Efficacy And Safety Of Domestic Bortezomib And Brand Name Bortezomib In The Treatment Of Newly Diagnosed Multiple Myeloma

ObjectiveProteasome inhibitor(PIs)has become the cornerstone drug for the treatment of multiple myeloma(MM)because of its unique ubiquitin effect.The first generation of proteasome inhibitor,represented by Velcade,significantly improved the prognosis and survival of MM patients.Because of its high price,MM patients can not afford it in some developing countries.Since the launch of domestic bortezomib in 2017,it has provided more choices for clinicians and patients with multiple myeloma,but domestic bortezomib's listing lacks effective and safe clinical research data.The purpose of this study is to observe the efficacy and safety of domestic bortezomib and brand name bortezomib in the treatment with newly diagnosed multiple myeloma(NDMM).MethodsFrom May 2017 to February 2019,176 patients with NDMM in our hospital?first affiliated hospital of XinXiang medical college and HuaiHe hospital of HeNan university,were collected and divided into two groups(88 cases received Xintai,88cases received Wanke).All patients were treated with bortezomib+thalidomide+dexamethasone(VTD)regimen,the specific dose:V1.3mg/m~2 d1,4,8,11 subcutaneous injection;T 100mg oral before sleep;D 10-20mg/d d1-2,4-5,8-9,11-12 intravenous drip,1 course of treatment every 21 days.To study the efficacy and safety of domestic bortezomib(Xintai)in patients with NDMM,the overall response rate(ORR),?very good partial remission(VGPR)rate and complete remission(CR)rate between the two groups after 2?4 and 6 courses of VTD regimen were compared;ORR,?VGPR and CR,in different revised international staging system(RISS)stage groups and age groups were also compared.Moreover,the adverse reactions between two groups were recorded and compared.ResultsDomestic bortezomib(Xintai)group and brand name bortezomib(Wanke)group were comparable in sex?age?M protein type?Durie-Salmon stage?International staging system stage?Revised international staging system stage?renal function?plasma cell load,viral hepatitis B?extramedullary infiltration?myelofibrosis and cytogenetic.In domestic bortezomib(Xintai)group,ORR??VGPR and CR were64.77%?23.86%and 5.68%respectively after 2 courses of treatment;ORR??VGPR and CR were 65.91%?45.45%and 25.00%respectively after 4 courses of treatment;ORR??VGPR and CR were 91.67%?66.67%and 41.67%respectively after 6 courses of treatment.In brand name bortezomib(Wanke),ORR??VGPR and CR were55.68%?25.00%and 13.64%respectively after 2 courses of treatment;ORR??VGPR and CR were 55.88%?35.29%and 16.18%respectively after 4 courses of treatment;ORR??VGPR and CR were 88.46%?69.23%and 46.15%respectively after 6 courses of treatment.After 2?4 and 6 courses of VTD,there was no significant difference in ORR??VGPR and CR(P>0.05).With the increase of the number of courses,ORR??VGPR and CR increased in both groups,and the increase of?VGPR and CR in domestic bortezomib(Xintai)group was significantly higher in 4 courses than that in2 courses(P<0.05).In brand name bortezomib(Wanke)group,the increase of ORR??VGPR and CR in 6 courses was significantly higher than that in 4 courses(P<0.05).There was no significant difference in ORR??VGPR and CR between domestic bortezomib(Xintai)group and brand name bortezomib(Wanke)group in different RISS stgge groups and different age groups(P>0.05).There was no significant difference in the incidence of thrombocytopenia?neutropenia?digestive tract reaction?peripheral neuropathy?infection and rash between the two groups(P>0.05).ConclusionThe curative effects on NDMM were equivalent between domestic bortezomib and brand name bortezomib;the maximum therapeutic effect occurred after four or more courses of VTD regimen;the toxic and side effects of two groups were similar;domestic bortezomib was less expensive and more economical than brand name bortezomib.