Bortezomib Upfront in Myeloma, Survival Advantage Confirmed

Zosia Chustecka

December 13, 2011

December 13, 2011 — Final 5-year results confirm the survival advantage seen previously with the addition of bortezomib (Velcade, Millennium) to standard therapy in patients with newly diagnosed multiple myeloma.

Previous long-term overall survival data, from a 3-year follow-up of the VISTA (Velcade as Initial Standard Therapy in Multiple Myeloma) trial, have already been added to the product's labeling.

The 5-year data come from the final analysis of the phase 3 VISTA trial, and were presented here at the American Society of Hematology 53rd Annual Meeting.

The addition of bortezomib to standard treatment with melphalan and prednisone (MP) significantly improved overall survival, compared with MP alone (56.4 vs 43.1 months; P = .0004). Adding bortezomib to the initial therapy resulted in "an impressive 13.3 month increase in the median overall survival after 5 years of follow-up," said lead author Jesús San Miguel, MD, PhD, from the Hospital Clínico Universitario de Salamanca, Spain.

Time to next treatment was significantly longer for patients who received bortezomib plus MP upfront than for patients who received MP alone (median, 27.0 vs 19.2 months; P < .0001), as was the treatment-free interval (16.6 vs 8.3 months; P < .0001).

"These data are reassuring and important," David Siegel, MD, PhD, chief of multiple myeloma at the John Theurer Cancer Center, Hackensack University Medical Center, New Jersey, told Medscape Medical News. Despite the fact that there was widespread use of bortezomib and other therapies at relapse — and hence a considerable crossover effect — the initial treatment with bortezomib continued to have an significant impact on overall survival.

This was not the case in a similar trial of thalidomide added to MP in initial therapy, he said. Even though the addition of thalidomide improved response rate and event-free survival, the eventual overall survival was similar in the 2 groups. In that trial, there was also a considerable crossover effect, but patients who received salvage therapy with thalidomide did just as well as those who were initially treated with thalidomide added to MP upfront.

The VISTA trial is important historically, Dr. Siegel said, because it was the registration trial for bortezomib use upfront in newly diagnosed patients. "These final results confirm that for de novo patients, bortezomib is the most important add-on therapy," he said.

The VISTA trial was sponsored by Millennium, the manufacturer of bortezomib. Dr. San Miguel reports acting as a consultant for Millennium, Janssen-Cilag, and Celgene.

American Society of Hematology (ASH) 53rd Annual Meeting: Abstract 476. Presented December 12, 2011.

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