title: Clinical assessment of bortezomib for multiple myeloma in comparison with thalidomide.
abstract: OBJECTIVE
  We studied the efficacy and safety of bortezomib (BOR) for treatment of multiple myeloma in comparison with thalidomide (THAL) by reference to adverse events, and searched for laboratory markers that could be used for prognostication of patients.
  
  
  METHODS
  Biochemical data of patients receiving BOR and THAL for treatment of multiple myeloma at the Japanese Red Cross Narita Hospital were investigated retrospectively, after obtaining Institutional Review Board approval. Judgment of curative effects complied with the effects criteria of the International Myeloma Working Group (IMWG).
  
  
  RESULTS
  BOR showed a higher rate of effectiveness than THAL for refractory multiple myeloma, and its effects were rapid. BOR treatment prolonged the survival time of THAL-resistant patients. The efficacy of BOR was unrelated to patient age, the number of previous therapeutic regimens, or the disease period. After medication with BOR, patients in whom it had been effective tended to show an increase of the serum alkaline phosphatase (ALP) level. Thrombocytopenia (86.2%) and leucopenia (69.0%) were observed at high frequencies, but no previously unreported adverse events or fatalities were associated with BOR therapy.
  
  
  CONCLUSIONS
  It is suggested that BOR has therapeutic efficacy for multiple myeloma as a first-line medical treatment and/or for patients with THAL resistance, and can improve prognosis and survival. Since serum ALP elevation was observed in many patients for whom BOR was effective, this may be a predictor of BOR efficacy.
authors.affiliation: Department of Toxicology and Pharmacology, Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba, Japan. satoh@phar.toho-u.ac.jp
authors.forename: Mitsutoshi
authors.initials: M
authors.lastname: Satoh
authors.forename: Rieko
authors.initials: R
authors.lastname: Oguro
authors.forename: Chigusa
authors.initials: C
authors.lastname: Yamanaka
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Takada
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Matsuura
authors.forename: Toyomi
authors.initials: T
authors.lastname: Akiba
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Aotsuka
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tani
authors.forename: Hisashi
authors.initials: H
authors.lastname: Wakita
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D001897:Boronic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D006801:Humans; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D013534:Survival; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D000469:Alkaline Phosphatase