Takaku Tomoiku, Iriyama Noriyoshi, Mitsumori Toru, Sato Eriko, Gotoh Akihiko, Kirito Keita, Noguchi Masaaki, Koike Michiaki, Sakamoto Junichi, Oba Koji, Komatsu Norio
Department of Hematology, Juntendo University School of Medicine, Tokyo, Japan.
Oncology. 2018;94(2):85-91. doi: 10.1159/000481945. Epub 2017 Nov 18.
The use of tyrosine kinase inhibitors led to an improvement in the prognoses of patients with chronic myeloid leukemia (CML). The aims of this study were to investigate the efficacy and safety of dasatinib in Japanese patients and to explore the factors that affect the achievement of molecular responses.
The primary endpoint was a major molecular response (MMR) by 12 months. The halving time for BCR-ABL1 transcripts was calculated using transcript levels.
Thirty-two patients with chronic-phase CML (CML-CP) were enrolled and 30 received 100 mg dasatinib once daily. At 24 months of follow-up, 21 (72%) and 24 (83%) patients achieved an MMR by 12 and 24 months, respectively; the rates of a deep molecular response (DMR) by 12 and 24 months were 48 and 59%, respectively. A shorter halving time of BCR-ABL1 transcripts (≤10.6 days) accurately predicted both an MMR and a DMR. The incidence of pleural effusion was 50%. Our study reconfirmed the efficacy and safety of dasatinib treatment in Japanese patients with newly diagnosed CML-CP. In addition, the usefulness of the halving time of BCR-ABL1 transcripts was validated.
These data emphasize the significance of an early treatment response in achieving a DMR during dasatinib therapy.
酪氨酸激酶抑制剂的使用改善了慢性髓性白血病（CML）患者的预后。本研究旨在调查达沙替尼对日本患者的疗效和安全性，并探索影响分子反应达成的因素。
主要终点是12个月时的主要分子反应（MMR）。使用转录本水平计算BCR-ABL1转录本的半衰期。
32例慢性期CML（CML-CP）患者入组，30例患者接受每日一次100mg达沙替尼治疗。在随访24个月时，分别有21例（72%）和24例（83%）患者在12个月和24个月时达到MMR；12个月和24个月时的深层分子反应（DMR）率分别为48%和59%。BCR-ABL1转录本较短的半衰期（≤10.6天）可准确预测MMR和DMR。胸腔积液的发生率为50%。我们的研究再次证实了达沙替尼治疗日本新诊断CML-CP患者的疗效和安全性。此外，BCR-ABL1转录本半衰期的实用性得到了验证。
这些数据强调了早期治疗反应在达沙替尼治疗期间实现DMR的重要性。
