| Objective To evaluate the efficacy and safety of sorafenib in the treatment of Chinese patients with metastatic renal cell carcinoma.Methods This clinical trial was performed from May 2007 till now.16 patients with metastatic renal cell carcinoma not suitable for curative treatment were enrolled. pathological diagnoses of primary tumors were clear cell carcinoma.All patients received oral sorafenib as single agent at the dose of 400 mg twice a day until disease progression or intolerable toxicities occurred.Some of them received more or less according to the situations of patients.Results All patients were evaluable for response and toxicity assessment.CR or PR has not been observed in our group.13 patients achieved disease stabilizations(SD),and 5 of them had progressive disease(PD) and then received 600mg twice a day with a result of SD.3 patients had progressive disease,and 2 of them died with the other one had PD and then got another trial(sunitinib).The disease control rate were 81.2%(13/16),and the median progression free survival time was 8.5 months.Common side effects included alopecia 3 cases,diarrhea 9 cases,hand-foot syndrome 9 cases, rush 5 cases,anorexia 6 cases,fatigue 3 cases,hypertension 4 cases,nausea 2 cases, dental ulcer 2 cases.Conclusions Sorafenib has prominent anti-tumor activity in Chinese metastatic renal cancer patients with most adverse events being grade 1 or 2.patients can tolerate it very well.Further follow up and more specimens are needed to analyse the impact on the survival of patients. |
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