Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).

Abstract

SWOG S0777, a randomized phase III trial, compared bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd). This updated analysis includes 460 patients evaluable for survival endpoints: 225 eligible and analyzable patients were randomized to Rd and 235 to VRd. The 6-month induction was six 28-day cycles of Rd and eight 21-day cycles of VRd followed by Rd maintenance for all patients. Median follow up is 84 months. Median PFS is 41 months for VRd and 29 months for Rd: stratified hazard ratio (96% Wald Confidence Interval) was 0.742 (0.594, 0.928) and one-sided stratified log-rank P-value 0.003. Median OS for VRd is still not reached with median OS for Rd being 69 months: stratified hazard ratio (96% Wald Confidence Interval) was 0.709 (0.543, 0.926) and stratified two-sided P-value was 0.0114. Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])). Median duration of Rd maintenance was 17.1 months. The addition of bortezomib to lenalidomide dexamethasone for induction therapy results in a statistically significant and clinically meaningful improvement in PFS as well as better OS. VRd continues to represent an appropriate standard of care irrespective of age.

• Authors: Brian G M Durie, Antje Hoering, Rachael Sexton, Muneer H Abidi, Joshua Epstein, S Vincent Rajkumar, Angela Dispenzieri, Stephen P Kahanic, Mohan C Thakuri, Frederic J Reu, Christopher M Reynolds, Robert Z Orlowski, Bart Barlogie
• Journal: Blood cancer journal (Blood Cancer J) Vol. 10 Issue 5 Pg. 53 (05 11 2020) ISSN: 2044-5385 [Electronic] United States
• PMID: 32393732 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Bortezomib
• Dexamethasone
• Lenalidomide

Topics

• Aged
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bortezomib (therapeutic use)
• Dexamethasone (therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Lenalidomide (therapeutic use)
• Male
• Multiple Myeloma (drug therapy)
• Survival Analysis
• Transplantation, Autologous
• Treatment Outcome