[A cohort study comparing the efficacy and safety of bortezomib plus dexamethasone versus bortezomib, epirubicin and dexamethasone in patients with multiple myeloma].

ABSTRACT

OBJECTIVE: Bortezomib plus dexamethasone (BD) and bortezomib, epirubicin plus dexamethasone (PAD) are both front-line regimens of multiple myeloma. This study aimed to assess the efficacy and safety of BD versus PAD regimens in multiple myeloma. METHODS: All 208 patients with newly diagnosed multiple myeloma using either BD or PAD front-line regimens were enrolled between November 2006 and July 2014. Front-line chemotherapy regimens were 2-7 cycles. Response rates, overall survival, progression-free survival, and adverse effects were retrospectively analyzed. RESULTS: (1) In PAD group, the overall response rate was 82.9% [complete response(CR) 28.6%, very good partial response(VGPR) 12.9%], which was similar as that in BD group [70.3% (CR 26.8%, VGPR 5.1%), P=0.049]. The estimated median progression-free survival was 34.0 months in PAD group versus 25.0 months in BD group (P=0.010). (2) The triplet regimen has a higher accumulated response rate along with chemotherapy cycles, but it didn't show any difference with the doublet regimen. (3) In elderly patients (>65 years old), the overall response rates in two groups had no significant difference (P=0.769), while in patients ≤65 years old, PAD regimen were more effective than BD regimen (P=0.037). (4) Grade 3 and 4 adverse events were recorded with a higher number of patients in the PAD group than those in the BD group. CONCLUSIONS: Compared with BD regimen, PAD regimen improves the initial response rates, especially deep responses, as well as progression-free survival in patients with newly diagnosed multiple myeloma. However, more severe toxicities are accordingly higher. In elderly patients, overall response rate, estimated median progression-free survival, and median overall survival are all comparable in both regimens.