NEW YORK (Reuters Health) – For patients with multiple myeloma who are not eligible for autologous stem-cell transplantation, a four-drug combination regimen is promising. Adding thalidomide to bortezomib-melphalan-prednisone, and following with bortezomib-thalidomide maintenance, significantly slows progression, an Italian team reports.
Dr. Antonio Palumbo, with the University of Torino, and colleagues explain in the Journal of Clinical Oncology online October 11 that the combination of bortezomib (Velcade), melphalan and prednisone (VMP) and melphalan-prednisone-thalidomide are now “regarded as the new standards of care for newly diagnosed myeloma in patients older than age 65 years.” Also, it has recently been shown that maintenance therapy after induction improves progression-free survival.
In the current study, the researchers randomized 511 patients (median age 71) to induction with bortezomib, melphalan, prednisone and thalidomide (VMPT) followed by maintenance with bortezomib and thalidomide (VT), or to induction with VMP and no maintenance therapy. Treatment was completed by 161 patients in each arm of the trial.
“During induction therapy, CR (complete response) rate was 38% with VMPT-VT and 24% with VMP (p<0.001), VGPR (very good partial response) rate or better was 59% with VMPT-VT and 50% with VMP (p=0.03),” the team found.
After a median follow-up of just under 2 years, the median progression-free survival had not been reached in the VMPT-VT group, while in the VMP group it was 27.3 months, according to the report.
Estimated 3-year progression-free survival in the two groups was 56% vs 41%, respectively (HR, 0.67; p=0.008), Dr. Palumbo and colleagues report.
Also at the 3-year point, 72% of the VMPT-VT group and 60% of those given VMP had not proceeded to the next level of treatment (HR, 0.58; p=0.007).
Rates of deaths, hematologic adverse events and infections were similar in the two groups, but the occurrence of cardiac complications, thromboembolic events and neuropathy were somewhat higher with VMPT-VT than VMP.
“In conclusion,” the authors write, “this study showed that VMPT-VT was superior to VMP, one of the latest and more effective standards of care for elderly patients, in terms of response rate and progression-free survival.”
Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: A Randomized Controlled Trial
J Clin Oncol 2010.