Efficacy and safety of advanced renal cell carcinoma patients treated with sorafenib: roles of cytokine pretreatment.

ABSTRACT

BACKGROUND: We conducted a retrospective, questionnaire-based analysis to assess the outcomes of advanced renal cell carcinoma (RCC) in Japanese patients treated with sorafenib in the daily clinical setting. PATIENTS AND METHODS: Patients (n = 110) were treated with sorafenib 400 mg twice daily at 12 centers. Overall survival (OS), progression-free survival (PFS), safety, and prognostic factors associated with PFS were assessed. RESULTS: The median OS was not reached within the study period, while the median PFS was 11.0 mo [95 % confidence interval (CI), 6.6 to 14.4 mo]. Univariate analysis showed that higher C-reactive protein (CRP) level, lower Na(+) level, and presence of liver metastasis were significant predictors of poorer PFS (p < 0.05, respectively). Among these variables, multivariate analysis identified higher CRP level (p = 0.004) and the presence of liver metastasis (p < 0.001) as being significantly associated with poorer PFS. The most common adverse event was skin toxicity (67 %), followed by gastrointestinal symptoms (26 %), hypertension (22 %), fatigue (19 %), hematological toxicity (10 %), and hemorrhage (6 %). The incidence of adverse events was comparable to that of previously reported clinical trials. CONCLUSIONS: Multivariate analysis indicated that CRP and liver metastasis were negatively associated with prognosis. Sorafenib therapy for Japanese patients with advanced RCC was effective and well tolerated.