Final 3-year Results of the Dasatinib Discontinuation Trial in Patients With Chronic Myeloid Leukemia Who Received Dasatinib as a Second-line Treatment.
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Okada Masaya, 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
Аннотация
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.