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)

被引:171
作者
Durie, Brian G. M. [1 ]
Hoering, Antje [2 ]
Sexton, Rachael [2 ]
Abidi, Muneer H. [3 ]
Epstein, Joshua [4 ]
Rajkumar, S. Vincent [5 ]
Dispenzieri, Angela [5 ]
Kahanic, Stephen P. [6 ]
Thakuri, Mohan C. [7 ]
Reu, Frederic J. [8 ]
Reynolds, Christopher M. [9 ]
Orlowski, Robert Z. [10 ]
Barlogie, Bart
机构
[1] Cedars Sinai Canc Ctr, Los Angeles, CA 90048 USA
[2] SWOG Stat Ctr, Seattle, WA USA
[3] Michigan State Univ, Spectrum Hlth Canc Ctr, Grand Rapids, MI USA
[4] Univ Arkansas Med Sci, Myeloma Inst, Little Rock, AR 72205 USA
[5] Mayo Clin, Div Hematol, Rochester, MN USA
[6] Siouxland Reg Canc Ctr, Sanford NCORP North Cent Plains, Sioux City, IA USA
[7] Canc Care Western NC, Asheville, NC USA
[8] Cleveland Clin, Taussig Canc Inst, Dept Hematol & Med Oncol, Cleveland, OH 44106 USA
[9] St Joseph Mercy Hosp, Michigan Canc Res Consortium NCORP, Ann Arbor, MI 48104 USA
[10] Univ Texas MD Anderson Canc Ctr, Dept Lymphoma & Myeloma, Houston, TX 77030 USA
关键词
PLUS DEXAMETHASONE; COMBINATION THERAPY; RESPONSE CRITERIA; CLINICAL-TRIALS; CEREBLON;
D O I
10.1038/s41408-020-0311-8
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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