Ankara City Hospital, Clinic of Hematology, Ankara, Turkey
Çukurova University Faculty of Medicine, Department of Hematology, Ankara, Turkey
Turk J Haematol. 2022 Aug 25;39(3):196-203. doi: 10.4274/tjh.galenos.2022.2022-0024. Epub 2022 May 27.
Achieving an early molecular response (EMR) is crucial for improving the prognosis of patients with chronic myeloid leukemia (CML). The halving time (HT) and reduction ratio (RR) of transcript levels have recently emerged as additional prognostic indexes besides the International Scale (IS). We aimed to investigate the prognostic role of transcript levels, HT, and RR on molecular response kinetics at 3 months in patients with newly diagnosed chronic-phase (CP)-CML.
Forty patients with CP-CML who received first-line imatinib treatment were included in this study. transcript levels and molecular responses at baseline and at 3, 6, 12, and 24 months of treatment were evaluated retrospectively. Major molecular response (MMR) at 12 months and event-free survival (EFS) were determined as primary endpoints and the effects of treatment kinetics on these parameters were examined.
Of the 40 patients, IS was ≤10% at 3 months in 72.5%, representing EMR. The rate of event occurrence was 45.5% in patients with IS of >10%, whereas it was 6.9% in those with IS of ≤10% (p=0.004). MMR was detected in 62.1% of the patients with EMR and in 9.1% of those without EMR (p=0.003). The cut-off value for achieving MMR was 24 days for HT and 0.04 for RR. Deep molecular response (DMR) at 24 months was associated with HT of ≤24 days and RR of ≤0.04. EFS was found to be significantly better in the group with IS of ≤10% and HT of ≤24 days (p=0.001) and in the group with IS of ≤10% and RR of ≤0.04 (p=0.007) compared to others.
Our findings revealed that MMR could be predicted via EMR as well as by HT and RR. Additionally, HT of ≤24 days and RR of ≤0.04 were more important than IS of ≤10% in achieving DMR at 24 months, and the combination of IS of ≤10% with both HT of ≤24 days and RR of ≤0.04 has the best predictive value for EFS.
对于慢性髓性白血病（CML）患者，获得早期分子学反应（EMR）是改善预后的关键。除国际标准（IS）外，转录本水平的减半时间（HT）和减少率（RR）最近已成为额外的预后指标。我们旨在研究新诊断的慢性期（CP）-CML 患者治疗 3 个月时转录本水平、HT 和 RR 对分子反应动力学的预后作用。
本研究纳入了 40 例接受一线伊马替尼治疗的 CP-CML 患者。回顾性评估了基线和治疗 3、6、12 和 24 个月时的转录本水平和分子反应。12 个月时的主要分子反应（MMR）和无事件生存（EFS）作为主要终点，并检查了治疗动力学对这些参数的影响。
在 40 例患者中，3 个月时 IS≤10%的患者占 72.5%，代表 EMR。IS＞10%的患者中，事件发生率为 45.5%，而 IS≤10%的患者为 6.9%（p=0.004）。EMR 患者的 MMR 检出率为 62.1%，而无 EMR 的患者为 9.1%（p=0.003）。达到 MMR 的 HT 截止值为 24 天，RR 为 0.04。24 个月时的深度分子反应（DMR）与 HT≤24 天和 RR≤0.04 相关。与其他患者相比，IS≤10%且 HT≤24 天（p=0.001）和 IS≤10%且 RR≤0.04（p=0.007）的患者 EFS 显著更好。
我们的研究结果表明，通过 EMR 以及 HT 和 RR 可以预测 MMR。此外，在 24 个月时达到 DMR 方面，HT≤24 天和 RR≤0.04 比 IS≤10%更为重要，而 IS≤10%与 HT≤24 天和 RR≤0.04 的联合具有最佳的 EFS 预测价值。
