Long term results of a randomized study performed by Intergruppo Italiano Linfomi comparing Mini-CEOP vs P-VEBEC in elderly patients with diffuse large B-cell lymphoma

Leuk Lymphoma. 2007 Feb;48(2):367-73. doi: 10.1080/10428190601078100.

Abstract

The Intergruppo Italiano Linfomi started, in 1996, a randomized trial for the initial treatment of elderly patients (older than 65 years) with Diffuse Large B-Cell Lymphoma (B-DLCL) comparing 6 courses of Mini-CEOP vs 8 weeks of P-VEBEC chemotherapy. Study objectives were survival, response and Quality of Life (QoL). Two hundred and thirty-two patients were evaluable for final analysis. Complete Response (CR) and Overall Response Rates (ORR) were 54% vs 66% (p = 0.107) and 90% vs 78% (p = 0.021) for P-VEBEC and Mini-CEOP, respectively. With a median follow-up of 72 months, the 5-year Overall Survival (OS), Relapse Free Survival (RFS), and Failure Free Survival (FFS) were 32%, 52%, and 21%, respectively. Subjects achieving a CR showed improvement of QoL regardless of treatment arm. Both Mini-CEOP and P-VEBEC determined a similar outcome for elderly patients with B-DLCL, with a third of patients alive after more than 6 years of follow-up. Both regimens can be considered equally for combination treatment with anti-CD20 monoclonal antibody.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / therapeutic use
  • Cyclophosphamide / therapeutic use
  • Disease-Free Survival
  • Epirubicin / therapeutic use
  • Etoposide / therapeutic use
  • Female
  • Humans
  • Lymphoma, B-Cell / drug therapy*
  • Lymphoma, Large B-Cell, Diffuse / drug therapy*
  • Male
  • Prednisone / therapeutic use
  • Quality of Life
  • Survival Rate
  • Time Factors
  • Treatment Outcome
  • Vinblastine / therapeutic use
  • Vincristine / therapeutic use

Substances

  • Bleomycin
  • Epirubicin
  • Vincristine
  • Vinblastine
  • Etoposide
  • Cyclophosphamide
  • Prednisone

Supplementary concepts

  • CEOP protocol 1
  • P-VEBEC protocol