title: [A comparison of efficacy and safety between Chinese generic imatinib versus branded imatinib in patients with newly-diagnosed chronic myeloid leukemia in the chronic phase: a single-center prospective cohort study].
abstract: Objective:To compare the efficacy and safety between Chinese generic imatinib (Xinwei®, Jiansu Hansoh Pharmaceutical Group Co., Ltd.) versus branded imatinib (Glivec®, Novartis) in patients with newly-diagnosed chronic myeloid leukemia in chronic phase (CML-CP).Methods:Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients' financial capability. The efficacy and adverse effects were evaluated.Results:From January 2014 to September 2015, 145 eligible patients were assigned to Xinwei (n=89) or Glivec (n=56) group. All patients were treated and followed up at least 3 months. At 3 months, the complete response rates were 95.5%(85/89) and 100%(56/56), major cytogenetic response rates were 74.2%(66/89) and 80.4%(45/56), and the proportions of achieving BCR-ALBIS≤10% were 76.1%(67/88) and 82.1%(46/56) in Xinwei and Glivec groups respectively (allP>0.05). With a median follow-up of 12 months, 2 patients in each group progressed to accelerate or blast phase. Hematologic and non-hematologic side effects were similar between the 2 groups.Conclusions:Early hematological, cytogenetic and molecular responses between Xinwei and Glivec are comparable in newly-diagnosed CML-CP patients. The progression rate and side effects are also similar between the 2 groups.
authors.affiliation: Peking University People's Hospital, Peking University Institute of Hematology, Beijing 100044, China.
authors.forename: H X
authors.initials: HX
authors.lastname: Shi
authors.forename: Y Z
authors.initials: YZ
authors.lastname: Qin
authors.forename: Y Y
authors.initials: YY
authors.lastname: Lai
authors.forename: X J
authors.initials: XJ
authors.lastname: Huang
authors.forename: Q
authors.initials: Q
authors.lastname: Jiang
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People / Q000706:statistics & numerical data; D018450:Disease Progression; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate / Q000627:therapeutic use*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D000068877:Imatinib Mesylate