VELCADE BOOSTS SURVIVAL IN MM

NEW YORK (Reuters Health) Apr 13 - The survival benefit of adding bortezomib (Velcade) to melphalan and prednisone for first-line treatment of multiple myeloma persists even after long-term follow-up and salvage therapy, researchers reported online April 5th in the Journal of Clinical Oncology.

"This confirmed survival advantage represents an important finding, as an overall survival benefit has not been consistently reported" in any other trials of newer agents versus the melphalan/prednisone combination, the researchers said.

Their results, from the phase III VISTA trial, confirm a 2008 report from the same study, in which the triple-drug regimen was more effective than melphalan plus prednisone alone. Patients who required salvage therapy received bortezomib, thalidomide or lenalidomide.

In their more recent paper, senior author Dr. Jesus F. San Miguel of Hospital Universitario de Salamanca in Spain and colleagues reported that the efficacy of salvage was similarly effective whether patients had received all three drugs or just two, "demonstrating that the use of bortezomib upfront does not preclude the successful use of novel agents at relapse."

In addition, survival was no worse, "and may even be longer," in patients who received first-line therapy that included bortezomib, "indicating that first-line bortezomib use does not induce more resistant relapse."

At the outset of the study, the researchers treated 682 multiple myeloma patients (median age 71) with up to nine 6-week cycles of melphalan 9 mg/m2 and prednisone 60 mg/m2 (days 1 to 4, all cycles) and, in those randomized to receive it, bortezomib 1.3 mg/m2 for eight days in cycles 1-4 and four days in cycles 5-9). In all cases, patients were receiving first-line treatment and were ineligible for high-dose therapy.

At a median follow-up of 36.7 months, 3-year overall survival was 68.5% in patients who received bortezomib versus 54.0% in those who did not.

Overall, 411 patients required subsequent therapy. Patients who had received bortezomib had a significantly longer median time to salvage therapy (28.1 vs 19.2 months) and a longer median treatment-free interval (17.6 vs 8.4 months).

Rates of mortality and treatment discontinuation for adverse events were similar in the two groups.

The researchers conclude that "using bortezomib-based treatment in the first-line setting provides greater survival benefit to patients compared with the approach of administering first-line treatment with conventional agents and saving bortezomib- and other novel agent-based treatment for salvage."

J Clin Oncol 2010.