Xinan Sheng1, Feng Bi2, Xiubao Ren3, Ying Cheng4, Jinwan Wang5, Brad Rosbrook6, Ming Jiang7, Jun Guo1. 1. Key Laboratory of Carcinogenesis & Translational Research (Ministry of Education/Beijing), Department of Renal Cancer & Melanoma, Peking University Cancer Hospital & Institute, Beijing, PR China. 2. Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, PR China. 3. Department of Biology Treatment, Tianjin Oncology Hospital, Tianjin, PR China. 4. Department of Oncology, Jilin Provincial Cancer Hospital, Changchun, Jilin Province, PR China. 5. Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, PR China. 6. Pfizer Oncology, San Diego, CA, USA. 7. Pfizer Oncology Medical Affairs, Shanghai, PR China.
Abstract
AIM: Efficacy/safety of first-line axitinib in Asian patients with metastatic renal cell carcinoma. METHODS: Patients were assigned (2:1) to 5-mg axitinib (n = 48) or 400-mg sorafenib (n = 24) twice daily. Primary end point was progression-free survival. Objective response rate, overall survival and adverse events were also assessed. RESULTS: For axitinib versus sorafenib, hazard ratio for progression-free survival was 0.652 (95% CI: 0.340-1.252; p = 0.0989), objective response rate was higher (35.4 vs 16.7%; p = 0.0495), overall survival longer (hazard ratio: 0.739; 95% CI: 0.397-1.375; p = 0.1683). Palmar-plantar erythrodysesthesia (57.4%), diarrhea (55.3%), hypertension (51.1%) were commonest adverse events with axitinib; palmar-plantar erythrodysesthesia (50.0%) with sorafenib. CONCLUSION: Axitinib improved efficacy in Asian patients with metastatic renal cell carcinoma; adverse events were consistent with previous findings.
RCT Entities:
AIM: Efficacy/safety of first-line axitinib in Asian patients with metastatic renal cell carcinoma. METHODS:Patients were assigned (2:1) to 5-mg axitinib (n = 48) or 400-mg sorafenib (n = 24) twice daily. Primary end point was progression-free survival. Objective response rate, overall survival and adverse events were also assessed. RESULTS: For axitinib versus sorafenib, hazard ratio for progression-free survival was 0.652 (95% CI: 0.340-1.252; p = 0.0989), objective response rate was higher (35.4 vs 16.7%; p = 0.0495), overall survival longer (hazard ratio: 0.739; 95% CI: 0.397-1.375; p = 0.1683). Palmar-plantar erythrodysesthesia (57.4%), diarrhea (55.3%), hypertension (51.1%) were commonest adverse events with axitinib; palmar-plantar erythrodysesthesia (50.0%) with sorafenib. CONCLUSION:Axitinib improved efficacy in Asian patients with metastatic renal cell carcinoma; adverse events were consistent with previous findings.
Entities:
Keywords:
Asian patients; axitinib; progression-free survival; renal cell carcinoma