尼洛替尼一线治疗慢性髓性白血病的疗效及影响实现分子学反应的因素分析

OBJECTIVE: This study aimed to investigate the efficacy and safety of nilotinib as the first-line treatment for patients with chronic myelogenous leukemia (CML) and analyze the factors affecting the realization of the major molecular response. METHODS: A retrospective study was conducted on 86 newly diagnosed CML patients from the Affiliated Cancer Hospital of Zhengzhou University from January 2014 to June 2017, who were using nilotinib 300 mg, twice a day, as the first-line treatment. There were 49 males and 37 females. RESULTS: At 12 months, the MMR, MR4, and MR4.5 rates were 59.3%, 22.1%, and 15.1%, respectively. At 24 months, the MMR, MR4, and MR4.5 rates were 76.2%, 44.0%, and 27.4%, respectively.The median follow-up time was 42 months (range, 21–66 months). The median progression-free survival time (PFS) was 42 months (range, 9–66 months) at a PFS rate of 93%. The time required for BCR-ABL transcript to decrease by half compared with the diagnosis was defined as the halving time (HT). HT was the influencing factor of the 12-month MMR (OR=0.896, P<0.001) and MR4.5 (OR=0.377, P=0.003). The most common non-hematologic adverse reactions were rash (37.2%) and headache (32.6%), and most were grade 1/2. The most common hematologic adverse reactions were mainly neutropenia (27.9%) and thrombocytopenia (32.4%). CONCLUSION: Nilotinib was an effective and safe first-line treatment for CML patients. HT ≤ 13.68 days is protective factor for long-term progression-free survival.