A Single-Center Real-World Study Of The Efficacy And Safety Of Bortezomib In The Treatment Of Multiple Myeloma

Objective: This study aims to investigate the efficacy and safety of bortezomib(BTZ)-based induction regimen in the treatment of newly diagnosed multiple myeloma(NDMM),providing data basis for a multi-center real-world study.Methods: A retrospective analysis was performed on 134 newly diagnosed multiple myeloma patients treated with bortezomib based regimen in the Department of Hematology,Yijishan Hospital,Wannan Medical College from January 1,2015 to September 31,2022.Among them,22 were VD regimen,47 were VCD regimen,22 were VTD regimen,28 were VRD regimen,and 15 were VAD regimen.Data on gender,age,M protein type,bone marrow plasma cell ratio,white blood cells,platelets,hemoglobin,serum calcium,urea,creatinine,lactate dehydrogenase,albumin,β2microglobulin,stage,risk stratification,treatment regimen,adverse reactions and survival benefit were collected.The efficacy and safety of different induction regiments were followed up for 2,4,6,and 8 courses.Survival analysis was performed for 5regiments,and survival analysis was performed for high-risk patients labeled with risk based on m SMRAT 3.0 risk stratification.Results: Among the 134 newly diagnosed patients with multiple myeloma,84 were males and 50 were females.The onset age was 33-85 years old,the median age was 63 years old,and 41.8% were patients > 65 years old.In DS staging,there were 12 cases of stage I to II and 122 cases of stage III;in ISS staging,57 cases of stage I to II and 77 cases of stage III;in R-ISS staging,77 cases of stage I to II and 39 cases of stage III(18 cases could not be performed R-ISS staging due to lack of data).ORR of VD regimen,VCD regimen,VTD regimen,VRD regimen and VAD regimen in the second course of treatment were 68.2%,87.2%,81.8%,85.7% and 80%,respectively(H=4.846,P=0.303).ORR of the fourth course of treatment were 68.2%,91.5%,81.8%,96.4% and 80%(H=10.087,P=0.039),and pairwise comparison showed that there was a difference in ORR between VRD group and VD group((P=0.005,adjusted P=0.046).ORR of the sixth course was 68.2%,87.2%,72.7%,89.3%,66.7%(H=7.263,P=0.123).ORR of the 8th course was 68.2%,85.1%,72.7%,89.3%,66.7%(H=6.266,P=0.180).The m PFS of VD regimen,VCD regimen,VTD regimen,VRD regimen and VAD regimen were 11 months,21 months,18 months,23 months and 20 months,respectively(P=0.034).Paired comparison showed that VD group vs VCD group(11months vs 21 months,P < 0.01).VD group vs VRD group(11 months vs 23 months,P< 0.01),VD group vs VAD group(11 months vs 20 months,P > 0.05),VD group vs VTD group(11 months vs 18 months,P > 0.05),and no significant difference was found among all three regiments(P > 0.05).The m OS of VD regimen was 34 months,VTD regimen was 48 months,VCD regimen was 47 months,VRD regimen and VAD regimen did not reach m OS.There were significant differences in OS among the five regiments(P < 0.01).Paired comparison showed that there were differences in OS between the two-drug regimen and all three-drug regimen groups.But there was no significant difference in OS among the three drug regimens.There were significant differences in PFS and OS between the risk group and the high risk group(m OS: 53 months VS 38 months,P=0.003;m PFS: 24 months VS 18 months,P=0.0002).The five treatment regimens were associated with leukopenia(P=0.254),thrombocytopenia(P=0.813),pulmonary infection(P=0.137),digestive tract reaction(P=0.191),peripheral neuropathy(P=0.074),herpes zoster(P=0.989),fatigue(P=0.954),liver function impairment(P=0.18)1)There was no significant difference in cardiac function damage(P=0.107).Conclusion: 1.Btz-based regimen can make NDMM patients achieve partial remission at an early stage.2.In the treatment of NDMM patients with BTZ-based regimen,the three-drug regimen can bring higher ORR and significantly prolong PFS and OS than the two-drug regimen.3.In the treatment of NDMM patients with BTZ-based regimen,the marked risk group obtained longer PFS and OS than the high-risk group.4.There was no significant difference in adverse reactions between the three-drug regimen and the two-drug regimen based on BTZ.