| Objective: To investigate the similarities and differences of efficacy and safety about bortezomib based treatment and non-bortezomib based therapy in treatment of patients with newly diagnosed multiple myeloma(MM),and analyze the OS and PFS of the patients as well as the effect of cumulative bortezomib dose,then discuss the the possible factors affecting early mortality and prognosis.Methods: We chose 108 patients who were newly diagnosed with MM in the Department of Hematology of the Third Hospital of Hebei Medical University from January 1,2012 to December 2,2015,which were divided into bortezomib group(37 cases)and bortezomib free group(71 cases).Follow up to January 1,2016.The proportion of male was higher in bortezomib group(73%vs48%,P=0.013),the difference between the age,follow-up time,MM type,DS staging,and ISS staging system of the two groups were not significant(P > 0.05).Results: 1 Comparison of therapeutic effects between bortezomib group and bortezomib free group 1.1 Bortezomib groupAmong the 37 cases,10 cases reached CR(27%),10 cases reached VGPR(27%)and 10 cases reached PR(27%),ORR reached to 81.1%.During the follow-up period,9 cases recurred,of which,1 case recurred for two times and 7 cases died in the end(6 cases died early in the first 6 months);、1.2 Bortezomib free groupAmong the 71 cases,12 cases reached CR(16.9%),9 cases reached VGPR(12.7%),29 cases reached PR(40.8%),ORR reached to 70.4%,During the follow-up period,36 cases recurred,of which,7 case recurred for two times and 1 case recurred for three times,17 cases died in the end(3 cases died early in the first 6 months);1.3 Comparison of curative effect between the two groupsThe ORR of bortezomib group was higher than that of bortezomib free group(81.1% vs 70.4%,P=0.230)and so as to the rate of ≥VGPR(54.1%vs29.6%,P=0.013),but we did not find age factors can affect the curative effect;1.4 Comparison of how many courses it requires to reach optimal efficacy between the two groupsThe median of cycles was 2 in bortezomib group,with an average of 1.68 cycles(range,1-4);while bortezomib free group received a median of 4 cycles,with an average of 4.2 cycles(range,1-7);P < 0.001;2 The relationship between remission depth and PFS or OSThe censoring proportion of the two groups was less than 70%,PFS survival analysis could be carried out,however,the mortality rate of the two groups was less than 30%,so the median OS was not reached;2.1 Bortezomib group≥VGPR(median PFS 23 months)VS <VGPR(median PFS 6 months),P=0.022;≥PR(median PFS 23 months)VS < PR(median PFS 2 months),P < 0.001;the differences were statistically significant;2.2 Bortezomib free group≥VGPR(median PFS 24 months)VS <VGPR(median PFS 12 months),P < 0.05,the difference was statistically significant;≥PR(median PFS 17 months)VS <PR(median PFS 9 months),P=0.141;the difference was not statistically significant;2.3 The overall≥VGPR(median PFS 23 months)VS <VGPR(median PFS 12 months),P < 0.05;≥PR(median PFS 18 months)VS <PR(median PFS 6 months),P < 0.005;the differences were statistically significant;3 The relationship between the cumulative dose of bortezomib and PFS during induction and consolidation therpyThe median cumulative dose of bortezomib was 15.6mg/m2.Using K-M(Kaplan Meier)method to draw survival curves,the PFS of more than 15.6 mg/m2 group(17 cases)are 23 months and less than 15.6 mg/m2 group(20 cases)with 10 months,P=0.019;4 PFS survival analysis in patients with MMSingle factor analysis showed that the P value of whether the patients combine with coronary heart disease,plasmacytic leukemia as a result of disease progression,PLT decrease,hypoalbuminemia,LDH>250 U/L were less than 0.05,the difference was statistically significant.Within the age(P=0.224),different groups(P=0.590),ISS III(P=0.090),multivariate analysis results showed that the application of bortezomib as a protective factor of PFS,ISS III,65 years or older,plasmacytic leukemia as a result of disease progression,hypoalbuminemia,LDH > 250 U/L are PFS risk factors.The median PFS of bortezomib group was about 10 months longer than that of bortezomib free group(23 VS12 months,P=0.019);5 Independent risk factors for early death in patients with MMThere were 9 cases of early death in all 108 patients,including bortezomib group of 6 cases and bortezomib free group of 3 cases.Single factor analysis indicated that different groups(P=0.046),combine with coronary heart disease(P=0.001),PLT decrease(P=0.017),LDH > 250 U/L(P=0.001)were associated with early death;multivariate Logistic regression analysis pointed out that LDH > 250 U/L(P=0.025,OR 0.157,95%CI 0.031-0.789)and combine with coronary heart disease(P=0.016,OR 0.136,95%CI 0.027-0.686)are the independent risk factors of early death in MM patients;6 Safety evaluation of chemotherapyEvaluation shows that after chemotherapy neutropenia(P=0.001),anemia(P=0.001)and electrolyte disorder(P<0.001)were find at a high frequency in bortezomib free group,the decrease of PLT was more obvious in bortezomib group(P=0.006).Conclusions:1 The curative effect of bortezomib group was higher than that of bortezomib free group,and the reaction rate was faster;2 In the bortezomib group,the efficacy of PR and above can significantly prolong the PFS,while the bortezomib free group should be more than VGPR;3 High cumulative doses of bortezomib can prolong PFS in patients with MM;4 The median PFS of bortezomib group was about 10 months longer than that of bortezomib free group(23 VS12 months,P=0.019),and ISS III,65 years or older,plasmacytic leukemia as a result of disease progression,hypoalbuminemia,LDH > 250 U/L are risk factors of PFS;the median OS was not reached;5 LDH > 250 U/L and combine with coronary atherosclerotic heart disease were independent risk factors for early death in patients with MM,bortezomib did not reduce early mortality;6 The decrease of PLT was more obvious in bortezomib group while neutropenia,anemia and electrolyte disorder were find at a high frequency in bortezomib free group7 In this study,there were some limitations,such as the small sample size and the selection of patients from a single center.The conclusion is not comprehensive,in order to achieve a better and more meaningful results,we need to expand the sample size and form a multi-center cooperation. |
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