Among patients with transplant-ineligible newly diagnosed multiple myeloma, a twice-weekly first-cycle dose of bortezomib with a high dose of melphalan and a high cumulative dose of both bortezomib and melphalan appears to improve progression-free survival (PFS) compared with a less-intensive melphalan, prednisone and bortezomib (MPB) regimen, according to research published in Cancer Science.
The randomized phase 2 JCOG1105 trial previously suggested that the higher-dose MPB regimen (arm A of the study) yields improved PFS and complete response rates compared with the lower-intensity MPB regimen (arm B). Patients in arm A did not, furthermore, have a greater number of intolerable toxicities than did those in arm B. In the present letter to the editor in Cancer Science, researchers reported the preplanned 3-year analysis from JCOG1105.
Overall, 91 patients were included in the study, of whom 45 were randomly assigned to arm A, while 46 were assigned to arm B. Data cutoff was in June 2019; at this point, the median follow-up was 47.3 months (range, 10.4-71.1).
Analysis showed that at 1, 3, and 5 years, the PFS rates were 86.0% (95% CI, 71.6%-93.5%), 27.9% (95% CI, 15.6%-41.6%), and 16.4% (95% CI, 5.8%-31.8%), respectively in arm A, and 73.3% (95% CI, 57.8%-83.9%), 13.3% (95% CI, 5.4%-24.9%), and not estimable in arm B (hazard ratio [HR], 1.69; 95% CI, 1.06-2.68).
Female patients, furthermore, appeared to have improved PFS in arm A (HR, 2.87; 95% CI, 1.34-6.61), as did patients with a performance status of 2 or 3 (HR, 4.32 95% CI, 1.42-13.1). These findings were not noted in male patients or in patients with a performance status of 0 or 1.
Overall survival rates were similar between the 2 arms: at 5 years, the overall survival rate was 73.4% (95% CI, 54.8%-85.3%) in arm A vs 56.8% (95% CI, 31.2%-76.0%) in arm B (HR, 1.58; 95% CI, 0.71-3.53).
“In summary, the final analysis of JCOG1105 demonstrated that twice-weekly dosing of bortezomib in the first cycle along with higher dose of melphalan and higher cumulative dose of both bortezomib and melphalan (Arm A) confers sustained PFS benefit with no new [adverse event]-related concerns,” the authors wrote in their report.
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures.
Reference
Maruyama D, Iida S, Machida R, et al. Final analysis of randomized phase II study optimizing melphalan, prednisolone, bortezomib in multiple myeloma (JCOG1105). Published online July 21, 2022. Cancer Sci. doi:10.1111/cas.15484
This article originally appeared on Hematology Advisor