The Lancet study shows addition of bortezomib significantly improves survival in treatment-naÃ¯ve patients with multiple myeloma.
In treatment-naïve patients with multiple myeloma, including bortezomib in the treatment plan improved significantly progression-free survival (PFS) and overall survival (OS) in patients who were receiving lenalidomide and dexamethasone. These results were published by National Cancer Institute—sponsored Southwest Oncology Group (SWOG) cooperative study group in The Lancet.
For their study, researchers enrolled 525 patients with newly diagnosed multiple myeloma between April, 2008, and February 2012, who were not scheduled to immediately receive autologous stem cell transplant. Of these, only 473 were eligible for the final study. The randomized, open-label phase 3 trial recruited patients 18 and older (range, 28 to 87 years) to receive either an initial treatment of bortezomib with lenalidomide and dexamethasone (VRd group) or lenalidomide and dexamethasone alone (Rd group). VRd was given as eight 21-day cycles and Rd as six 28-day cycles. Primary trial end point was PFS.
Median PFS was 43 months in the VRd group, compared with 30 months in the Rd group (stratified hazard ratio [HR], 0·712; 96% CI, 0·56-0·906; 1-sided P = ·0018). Median OS too was significantly better for the VRd group—it was 75 months (more than 6 years) compared with 64 months (more than 5 years) in the Rd group (HR, 0·709; 95% CI, 0·524-0·959; 2-sided P = ·025).
About 82% (198/241) of patients in the VRd group experienced adverse events (AEs) of grade 3 or higher compared with 75% (169/226) of patients in the Rd group—23% of those who experienced AEs in the VRd group and 10% of those who experienced AEs in the Rd group discontinued induction treatment. While the VRd group documented 2 treatment-related deaths, there were none in the Rd group.
“There's a lot of excitement about these research findings and this treatment option, which helps myeloma patients stay healthier longer and gives them more time to spend with people they love,” said the study’s principal investigator Brian G.M. Durie, MD, a physician at Cedars-Sinai Outpatient Cancer Center in Los Angeles and chairman of the board at the International Myeloma Foundation, in a statement. “Because the research was so solid, and the findings so strong, we're looking at a potential new standard of care.”
Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial [published online December 22, 2016]. Lancet. doi: http://dx.doi.org/10.1016/S0140-6736(16)31594-X.