title: Bortezomib, dexamethasone plus thalidomide for treatment of newly diagnosed multiple myeloma patients with or without renal impairment.
abstract: OBJECTIVE
  To investigate the efficacy and safety of the treatment of the newly diagnosed multiple myeloma (MM) with or without renal impairment receiving the therapy of bortezomib, dexamethasone plus thalidomide (BTD) regimen in order to analyze the effects of BTD regimen on the prognosis of the MM patients with renal impairment compared with the patients without renal impairment.
  
  
  METHODS
  Seventy-two newly diagnosed MM patients entered into our study and all the patients belonged to International Stage System (ISS) 3 in which transplantation patients were excluded or the patients refused receiving transplantation therapy. According to the level of serum creatinine (Scr), the patients were divided into two groups including group 1 (n=42) (Scr <2 mg/dL) and group 2 (n=30) (Scr ≥2 mg/dL). All the patients received the therapy of BTD regimen as induction therapy, and the median treatment time was 5 (range, 2-8) cycles. The outcome was analyzed retrospectively.
  
  
  RESULTS
  The overall remission (OR) rates were 81.0% (group 1) and 80.0% (group 2). There was no statistical difference between the two groups (P>0.05). In group 2, 10 patients (33.3%) got renal function reversal, 14 patients (46.7%) got improved renal function and the median time to renal function reversal was 1.4 (range, 0.7-3.0) months. Among 12 patients with hemodialysis at diagnosis, 8 patients got rid of hemodialysis after median 4 cycles of therapy (range, 3-6 cycles). After a median follow-up period of 16 (range, 2-31) months, 5 patients (11.9%) in group 1 died and 9 patients (30.0%) in group 2 died (P=0.056). The 2-year estimate of overall survival was 77.3% in group 1 and 63.8% in group 2, respectively (P=0.188). During a median follow-up time of 13.0 months (range, 2-25 months), 15 patients (35.7%) in group 1 progressed and 13 patients (43.3%) in group 2 progressed (P=0.513). The 2-year estimate of response duration was 50.6% in group 1 and 42.1% in group 2, respectively (P=1). The main toxicities in the two groups included thrombocytopenia, peripheral neuropathy (PN), infection, herpes zoster and so on. The incidence of grade 3 and 4 adverse events was low.
  
  
  CONCLUSIONS
  BTD regimen may become the front-line therapy for the newly diagnosed MM patients with renal impairment because BTD regimen can improve the prognosis of the patients with renal impairment as good as the patients without renal impairment.
authors.affiliation: Department of Hematology & Multiple Myeloma Research Center of Beijing, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing 100020, China.
authors.forename: Guangzhong
authors.initials: G
authors.lastname: Yang
authors.forename: Wenming
authors.initials: W
authors.lastname: Chen
authors.forename: Yin
authors.initials: Y
authors.lastname: Wu
keywords: Myeloma; bortezomib; renal impairment