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Clinical Trial
. 2020 May 11;10(5):53.
doi: 10.1038/s41408-020-0311-8.

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)

Brian G M Durie  1 , Antje Hoering  2 , Rachael Sexton  2 , Muneer H Abidi  3 , Joshua Epstein  4 , S Vincent Rajkumar  5 , Angela Dispenzieri  5 , Stephen P Kahanic  6 , Mohan C Thakuri  7 , