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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-9862874 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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