Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation:

Garderet, Laurent;Iacobelli, Simona;Moreau, Philippe;Dib, Mamoun;Gahrton, Gösta;et.al.
(2012) Journal of Clinical Oncology — Vol. 30, n° 20, p. 2475-2482 (2012)

Files

GarderetLetal-JClinOncol2012.pdf
  • Restricted Access
  • Adobe PDF
  • 5.5 MB
No access

Details

Authors
  • Garderet, Laurent
    Author
  • Iacobelli, Simona
    Author
  • Moreau, Philippe
    Author
  • Dib, Mamoun
    Author
  • Gahrton, Gösta
    Author
Show more
Abstract
PURPOSE: This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus a dual combination (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT). PATIENTS AND METHODS: Overall, 269 patients were randomly assigned to receive bortezomib (1.3 mg/m(2) intravenous bolus) or no bortezomib for 1 year, in combination with thalidomide (200 mg per day orally) and dexamethasone (40 mg orally once a day on 4 days once every 3 weeks). Bortezomib was administered on days 1, 4, 8, and 11 with a 10-day rest period (day 12 to day 21) for eight cycles (6 months), and then on days 1, 8, 15, and 22 with a 20-day rest period (day 23 to day 42) for four cycles (6 months). RESULTS: Median time to progression (primary end point) was significantly longer with VTD than TD (19.5 v 13.8 months; hazard ratio, 0.59; 95% CI, 0.44 to 0.80; P = .001), the complete response plus near-complete response rate was higher (45% v 25%; P = .001), and the median duration of response was longer (17.2 v 13.4 months; P = .03). The 24-month survival rate was in favor of VTD (71% v 65%; P = .093). Grade 3 peripheral neuropathy was more frequent with VTD (29% v 12%; P = .001) as were the rates of grades 3 and 4 infection and thrombocytopenia. CONCLUSION: VTD was more effective than TD in the treatment of patients with MM with progressive or relapsing disease post-ASCT but was associated with a higher incidence of grade 3 neurotoxicity.
Affiliations

Citations

  • APA
  • Chicago
  • FWB

Garderet, L., Iacobelli, S., Moreau, P., Dib, M., Lafon, I., Niederwieser, D., Masszi, T., Fontan, J., Michallet, M., Gratwohl, A., Milone, G., Doyen, C., Pegourie, B., Hajek, R., Casassus, P., Kolb, B., Chaleteix, C., Hertenstein, B., Onida, F., et al. (2012). Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: Journal of Clinical Oncology, 30(20), 2475-2482. https://doi.org/10.1200/JCO.2011.37.4918 (Original work published 2012)