Establishment of the novel targeted therapy and its biomarker for the patients with renal cell cancer

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We analyzed the treatment efficacy and safety profile of sunitinib for patients with metastatic renal cell cancer(RCC) in ordinary clinical practice. In addition, we investigated the prognostic clinicopathological factors in these patients. Sunitinib has a favorable efficacy/safety profile for Japanese metastatic RCC patients in clinical practice. MSKCC prognostic factors seem to be still valid to predict survival in metastatic RCC in the era of molecular targeted therapy.In addition, we investigated the inhibitory effect of sunitinib against the progression of RCC in vitro and in vivo. Sunitinib did not inhibit the growth of RCC cells in vitro at clinically or experimentally achievable serum levels(100 nM. 1μM). However, sunitinib prevented the growth of ACHN^<Luc> RCC cells in the bone metastatic mouse model. The number of osteoclasts in sunitinib-treated mice was significantly less than that in control mice. Serum and urine levels of NTx in patients with metastatic RCC declined significantly during the first 4 weeks of sunitinib treatment.