Sunitinib in metastatic renal cell carcinoma: An ethnic Asian subpopulation analysis for safety and efficacy

Se Hoon Lee, Yung Jue Bang, Paul Mainwaring, Christina Ng, John W.C. Chang, Philip Kwong, Rubi K. Li, Virote Sriuranpong, Chee Keong Toh, Jinyu Yuan, Susan Pitman Lowenthal, Hyuncheol Chung

Research output: Contribution to journalArticle

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Abstract

Aims: We evaluated and compared the safety and efficacy of sunitinib in Asian and non-Asian patients with metastatic renal cell carcinoma enrolled in a previously reported global expanded access program. Methods: Previously treated and treatment-naïve patients received open-label sunitinib at a starting dose of 50mg/day for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles. Safety was assessed regularly, tumor measurements were performed per local practice, and survival data collected where possible. Results: Data were available for 212 Asian patients from Asian sites (Asian-A), 113 Asian patients from non-Asian sites (Asian-O) and 4046 non-Asian patients. The most common grade 3/4 treatment-related adverse events were neutropenia, thrombocytopenia, hand-foot syndrome, diarrhea, asthenia and fatigue. The incidence of many adverse events was greater in Asian-A than in Asian-O or non-Asian patients. Sunitinib efficacy was comparable between Asian and non-Asian patients, with an objective response rate of 18% versus 14%; median progression-free survival of 8.7 versus 10.9 months; and overall survival of 18.9 versus 18.4 months, respectively. Conclusions: Sunitinib demonstrated tolerable safety and similar efficacy in Asian and non-Asian patients. Geographic differences in the reported frequency of specific adverse events were noted across Asian patients.

Original languageEnglish
Pages (from-to)237-245
Number of pages9
JournalAsia-Pacific Journal of Clinical Oncology
Volume10
Issue number3
DOIs
Publication statusPublished - 2014 Jan 1

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Renal Cell Carcinoma
Safety
Hand-Foot Syndrome
sunitinib
Asthenia
Survival
Neutropenia
Thrombocytopenia
Disease-Free Survival
Fatigue
Diarrhea
Therapeutics
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology

Cite this

Lee, Se Hoon ; Bang, Yung Jue ; Mainwaring, Paul ; Ng, Christina ; Chang, John W.C. ; Kwong, Philip ; Li, Rubi K. ; Sriuranpong, Virote ; Toh, Chee Keong ; Yuan, Jinyu ; Pitman Lowenthal, Susan ; Chung, Hyuncheol. / Sunitinib in metastatic renal cell carcinoma : An ethnic Asian subpopulation analysis for safety and efficacy. In: Asia-Pacific Journal of Clinical Oncology. 2014 ; Vol. 10, No. 3. pp. 237-245.
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abstract = "Aims: We evaluated and compared the safety and efficacy of sunitinib in Asian and non-Asian patients with metastatic renal cell carcinoma enrolled in a previously reported global expanded access program. Methods: Previously treated and treatment-na{\"i}ve patients received open-label sunitinib at a starting dose of 50mg/day for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles. Safety was assessed regularly, tumor measurements were performed per local practice, and survival data collected where possible. Results: Data were available for 212 Asian patients from Asian sites (Asian-A), 113 Asian patients from non-Asian sites (Asian-O) and 4046 non-Asian patients. The most common grade 3/4 treatment-related adverse events were neutropenia, thrombocytopenia, hand-foot syndrome, diarrhea, asthenia and fatigue. The incidence of many adverse events was greater in Asian-A than in Asian-O or non-Asian patients. Sunitinib efficacy was comparable between Asian and non-Asian patients, with an objective response rate of 18{\%} versus 14{\%}; median progression-free survival of 8.7 versus 10.9 months; and overall survival of 18.9 versus 18.4 months, respectively. Conclusions: Sunitinib demonstrated tolerable safety and similar efficacy in Asian and non-Asian patients. Geographic differences in the reported frequency of specific adverse events were noted across Asian patients.",
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Lee, SH, Bang, YJ, Mainwaring, P, Ng, C, Chang, JWC, Kwong, P, Li, RK, Sriuranpong, V, Toh, CK, Yuan, J, Pitman Lowenthal, S & Chung, H 2014, 'Sunitinib in metastatic renal cell carcinoma: An ethnic Asian subpopulation analysis for safety and efficacy', Asia-Pacific Journal of Clinical Oncology, vol. 10, no. 3, pp. 237-245. https://doi.org/10.1111/ajco.12163

