Department of Hematology Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8603, Japan.
Department of Hematology, National Hospital Organization Disaster Medical Center, Tachikawa, Japan.
Int J Hematol. 2020 Mar;111(3):401-408. doi: 10.1007/s12185-019-02801-z. Epub 2020 Jan 1.
Treatment outcomes for chronic myeloid leukemia (CML) have dramatically improved with the development of tyrosine kinase inhibitors (TKI). However, due to the improved prognosis for CML, problems have arisen from long-term administration of TKI. The present study sought to verify whether more patients could achieve treatment-free remission (TFR) after stopping the administration of dasatinib using dasatinib as frontline treatment. Treatment-naïve chronic phase CML cases were treated with dasatinib as frontline treatment. Dasatinib treatment was stopped for 26 patients who achieved deep molecular response (DMR) within 24 months and were able to maintain DMR for an additional 2 years. Ten patients (38.5%) achieved DMR maintenance after 12 months. Recurrence was confirmed in 16 patients, and the median recurrence-free survival time was 5.1 months. The cumulative DMR rates at six and 12 months after restarting treatment were 84.6% and 100%, respectively. The results of this study demonstrated that the DMR maintenance rate after 12 months was 38.5%, which was not significantly different from previous TKI stop trials. The 2-year dasatinib administration period after reaching DMR did not contribute to improve TFR rates. These results suggest that the type of TKI is not associated with better TFR rates.
随着酪氨酸激酶抑制剂（TKI）的发展，慢性髓性白血病（CML）的治疗效果有了显著改善。然而，由于 CML 的预后得到改善，长期使用 TKI 出现了一些问题。本研究旨在验证使用达沙替尼作为一线治疗时，停止达沙替尼治疗后是否有更多患者可以实现无治疗缓解（TFR）。采用达沙替尼作为一线治疗方案，对未经治疗的慢性期 CML 患者进行治疗。对于在 24 个月内达到深度分子反应（DMR）且能够额外维持 2 年 DMR 的 26 例患者停止达沙替尼治疗。10 例患者（38.5%）在 12 个月后维持 DMR。16 例患者复发，无复发生存时间的中位数为 5.1 个月。重新开始治疗后 6 个月和 12 个月的累积 DMR 率分别为 84.6%和 100%。本研究结果表明，12 个月后的 DMR 维持率为 38.5%，与之前的 TKI 停药试验没有显著差异。达到 DMR 后再使用达沙替尼 2 年并没有提高 TFR 率。这些结果表明，TKI 的类型与更好的 TFR 率无关。
