Bortezomib-containing regimens are effective in multiple myeloma--results of a non-interventional phase IV study

Oncol Res Treat. 2015;38(4):167-73. doi: 10.1159/000381297. Epub 2015 Mar 31.

Abstract

Background/aims: 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bortezomib / administration & dosage*
  • Bortezomib / adverse effects
  • Female
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Male
  • Methylprednisolone / adverse effects
  • Methylprednisolone / therapeutic use
  • Middle Aged
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / pathology
  • Neoplasm Staging
  • Prospective Studies

Substances

  • Bortezomib
  • Methylprednisolone