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Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)

Non-clear cell renal cell carcinoma (nccRCC) represents a heterogeneous histological group which is 20–25% of those with renal cell carcinoma (RCC). Patients with nccRCC have limited therapeutic options due to their exclusion from phase III randomized trials. The aim of the present study was to inve...

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Autores principales: Stellato, Marco, Buti, Sebastiano, Maruzzo, Marco, Bersanelli, Melissa, Pierantoni, Francesco, De Giorgi, Ugo, Di Napoli, Marilena, Iacovelli, Roberto, Vitale, Maria Giuseppa, Ermacora, Paola, Malgeri, Andrea, Maiorano, Brigida Anna, Prati, Veronica, Mennitto, Alessia, Cavo, Alessia, Santoni, Matteo, Carella, Claudia, Fratino, Lucia, Procopio, Giuseppe, Verzoni, Elena, Santini, Daniele
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9862874/
https://www.ncbi.nlm.nih.gov/pubmed/36674615
http://dx.doi.org/10.3390/ijms24021096
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author Stellato, Marco
Buti, Sebastiano
Maruzzo, Marco
Bersanelli, Melissa
Pierantoni, Francesco
De Giorgi, Ugo
Di Napoli, Marilena
Iacovelli, Roberto
Vitale, Maria Giuseppa
Ermacora, Paola
Malgeri, Andrea
Maiorano, Brigida Anna
Prati, Veronica
Mennitto, Alessia
Cavo, Alessia
Santoni, Matteo
Carella, Claudia
Fratino, Lucia
Procopio, Giuseppe
Verzoni, Elena
Santini, Daniele
author_facet Stellato, Marco
Buti, Sebastiano
Maruzzo, Marco
Bersanelli, Melissa
Pierantoni, Francesco
De Giorgi, Ugo
Di Napoli, Marilena
Iacovelli, Roberto
Vitale, Maria Giuseppa
Ermacora, Paola
Malgeri, Andrea
Maiorano, Brigida Anna
Prati, Veronica
Mennitto, Alessia
Cavo, Alessia
Santoni, Matteo
Carella, Claudia
Fratino, Lucia
Procopio, Giuseppe
Verzoni, Elena
Santini, Daniele
author_sort Stellato, Marco
collection PubMed
description Non-clear cell renal cell carcinoma (nccRCC) represents a heterogeneous histological group which is 20–25% of those with renal cell carcinoma (RCC). Patients with nccRCC have limited therapeutic options due to their exclusion from phase III randomized trials. The aim of the present study was to investigate the effectiveness and tolerability of pembrolizumabaxitinib combination in chromophobe and papillary metastatic RCC (mRCC) patients enrolled in the I-RARE (Italian Registry on rAre genitor-uRinary nEoplasms) observational ongoing study (Meet-URO 23). Baseline characteristics, objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) and toxicities were retrospectively and prospectively collected from nccRCC patients treated in 14 Italian referral centers adhering to the Meet-Uro group, from December 2020 to April 2022. Only patients with chromophobe and papillary histology were considered eligible for the present pre-specified analysis. There were 32 eligible patients who received pembrolizumab-axitinib as first-line treatment, of whom 13 (40%) had chromophobe histology and 19 (60%) were classified as papillary RCC. The DCR was 78.1% whereas ORR was 43.7% (11 patients achieved stable disease and 14 patients obtained partial response: 9/19 papillary, 5/13 chromophobe). Six patients (18.7%) were primary refractory. Median PFS was 10.8 months (95%CI 1.7–11.5). Eleven patients (34.3%) interrupted the full treatment due to immune-related adverse events (irAEs): G3 hepatitis (n = 5), G3 hypophisitis (n = 1), G3 diarrhea (n = 1), G3 pancreatitis (n = 1), G3 asthenia (n = 1). Twelve patients (37.5%) temporarily interrupted axitinib only due to persistent G2 hand-foot syndrome or G2 hypertension. Pembrolizumab-axitinib combination could be an active and feasible first-line treatment option for patients with papillary or chromophobe mRCC.
