Sunitinib for Asian patients with advanced renal cell carcinoma

A comparable efficacy with different toxicity profiles

Hyo Song Kim, Min Hee Hong, Kiyeol Kim, Sang Joon Shin, Joong Bae Ahn, Hei Chul Jeung, Hyuncheol Chung, Youngil Koh, Se Hoon Lee, Yung Jue Bang, SunYoung Rha

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Objective: We aimed to describe the efficacy and safety of sunitinib in unselected Korean advanced renal cell carcinoma (RCC) patients. Patients and Methods: From November 2005 to August 2008, 132 histologically confirmed advanced RCC patients (100 in the global expanded access program) were enrolled. Response and toxicity were assessed regularly according to the protocol. Results: Within this population, 82.6% had clear cell RCC, and 28.8% were treatment naïve. Patients received a median of 5 cycles of sunitinib (range 1-30), and the mean relative dose intensity was 82.0 ± 14.20 (SD). The progression-free survival (PFS) and overall survival rates were 8.2 and 23.1 months, respectively. For the 130 evaluable patients, the objective response rate was 34.1% (n = 45); 44.7% (n = 59) exhibited stable disease. Reasons for discontinuation were disease progression (75.0%) and toxicity (7.6%). The most frequent adverse events were thrombocytopenia (75.0%), neutropenia (70.5%), and anemia (69.7%). Low body surface area (OR = 4.2, 95% CI 1.2-13.8, p = 0.02) and previously treated status (OR = 3.1, 95% CI 1.3-7.4, p = 0.01) were highly predictive of grade 3-4 toxicities. Based on these findings, a nomogram predicting the probability of 12-month PFS was constructed, giving a concordance index of 0.675. Conclusions: Despite the different toxicity profiles, maintaining adequate dose modifications and a careful follow-up enables comparable treatment outcomes for unselected Korean advanced RCC patients.

Original languageEnglish
Pages (from-to)395-405
Number of pages11
JournalOncology
Volume80
Issue number5-6
DOIs
Publication statusPublished - 2011 Aug 1

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Renal Cell Carcinoma
Disease-Free Survival
Nomograms
Body Surface Area
Neutropenia
Thrombocytopenia
Disease Progression
sunitinib
Anemia
Survival Rate
Safety
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Kim, Hyo Song ; Hong, Min Hee ; Kim, Kiyeol ; Shin, Sang Joon ; Ahn, Joong Bae ; Jeung, Hei Chul ; Chung, Hyuncheol ; Koh, Youngil ; Lee, Se Hoon ; Bang, Yung Jue ; Rha, SunYoung. / Sunitinib for Asian patients with advanced renal cell carcinoma : A comparable efficacy with different toxicity profiles. In: Oncology. 2011 ; Vol. 80, No. 5-6. pp. 395-405.
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title = "Sunitinib for Asian patients with advanced renal cell carcinoma: A comparable efficacy with different toxicity profiles",
abstract = "Objective: We aimed to describe the efficacy and safety of sunitinib in unselected Korean advanced renal cell carcinoma (RCC) patients. Patients and Methods: From November 2005 to August 2008, 132 histologically confirmed advanced RCC patients (100 in the global expanded access program) were enrolled. Response and toxicity were assessed regularly according to the protocol. Results: Within this population, 82.6{\%} had clear cell RCC, and 28.8{\%} were treatment na{\"i}ve. Patients received a median of 5 cycles of sunitinib (range 1-30), and the mean relative dose intensity was 82.0 ± 14.20 (SD). The progression-free survival (PFS) and overall survival rates were 8.2 and 23.1 months, respectively. For the 130 evaluable patients, the objective response rate was 34.1{\%} (n = 45); 44.7{\%} (n = 59) exhibited stable disease. Reasons for discontinuation were disease progression (75.0{\%}) and toxicity (7.6{\%}). The most frequent adverse events were thrombocytopenia (75.0{\%}), neutropenia (70.5{\%}), and anemia (69.7{\%}). Low body surface area (OR = 4.2, 95{\%} CI 1.2-13.8, p = 0.02) and previously treated status (OR = 3.1, 95{\%} CI 1.3-7.4, p = 0.01) were highly predictive of grade 3-4 toxicities. Based on these findings, a nomogram predicting the probability of 12-month PFS was constructed, giving a concordance index of 0.675. Conclusions: Despite the different toxicity profiles, maintaining adequate dose modifications and a careful follow-up enables comparable treatment outcomes for unselected Korean advanced RCC patients.",
author = "Kim, {Hyo Song} and Hong, {Min Hee} and Kiyeol Kim and Shin, {Sang Joon} and Ahn, {Joong Bae} and Jeung, {Hei Chul} and Hyuncheol Chung and Youngil Koh and Lee, {Se Hoon} and Bang, {Yung Jue} and SunYoung Rha",
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Kim, HS, Hong, MH, Kim, K, Shin, SJ, Ahn, JB, Jeung, HC, Chung, H, Koh, Y, Lee, SH, Bang, YJ & Rha, S 2011, 'Sunitinib for Asian patients with advanced renal cell carcinoma: A comparable efficacy with different toxicity profiles', Oncology, vol. 80, no. 5-6, pp. 395-405. https://doi.org/10.1159/000330361

