比较新诊断的慢性髓性白血病患者使用仿制药伊马替尼和品牌药伊马替尼的疗效和安全性，并考虑社会经济特征：来自单个中心的回顾性研究。
Comparable Efficacy and Safety of Generic Imatinib and Branded Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia With a Consideration of Socioeconomic Characteristics: A Retrospective Study From a Single Center.
机构信息
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China.
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, Beijing, China; Research Unit of Key Technique for Diagnosis and Treatments of Hematologic Malignancies, Chinese Academy of Medical Sciences, Beijing, China.
出版信息
Clin Lymphoma Myeloma Leuk. 2020 Jun;20(6):e304-e315. doi: 10.1016/j.clml.2020.01.009. Epub 2020 Jan 27.
INTRODUCTION
To compare the efficacy and safety of generic and branded imatinib in adults with newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP), we retrospectively reviewed data from patients CML-CP who received generic or branded imatinib.
PATIENTS AND METHODS
A propensity score matching (PSM) study was performed. A Cox regression model was used to identify factors associated with responses and outcomes.
RESULTS
Four hundred forty-two adults receiving generic imatinib (n = 236) or Glivec (Novartis, Basel, Switzerland; n = 206) were included. There were more patients with rural household registration (P < .001), lower education level (P < .001), divorced or widowed status (P = .009), higher white blood cell counts (P = .019), splenomegaly (P < .001), and longer intervals from diagnosis to imatinib initiation (P = .033) in the generic cohort. During the follow-up, there was no significant difference between the 2 cohorts in the 4-year probabilities of achieving a complete cytogenetic response (97.0% vs. 97.3%; P = .736), major molecular response (87.8% vs. 90.1%; P = .113), and molecular response (32.5% vs. 38.8%; P = .186), as well as failure-free survival (77.3% vs. 81.4%; P = .313), progression-free survival (94.4% vs. 95.8%; P = .489), and overall survival (96.8% vs. 98.3%; P = .088). Multivariate analyses showed that the drug type was not associated with responses and outcomes. After the PSM procedure, 177 pairs of patients with comparable baseline characteristics were reanalyzed. Multivariate analyses confirmed that generic or branded imatinib used as first-line therapy was not associated with either responses or outcomes.
CONCLUSION
Sociodemographic characteristics might influence the tyrosine kinase inhibitor that patients chose. Generic and branded imatinib as first-line therapy had comparable efficacy and safety in CML-CP patients.
简介
为了比较新诊断的慢性髓性白血病慢性期（CML-CP）成人患者中通用和品牌伊马替尼的疗效和安全性，我们回顾性分析了接受通用或品牌伊马替尼治疗的 CML-CP 患者的数据。
方法
进行了倾向评分匹配（PSM）研究。使用 Cox 回归模型确定与反应和结局相关的因素。
结果
共纳入 442 例接受通用伊马替尼（n=236）或格列卫（瑞士巴塞尔诺华公司；n=206）的成年人。通用组患者中农村户籍（P<0.001）、受教育程度较低（P<0.001）、离异或丧偶状态（P=0.009）、白细胞计数较高（P=0.019）、脾肿大（P<0.001）、从诊断到伊马替尼开始的时间间隔较长（P=0.033）的患者更多。在随访期间，2 组患者在 4 年达到完全细胞遗传学反应的概率（97.0%对 97.3%；P=0.736）、主要分子反应（87.8%对 90.1%；P=0.113）和分子反应（32.5%对 38.8%；P=0.186）、无失败生存（77.3%对 81.4%；P=0.313）、无进展生存（94.4%对 95.8%；P=0.489）和总生存（96.8%对 98.3%；P=0.088）无显著差异。多变量分析显示，药物类型与反应和结局无关。在 PSM 程序后，重新分析了 177 对具有相似基线特征的患者。多变量分析证实，作为一线治疗的通用或品牌伊马替尼与反应或结局无关。
结论
社会人口统计学特征可能影响患者选择的酪氨酸激酶抑制剂。通用和品牌伊马替尼作为一线治疗在 CML-CP 患者中具有相似的疗效和安全性。
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