| Title | Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study |
| Authors | Zhang, Li Meng, Li Liu, Bingcheng Zhang, Yanli Zhu, Huanling Cui, Jiuwei Sun, Aining Hu, Yu Jin, Jie Jiang, Hao Zhang, Xi Li, Yan Liu, Li Zhang, Wanggang Liu, Xiaoli Gu, Jian Qiao, Jianhui Ouyang, Guifang Liu, Xin Luo, Jianmin Jiang, Ming Xie, Xiaobao Li, Jianyong Zhao, Chunting Zhang, Mei Yang, Tonghua Wang, Jianxiang |
| Affiliation | Chinese Acad Med Sci, Natl Clin Res Ctr Blood Dis, Inst Hematol, State Key Lab Expt Hematol, Tianjin, Peoples R China Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China Henan Canc Hosp, Zhengzhou, Henan, Peoples R China Sichuan Univ, West China Coll Med, Chengdu, Sichuan, Peoples R China First Hosp Jilin Univ, Changchun, Jilin, Peoples R China Soochow Univ, Jiangsu Inst Hematol, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China Zhejiang Univ, Affiliated Hosp 1, Hangzhou, Zhejiang, Peoples R China Peking Univ, Peking Univ Peoples Hosp, Inst Hematol, Beijing, Peoples R China Army Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China China Med Univ, Hosp 1, Shenyang, Peoples R China Fourth Mil Med Univ, Tangdu Hosp, Xian, Shaanxi, Peoples R China Xi An Jiao Tong Univ, Affiliated Hosp 2, Xian, Shaanxi, Peoples R China Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China Yangzhou Univ, Yangzhou Inst Hematol, Clin Med Coll, Yangzhou, Jiangsu, Peoples R China 307th Hosp Mil Chinese Peoples Liberat Army, Beijing, Peoples R China Ningbo First Hosp, Ningbo, Zhejiang, Peoples R China AnHui Prov Hosp, Hefei, Anhui, Peoples R China Hebei Med Univ, Hosp 2, Shijiazhuang, Hebei, Peoples R China Xinjiang Med Univ, Affiliated Hosp 1, Urumqi, Peoples R China First Peoples Hosp Changzhou, Changzhou, Jiangsu, Peoples R China Nanjing Med Univ, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China Qingdao Univ, Affiliated Hosp, Qingdao, Shandong, Peoples R China Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Shaanxi, Peoples R China First Peoples Hosp Yunnan Prov, Kunming, Yunnan, Peoples R China |
| Keywords | HARMONIZING CURRENT METHODOLOGY BCR-ABL TRANSCRIPTS FOLLOW-UP MOLECULAR RESPONSE DASATINIB THERAPY CML RECOMMENDATIONS NILOTINIB SURVIVAL |
| Issue Date | 1-Jan-2021 |
| Publisher | CLINICAL CANCER RESEARCH |
| Abstract | Purpose Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. We evaluated the efficacy and safety of flumatinib versus imatinib, for first-line treatment of chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML-CP). Patients and Methods: In this study, 394 patients were randomized 1:1 to flumatinib 600 mg once daily (n = 196) or imatinib 400 mg once daily (n = 198) groups. Results: The rate of major molecular response (MMR) at 6 months (primary endpoint) was significantly higher with flumatinib than with imatinib (33.7% vs. 18.3%; P = 0.0006), as was the rate of MMR at 12 months (52.6% vs. 39.6%; P = 0.0102). At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs. 53.3%; P < 0.0001). Compared with patients receiving imatinib, more patients receiving flumatinib achieved molecular remission 4 (MR4) at 6, 9, and 12 months (8.7% vs. 3.6%, P = 0.0358; 16.8% vs. 5.1%, P = 0.0002; and 23.0% vs. 11.7%, P = 0.0034, respectively). No patients had progression to accelerated phase or blast crisis in the flumatinib arm versus 4 patients in the imatinib arm by 12 months. Adverse events of edema, pain in extremities, rash, neutropenia, anemia, and hypophosphatemia were more frequent in imatinib arm, whereas diarrhea and alanine transaminase elevation were more frequent in flumatinib arm. Conclusions: Patients receiving flumatinib achieved significantly higher rates of responses, and faster and deeper responses compared with those receiving imatinib, indicating that flumatinib can be an effective first-line treatment for CML-CP. |
| URI | http://hdl.handle.net/20.500.11897/603233 |
| ISSN | 1078-0432 |
| DOI | 10.1158/1078-0432.CCR-20-1600 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
