7118 An Asian subpopulation analysis of the safety and efficacy of sunitinib in metastatic renal cell carcinoma

Lee, S.; Chung, Hsingwen; Mainwaring, Paul N.; Ng, Chun Wai; Chang, Jui-Chi; Kwong, Philip Wai-Kay; Li, R.K.; Sriuranpong, V.; Toh, Chee-Keong; Lowenthal, Susan Pitman

doi:10.1016/s1359-6349(09)71451-x

Cited by 13 publications

(19 citation statements)

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“…For example, ad hoc analyses indicated that several AEs occurred significantly more often in Asian patients, relative to white patients, such as hand-foot syndrome that occurred in 70% of Asian patients compared with 28% of white patients ( P <0.001). This is consistent with previous studies of sunitinib and sorafenib in Asian RCC patients, including Japanese, Chinese, and Korean patients (Sun et al , 2008; Hong et al , 2009; Lee et al , 2009; Tomita et al , 2010; Naito et al , 2011). For example, the incidences of hand-foot syndrome and hypertension were higher in Japanese and Chinese patients receiving sorafenib, in comparison with Western patients; similarly, thrombocytopenia and neutropenia occurred more frequently in Japanese and Korean patients receiving sunitinib.…”

Section: Discussionsupporting

confidence: 93%

“…We explored ethnic-based differences in baseline characteristics and survival, as there have been differences in outcome and tolerability reported to sunitinib by ethnicity (Hong et al , 2009; Lee et al , 2009; Tomita et al , 2010). We identified a group of patients with long-term OS, defined as OS of ⩾30 months, and examined pretreatment features in this cohort of patients.…”

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confidence: 99%

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Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma

et al. 2013

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Background:Prognostic factors for progression-free survival (PFS), overall survival (OS), and long-term OS (⩾30 months) were investigated in sunitinib-treated patients with metastatic renal cell carcinoma (RCC).Methods:Data were pooled from 1059 patients in six trials. Baseline variables, including ethnicity, were analysed for prognostic significance by Cox proportional-hazards model.Results:Median PFS and OS were 9.7 and 23.4 months, respectively. Multivariate analysis of PFS and OS identified independent predictors, including ethnic origin, Eastern Cooperative Oncology Group performance status, time from diagnosis to treatment, prior cytokine use, haemoglobin, lactate dehydrogenase, corrected calcium, neutrophils, platelets, and bone metastases (OS only). Characteristics of long-term survivors (n=215, 20%) differed from those of non-long-term survivors; independent predictors of long-term OS included ethnic origin, bone metastases, and corrected calcium. There were no differences in PFS (10.5 vs 7.2 months; P=0.1006) or OS (23.8 vs 21.4 months; P=0.2135) in white vs Asian patients; however, there were significant differences in PFS (10.5 vs 5.7 months; P<0.001) and OS (23.8 vs 17.4 months; P=0.0319) in white vs non-white, non-Asian patients.Conclusion:These analyses identified risk factors to survival with sunitinib, including potential ethnic-based differences, and validated risk factors previously reported in advanced RCC.

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Section: Discussionsupporting

confidence: 93%

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confidence: 99%

Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma

et al. 2013

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“…The sunitinib in mRCC expanded‐access program (EAP) was established to provide sunitinib on a compassionate‐use basis to mRCC patients who were ineligible for ongoing sunitinib clinical trials or prior to its regulatory approval in their countries, but who were considered by investigators to be likely to benefit from sunitinib treatment 4 . The program included 4564 patients from 246 sites in 52 countries, including 325 Asian patients from Hong Kong, Malaysia, Singapore, South Korea, Taiwan, Thailand and the Philippines 4,7 . Histologically confirmed mRCC patients who were either previously treated or treatment naive were enrolled.…”

Section: Use Of Sunitinib In Asian Patientsmentioning

confidence: 99%

Management of sunitinib adverse events in renal cell carcinoma patients: The Asian experience

Zhou

2012

Asia-Pac J Clncl Oncology

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Sunitinib is the gold standard of care for patients with metastatic renal cell carcinoma, demonstrating an overall survival benefit of over 2 years in a pivotal phase 3 trial of 750 patients. While sunitinib is generally well tolerated with most adverse events, manifesting as mild to moderate in severity and manageability, it has a distinctive adverse event profile that benefits from careful monitoring during treatment. As sunitinib gains widespread use across the globe, best practices are being developed for specific patient groups. This review will focus on the current clinical trial data in Asian populations and on the mechanism, incidence and management of selected sunitinib-related adverse events, including hand-foot syndrome, hypertension, proteinuria, cardiac toxicities, myelosupression, fatigue/asthenia, hypothyroidism, diarrhea and hepatotoxicity. Taken together, the developing body of literature reviewed here demonstrates that sunitinib is well tolerated in Asian patients and provides efficacy that is similar, if not superior, to other patient groups. Asian patients, like all patients, should begin treatment of sunitinib at 50 mg on Schedule 4/2 (4 weeks on treatment/2 weeks off). Prophylactic measures, good communication between patient and health-care providers, and early, aggressive intervention at the development of adverse events can limit the dose reductions required and maximize both patients' response to treatment and their quality of life.

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“…The most common treatment-related grade 3-5 adverse events and laboratory abnormalities in Japanese patients were fatigue and hand-foot syndrome, decreased counts for platelets and neutrophils and increased lipase [32]. Lee et al [33] also reported that Asian patients treated at Asian sites had a higher frequency of leukopenia, thrombocytopenia, stomatitis and hand-foot syndrome and a lower incidence of diarrhea, compared with non-Asian patients. Until now, it is not clear why the tolerability and efficacy of sunitinib may differ to some extent in Japanese and Western populations.…”

Section: Sunitinibmentioning

confidence: 99%

Treatment of metastatic renal cell carcinoma and renal pelvic cancer

Tanji

Yokoyama

2011

Clin Exp Nephrol

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A better understanding of the molecular biology of renal cell carcinoma (RCC) and the emergence of molecular targeted drugs have revolutionized the treatment for patients with metastatic RCC (mRCC). Multi-targeted tyrosine kinase inhibitors (sorafenib and sunitinib) and mammalian target of rapamycin inhibitors (temsirolimus and everolimus) have recently shown superiority over interferon-α or placebo. However, while the molecular targeted drugs have demonstrated encouraging results, these drugs have also sometimes induced unexpected adverse events. Control of adverse events is important to obtain the maximum effectiveness and sustain quality of life for patients. Because renal pelvic cancer has many similarities in pathogenesis with urinary bladder cancer, the same chemotherapeutic regimen is often proposed for patients with metastatic renal pelvic cancer. Combined chemotherapy with gemcitabine and cisplatin is now widely considered to be first-line chemotherapy against these metastatic diseases; however, there are still unresolved problems with this treatment, including the limited survival benefit. To select new therapeutic modalities, a more profound understanding of the molecular biology of renal pelvic cancer is crucial. The purpose of this review is to summarize the current evidence supporting the role and activities of new chemotherapeutic agents and to reveal potential future directions in the management of mRCC and renal pelvic cancer.

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7118 An Asian subpopulation analysis of the safety and efficacy of sunitinib in metastatic renal cell carcinoma

Cited by 13 publications

References 0 publications

Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma

Prognostic factors for survival in 1059 patients treated with sunitinib for metastatic renal cell carcinoma

Management of sunitinib adverse events in renal cell carcinoma patients: The Asian experience

Treatment of metastatic renal cell carcinoma and renal pelvic cancer

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