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spelling pubmed-98628742023-01-22 Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a) Stellato, Marco Buti, Sebastiano Maruzzo, Marco Bersanelli, Melissa Pierantoni, Francesco De Giorgi, Ugo Di Napoli, Marilena Iacovelli, Roberto Vitale, Maria Giuseppa Ermacora, Paola Malgeri, Andrea Maiorano, Brigida Anna Prati, Veronica Mennitto, Alessia Cavo, Alessia Santoni, Matteo Carella, Claudia Fratino, Lucia Procopio, Giuseppe Verzoni, Elena Santini, Daniele Int J Mol Sci Article Non-clear cell renal cell carcinoma (nccRCC) represents a heterogeneous histological group which is 20–25% of those with renal cell carcinoma (RCC). Patients with nccRCC have limited therapeutic options due to their exclusion from phase III randomized trials. The aim of the present study was to investigate the effectiveness and tolerability of pembrolizumabaxitinib combination in chromophobe and papillary metastatic RCC (mRCC) patients enrolled in the I-RARE (Italian Registry on rAre genitor-uRinary nEoplasms) observational ongoing study (Meet-URO 23). Baseline characteristics, objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) and toxicities were retrospectively and prospectively collected from nccRCC patients treated in 14 Italian referral centers adhering to the Meet-Uro group, from December 2020 to April 2022. Only patients with chromophobe and papillary histology were considered eligible for the present pre-specified analysis. There were 32 eligible patients who received pembrolizumab-axitinib as first-line treatment, of whom 13 (40%) had chromophobe histology and 19 (60%) were classified as papillary RCC. The DCR was 78.1% whereas ORR was 43.7% (11 patients achieved stable disease and 14 patients obtained partial response: 9/19 papillary, 5/13 chromophobe). Six patients (18.7%) were primary refractory. Median PFS was 10.8 months (95%CI 1.7–11.5). Eleven patients (34.3%) interrupted the full treatment due to immune-related adverse events (irAEs): G3 hepatitis (n = 5), G3 hypophisitis (n = 1), G3 diarrhea (n = 1), G3 pancreatitis (n = 1), G3 asthenia (n = 1). Twelve patients (37.5%) temporarily interrupted axitinib only due to persistent G2 hand-foot syndrome or G2 hypertension. Pembrolizumab-axitinib combination could be an active and feasible first-line treatment option for patients with papillary or chromophobe mRCC. MDPI 2023-01-06 /pmc/articles/PMC9862874/ /pubmed/36674615 http://dx.doi.org/10.3390/ijms24021096 Text en © 2023 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
Stellato, Marco
Buti, Sebastiano
Maruzzo, Marco
Bersanelli, Melissa
Pierantoni, Francesco
De Giorgi, Ugo
Di Napoli, Marilena
Iacovelli, Roberto
Vitale, Maria Giuseppa
Ermacora, Paola
Malgeri, Andrea
Maiorano, Brigida Anna
Prati, Veronica
Mennitto, Alessia
Cavo, Alessia
Santoni, Matteo
Carella, Claudia
Fratino, Lucia
Procopio, Giuseppe
Verzoni, Elena
Santini, Daniele
Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title_full Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title_fullStr Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title_full_unstemmed Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title_short Pembrolizumab Plus Axitinib for Metastatic Papillary and Chromophobe Renal Cell Carcinoma: NEMESIA (Non Clear MEtaStatic Renal Cell Carcinoma Pembrolizumab Axitinib) Study, a Subgroup Analysis of I-RARE Observational Study (Meet-URO 23a)
title_sort pembrolizumab plus axitinib for metastatic papillary and chromophobe renal cell carcinoma: nemesia (non clear metastatic renal cell carcinoma pembrolizumab axitinib) study, a subgroup analysis of i-rare observational study (meet-uro 23a)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9862874/
https://www.ncbi.nlm.nih.gov/pubmed/36674615
http://dx.doi.org/10.3390/ijms24021096
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