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

Efficacy of nilotinib in the first-line treatment of chronic myeloid leukemia and the analysis of factors affecting molecular responses

目的探讨尼洛替尼一线治疗慢性髓性白血病(CML)的疗效及安全性,并分析影响实现主要分子学反应的因素。方法回顾性分析郑州大学附属肿瘤医院2014年1月至2017年6月收治的86例新诊断为CML的患者,均接受尼洛替尼300 mg每日两次作为一线治疗,其中男性49例,女性37例。结果12个月时获主要分子学反应(MMR)、分子学反应4(MR4)、分子学反应4.5(MR4.5)的患者比例分别为59.3%、22.1%、15.1%;24个月时,获MMR、MR4、MR4.5的患者比例分别为76.2%、44.0%、27.4%。中位随访42(21~66)个月,中位无进展生存(PFS)时间为42(9~66)个月,PFS率为93%。BCR-ABLIS融合基因较诊断时下降一半所需要的时间定义为减半时间(HT),HT是CML患者12个月能否达到MMR(OR=0.896,P<0.001)及MR4.5(OR=0.377,P=0.003)的影响因素。非血液学不良反应中最常见的为皮疹(37.2%)和头痛(32.6%),大多数为1/2级,血液学不良反应主要为中性粒细胞减少(27.9%)和血小板减少(32.4%)。结论尼洛替尼一线治疗CML具有较优的有效性和安全性,HT≤13.68 d可能是长期无进展生存的保护因素。

Objectives 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.