Efficacy and Safety of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma

Suyama, Takahito; Ueda, Takeshi; Fukasawa, Satoshi; Komaru, Atsushi; Kobayashi, Masayuki; Naya, Yukio; Nihei, Naoki; Ichikawa, Tomohiko

doi:10.4236/jct.2011.23046

Cited by 3 publications

(3 citation statements)

References 17 publications

(27 reference statements)

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“…Advanced understanding of the molecular biology of RCC led to the development and approval of several drugs that inhibit vascular endothelial growth factor receptor (VEGFR) signaling pathways (i.e. sorafenib, sunitinib, bevacizumab/IFN-α, pazopanib and axitinib) (9,11–17) or mammalian target of rapamycin pathways (i.e. temsirolimus and everolimus) (18,19).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

Ueda

Uemura

Tomita

et al. 2013

Japanese Journal of Clinical Oncology

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ObjectiveAxitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated.MethodsA subgroup analysis was conducted in Japanese patients enrolled in the randomized Phase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma.ResultsTwenty-five (of 361) and 29 (of 362) patients randomized to the axitinib and sorafenib arms, respectively, were Japanese and included in this analysis. Median progression-free survival in Japanese patients was 12.1 months (95% confidence interval 8.6 to not estimable) for axitinib and 4.9 months (95% confidence interval 2.8–6.6) for sorafenib (hazard ratio 0.390; 95% confidence interval 0.130–1.173; stratified one-sided P = 0.0401). The objective response rate was 52.0% for axitinib and 3.4% for sorafenib (P = 0.0001). The common all-causality adverse events (all grades) in Japanese patients were dysphonia (68%), hypertension (64%), hand–foot syndrome (64%) and diarrhea (56%) for axitinib, and hand–foot syndrome (86%), hypertension (62%) and diarrhea (52%) for sorafenib. The safety profiles of axitinib and sorafenib in Japanese patients were generally similar to those observed in the overall population, with the exceptions of higher incidences of hypertension, dysphonia, hand–foot syndrome, hypothyroidism and stomatitis.ConclusionsAxitinib is efficacious and well tolerated in Japanese patients with previously treated metastatic renal cell carcinoma, consistent with the results in the overall population, providing a new targeted therapy for these Japanese patients.

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Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

Ueda

Uemura

Tomita

et al. 2013

Japanese Journal of Clinical Oncology

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“…In many cases, however, doses must be reduced or therapy must be discontinued as a result of toxicities, including hand-foot syndrome and malaise. 3 Recently, switching from traditional to alternative schedules of sunitinib treatment was reported to be effective. 4,5 However, no studies on this topic have been carried out in Japan.…”

Section: Introductionmentioning

confidence: 99%

“…Sunitinib at 50 mg/day with the 4/2 schedule is the approved standard dosing for mRCC. In many cases, however, doses must be reduced or therapy must be discontinued as a result of toxicities, including hand–foot syndrome and malaise . Recently, switching from traditional to alternative schedules of sunitinib treatment was reported to be effective .…”

Section: Introductionmentioning

confidence: 99%

Efficacy of traditional and alternative sunitinib treatment schedules in Japanese patients with metastatic renal cell carcinoma

et al. 2014

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Abbreviations & Acronyms AE = adverse events ALP = alkaline phosphatase AS = alternative schedule AST = aspartate aminotransferase ECOG PS = Eastern Cooperative Oncology Group performance status IFN-α = interferon alpha LDH = serum lactate dehydrogenase LLN = lower limit of normal mRCC = metastatic renal cell carcinoma MSKCC = Memorial Sloan-Kettering Cancer Center OS = overall survival PFS = progression-free survival TS = traditional schedule TTF = time to treatment failure ULN = upper limit of normal WBC = white blood cell Abstract: We report the adverse events and efficacy of traditional (4 weeks on 2 weeks off) and alternative sunitinib treatment schedules for Japanese patients with metastatic renal cell carcinoma. We retrospectively investigated 54 patients who received sunitinib for metastatic renal cell carcinoma between May 2006 and June 2012: 32 received a traditional treatment schedule and 22 received an alternative schedule. According to the Memorial Sloan-Kettering Cancer Center risk classification, five patients had favorable prognoses, 42 had intermediate prognoses and seven had poor prognoses. The mean observation periods were 16.3 and 20 months for the traditional and alternative schedule groups, respectively. Adverse events were significantly less common in the alternative schedule group, including most high-grade events. In the traditional and alternative schedule groups, median times to failure were 4.1 and 11.6 months (P = 0.040), median progression-free survival times were 4.1 and 11.3 months (P = 0.031), and median overall survival times were 12.0 and 32.1 months (P = 0.018), respectively. Each of these measures was better in the group of patients who received an alternative treatment schedule, suggesting that individualized changes to the sunitinib administration schedule can be effective.

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Modeling Drug-Induced Anorexia by Molecular Topology

Gálvez-Llompart

Gálvez

García-Domènech

et al. 2012

J. Chem. Inf. Model.

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Molecular topology (MT) has demonstrated to be a very good technique for describing molecular structures and to predict physical, chemical, and biological properties of compounds. In this paper, a topological-mathematical model based on MT has been developed for identifying drug compounds showing anorexia as a side effect. An external validation (test set) has been carried out, yielding over an 80% correct classification in the active and inactive compounds. These results reinforce the role of MT as a potential useful tool for predicting drug side effects.

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Efficacy and Safety of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma

Abstract: ABSTRACT

Cited by 3 publications

References 17 publications

Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

Efficacy of traditional and alternative sunitinib treatment schedules in Japanese patients with metastatic renal cell carcinoma

Modeling Drug-Induced Anorexia by Molecular Topology

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