Nakamae Hirohisa, Yamamoto Masahide, Sakaida Emiko, Kanda Yoshinobu, Ohmine Ken, Ono Takaaki, Matsumura Itaru, Ishikawa Maho, Aoki Makoto, Maki Akio, Shibayama Hirohiko
Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
Department of Hematology, Medical Hospital of Tokyo Medical and Dental University, Tokyo, Japan.
Int J Hematol. 2022 Jan;115(1):33-42. doi: 10.1007/s12185-021-03216-5. Epub 2021 Sep 11.
In the 10-year analysis of Japanese patients with newly diagnosed CML-CP in the ENESTnd trial, nilotinib yielded higher cumulative response rates. There were no new occurrences of disease progression or deaths since the 5-year analysis. Cumulative 10-year rates of MMR and MR were higher in the nilotinib arms [300 mg twice daily (BID), 86.2% and 69.0%, respectively; 400 mg BID, 78.3% and 69.6%, respectively] than the imatinib arm (400 mg once daily, 60.0% and 48.0%, respectively). Nasopharyngitis (85.7%, 77.3%, 79.2%), rash (50.0%, 68.2%, 37.5%), headache (39.3%, 45.5%, 25.0%), and back pain (39.3%, 50.0%, 29.2%) were the most frequently reported all-grade adverse events (AEs) for nilotinib 300 and 400 mg BID and imatinib, respectively. Cardiovascular AEs were more common with nilotinib than with imatinib. More patients on nilotinib had pre-diabetic and diabetic levels of HbA1c (300 mg BID, 17.9% and 10.7%, respectively; 400 mg BID, 22.7% and 18.2%, respectively) compared with imatinib (4.2% each). Overall, 10-year results from the Japanese cohort are consistent with prior results from the full ENESTnd cohort and the Japanese subgroup, and continue to support the long-term use of nilotinib in Japanese patients with newly diagnosed CML-CP, but with proper monitoring and management of comorbidities.
在ENESTnd试验中对日本新诊断慢性期慢性髓性白血病（CML-CP）患者进行的10年分析中，尼罗替尼产生了更高的累积缓解率。自5年分析以来，没有新的疾病进展或死亡病例出现。尼罗替尼治疗组（每日两次300mg，分别为86.2%和69.0%；每日两次400mg，分别为78.3%和69.6%）的10年累积主要分子学缓解（MMR）率和分子学缓解（MR）率高于伊马替尼治疗组（每日一次400mg，分别为60.0%和48.0%）。鼻咽炎（85.7%、77.3%、79.2%）、皮疹（50.0%、68.2%、37.5%）、头痛（39.3%、45.5%、25.0%）和背痛（39.3%、50.0%、29.2%）分别是尼罗替尼每日两次300mg和400mg以及伊马替尼最常报告的所有级别的不良事件（AE）。尼罗替尼的心血管不良事件比伊马替尼更常见。与伊马替尼（各4.2%）相比，更多接受尼罗替尼治疗的患者糖化血红蛋白（HbA1c）处于糖尿病前期和糖尿病水平（每日两次300mg，分别为17.9%和10.7%；每日两次400mg，分别为22.7%和18.2%）。总体而言，日本队列的10年结果与整个ENESTnd队列和日本亚组先前的结果一致，并继续支持尼罗替尼在日本新诊断CML-CP患者中的长期使用，但需对合并症进行适当监测和管理。
