NEW YORK (Reuters Health) – Response rates are higher when bortezomib plus dexamethasone rather than vincristine plus doxorubicin plus dexamethasone (VAD) is used as induction therapy before stem-cell transplantation in patients newly diagnosed with multiple myeloma, a French team has shown.

They say bortezomib plus dexamethasone should be considered a standard of care in this setting.

Dr. Jean-Luc Harousseau, at Centre René Gauducheau in Nantes/St. Herblain, and colleagues conducted a phase III trial of the two regimens in 482 patients with untreated symptomatic multiple myeloma. Half the patients in each treatment arm were also assigned to consolidation therapy with dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP)

Postinduction complete response or near complete response (CR/nCR) rates, the primary endpoint, were 14.8% with bortezomib/dexamethasone compared to 6.4% with VAD, the investigators report in the Journal of Clinical Oncology published ahead of print on September 7. Corresponding rates of at least very good partial response (VGPR) were 37.7% vs 15.1%, and overall response rates were 78.5% vs 62.8%. All the differences were statistically significant.

“Response rates were similar in patients who did and did not receive DCEP,” according to the report.

Following autologous stem cell transplantation, median progression-free survival was 36.0 months in the group treated with bortezomib and dexamethasone compared with 29.7 months for those receiving VAD, a trend that did not reach statistical significance (p=0.064).

As for side effects, severe adverse events were similar in the two groups but hematologic toxicity occurred in 7 patients given VAD versus none in the bortezomib group. However, peripheral neuropathy occurred in more bortezomib patients (52.7%) than VAD patients (32.2%)

“In conclusion,” the authors write, “bortezomib plus dexamethasone should now be considered a standard induction treatment before transplantation to which other regimens, including novel agents, should be compared.”

Reference:

Bortezomib Plus Dexamethasone Is Superior to Vincristine Plus Doxorubicin Plus Dexamethasone As Induction Treatment Prior to Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: Results of the IFM 2005-01 Phase III Trial

J Clin Oncol 2010.