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Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study
PURPOSE: The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not b...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Cancer Association
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912146/ https://www.ncbi.nlm.nih.gov/pubmed/28546525 http://dx.doi.org/10.4143/crt.2016.584 |
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author | Jung, Ki Sun Lee, Su Jin Park, Se Hoon Lee, Jae-Lyun Lee, Se-Hoon Lim, Jae Yun Kang, Jung Hun Lee, Suee Rha, Sun Young Lee, Kyung Hee Kim, Ho Young Lim, Ho Yeong |
author_facet | Jung, Ki Sun Lee, Su Jin Park, Se Hoon Lee, Jae-Lyun Lee, Se-Hoon Lim, Jae Yun Kang, Jung Hun Lee, Suee Rha, Sun Young Lee, Kyung Hee Kim, Ho Young Lim, Ho Yeong |
author_sort | Jung, Ki Sun |
collection | PubMed |
description | PURPOSE: The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC. MATERIALS AND METHODS: Patientswith locally advanced or metastatic nccRCC, exceptfor collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cyclewas defined as 4weeks and tumorresponsewas evaluated every two cycles. The primary objective was overall response rate (ORR). RESULTS: A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27 to 76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% confidence interval, 10.9 to 22.1) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay. CONCLUSION: In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC. |
format | Online Article Text |
id | pubmed-5912146 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Korean Cancer Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-59121462018-05-01 Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study Jung, Ki Sun Lee, Su Jin Park, Se Hoon Lee, Jae-Lyun Lee, Se-Hoon Lim, Jae Yun Kang, Jung Hun Lee, Suee Rha, Sun Young Lee, Kyung Hee Kim, Ho Young Lim, Ho Yeong Cancer Res Treat Original Article PURPOSE: The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC. MATERIALS AND METHODS: Patientswith locally advanced or metastatic nccRCC, exceptfor collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cyclewas defined as 4weeks and tumorresponsewas evaluated every two cycles. The primary objective was overall response rate (ORR). RESULTS: A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27 to 76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% confidence interval, 10.9 to 22.1) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay. CONCLUSION: In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC. Korean Cancer Association 2018-04 2017-05-22 /pmc/articles/PMC5912146/ /pubmed/28546525 http://dx.doi.org/10.4143/crt.2016.584 Text en Copyright © 2018 by the Korean Cancer Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Jung, Ki Sun Lee, Su Jin Park, Se Hoon Lee, Jae-Lyun Lee, Se-Hoon Lim, Jae Yun Kang, Jung Hun Lee, Suee Rha, Sun Young Lee, Kyung Hee Kim, Ho Young Lim, Ho Yeong Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title | Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title_full | Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title_fullStr | Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title_full_unstemmed | Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title_short | Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study |
title_sort | pazopanib for the treatment of non-clear cell renal cell carcinoma: a single-arm, open-label, multicenter, phase ii study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912146/ https://www.ncbi.nlm.nih.gov/pubmed/28546525 http://dx.doi.org/10.4143/crt.2016.584 |
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