title: Weekly bortezomib/methylprednisolone is effective and well tolerated in relapsed multiple myeloma.
abstract: BACKGROUND
  The standard schedule of bortezomib requires frequent infusions and is often associated with dose-dependent, adverse effects such as sensory neuropathy and thrombocytopenia. Because of the known additive effect between bortezomib and glucocorticoid, we explored weekly bortezomib/methylprednisolone in patients with relapsed multiple myeloma.
  
  
  METHODS
  Twenty-nine patients were treated at Indiana University with bortezomib (1.3 mg/m2) and methylprednisolone (500-2000 mg) intravenously on days 1, 8, and 15 of 28-day cycles. Response was evaluated using the Blade criteria. Twenty-one patients (70%) had previous stem cell transplantation, and 13 were in third relapse or higher.
  
  
  RESULTS
  A response was observed in 18 patients (62%): 1 (3%) complete response, 1 (3%) near complete response, and 16 (55%) partial responses. Six (21%) had stable disease, and 5 (17%) had disease progression. The median time to progression, which was defined from the beginning of therapy until progression, was 6.6 months (95% confidence interval, 6.4-9.2 months). The median number of treatment cycles was 6 (range, 2-12 cycles). The median overall survival was 20.2 months (lower 95% confidence interval, 13.1 months). The most common toxicities were fatigue and gastrointestinal disturbances. Grade >or= 3 adverse effects included neuropathy (2 grade 3), gastrointestinal side effects (1 grade 3), and congestive heart failure (1 grade 3).
  
  
  CONCLUSIONS
  The weekly bortezomib/methylprednisolone regimen was well tolerated and yielded a response rate comparable with the standard schedule of bortezomib alone. Our data support further investigation of this regimen in larger patient cohorts.
authors.affiliation: Indiana University Cancer Center, Indianapolis, IN, USA.
authors.forename: Attaya
authors.initials: A
authors.lastname: Suvannasankha
authors.forename: Gina G
authors.initials: GG
authors.lastname: Smith
authors.forename: Beth E
authors.initials: BE
authors.lastname: Juliar
authors.forename: Rafat
authors.initials: R
authors.lastname: Abonour
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000401:mortality / Q000628:therapy*; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D015996:Survival Rate
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D008775:Methylprednisolone