Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens. Academic Article uri icon

Overview

abstract

  • PURPOSE: The US community-based, phase IIIB UPFRONT trial was designed to compare three frontline bortezomib-based regimens in transplantation-ineligible patients with myeloma. PATIENTS AND METHODS: Patients (N = 502) were randomly assigned 1:1:1 to 24 weeks (eight 21-day cycles) of induction with bortezomib-dexamethasone (VD; n = 168; intravenous bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11 plus oral dexamethasone 20 mg, days 1, 2, 4, 5, 8, 9, 11, and 12 [cycles 1 to 4], or 1, 2, 4, and 5 [cycles 5 to 8]), bortezomib-thalidomide-dexamethasone (VTD; n = 167; bortezomib and dexamethasone as before plus oral thalidomide 100 mg, days 1 to 21), or bortezomib-melphalan-prednisone (VMP; n = 167; bortezomib as before plus oral melphalan 9 mg/m(2) and oral prednisone 60 mg/m(2), days 1 to 4, every other cycle), followed by 25 weeks (five 35-day cycles) of bortezomib maintenance (1.6 mg/m(2), days 1, 8, 15, and 22). The primary end point was progression-free survival. RESULTS: After 42.7 months' median follow-up, median progression-free survival with VD, VTD, and VMP was 14.7, 15.4, and 17.3 months, respectively; median overall survival was 49.8, 51.5, and 53.1 months, with no significant differences among treatments for either end point (global P = .46 and P = .79, respectively, Wald test). Overall response rates were 73% (VD), 80% (VTD), and 70% (VMP). Adverse events were more common with VTD than VD or VMP. Bortezomib maintenance was feasible without producing cumulative toxicity. CONCLUSION: Although all bortezomib-containing regimens produced good outcomes, VTD and VMP did not appear to offer an advantage over VD in transplantation-ineligible patients with myeloma treated in US community practice.

authors

  • Niesvizky, Ruben
  • Flinn, Ian W
  • Rifkin, Robert
  • Gabrail, Nashat
  • Charu, Veena
  • Clowney, Billy
  • Essell, James
  • Gaffar, Yousuf
  • Warr, Thomas
  • Neuwirth, Rachel
  • Zhu, Yanyan
  • Elliott, Jennifer
  • Esseltine, Dixie-Lee
  • Niculescu, Liviu
  • Reeves, James

publication date

  • June 8, 2015

Research

keywords

  • Antineoplastic Combined Chemotherapy Protocols
  • Bortezomib
  • Multiple Myeloma

Identity

Scopus Document Identifier

  • 84941261863

Digital Object Identifier (DOI)

  • 10.1200/JCO.2014.58.7618

PubMed ID

  • 26056177

Additional Document Info

volume

  • 33

issue

  • 33