Sunitinib for Asian patients with advanced renal cell carcinoma : A comparable efficacy with different toxicity profiles. / Kim, Hyo Song; Hong, Min Hee; Kim, Kiyeol; Shin, Sang Joon; Ahn, Joong Bae; Jeung, Hei Chul; Chung, Hyuncheol; Koh, Youngil; Lee, Se Hoon; Bang, Yung Jue; Rha, SunYoung.

In: Oncology, Vol. 80, No. 5-6, 01.08.2011, p. 395-405.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Sunitinib for Asian patients with advanced renal cell carcinoma

T2 - A comparable efficacy with different toxicity profiles

AU - Kim, Hyo Song

AU - Hong, Min Hee

AU - Kim, Kiyeol

AU - Shin, Sang Joon

AU - Ahn, Joong Bae

AU - Jeung, Hei Chul

AU - Chung, Hyuncheol

AU - Koh, Youngil

AU - Lee, Se Hoon

AU - Bang, Yung Jue

AU - Rha, SunYoung

PY - 2011/8/1

Y1 - 2011/8/1

N2 - Objective: We aimed to describe the efficacy and safety of sunitinib in unselected Korean advanced renal cell carcinoma (RCC) patients. Patients and Methods: From November 2005 to August 2008, 132 histologically confirmed advanced RCC patients (100 in the global expanded access program) were enrolled. Response and toxicity were assessed regularly according to the protocol. Results: Within this population, 82.6% had clear cell RCC, and 28.8% were treatment naïve. Patients received a median of 5 cycles of sunitinib (range 1-30), and the mean relative dose intensity was 82.0 ± 14.20 (SD). The progression-free survival (PFS) and overall survival rates were 8.2 and 23.1 months, respectively. For the 130 evaluable patients, the objective response rate was 34.1% (n = 45); 44.7% (n = 59) exhibited stable disease. Reasons for discontinuation were disease progression (75.0%) and toxicity (7.6%). The most frequent adverse events were thrombocytopenia (75.0%), neutropenia (70.5%), and anemia (69.7%). Low body surface area (OR = 4.2, 95% CI 1.2-13.8, p = 0.02) and previously treated status (OR = 3.1, 95% CI 1.3-7.4, p = 0.01) were highly predictive of grade 3-4 toxicities. Based on these findings, a nomogram predicting the probability of 12-month PFS was constructed, giving a concordance index of 0.675. Conclusions: Despite the different toxicity profiles, maintaining adequate dose modifications and a careful follow-up enables comparable treatment outcomes for unselected Korean advanced RCC patients.

AB - Objective: We aimed to describe the efficacy and safety of sunitinib in unselected Korean advanced renal cell carcinoma (RCC) patients. Patients and Methods: From November 2005 to August 2008, 132 histologically confirmed advanced RCC patients (100 in the global expanded access program) were enrolled. Response and toxicity were assessed regularly according to the protocol. Results: Within this population, 82.6% had clear cell RCC, and 28.8% were treatment naïve. Patients received a median of 5 cycles of sunitinib (range 1-30), and the mean relative dose intensity was 82.0 ± 14.20 (SD). The progression-free survival (PFS) and overall survival rates were 8.2 and 23.1 months, respectively. For the 130 evaluable patients, the objective response rate was 34.1% (n = 45); 44.7% (n = 59) exhibited stable disease. Reasons for discontinuation were disease progression (75.0%) and toxicity (7.6%). The most frequent adverse events were thrombocytopenia (75.0%), neutropenia (70.5%), and anemia (69.7%). Low body surface area (OR = 4.2, 95% CI 1.2-13.8, p = 0.02) and previously treated status (OR = 3.1, 95% CI 1.3-7.4, p = 0.01) were highly predictive of grade 3-4 toxicities. Based on these findings, a nomogram predicting the probability of 12-month PFS was constructed, giving a concordance index of 0.675. Conclusions: Despite the different toxicity profiles, maintaining adequate dose modifications and a careful follow-up enables comparable treatment outcomes for unselected Korean advanced RCC patients.

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