Pazopanib for the treatment of non-clear cell renal cell carcinoma: A single-arm, open-label, multicenter, phase II study

Ki Sun Jung, Su Jin Lee, Se Hoon Park, Jae Lyun Lee, Se Hoon Lee, Jae Yun Lim, Jung Hun Kang, Suee Lee, Sun Young Rha, Kyung Hee Lee, Ho Young Kim, Ho Yeong Lim

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Abstract

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 Patients with locally advanced or metastatic nccRCC, except for collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cycle was defined as 4 weeks and tumor response was 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.

Original languageEnglish
Pages (from-to)488-494
Number of pages7
JournalCancer Research and Treatment
Volume50
Issue number2
DOIs
Publication statusPublished - 2018 Apr 1

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Renal Cell Carcinoma
Therapeutics
pazopanib
Safety
Korea
Vascular Endothelial Growth Factor A
Disease-Free Survival
Disease Progression
Histology
Confidence Intervals
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

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. In: Cancer Research and Treatment. 2018 ; Vol. 50, No. 2. pp. 488-494.
@article{8584b9b69a584194bbab81b7854b948f,
title = "Pazopanib for the treatment of non-clear cell renal cell carcinoma: A single-arm, open-label, multicenter, phase II study",
abstract = "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 Patients with locally advanced or metastatic nccRCC, except for collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cycle was defined as 4 weeks and tumor response was 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.",
author = "Jung, {Ki Sun} and Lee, {Su Jin} and Park, {Se Hoon} and Lee, {Jae Lyun} and Lee, {Se Hoon} and Lim, {Jae Yun} and Kang, {Jung Hun} and Suee Lee and Rha, {Sun Young} and Lee, {Kyung Hee} and Kim, {Ho Young} and Lim, {Ho Yeong}",
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doi = "10.4143/crt.2016.584",
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Jung, KS, Lee, SJ, Park, SH, Lee, JL, Lee, SH, Lim, JY, Kang, JH, Lee, S, Rha, SY, Lee, KH, Kim, HY & Lim, HY 2018, 'Pazopanib for the treatment of non-clear cell renal cell carcinoma: A single-arm, open-label, multicenter, phase II study', Cancer Research and Treatment, vol. 50, no. 2, pp. 488-494. https://doi.org/10.4143/crt.2016.584

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.

In: Cancer Research and Treatment, Vol. 50, No. 2, 01.04.2018, p. 488-494.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Pazopanib for the treatment of non-clear cell renal cell carcinoma

T2 - A single-arm, open-label, multicenter, phase II study

AU - Jung, Ki Sun

AU - Lee, Su Jin

AU - Park, Se Hoon

AU - Lee, Jae Lyun

AU - Lee, Se Hoon

AU - Lim, Jae Yun

AU - Kang, Jung Hun

AU - Lee, Suee

AU - Rha, Sun Young

AU - Lee, Kyung Hee

AU - Kim, Ho Young

AU - Lim, Ho Yeong

PY - 2018/4/1

Y1 - 2018/4/1

N2 - 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 Patients with locally advanced or metastatic nccRCC, except for collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cycle was defined as 4 weeks and tumor response was 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.

AB - 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 Patients with locally advanced or metastatic nccRCC, except for collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cycle was defined as 4 weeks and tumor response was 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.

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