Continuous Prednisolone Versus Conventional Prednisolone With VMCP-interferon-alpha2b as First-Line Chemotherapy in Elderly Patients With Multiple Myeloma

Br J Haematol. 2005 Nov;131(3):329-37. doi: 10.1111/j.1365-2141.2005.05779.x.

Abstract

We report on a randomised trial that aimed to compare the efficacy of continued daily prednisolone treatment during the entire induction phase, with prednisolone given for 2 weeks of each cycle in combination with VMCP (vincristine, melphalan, cyclophosphamide, prednisolone)-interferon-alpha 2b (IFN-alpha 2b) treatment in 299 previously untreated elderly patients (median age: 67 years) with multiple myeloma. After completion of induction treatment patients were randomised to IFN-alpha 2b with or without prednisolone, thrice weekly. Response rate was 62% in the continuous and 60% in the control arm (intent to treat analysis, P=0.81). Progression-free survival [median: 20 months vs. 19 months; hazard ratio (HR): 0.99, 95% confidence interval (CI): 0.74-1.33, P=0.97] and overall survival (median: 34 months vs. 37 months; HR: 1.16, 95% CI: 0.85-1.59, P=0.35) were similar in both groups. Reduced performance status (Eastern Cooperative Oncology Group, grades 2-4) was the predominant risk factor for poor survival followed by age >65 years, high beta2-microglobulin, and impaired renal function. There was more grades 3-4 dyspnoea and cardiac impairment and grades 1-2 hyperglycaemia, but less nausea, emesis and anaemia in patients on continuous prednisolone therapy. In conclusion, continuing prednisolone treatment during the entire duration of the induction phase with VMCP-IFN-alpha 2b did not improve outcome.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cyclophosphamide / administration & dosage
  • Drug Administration Schedule
  • Female
  • Glucocorticoids / administration & dosage*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Male
  • Melphalan / administration & dosage
  • Middle Aged
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / pathology
  • Neoplasm Staging
  • Prednisolone / administration & dosage*
  • Prednisone / administration & dosage
  • Recombinant Proteins
  • Survival Analysis
  • Treatment Outcome
  • Vincristine / administration & dosage

Substances

  • Glucocorticoids
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Vincristine
  • Cyclophosphamide
  • Prednisolone
  • Melphalan
  • Prednisone

Supplementary concepts

  • VMCP protocol