Treatment of chronic-phase chronic myeloid leukemia in patients randomized to dasatinib or imatinib after suboptimal responses to three months of imatinib therapy: final 5-year results from DASCERN
Jorge E. Cortes,
Qian Jiang,
Jianxiang Wang,
Jianyu Weng,
Huanling Zhu,
Xiaoli Liu,
Andreas Hochhaus,
Dong-Wook Kim,
Jerald Radich,
Michael Savona,
Patricia Martin-Regueira,
Oumar Sy,
Giuseppe Saglio
Affiliations
Jorge E. Cortes
Department of Medicine, Georgia Cancer Center at Augusta University, Augusta, GA
Qian Jiang
Department of Hematology, Peking University People’s Hospital, Beijing
Jianxiang Wang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin
Jianyu Weng
Department of Hematology, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou
Huanling Zhu
Department of Hematology, West China Hospital of Sichuan University, Chengdu
Xiaoli Liu
Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou
Early molecular response (EMR) at 3 months is predictive of improved overall survival (OS) and progression-free survival (PFS) in patients with chronic myeloid leukemia in the chronic phase (CML-CP). Although about one-third of patients treated with first-line imatinib do not achieve EMR, long-term OS and PFS are still observed in most patients. DASCERN (NCT01593254) is a prospective, phase IIb, randomized trial evaluating a switch to dasatinib in patients who have not achieved EMR after 3 months of treatment with first-line imatinib. Early analysis demonstrated an improved major molecular response (MMR) rate at 12 months with dasatinib versus imatinib (29% vs. 13%, P=0.005). Here, we report results from the final 5-year follow-up. In total, 174 patients were randomized to dasatinib and 86 to remain on imatinib. Forty-six (53%) patients who remained on imatinib but subsequently experienced failure were allowed to cross over to dasatinib per protocol. At a minimum follow-up of 60 months, the cumulative MMR rate was significantly higher in patients randomized to dasatinib versus imatinib (77% vs. 44%, P
