Final 3-year results of the dasatinib discontinuation trial in patients with chronic myeloid leukemia who received dasatinib as a second-line treatment, clin lymphoma

• 森田, 智視

  Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine

• Imagawa, Jun

• Tanaka, Hideo

• Nakamae, Hirohisa

• Hino, Masayuki

• Murai, Kazunori

• Ishida, Yoji

• Kumagai, Takashi

• Sato, Seiichi

• Ohashi, Kazuteru

• Sakamaki, Hisashi

• Wakita, Hisashi

• Uoshima, Nobuhiko

• Nakagawa, Yasunori

• Minami, Yosuke

• Ogasawara, Masahiro

• Takeoka, Tomoharu

• Akasaka, Hiroshi

• Utsumi, Takahiko

• Uike, Naokuni

• Sato, Tsutomu

• Ando, Sachiko

• Usuki, Kensuke

• Mizuta, Syuichi

• Hashino, Satoshi

• Nomura, Tetsuhiko

• Shikami, Masato

• Fukutani, Hisashi

• Ohe, Yokiko

• Kosugi, Hiroshi

• Shibayama, Hirohiko

• Maeda, Yasuhiro

• Fukushima, Toshihiro

• Yamazaki, Hirohito

• Tsubaki, Kazuo

• Kukita, Toshimasa

• Adachi, Yoko

• Nataduka, Toshiki

• Sakoda, Hiroto

• Yokoyama, Hisayuki

• Okamoto, Takahiro

• Shirasugi, Yukari

• Onishi, Yasushi

• Nohgawa, Masaharu

• Yoshihara, Satoshi

• Morita, Satoshi

• Sakamoto, Junichi

• Kimura, Shinya

• DADI Trial Group, Japan

書誌事項

タイトル別名

• Final 3-year Results of the Dasatinib Discontinuation Trial in Patients With Chronic Myeloid Leukemia Who Received Dasatinib as a Second-line Treatment

抄録

Introduction: We previously reported an interim analysis of the DADI (dasatinib discontinuation) trial. The results showed that 48% of patients with chronic myeloid leukemia in the chronic phase who maintained a deep molecular response (DMR) for ≥ 1 year could discontinue second- or subsequent-line dasatinib treatment safely at a median follow-up of 20 months. However, the results from longer follow-up periods would be much more useful from a clinical perspective. Patients and Methods: The DADI trial was a prospective, multicenter trial conducted in Japan. After confirming a stable DMR for ≥ 1 year, dasatinib treatment subsequent to imatinib or nilotinib was discontinued. After discontinuation, the loss of DMR (even of 1 point) was defined as stringent molecular relapse, thereby triggering therapy resumption. The predictive factors of treatment-free remission (TFR) were analyzed. Results: The median follow-up period was 44.0 months (interquartile range, 40.5-48.0 months). The estimated overall TFR rate at 36 months was 44.4% (95% confidence interval, 32.0%-56.2%). Only 2 patients developed a molecular relapse after the 1-year cutoff point. The presence of imatinib resistance was a significant risk factor for molecular relapse. Moreover, high natural killer cell and low γδ+ T-cell and CD4+ regulatory T-cell (CD25+CD127low) counts before discontinuation correlated significantly with successful therapy discontinuation. Conclusion: These findings suggest that discontinuation of second- or subsequent-line dasatinib after a sustained DMR of ≥ 1 year is feasible, especially for patients with no history of imatinib resistance. In addition, the natural killer cell count was associated with the TFR.

収録刊行物

• Clinical Lymphoma Myeloma and Leukemia

  Clinical Lymphoma Myeloma and Leukemia 18 (5), 353-360.e1, 2018-05

  Elsevier BV

キーワード

• CML
• DADI
• Natural killer cell
• Stop trial
• Treatment-free remission

詳細情報

• CRID: 1050282810834206976
• NII論文ID: 120006463738
• ISSN: 21522650
• DOI: 10.1016/j.clml.2018.03.004
• HANDLE: 2433/230949
• Web Site: https://api.elsevier.com/content/article/PII:S215226501731947X?httpAccept=text/xml
• Web Site: https://api.elsevier.com/content/article/PII:S215226501731947X?httpAccept=text/plain
• 本文言語コード: en
• 資料種別: journal article
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