Sunitinib in metastatic renal cell carcinoma : An ethnic Asian subpopulation analysis for safety and efficacy. / Lee, Se Hoon; Bang, Yung Jue; Mainwaring, Paul; Ng, Christina; Chang, John W.C.; Kwong, Philip; Li, Rubi K.; Sriuranpong, Virote; Toh, Chee Keong; Yuan, Jinyu; Pitman Lowenthal, Susan; Chung, Hyuncheol.

In: Asia-Pacific Journal of Clinical Oncology, Vol. 10, No. 3, 01.01.2014, p. 237-245.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Sunitinib in metastatic renal cell carcinoma

T2 - An ethnic Asian subpopulation analysis for safety and efficacy

AU - Lee, Se Hoon

AU - Bang, Yung Jue

AU - Mainwaring, Paul

AU - Ng, Christina

AU - Chang, John W.C.

AU - Kwong, Philip

AU - Li, Rubi K.

AU - Sriuranpong, Virote

AU - Toh, Chee Keong

AU - Yuan, Jinyu

AU - Pitman Lowenthal, Susan

AU - Chung, Hyuncheol

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Aims: We evaluated and compared the safety and efficacy of sunitinib in Asian and non-Asian patients with metastatic renal cell carcinoma enrolled in a previously reported global expanded access program. Methods: Previously treated and treatment-naïve patients received open-label sunitinib at a starting dose of 50mg/day for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles. Safety was assessed regularly, tumor measurements were performed per local practice, and survival data collected where possible. Results: Data were available for 212 Asian patients from Asian sites (Asian-A), 113 Asian patients from non-Asian sites (Asian-O) and 4046 non-Asian patients. The most common grade 3/4 treatment-related adverse events were neutropenia, thrombocytopenia, hand-foot syndrome, diarrhea, asthenia and fatigue. The incidence of many adverse events was greater in Asian-A than in Asian-O or non-Asian patients. Sunitinib efficacy was comparable between Asian and non-Asian patients, with an objective response rate of 18% versus 14%; median progression-free survival of 8.7 versus 10.9 months; and overall survival of 18.9 versus 18.4 months, respectively. Conclusions: Sunitinib demonstrated tolerable safety and similar efficacy in Asian and non-Asian patients. Geographic differences in the reported frequency of specific adverse events were noted across Asian patients.

AB - Aims: We evaluated and compared the safety and efficacy of sunitinib in Asian and non-Asian patients with metastatic renal cell carcinoma enrolled in a previously reported global expanded access program. Methods: Previously treated and treatment-naïve patients received open-label sunitinib at a starting dose of 50mg/day for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles. Safety was assessed regularly, tumor measurements were performed per local practice, and survival data collected where possible. Results: Data were available for 212 Asian patients from Asian sites (Asian-A), 113 Asian patients from non-Asian sites (Asian-O) and 4046 non-Asian patients. The most common grade 3/4 treatment-related adverse events were neutropenia, thrombocytopenia, hand-foot syndrome, diarrhea, asthenia and fatigue. The incidence of many adverse events was greater in Asian-A than in Asian-O or non-Asian patients. Sunitinib efficacy was comparable between Asian and non-Asian patients, with an objective response rate of 18% versus 14%; median progression-free survival of 8.7 versus 10.9 months; and overall survival of 18.9 versus 18.4 months, respectively. Conclusions: Sunitinib demonstrated tolerable safety and similar efficacy in Asian and non-Asian patients. Geographic differences in the reported frequency of specific adverse events were noted across Asian patients.

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