Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.
机构:[1]Georgia Cancer Center, Augusta University, Augusta, GA, USA[2]Peking University People’s Hospital, Beijing, China[3]Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China[4]Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China[5]West China Hospital of Sichuan University, Chengdu, Sichuan, China四川大学华西医院[6]Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China[7]Universitätsklinikum Jena, Jena, Germany[8]The Catholic University of Korea, Seoul, Republic of Korea[9]Fred Hutchinson Cancer Research Center, Seattle, WA, USA[10]Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA[11]Bristol Myers Squibb, Princeton, NJ, USA[12]University of Turin, Turin, Italy
Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.
基金:
This study was sponsored and funded by Bristol
Myers Squibb.
第一作者机构:[1]Georgia Cancer Center, Augusta University, Augusta, GA, USA
通讯作者:
推荐引用方式(GB/T 7714):
Jorge E. Cortes,Qian Jiang,Jianxiang Wang,et al.Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.[J].LEUKEMIA.2020,34(8):2064-2073.doi:10.1038/s41375-020-0805-1.
APA:
Jorge E. Cortes,Qian Jiang,Jianxiang Wang,Jianyu Weng,Huanling Zhu...&Giuseppe Saglio.(2020).Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study..LEUKEMIA,34,(8)
MLA:
Jorge E. Cortes,et al."Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.".LEUKEMIA 34..8(2020):2064-2073