Skip to main content
Top
Published in: BMC Urology 1/2016

Open Access 01-12-2016 | Research article

A Korean multi-center, real-world, retrospective study of first-line pazopanib in unselected patients with metastatic renal clear-cell carcinoma

Authors: Moon Jin Kim, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Su Jin Lee, Ho Yeong Lim

Published in: BMC Urology | Issue 1/2016

Login to get access

Abstract

Background

The efficacy and/or tolerability of pazopanib in patients with metastatic renal cell carcinoma (mRCC) have been found to differ in Western and Asian populations. This retrospective multicenter study analyzed the results of first-line pazopanib treatment in 93 consecutive patients with mRCC who were treated at the medical oncology departments of three tertiary cancer centers in Seoul, Korea.

Methods

The decision to administer pazopanib as first-line therapy was at the discretion of the treating physician in all patients with mRCC. Patients enrolled in clinical trials were excluded to ensure that the results would reflect real-world outcomes representative of daily clinical settings. All patients received 800 mg/day pazopanib. Outcomes included response rate, progression-free survival (PFS), overall survival (OS), and safety.

Results

The 93 patients included72 (77 %) male and 21 (23 %) female individuals, of median age 65 years (range, 19–84 years). The median number of metastatic sites per patient was two (range, 1–5), with the lungs being the most frequently involved site. Most patients had favorable (n = 46) or intermediate (n = 36) risk as determined by Memorial Sloan Kettering Cancer Center criteria. Pazopanib was generally welltolerated: the major hematologic adverse effect was grade 1/2 anemia (14 %); and the most frequently observed non-hematologic toxicity was grade 1/2 mucositis (22 %), followed by hair discoloration and hypertension. Of the 93 patients, three (3 %) showed complete response, 52 (56 %) showed partial response, and 21 (23 %) showed stable disease, making the objective response rate 59 % and the disease control rate 82 %. At a median follow-up of 21 months, the estimated median PFS and OS were 12.2 months (95 % confidence interval, 7.1–17.4 months) and 21.9 months (95 % confidence interval, 12.9–30.9 months), respectively.

Conclusions

In this retrospective study, first-line therapy with pazopanib demonstrated clinically relevant efficacy and tolerability in unselected real-world Korean patients with mRCC. OS and PFS of these Korean patients were similar to those reported in phase III trials.
Literature
1.
2.
go back to reference Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17:2530–40.CrossRefPubMed Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17:2530–40.CrossRefPubMed
4.
go back to reference Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356:115–24.CrossRefPubMed Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356:115–24.CrossRefPubMed
5.
go back to reference Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125–34.CrossRefPubMed Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125–34.CrossRefPubMed
6.
go back to reference Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28:1061–8.CrossRefPubMed Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28:1061–8.CrossRefPubMed
7.
go back to reference Motzer RJ, Jonasch E, Agarwal N, Beard C, Bhayani S, Bolger GB, et al. National Compresensive Cancer Networks. Kidney cancer, version 2.2014. J Natl Compr Canc Netw. 2014;12:175–82.CrossRefPubMed Motzer RJ, Jonasch E, Agarwal N, Beard C, Bhayani S, Bolger GB, et al. National Compresensive Cancer Networks. Kidney cancer, version 2.2014. J Natl Compr Canc Netw. 2014;12:175–82.CrossRefPubMed
8.
go back to reference Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013;369:722–31.CrossRefPubMed Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013;369:722–31.CrossRefPubMed
9.
go back to reference Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014;32:1412–8.CrossRefPubMed Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014;32:1412–8.CrossRefPubMed
10.
go back to reference Guo J, Jin J, Huang Y, Wang JW, Lim HY, Uemura H, et al. Comparison of PFS and safety for Asian compared to North American and European populations in the phase III trial of pazopanib versus sunitinib in patients with treatment-naive RCC (COMPARZ). J Clin Oncol. 2013;31(Suppl 6): Abstr 366. Guo J, Jin J, Huang Y, Wang JW, Lim HY, Uemura H, et al. Comparison of PFS and safety for Asian compared to North American and European populations in the phase III trial of pazopanib versus sunitinib in patients with treatment-naive RCC (COMPARZ). J Clin Oncol. 2013;31(Suppl 6): Abstr 366.
11.
go back to reference Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.CrossRefPubMed Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.CrossRefPubMed
12.
go back to reference Heng DY, Xie W, Regan MM, Warren MA, Golshayan AR, Sahi C, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009;27:5794–9.CrossRefPubMed Heng DY, Xie W, Regan MM, Warren MA, Golshayan AR, Sahi C, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009;27:5794–9.CrossRefPubMed
13.
go back to reference Yoo C, Kim JE, Lee JL, Ahn JH, Lee DH, Lee JS, et al. The efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction. Jpn J Clin Oncol. 2010;40:980–5.CrossRefPubMed Yoo C, Kim JE, Lee JL, Ahn JH, Lee DH, Lee JS, et al. The efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction. Jpn J Clin Oncol. 2010;40:980–5.CrossRefPubMed
14.
go back to reference Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010;66:357–71.CrossRefPubMed Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010;66:357–71.CrossRefPubMed
15.
go back to reference Kim HS, Hong MH, Kim K, Shin SJ, Ahn JB, Jeung HC, et al. Sunitinib for Asian patients with advanced renal cell carcinoma: a comparable efficacy with different toxicity profiles. Oncology. 2011;80:395–405.CrossRefPubMed Kim HS, Hong MH, Kim K, Shin SJ, Ahn JB, Jeung HC, et al. Sunitinib for Asian patients with advanced renal cell carcinoma: a comparable efficacy with different toxicity profiles. Oncology. 2011;80:395–405.CrossRefPubMed
16.
go back to reference Lee SH, Bang YJ, Mainwaring P, Nq C, Chang JW, Kwong P. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014;10:237–45.CrossRefPubMed Lee SH, Bang YJ, Mainwaring P, Nq C, Chang JW, Kwong P. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014;10:237–45.CrossRefPubMed
Metadata
Title
A Korean multi-center, real-world, retrospective study of first-line pazopanib in unselected patients with metastatic renal clear-cell carcinoma
Authors
Moon Jin Kim
Se Hoon Park
Jae-Lyun Lee
Se-Hoon Lee
Su Jin Lee
Ho Yeong Lim
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2016
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/s12894-016-0163-5

Other articles of this Issue 1/2016

BMC Urology 1/2016 Go to the issue