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
10.3760/cma.j.issn.0578-1426.2016.12.003
- VernacularTitle:国产与原研伊马替尼治疗初发慢性髓性白血病慢性期患者有效性和安全性比较的单中心、前瞻性队列研究
- Author:
Hongxia SHI
;
Yazhen QIN
;
Yueyun LAI
;
Xiaojun HUANG
;
Qian JIANG
- Keywords:
Leukemia,myelogenous,chronic;
Treatment outcome;
Imatinib;
Branded drugs;
Generic drugs
- From:
Chinese Journal of Internal Medicine
2016;55(12):922-926
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the efficacy and safety between Chinese generic imatinib (Xinwei(R),Jiansu Hansoh Pharmaceutical Group Co.,Ltd.) versus branded imatinib (Glivec(R),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 (all P ＞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.
