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


METHODS
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.


RESULTS
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%).


CONCLUSIONS
VD has higher CR + nCR rate compared with VADM and can be tolerant in most patients. VD is safe in patients with renal inadequacy.
Li
Juan
J
Department of Hematology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.
Zeng
Li-jin
LJ
Zhao
Ying
Y
Su
Chang
C
Huang
Bei-hui
BH
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone