Overall Survival and Updated Results from a Phase II Study of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma

Tomita, Yoshihiko; Shinohara, Nobuo; Yuasa, Takeshi; Fujimoto, Hiroyuki; Niwakawa, Masashi; Mugiya, Soichi; Miki, Tsuneharu; Uemura, Hirotsugu; Nonomura, Norio; Takahashi, Masayuki; Hasegawa, Yoshihiro; Agata, Naoki; Houk, Brett E.; Naito, Seiji; Akaza, Hideyuki

doi:10.1093/jjco/hyq146

Cited by 102 publications

(95 citation statements)

References 9 publications

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“…(3,4) In Japan, the MSKCC risk classification is widely used not only in clinical trials, but also in daily clinical practice. (5,6) However, whether this risk classification is useful for predicting outcomes in Japanese patients with metastatic RCC is not unclear. Recently, we performed a retrospective study on the MSKCC risk classification in patients with metastatic RCC and reported its applicability to Japanese patients.…”

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confidence: 99%

A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

et al. 2012

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The aims of the present study were to: (i) develop a clinically useful prognostic classification in Asian patients with metastatic renal cell carcinoma (RCC) by combining metastatic features with several pretreatment parameters; and (ii) evaluate the validity of this prognostic classification. Baseline characteristics and outcomes were collected for 361 patients who underwent interferon-a-based therapy between 1995 and 2005. Relationships between overall survival (OS) and potential prognostic factors were assessed using Cox's proportional hazard model. The predictive performance of the model was evaluated using bootstrap resampling procedures and by using an independent dataset obtained from randomly selected institutions. The predictive accuracy was measured using the concordance index (c-index). Four factors were identified as independent prognostic factors: time from initial diagnosis to treatment, anemia, elevated lactate dehydrogenase (LDH), and poor prognostic metastatic group (liver only, bone only, or multiple organ metastases). Each patient was assigned to one of three risk groups: favorable risk (none or one factor; n = 120), in which median OS was 51 months; intermediate risk (two factors; n = 101), in which median OS was 21 months; and poor risk (three or four factors; n = 102), in which median OS was 10 months. The c-index was 0.72 in the original dataset and 0.72 in 500 random bootstrap samples. In the independent dataset for external validation, the c-index was 0.73. Thus, the new prognostic classification is easily applicable for Asian patients with previously untreated metastatic RCC and should be incorporated into patient care, as well as clinical trials performed in Asia. (Cancer Sci 2012; 103: 1695-1700 W ith the advent of molecular targeted therapy, treatment for metastatic renal cell carcinoma (RCC) has changed markedly. At present, drugs that should be used for molecular targeted therapy are usually selected on the basis of the Memorial Sloan-Kettering Cancer Center (MSKCC) risk classification.(1,2) This results from the fact that clinical trials of molecular targeted drugs, such as sunitinib and temsirolimus, have been performed by selecting subjects on the basis of this risk classification and their usefulness has been clarified. (3,4) In Japan, the MSKCC risk classification is widely used not only in clinical trials, but also in daily clinical practice.(5,6) However, whether this risk classification is useful for predicting outcomes in Japanese patients with metastatic RCC is not unclear. Recently, we performed a retrospective study on the MSKCC risk classification in patients with metastatic RCC and reported its applicability to Japanese patients.(7) However, when this risk classification was used in Japanese RCC patients, the percentage of patients in the poor risk group was high compared with that in Western series and the survival period of the poor risk group was twice as long in Japanese patients as that in patients in Western countries. (7,8) This may be because multiple organ me...

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A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

et al. 2012

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“…The updated efficacy and safety data in the present report confirmed that S-1 was effective in patients who had failed to respond to prior cytokine treatment, and no new safety-related findings were detected during .3 years from the interim analysis to the final data cutoff. We acknowledge that this is not a randomized study and the efficacy results of the final analysis should be considered as exploratory; however, it was encouraging that the median OS was 42.8 months and numerically longer when compared with those reported in Japanese studies of sorafenib (25.3 months) and sunitinib (32.5 months) (17,18). This study was initiated before the approval of TKIs and mammalian target of rapamycin inhibitors in Japan.…”

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confidence: 95%

Final Results of a Phase II Study of S-1 in Patients with Cytokine-refractory Metastatic Renal Cell Carcinoma

Naito

Tatsugami

Shinohara

et al. 2013

Japanese Journal of Clinical Oncology

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Objective: A planned primary analysis of a Phase II study of S-1 demonstrated that the drug was active and tolerable in Japanese patients with cytokine-refractory metastatic renal cell carcinoma. Furthermore, pharmacogenomic analysis suggested that low expression of thymidylate synthase mRNA may have been associated with clinical outcome in terms of overall response rate and progression-free survival. Here, we report the results of the final analysis assessing the efficacy and safety of S-1 including overall survival. Methods: Patients with renal cell carcinoma were eligible if they had had at least one regimen of cytokine for metastatic disease. S-1 was orally administered on Days 1 -28 of a 42-day cycle until disease progression. The primary endpoint was the overall response rate, and the secondary endpoint included progression-free survival, overall survival and safety. Results: A total of 45 patients were treated with S-1 and were fully assessable for efficacy and safety. At the final analysis, a response was seen in 11 patients (overall response rate, 24.4%; 95% confidence interval: 12.9 -39.5%), including two patients who achieved a complete response. The final median progression-free and overall survival were 9.2 and 42.8 months, respectively. The safety profile of S-1 was favorable. It was suggested that there was no relation between overall survival and the expression level of thymidylate synthase. Conclusion: This final analysis confirms that S-1 treatment is effective and safe in patients with cytokine-refractory renal cell carcinoma.

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“…Hypothyroidism was also considered to be an important AE associated with sunitinib treatment, for which 31 patients (53.4%) required medication during this study. ficacy and safety of these agents in the Western world [7,8,11], only few reports have described findings in Asian populations [12][13][14]19]. In 2010, Tomita et al reported updated results from a Phase II trial of sunitinib in the Japanese population [14].…”

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confidence: 99%

“…In addition, only patients with clear-cell histology were eligible for the study [8]. Although sunitinib has been universally prescribed to patients with mRCC, few studies have examined the efficacy and safety of this agent in daily clinical practice, especially in patients of Asian ethnicity [12][13][14][15]. Here, we assessed the efficacy and safety of sunitinib in Japanese patients with mRCC in general clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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

Suyama¹,

Ueda²,

Fukasawa³

et al. 2011

JCT

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Overall Survival and Updated Results from a Phase II Study of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma

Cited by 102 publications

References 9 publications

A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

Final Results of a Phase II Study of S-1 in Patients with Cytokine-refractory Metastatic Renal Cell Carcinoma

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

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