| [Background]Multiple myeloma(MM)is a malignant plasma cell disease.Main clinical manifestations of MM include bone pain,recurrent or persistent infection,anemia,renal impairment or the co-existence of the above symptoms.Although the application of multiple therapeutic regimens has significantly increased the remission rate and improved overall survival of MM,MM remains an incurable disease.At present,the aim of its treatment is to maximize the survival time and quality of life of the patients.Maintenance treatment following ASCT or remission is beneficial to eliminate the minimal residual disease(MRD)further and prolong survival in patients with multiple myeloma.At now,drugs in maintenance treatment include glucocorticoid,interferon,immunomodulator,proteasome inhibitor and so on.In China,bortezomib and lenalidomide are commonly used in maintenance therapy,and bortezomib is the main one.However,the use of bortezomib is limited by several factors,such as drug resistance and side-effects.Especially since the COVID-19 outbreak in 2019,multiple consensus statements have suggested switching from intravenous or subcutaneous medications to oral medications for treatment of MM,to reduce outpatient visits or hospitalizations,and to minimize the risk of 2019-nCoV infection.Ixazomib(Ninlaro(?))is a highly selective reversible protease inhibitor developed by Takeda Pharmaceutical Company Limited.It was approved by FDA in 2015 for treatment of relapsed or refractory multiple myeloma(RRMM)in combination with lenalidomide and dexamethasone.As the first reversible oral form proteasome inhibitor,ixazomib brings great convenience to patients and helps relieve the strain on medical resources,showing great promise for it as a maintenance therapy drug for MM.[Objective]Statistical analysis of clinical trials of patients with MM who received ixazomib maintenance therapy was conducted to evaluate its effectiveness and safety,and finally provide guidance for the selection of maintenance therapy in clinical practice,so as to improve the survival time and quality of life of MM patients.[Methods]A search for clinical trials was conducted by two independent investigators using the following electronic databases:PubMed,Web of Science,Embase,the Cochrane Library and proceedings from major international meetings in hematology and oncology.To identify that eligible studies were not omitted,we manually checked the reference lists of published reviews and International Clinical Trials Registry Platform.We also tried to contact the authors of the literature for more published and unpublished studies.The last search dated back to July,2020.The retrieved literatures were screened according to inclusion and excluding criteria.We carried out data extraction and the bias risk assessment for the finally included literatures.Stata 14.0 was used to statistically analyze the progression-free survival(PFS),the rate of response deepening,and the incidence of adverse reactions.[Results]Three clinical trials with a total of 1440 participants with newly diagnosed multiple myeloma(NDMM)were included in the present meta-analysis.The pooled HR of PFS was 0.69(95%CI=0.59-0.79),which suggested ixazomib maintenance therapy,a protective factor in patients with multiple myeloma,could prolong PFS remarkably.In addition,ixazomib is effective in deepening remission(RR=1.57;95%CI=1.26-1.96).In terms of adverse reactions,our analysis revealed higher incidences of grade 3-4 thrombocytopenia(RR=7.47;95%CI=2.06-27.06),neuropathy(RR=1.48;95%CI=1.14-1.92),grade 3-4 infections(RR=1.77;95%CI=1.21-2.59)and gastrointestinal disorders(RR=1.48;95%CI=1.32-1.66).There was no significant correlation between the use of ixazomib and grade 3-4 neutropenia(RR=1.46;95%CI=0.77-2.78,p=0.25)or the occurrence of new primary malignant tumor(R=0.88;95%CI=0.53-1.46,p=0.62).[Conclusion]Overall,our meta-analysis demonstrates the positive role of ixazomib in prolonging PFS in newly diagnosed patients with multiple myeloma and good tolerability. |
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