0.001) and PD (HR 0.2, 95%CI 0.09–0.47, <i<p</i< < 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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title_short	Early Effects of Nivolumab and Ipilimumab Combined Immunotherapy in the Treatment of Metastatic Melanoma in Poland: A Multicenter Experience
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