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

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.