Abstract
e15582 Background: This study was to investigate long-term efficacy of sorafenib and survival-related factors in Chinese patients with mRCC. Methods: 406 consecutive patients enrolled in this study between Oct. 2006 and Oct. 2009 from 6 comprehensive cancer centres in China. All cases were diagnosed as mRCC histopathologically without exception. 400mg sorafenib was orally taken twice daily until PD, death or intolerable toxic reaction. The primary endpoint was OS. The secondary endpoints were PFS and survival-related factors such as gender, age, ECOG PS, previous therapy and primary metastatic lesions. Data was analyzed using the SPSS statistical software. OS and PFS curves were output using the Kaplan-Meier method. Clinical parameters were included on univariate and multivariate analysis to evaluate associations with OS and PFS by the log-rank test and Cox proportional hazard models, P<0.05 (two-sided) was considered statistically significant. Results: 131 patients were available for survival analysis, including 96 males and 35 females. The median age was 60 years old. The median follow-up periods were 16.9 months. The median OS was 16.1 months. 1-year, 2-year and 3-year survival rates were 64.9%, 35.9% and 5.3%, respectively. The median PFS was 10.5 months. Univariate analysis demonstrated that OS was significantly associated with ECOG PS, metastatic lesions and previous therapy, whereas PFS was merely associated with ECOG PS and previous therapy. Multivariate analysis suggested that ECOG PS and previous therapy were independent prognostic factors for OS(P=0.004, P=0.019) and PFS (P=0.000, P=0.003), metastatic lesions was merely independent prognostic factor for OS (P=0.003). In the subgroup of patients with visceral metastasis, patients with lung metastasis alone had better prognosis than those with liver metastasis or dimerous metastasis. Conclusions: This long-term study demonstrated that sorafenib had good effects on Chinese patients with mRCC, especially for patients with lung metastasis alone. ECOG PS, metastatic lesions and previous therapy could be important parameters for survival and need attention in future.
Published Version
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