Comparative Study Of Domestic And Original Bortezomib In The First-Line Treatment Of Newly Diagnosed Multiple Myeloma

Objective: The clinical efficacy and safety of domestic and original bortezomib first-line treatment for newly diagnosed multiple myeloma(NDMM)patients were compared,and the factors affecting the clinical efficacy were analyzed,so as to provide theoretical basis for the clinical application of NDMM.Methods: 1.A retrospective analysis was performed on 60 NDMM patients who received bortezomib based chemotherapy in our hospital from January 2017 to September 2020,and they were divided into domestic bortezomib group(33 cases)(observation group)and original bortezomib group(27 cases)(control group).All patients received at least3 courses of regular chemotherapy.2.Collect the information of patients’ gender,age,first consultation department,classification,staging,white blood cell count,hemoglobin concentration,platelet count,lactate dehydrogenase,serum calcium,urea nitrogen,creatinine,beta 2-microglobulin,ferritin,hematuria immune fixation electrophoresis,imaging and ratio of plasma cells,bone marrow biopsy and bone marrow streaming,Fluorescence In Situ Hybridization(FISH)and chemotherapy adverse reactions in order to evaluate the efficacy and safety of bortezomib treatment between the two groups of patients and analyse the factors affecting the efficacy of patients.Results: 1.The complete response(CR)rate was 27.27% in the observation group and 29.63% in the control group,respectively.There was no significant difference in CR rate between the two groups(χ2=0.041,P=0.840).The rate of very good partial response or above(≥VGPR)in the observation group was 54.55%,and the rate of ≥VGPR in the control group was 55.56%,there was no statistical significance(χ2=0.006,P=0.938).The overall response rate(ORR)was 81.82% in the observation group and 77.78% in the control group,and there was no significant difference in ORR between the two groups(χ2=0.041,P=0.840).2.Subgroup analysis:1)According to the times of chemotherapy as stratification,there were no statistical differences in ORR,≥VGPR rate and CR rate between the two groups(P>0.05).However,Regardless of the observation group and the control group,the CR rate and ≥VGPR rate in the 6 courses of chemotherapy group were higher than those in the 3-4 courses of chemotherapy group,and the ≥VGPR rate was statistically different(P<0.05).2)According to age as stratification,there were no significant differences in CR rate and ≥VGPR rate within two groups(P>0.05).3)When R-ISS stage was used as the stratification basis,there were no statistical differences in CR rate and ≥VGPR rate between the observation group and the control group(P>0.05).However,intra-group analysis showed: in the observation group,CR rate and ≥VGPR rate in the patients with R-ISS stage I-II stage were higher than those in the patients with stage III stage,and there was statistical difference in ≥VGPR rate in the control group(P<0.05).4)There were no significant difference in CR rate and ORR between the two groups according to chemotherapy regimen(P>0.05).5)Based on the ferritin content at the time of initial diagnosis as the stratification basis,there were no statistical differences in CR rate and≥VGPR rate between the two groups(P>0.05).When analyzed within the two groups of patients,the CR rate and≥VGPR rate of patients with increased ferritin content at the time of initial diagnosis were lower than those with normal ferritin content,and the≥VGPR rate of the control group was statistically different(P<0.05).3.Safety analysis:Hematological adverse reactions in the course of chemotherapy include leukopenia and thrombocytopenia.Non-hematological adverse reactions include peripheral neuropathy,lung infection,constipation,diarrhea,liver damage,herpes zoster,and skin rash.Peripheral neuropathy was the most common adverse reactionin two groups.1 patient in the observation group was discontinued due to peripheral neuropathy and 1 patient in the control group was discontinued due to liver damage.There was no statistical difference in the incidence of adverse reactions between the observation group and the control group(P>0.05).Conclusion: 1.The clinical efficacy and adverse reactions of domestic bortezomib were similar to those of the original bortezomib based first-line therapy in patients with NDMM.2.The frequency of chemotherapy,R-ISS stage and ferritin level at first diagnosis were the influencing factors for the clinical efficacy of patients with NDMM,while the age of patients and chemotherapy regimen had no effect on the clinical efficacy of NDMM patients.