(HealthDay News) – For patients with newly diagnosed multiple myeloma (MM), induction treatment with a combination of bortezomib, doxorubicin, and dexamethasone (PAD) followed by bortezomib maintenance therapy improves complete response (CR), progression-free survival (PFS), and overall survival (OS) rates, according to a study published online July 16 in the Journal of Clinical Oncology.
Pieter Sonneveld, MD, PhD, of the Erasmus Medical Center in Rotterdam, Netherlands, and colleagues conducted an open-label, randomized Phase 3 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% vs. 15%). The CR rate was also significantly improved with bortezomib maintenance therapy (49% vs. 34%). Compared to those treated with VAD, patients treated with PAD had superior PFS after a median of 41 months (median 35 months vs. 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 2mg/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.