Clinicopathological and prognostic factors for long-term survival in Chinese patients with metastatic renal cell carcinoma treated with sorafenib: a single-center retrospective study

// Hai-Liang Zhang 1, 2, * , Xiao-Jian Qin 1, 2, * , Hong-Kai Wang 1, 2 , Wei-Jie Gu 1, 2 , Chun-Guang Ma 1, 2 , Guo-Hai Shi 1, 2 , Liang-Ping Zhou 2, 3 , Ding-Wei Ye 1, 2 1 Department of Urology, Fudan University, Shanghai Cancer Center, Shanghai 200032, P.R. China 2 Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, P.R. China 3 Department of Radiology, Fudan University, Shanghai Cancer Center, Shanghai 200032, P.R. China * These authors have contributed equally to this work Correspondence to: Ding-Wei Ye, e-mail: wyeli@163.com Keywords: sorafenib, advanced RCC, China, overall survival, prognostic factors Received: May 08, 2015      Accepted: October 01, 2015      Published: October 14, 2015 ABSTRACT Data on long-term survival and prognostic significance of demographic factors and adverse events (AEs) associated with sorafenib, an orally administered multikinase inhibitor in Chinese population with advanced renal cell carcinoma (RCC) are limited. Outcome data from adult patients ( n = 256) with advanced RCC who received sorafenib (400 mg twice daily) either as first-line or second-line therapy between April 2006 and May 2013 were analyzed retrospectively. The primary endpoint was median overall survival (OS), determined to be 22.2 (95% CI: 17.1–27.4) months, and the secondary endpoint was overall median progression-free survival (PFS), determined to be 13.6 (95% CI: 10.7–16.4) months at a median follow-up time of 61.8 (95% CI: 16.2–97.4) months. Analysis of the incidence of AEs revealed the most common side effect as hand-foot skin reactions (60.5%) followed by diarrhea (38.7%), fatigue (35.5%), alopecia (34.0%), rash (24.6%), hypertension (21.5%) and gingival hemorrhage (21.1%). Multivariate regression analysis revealed older age (≥ 58 years), lower Memorial Sloan-Kettering Cancer Center score, time from nephrectomy to sorafenib treatment, number of metastatic tumors and best response as significant and independent demographic predictors for improved PFS and/or OS ( p ≤ 0.05). Alopecia was identified as a significant and independent predictor of increased OS, whereas vomiting and weight loss were identified as significant predictors of decreased OS ( p ≤ 0.05). Sorafenib significantly improved OS and PFS in Chinese patients with advanced RCC. Considering the identified significant prognostic demographic factors along with the advocated prognostic manageable AEs while identifying treatment strategy may help clinicians select the best treatment modality and better predict survival in these patients.