Impact of Bortezomib on Survival in Previously Untreated MM Extends to 3 Years: Presented at ASH
By Betty S. Riggs
NEW ORLEANS -- December 9, 2009 -- After more than 3 years of follow-up, treatment with bortezomib plus melphalan and prednisone results in significantly longer overall survival (OS) than melphalan and prednisone alone for patients with previously untreated multiple myeloma (MM), according to results of a study presented here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition.
Maria-Victoria Mateos, MD, Hospital Universitario de Salamanca, Salamanca, Spain, and colleagues reported the findings on the international, phase 3 Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone (VISTA) study here on December 7.
The study included 682 patients with previously untreated multiple myeloma who were not eligible for high-dose therapy. Patients were randomised to receive either nine 6-week cycles of bortezomib 1.3 mg/m2 plus melphalan 9 mg/m2 and prednisone 60 mg/m2 (n = 344) or melphalan 9 mg/m2 and prednisone 60 mg/m2 alone (n = 338).
After disease progression, patients were followed for survival and subsequent therapy, including investigator-assessed best response to subsequent therapies.
The VISTA Study was stopped early because it demonstrated the superiority of bortezomib/melphalan/prednisone versus melphalan/prednisone alone across all efficacy endpoints, including OS, at the third interim analysis.
The purpose of this study was to conduct a planned, updated analysis of patients after a median follow-up of about 3 years and with the majority of patients having received subsequent therapy. The endpoints of interest were OS, time to new treatment (TNT), and median treatment-free interval (TFI).
After a median follow-up of 36.7 months, there was a 35% reduced risk of death with the bortezomib-containing regimen versus melphalan/prednisone (P = .0008) and the 3-year OS rates were 68.5% versus 54.0%, respectively.
At data cutoff (March 16, 2009), 178 (52%) of patients receiving bortezomib and 233 (69%) of patients receiving melphalan/prednisone had received subsequent therapy. TNT was 28.1 versus 19.2 months, respectively (P < .0001). Median TFI was 17.6 versus 8.4 months, respectively (P < .0001). A TFI of >=2 years was observed in 43% of the bortezomib-treated patients and 18% of the melphalan/prednisone patients.
In patients who received subsequent therapy, 3-year OS from randomisation was greater with the bortezomib combination (67.9%) than with melphalan/prednisone (55.9%; P = .021). Improved OS with the bortezomib combination was seen even though 50% of melphalan/prednisone patients received bortezomib as subsequent therapy.
There were no new safety findings. Of 159 patients receiving the bortezomib combination who reported peripheral neuropathy, 21 (13%), 36 (34%), and 39 (25%) received subsequent therapy with bortezomib, thalidomide, or lenalidomide-based regimens.
Funding for this study was provided by Johnson & Johnson Pharmaceutical Research and Development, and Millenium Pharmaceuticals Inc.
[Presentation title: Bortezomib Plus Melphalan-Prednisone Continues to Demonstrate a Survival Benefit vs Melphalan-Prednisone in the Phase III Vista Trial in Previously Untreated Multiple Myeloma After 3 Years’ Follow-Up and Extensive Subsequent Therapy Use. Abstract 3859]
|
