ObjectiveTo investigate the efficacy and safety of domestic bortezomib in treatment of patients with multiple myeloma (MM).
MethodsFrom January to December 2018, clinical case data of 28 MM patients who were treated with domestic bortezomib in Department of Hematology, First Affiliated Hospital of Xi′an Jiaotong University were enrolled in the study. Fourteen patients were male and 14 were female. Mean age was 60 years old (46-75 years old). Patients were treated with PCD (bortezomib+ cyclophosphamide+ dexamethasone) or PAD (bortezomib+ doxorubicin+ dexamethasone) regimens in 28 d as a course. Patients had received 2-8 courses. The bortezomib used in this study was domestic bortezomib. The clinical features, efficacy and adverse events of MM patients were analyzed retrospectively. This study met the requirements ofWorld Medical Association Declaration of Helsinkirevised in 2013.
Results① After treatment, among 28 MM patients, 16 cases had different degrees of remission, 10 cases were stable disease (SD), 2 cases were progressive disease (PD), objective response rate (ORR) was 57.1%(16/28) and effective rate was 92.8%(26/28). Complete remission (CR) rate of 28 MM patients was 21.4%(6/28), very good partial remission (VGPR) rate was 14.3%(4/28), and partial remission (PR) rate was 21.4%(6/28). ② After treatment of domestic bortezomib, main adverse events were paresthesia in the extremities and incidence rate was 35.7%(10/28). Incidence rates of leukopenia, thrombocytopenia, weak, constipation and diarrheal were 14.3%(4/28). Incidence rates of pulmonary infection, herpes zoster virus infection, dizziness, renal dysfunction and rash were 7.1%(2/28), and these symptoms were relieved after symptomatic treatment. One patient (3.5%) developed recurrent palpitations and discontinued treatment. Adverse events were Ⅰ-Ⅱstage, except 2 patients had Ⅲ-Ⅳ stage leukopenia.
ConclusionsDomestic bortezomib is effective and safe in the treatment of MM patients through preliminary evaluation. However, this study is a retrospective study with certain limitations.
