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.
Highlights
Renal cell carcinoma (RCC) is a heterogeneous group of tumors with distinct genetic and metabolic defects
The efficacy and tolerability of sorafenib in the treatment of advanced RCC is well established in the global population, while the data on long-term survival are primarily from the western population [5, 7, 8, 13,14,15,16,17,18,19,20,21]
The present retrospective study contributes valuable insights into the long-term survival of Chinese patients with advanced RCC treated with sorafenib as first-line or second-line therapy
Summary
Renal cell carcinoma (RCC) is a heterogeneous group of tumors with distinct genetic and metabolic defects It encompasses diverse clinical, histopathological, and molecular factors, which have a role in differential prognosis and therapeutic responses [1]. Previous studies, including the pivotal TARGET trial, have demonstrated promising evidence for sorafenib administered at a dose of 400 mg twice daily both as a first-line and second-line therapy for advanced RCC primarily in the western population [7, 8] These studies have shown varying improvement in progression-free survival (PFS), overall response rates, overall survival (OS), tolerance, and quality of life compared with other investigational agents including interferon, IFNα2a, tivozanib, temsirolimus, AMG 386, and axitinib [8,9,10,11]
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