|Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study|
|Qin, Shukui1; Bi, Feng2; Jin, Jie3; Cheng, Ying4; Guo, Jun5; Ren, Xiubao6; Huang, Yiran7; Tarazi, Jamal8; Tang, Jie9; Chen, Connie9; Kim, Sinil8; Ye, Dingwei10|
|关键词||Axitinib Renal Cell Carcinoma Sorafenib Vascular Endothelial Growth Factor Receptor Inhibitor|
|刊名||ONCOTARGETS AND THERAPY|
|WOS标题词||Science & Technology|
|类目[WOS]||Biotechnology & Applied Microbiology ; Oncology|
|研究领域[WOS]||Biotechnology & Applied Microbiology ; Oncology|
|关键词[WOS]||JAPANESE PATIENTS ; PHASE-II ; OPEN-LABEL ; PROGNOSTIC-FACTORS ; CLINICAL-PRACTICE ; KIDNEY CANCER ; AXIS TRIAL ; EFFICACY ; SAFETY ; SUNITINIB|
Background: This registrational trial evaluated the efficacy, safety, and patient-reported outcomes of axitinib versus sorafenib as a second-line treatment in Asian patients with clear-cell metastatic renal cell carcinoma (mRCC).
Methods: In this open-label, multicenter study, previously treated Asian patients with clear-cell mRCC were stratified by Eastern Cooperative Oncology Group performance status and prior therapy and randomized in a 2:1 ratio to receive axitinib (5 mg twice daily) or sorafenib (400 mg twice daily). The primary end point was progression-free survival (PFS) assessed by a masked independent review committee.
Results: A total of 204 Asian patients received axitinib (n=135) or sorafenib (n=69). Median PFS (95% confidence interval [CI]) was 6.5 (4.7-9.1) months with axitinib versus 4.8 (3.0-6.5) months with sorafenib (hazard ratio, 0.731; 95% CI, 0.506-1.058; one-sided P=0.0531). The objective response rate (95% CI) was 23.7% (16.8%-31.8%) with axitinib versus 10.1% (4.2%-19.8%) with sorafenib. Common, grade >= 3, all-causality adverse events were hypertension (19.3%), weight decrease (5.2%), and proteinuria (5.2%) with axitinib and hypertension (8.7%) and palmar-plantar erythrodysesthesia (7.2%) with sorafenib. In a time-to-deterioration composite end point of death, progression, and worsening of Functional Assessment of Cancer Therapy Kidney Symptom Index score, patients treated with axitinib demonstrated a 17%-24% risk reduction compared with sorafenib-treated patients.
Conclusion: Axitinib is clinically active and well tolerated in previously treated Asian patients with mRCC, consistent with the results from the global Phase III trial. These results establish axitinib as a second-line treatment option for Asian patients with mRCC.
|作者单位||1.Peking Univ, Hosp 1, Dept Urol, Beijing 100871, Peoples R China|
2.Tianjin Oncol Hosp, Dept Biol Treatment, Tianjin, Peoples R China
3.Pfizer Oncol, Clin Dev, San Diego, CA USA
4.Pfizer Inc, Global Outcomes Res, New York, NY USA
5.Nanjing Bayi Hosp, PLA Canc Ctr, Dept Med Oncol, Nanjing, Jiangsu, Peoples R China
6.Sichuan Univ, West China Hosp, Dept Med Oncol, Chengdu 610064, Sichuan Provinc, Peoples R China
7.Jilin Prov Canc Hosp, Dept Oncol, Changchun, Jilin Province, Peoples R China
8.Peking Univ, Canc Hosp Inst, Dept Renal Canc & Melanoma, Beijing 100871, Peoples R China
9.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Urol, Shanghai 200030, Peoples R China
10.Fudan Univ, Shanghai Canc Ctr, Dept Urol, Shanghai 200032, Peoples R China
|Qin, Shukui,Bi, Feng,Jin, Jie,et al. Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study[J]. ONCOTARGETS AND THERAPY,2015,8.|
|APA||Qin, Shukui.,Bi, Feng.,Jin, Jie.,Cheng, Ying.,Guo, Jun.,...&Ye, Dingwei.(2015).Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study.ONCOTARGETS AND THERAPY,8.|
|MLA||Qin, Shukui,et al."Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study".ONCOTARGETS AND THERAPY 8(2015).|