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Lancet Haematol. 2015 Dec;2(12):e528-35. doi: 10.1016/S2352-3026(15)00196-9. Epub 2015 Nov 10.

Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial.

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Department of Haematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Department of Haematology, Hiroshima City Asa Hospital, Hiroshima, Japan.
Division of Haematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Department of Haematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Department of Haematology and Oncology, Iwate Medical University, Morioka, Japan.
Department of Haematology, Ohme Municipal General Hospital, Tokyo, Japan.
Department of Internal Medicine, Fujimoto Sogo Hospital, Miyakonojo, Japan.
Haematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Centre Komagome Hospital, Tokyo, Japan.
Division of Haematology and Oncology, Japanese Red Cross Narita Hospital, Narita, Japan.
Department of Haematology, Matsushita Memorial Hospital, Moriguchi, Osaka, Japan.
Department of Haematology, Japanese Red Cross Medical Centre, Tokyo, Japan.
Division of Blood Transfusion and Division of Medical Oncology and Haematology, Kobe University Hospital, Kobe, Japan.
Department of Haematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Division of Haematology and Immunology, Otsu Red Cross Hospital, Otsu, Japan.
Department of Haematology, Shinko Hospital, Kobe, Japan.
Department of Haematology, Shiga Medical Centre for Adults, Moriyama, Japan.
Division of Haematology, National Kyushu Cancer Centre, National Hospital Organisation, Fukuoka, Japan.
Fourth Department of Internal Medicine, Sapporo Medical, University School of Medicine, Sapporo, Japan.
Department of Haematology, Teine Keijinkai Hospital, Sapporo, Japan.
Division of Haematology, NTT Medical Centre Tokyo, Tokyo, Japan.
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
NPO Epidemiological and Clinical Research Information Network (ECRIN), Okazaki, Japan.
Division of Haematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. Electronic address:



First-line imatinib treatment can be successfully discontinued in patients with chronic myeloid leukaemia after deep molecular response has been sustained for at least 2 years. We investigated the safety and efficacy of discontinuing second-line or subsequent dasatinib after at least 1 year of deep molecular response.


The Dasatinib Discontinuation trial was a prospective multicentre trial done in Japan. Eligible patients taking dasatinib and with confirmed stable deep molecular response were enrolled between April 1, 2011, and March 31, 2012. All patients received dasatinib consolidation therapy for at least 1 year. In those with sustained deep molecular response, dasatinib was discontinued. Patients were followed up every month in year 1 (clinical cutoff), every 3 months in year 2, and every 6 months in year 3 for deep molecular response and immunological profiles. The primary endpoint was the proportion of patients with treatment-free remission at 6 months after discontinuation. Molecular relapse was defined as loss of deep molecular response at any assessment. This study is registered, number UMIN000005130.


88 patients were enrolled in the consolidation phase, 24 were excluded from the discontinuation phase due to fluctuations in BCR-ABL1 transcript levels. One patient was excluded because of positive expression of major and minor BCR-ABL1 transcripts in chronic myeloid leukaemia cells and the detection of minor BCR-ABL1 transcripts during consolidation. Thus, 63 patients discontinued dasatinib treatment. The 25 patients who were excluded from discontinuation continued to receive dasatinib and none showed disease progression. Median follow-up was 20.0 months (IQR 16.5-24.0). Of the 63 patients who discontinued and were not excluded, 30 patients maintained deep molecular response while 33 patients had molecular relapses, all within the first 7 months after discontinuation. The estimated overall treatment-free remission was 49% (95% CI 36-61) at 6 months. No severe treatment-related toxic effects were seen. Treatment was restarted in the 33 patients with relapse; rapid molecular responses were seen in all 33 patients, of whom 29 (88%) regained deep molecular response within 3 months, as did the remaining four by 6 months.


Dasatinib discontinuation after sustained deep molecular response for more than 1 year is feasible.


Epidemiological and Clinical Research Information Network (ECRIN).

[Indexed for MEDLINE]

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