| Background:Multiple myeloma(MM)is one of the common hematological malignancies,which is characterized by abnormal proliferation of plasma cells and accounts for about 10%of all hematological malignancies.Chemotherapy is the main treatment for MM.Conventional first-line chemotherapy commonly uses anthracycline including doxorubicin,which has a certain effect.However,conventional anthracycline has obvious side effects,which is famous for its serious cardiotoxicity.Pegylated liposome doxorubicin(PLD)is the liposomal form of doxorubicin.PLD has been approved in combination with bortezomib for the treatment of refractory and recurrent MM(RRMM)patients in many countries.However,in terms of patients with newly diagnosed MM(NDMM),the anti-tumor efficacy and tolerability of PLD in different chemotherapy regimens have not been fully defined yet.In this study,we investigated the efficacy and safety of PLD in different combination therapies based on vindesine or bortezomib in NDMM patients to provide ideas for guiding clinical treatment and evaluating clinical prognosis.Methods:A total of 249 NDMM patients diagnosed between January 2008 and October 2019 were included in this retrospective study.Among them,112 patients received vindesine-based chemotherapy(35 vDD and 77 vAD)and 137 received bortezomib-based chemotherapy(58 VDD and 79 VD).The patients’ age,gender,disease classification,DS stage,ISS stage,the date of diagnosis,progress and death were collected retrospectively.The response rate,progression free survival(PFS),overall survival(OS)and treatment-related adverse events(AEs)were compared among the groups respectively based on vindesine and bortezomib chemotherapy.Results:In vindesine-based groups,the ORR was 65.7%(23/35)in vDD subgroup and 63.6%(49/77)in vAD subgroup,including 17.1%(6/35)patients achieved CR and 25.7%(9/35)patients achieved≥VGPR in vDD subgroup compared to 11.7%(9/77)of CR and 24.7%(19/77)of≥ VGPR in vAD subgroup,which were all considered no statistically significance.As for bortezomib-based group,although ORR between VDD(91.4%)and VD subgroup(84.8%;p=0.249)had no significant differences,the rate of achieving CR and≥VGPR were both significantly different between these two subgroups.48.3%(28/58)of the patients achieved CR and 74.1%(43/58)achieved≥VGPR in VDD subgroup,compared to 30.4%(24/79)achieving CR(p=0.033)and 57.0%(45/79)≥VGPR in VD subgroup(p=0.038).Between vDD and vAD subgroup,the median PFS was 28 months(95%CI,13-42 months)in vDD with 25 months(95%CI,19-30 months)in vAD.The median OS was 46 months(95%CI,28-63 months)in vAD with the median OS not reached in vDD subgroup partly because of the later use of PLD.However,neither PFS nor OS differed significantly between vDD and vAD subgroup(p=0.135,p=0.240,respectively).As for bortezomib regimens,the median PFS was 45 months(95%CI,23-66 months)and the median OS was 52 months(95%CI,32-71 months)in VD subgroup,comparing the median PFS and the median OS both not reached in VDD subgroup.Similarly,no significant differences were found between the VDD and VD subgroup in either PFS(p=0.875)or OS(p=0.448).In terms of safety,with the addition of PLD,the incidence of Grade 3/4 hematological toxicities,infection and gastrointestinal toxicities of VDD subgroup were significantly higher than that of VD subgroup(P=0.004,P=0.005,P=0.003).The occurrence rates of all cardiac AEs were similar between VDD and VD subgroup(p=0.509).For vindesine-based group,the occurrence rate of infection in vDD was significantly higher than in vAD subgroup(51.5%vs.24.7%,p=0.005),partly because of more Grade 3/4 hematological toxicities caused by PLD.Conclusion:In vindesine-based regimens,PLD did not show better anti-tumor effect than epirubicin,and PLD combined with vindesine and dexamethasone did not significantly prolong PFS or OS.The addition of PLD to VD brought deeper response without increased toxicity.While superior survival in a long term was not proved in our study. |
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