[Combination of bortezomib and dexamethasone for newly diagnosed multiple myeloma]

To analyzed retrospectively two groups of patients with newly diagnosed multiple myeloma (MM) receiving bortezomib and dexamethasone (VD) regimen and vincristine combined with pirarubicin and dexamethasone and melphalan(VADM) regimen.

Twenty-four patients were enrolled in a group of VD, receiving bortezomib 1.3mg/m(2) on days 1, 4, 8, 11 and dexamethasone 20mg on days 1-4 intravenously of every 21-day cycle. EBMT Standard was used to evaluate the efficacy and NCI-CTC V3.0 was used to decide the adverse effect. Thirty matched patients with newly diagnosed MM who received VADM were used as control group, receiving vincristine 0.4 mg/d and pirarubicin 9 mgxm(-2)xd(-1) and dexamethasone 20 mg/d and melphalan 12 mg/d on days 1 - 4 intravenously of every 28 day cycle.

With a median follow-up of 10.5 months in VD group, there were 87.5% patients (21/24) responded, including 12 cases (50.0%) of complete remission (CR) or near complete remission (nCR). The total response rate (RR) was 76.7% in VADM group, with no significant difference in VD group (P = 0.483). CR + nCR rate was significantly higher in VD group than in VADM group (10%) (P = 0.001). RR and CR + nCR of light chain patients in VD group were significantly higher than in VADM group (P = 0.025 and 0.040, respectively). The median time to response and to best response were significantly shorter in VD group than in VADM group. In VD group, the RR of 8 patients with renal dysfunction was 87.5%, and that of 16 with normal renal function was 75% (P = 0.631). There was no significant difference in adverse effects between patient with renal dysfunction and normal function (P > 0.05). The main adverse effects in VD group were fatigue (66.7%), diarrhea (58.3%), peripheral neuropathy (54.2%), thrombocytopenia (29.2%), infection (29.2%), fever (25.0%) and constipation (25.0%). Most of the adverse effects were mild (grade 1 - 2) and could be relieved by symptomatic treatments. The most common adverse event in VADM group was neutropenia (83.8%), infection (35.5%), vomiting (35.5%), loss of hair (32.5%) and thrombocytopenia (16.2%).

VD has higher CR + nCR rate compared with VADM and can be tolerant in most patients. VD is safe in patients with renal inadequacy.