Yushi Zhang1, Yongqiang Li1, Yi Cai1, Ke Wang2, Hanzhong Li3. 1. Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China. 2. Department of Epidemiology, Institute of Basic Medicine, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China. 3. Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China. Lihz12@yeah.net.
Abstract
PURPOSE: Several prognostic models have been developed to assess the efficacy and safety of sorafenib for metastatic renal cell carcinoma (mRCC), but few studies have validated its use in Chinese patients. The objective of this single center, single arm retrospective study was to examine the efficacy and safety of sorafenib and its related prognostic clinico-pathologic factors in Chinese mRCC patients. METHODS: One hundred thirty four mRCC patients were enrolled. All patients received 400 mg of sorafenib orally twice daily. The dose was subsequently adjusted in the event of treatment-induced toxicity. Tumor response, progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were determined. RESULTS: The median PFS and OS were 10 months (1-36 months) and 22 months (2-37 months), respectively. Complete, partial, and stable disease were observed in two (1.49%), 24 (17.91%), and 99 (73.88%) patients, respectively. Hand/foot skin reactions, diarrhea and fatigue were the most commonly observed AEs following sorafenib treatment. Among the AEs, only 13 grades 3 and 4 were observed. Multivariate analysis revealed that independent predictive factors for PFS included Eastern Cooperative Oncology Group (ECOG) status, Memorial Sloan-Kettering Cancer Center (MSKCC) risk status, and bone metastasis (all p < 0.05). Factors associated with OS included MSKCC risk values, bone metastasis and sorafenib-induced hypertension (all p < 0.05). CONCLUSION: The introduction of sorafenib therapy for mRCC in Chinese patients may lead to a favorable disease control with acceptable tolerability. In addition, the parameters predicting favorable outcomes, including ECOG status, MSKCC risk status and bone metastasis, may have prognostic value in clinical practice.
PURPOSE: Several prognostic models have been developed to assess the efficacy and safety of sorafenib for metastatic renal cell carcinoma (mRCC), but few studies have validated its use in Chinese patients. The objective of this single center, single arm retrospective study was to examine the efficacy and safety of sorafenib and its related prognostic clinico-pathologic factors in Chinese mRCC patients. METHODS: One hundred thirty four mRCC patients were enrolled. All patients received 400 mg of sorafenib orally twice daily. The dose was subsequently adjusted in the event of treatment-induced toxicity. Tumor response, progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were determined. RESULTS: The median PFS and OS were 10 months (1-36 months) and 22 months (2-37 months), respectively. Complete, partial, and stable disease were observed in two (1.49%), 24 (17.91%), and 99 (73.88%) patients, respectively. Hand/foot skin reactions, diarrhea and fatigue were the most commonly observed AEs following sorafenib treatment. Among the AEs, only 13 grades 3 and 4 were observed. Multivariate analysis revealed that independent predictive factors for PFS included Eastern Cooperative Oncology Group (ECOG) status, Memorial Sloan-Kettering Cancer Center (MSKCC) risk status, and bone metastasis (all p < 0.05). Factors associated with OS included MSKCC risk values, bone metastasis and sorafenib-induced hypertension (all p < 0.05). CONCLUSION: The introduction of sorafenib therapy for mRCC in Chinese patients may lead to a favorable disease control with acceptable tolerability. In addition, the parameters predicting favorable outcomes, including ECOG status, MSKCC risk status and bone metastasis, may have prognostic value in clinical practice.
Authors: S Patil; R A Figlin; T E Hutson; M D Michaelson; S Négrier; S T Kim; X Huang; R J Motzer Journal: Ann Oncol Date: 2010-07-25 Impact factor: 32.976
Authors: Daniel Y C Heng; Wanling Xie; Meredith M Regan; Lauren C Harshman; Georg A Bjarnason; Ulka N Vaishampayan; Mary Mackenzie; Lori Wood; Frede Donskov; Min-Han Tan; Sun-Young Rha; Neeraj Agarwal; Christian Kollmannsberger; Brian I Rini; Toni K Choueiri Journal: Lancet Oncol Date: 2013-01-09 Impact factor: 41.316
Authors: Daniel Y C Heng; Wanling Xie; Meredith M Regan; Mark A Warren; Ali Reza Golshayan; Chakshu Sahi; Bernhard J Eigl; J Dean Ruether; Tina Cheng; Scott North; Peter Venner; Jennifer J Knox; Kim N Chi; Christian Kollmannsberger; David F McDermott; William K Oh; Michael B Atkins; Ronald M Bukowski; Brian I Rini; Toni K Choueiri Journal: J Clin Oncol Date: 2009-10-13 Impact factor: 44.544