Monday, July 23, 2012 (Last Updated: 07/25/2012)
Pieter Sonneveld, M.D., Ph.D., of the Erasmus Medical Center in Rotterdam, Netherlands, and colleagues conducted an open-label, randomized phase III trial involving 827 patients with newly diagnosed, symptomatic MM. Participants were randomized to receive induction therapy with vincristine, doxorubicin, and dexamethasone (VAD) or PAD, followed by high-dose melphalan and autologous stem-cell transplantation. VAD-treated patients received thalidomide as the maintenance treatment and PAD-treated patients received maintenance bortezomib.
Compared to VAD, the researchers found that PAD induction yielded statistically significant superior CR and near CR rates (31 versus 15 percent). The CR rate was also significantly improved with bortezomib maintenance therapy (49 versus 34 percent). Compared to those treated with VAD, patients treated with PAD had superior PFS after a median of 41 months (median 35 versus 28 months; hazard ratio, 0.75; P = 0.002) and overall survival was superior in multivariate analysis (hazard ratio, 0.77; P = 0.049). The benefits of bortezomib induction and maintenance therapy were greatest in high-risk patients with creatinine levels in excess of 2 mg/dL and in those with deletion 17p13.
"This randomized multicenter trial in patients with MM who were eligible for high-dose therapy demonstrates that bortezomib during induction and maintenance treatment results in a better response, quality of response, PFS, and OS," the authors write.
The study was funded in part by Janssen-Cilag-Ortho Biotech. Several authors and the German Multicenter Myeloma Group disclosed financial ties to the pharmaceutical industry.
Hematology & Oncology
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