[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-ALB(IS)≤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.