title: Bortezomib-containing regimens are effective in multiple myeloma--results of a non-interventional phase IV study.
abstract: OBJECTIVE
  The incorporation of bortezomib into the chemotherapeutic regimens for non-transplant patients with multiple myeloma resulted in improved outcomes in controlled studies. This prospective, non-interventional study assessed the effectiveness and safety of bortezomib-containing regimens in daily practice.
  
  
  METHODS
  Patients with untreated or relapsed multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation and who were scheduled for bortezomib mono- or combination therapy or melphalan-prednisone (MP) alone were included in this study. Dosage and treatment decisions were at the discretion of the physicians.
  
  
  RESULTS
  353 patients received bortezomib-containing therapies and 37 patients MP alone. Overall response rates at treatment end were 65.9% for bortezomib-containing therapies and 50.0% for MP. Partial or complete remissions considered best responses were achieved in 82.6% (first line) and 63.8% (second or later line) of the bortezomib-treated patients. The median duration of response to bortezomib-containing therapies was 18.2 months in 109 first-line and 11.3 months in 110 second- or later-line patients. Adverse drug reactions of any grade were reported during the treatment phase in 79.6% (bortezomib) and 70.3% (MP) of treated patients.
  
  
  CONCLUSIONS
  Bortezomib-containing therapies were effective in patients with multiple myeloma in a real-life setting. The increasingly individualized treatment regimens of multiple myeloma require standardized assessments of response in daily practice.
authors: Onkologische Gemeinschaftspraxis, Agaplesion Bethanien Krankenhaus, Frankfurt/M., Germany.
authors: Wolfgang
authors: W
authors: Knauf
authors: Christoph
authors: C
authors: Tapprich
authors: Rudolf
authors: R
authors: Schlag
authors: Stefan
authors: S
authors: Schütz
authors: Burkhard
authors: B
authors: Alkemper
authors: Bernd
authors: B
authors: Gaede
authors: Daniel
authors: D
authors: Reschke
authors: Rudolf
authors: R
authors: Schmits
authors: Andreas
authors: A
authors: Schwarzer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011446:Prospective Studies
chemical_list: D000069286:Bortezomib; D008775:Methylprednisolone