Efficacy And Safety Evaluation Of Patients With Multiple Myeloma Treated With Domestic Generic Bortezomib Based Chemotherapy

Background and ObjctiveMultiple myeloma(MM),a disease resulted from a proliferation of monoclonal plasma cells,is the second most common hematologic malignancy.The response to treatment and survival of MM patients are heterogeneous.The etiology and pathogenesis are still unclear.With a high incidence rate in elderly people,the disease remains incurable and usually follows a relapsing course.Conventional chemotherapy had failed to show satisfactory results and overall survival was less than 3 years.A study had reported that the complete remission(CR)rate of MM patients treated with original bortezomib plus dexamethasone regimen was 14.8%,and the overall response(OR)rate was 78.5%.Therefore,bortezomib-based induction therapy has been the standard of care for patients due to its remarked activity in MM.However,studies accociated whether patients could benefit from domestic generic bortezomib have been rarely reported.Thus,in this study,we are going to observe the efficacy and safety of domestic generic bortezomib-based therapy in MM patients.MethodsSixty MM patients from April 2018 to February 2019 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed and divided into newly diagnosed MM group(NDMM)and relapsed/refractory MM group(RRMM)according to the stage of disease,meanwhile compared with seventy-five MM patients treated with original bortezomib from October 2016 to April 2018 in the same hospital.All patients were diagnosed and assessed by the criteria of?Chinese Guideline for the Diagnosis and Treatment of Multiple Myeloma(2017 Revised Edition)?.Each patient had accepted at least 2 courses of bortezomib based regimens.All adverse events were graded by the National Cancer Institute Common Terminology Criteria for Adverse Events(version 4.0).Finally,comparision of efficacy was evaluated by pearson chi-square test and Fisher's exact test.The difference was statistically significant if P value was less than 0.05.Result1.Sixty MM patients,in average,had received four cycles of treatment.The overall response rate(OR)was 73.3%,stringent complete remission rate (s CR)and complete remission rate(CR)were 28.3%,very good partial remission rate(VGPR)was 13.3%.There were forty-five patients in NDMM group,the OR rate was 84.4%,s CR/CR rate was 33.3%,VGPR rate was 15.6%.There were fifteen patients in RRMM group,the OR rate was 40%,s CR/CR rate was 13.3%,VGPR rate was 6.7%.The difference of OR rates between both groups was statistically significant(P<0.05).2.The efficacy of bortezomib-based induction was no relation with age, gender,hemoglobin(Hb),serum ?2-microglobulin(?2-MG),serum albumin(Abl),lactate dehydrogenase(LDH),serum creatinine(Scr),platelet(Plt), osteolytic destruction,immunoglobulin type,ISS stage,expression of CD56,CD28,CD81 and cytogenetic abnormality in this univariate analysis(P>0.05).3.Forty-four patients had accepted VTD regimen and sixteen patients had chosen VTCD regimen for therapies,the CR rates of these two subgroups were 25% and 37.5% respectively,the OR rates were 68.2% and 87.5% respectively.There were no significant different between two subgroups after comparision(P>0.05).4.The efficacy of original bortezomib-based treatment for seventy-five NDMM patients who had received four cycles of treatment in average was evaluated,the s CR/CR rate was 34.7%,OR rate was 81.3%.The s CR/CR rate was 46.3% and the OR rate was 90.2% in patients who had received more than four courses of original bortezomib based regimens.The s CR/CR rate was 41.9% and the OR rate was 87.1% in those who had received more than four courses domestic generic bortezomib based regimens.Domestic generic bortezomib had the similar efficacy to original bortezomib in the treatment of newly diagnosed multiple myeloma(P>0.05).5.The frequent adverse events of hematologic toxicities occurred during domestic generic bortezomib based treatment were leukopenia(16.7%)and thrombocytopenia(20.0%),all the levels could recover to baseline during the dosing rest period of each treatment cycle.And the common nonhematologic toxicities were peripheral neuropathy(33.3%,ranging fron grade 1 to 2 events), fatigue(23.3%),nausea or vomiting(18.3%),herpes zoster(5%).The common adverse reactions observed during original bortezomib treatment were leukopenia (22.7%),thrombocytopenia(29.3%),peripheral neuropathy(41.3%),fatigue (36.0%),nausea or vomiting(16.0%),herpes zoster(8.0%).Incidence rates of common adverse events were similar between domestic generic bortezomib and original bortezomib(P>0.05).ConclusionThe domestic generic bortezomib based regimen has a significant effect on patients with multiple myeloma.It is also advantageous for good tolerance.And domestic generic bortezomib is similar to original bortezomib in clinical efficacy and safety.