Efficacy And Safety Of Bortezomib-based Combination Therapy In The Treatment Of Newly Diagnosed Multiple Myeloma

【Objective】To compare the efficacy and safety of bortezomib-based combination therapy(bortezomib group) and conventional chemotherapy (conventional group) in patientswith newly diagnosed multiple myeloma(MM).【Methods】103newly diagnosed MM patients from July2008to December2012in the FujianMedical University Union Hospital were retrospectively analyzed. According topatients，willing,54received bortezomib-based combination therapy (bortezomibgroup) and49received conventional chemotherapy (conventional group). Theresponses and outcomes of different treatments were analyzed.【Results】The overall response rate (ORR) in the Bortezomib group（VD±T、PAD±T、VMD±T）was87.0%, including complete remission (CR) in7patients (13.0%),very goodpartial response (VGPR) in29patients (53.7%), partial response (PR) in11patients(20.4%).The ORR of the conventional group（VAD、DVD、MPT、DCEP）was67.3%,including CR in6patients (12.2%), VGPR in14patients (28.6%), PR in13patients(26.5%).The VGPR and ORR in the Bortezomib group were higher than in theconventional group (P=0.01﹑0.017, respectively）.Subgroup analysis showed,patients aged≤65years who received bortezomib-based therapy demonstrated abetter ORR compared with patients who received conventional therapy (90.9%vs.68.4%, P＜0.05). But ORR has no significant difference between the two groups inpatients＞65years (70.0%vs.63.6%;P＞0.05). Renal function subgroup analysisshowed that in creatinine＜135umol/L subgroup,the ORR of Bortezomib group wasbetter than that of conventional group (P=0.008).In creatinine≥135umol/Lsubgroup,the ORR have no significant difference between Bortezomib group andconventional group (P=0.661). With a median follow-up time of21months for allpatients, the overall survival (OS) times in Bortezomib group were longer thanconventional group(47months vs.36months), although no significant difference was observed (P=0.367). No significant difference was found in the progression freesurvival (PFS) among the two groups(24months vs.20months; P=0.154). Forabnormal renal function subgroup, the OS、PFS in patients who received bortezomibgroup were significantly longer than that of patients who received conventional group(p=0.022﹑0.008，respectively). Univariate analysis demonstrated that creatinine、β2microglobulin、the plasma cells ratio in bone marrow、international staging system、the deletion of13q were associated with OS, and that leukocytepenia、creatinine、β2microglobulin、the plasma cells ratio in bone marrow、international staging system、the deletion of13q were associated with PFS. Multivariate analysis showed that theplasma cells ratio in bone marrow was independent factors for PFS.The majoradverse events of the two groups during treatment were hematologic toxicities、infection、 gastrointestinal symptoms，peripheral neuropathy and fatigue．Theincidences of leukocytopenia and infection in Bortezomib group were higher thanconventional group, but patients can be tolerant.Other adverse events had nodifference between the two groups.【Conclusion】Bortezomib-based combination therapy is more effective than conventionalchemotherapy therapy in patients with newly diagnosed MM. The incidences ofleukocytopenia and infection were higher in bortezomib group，but the event could betolerant in most patients.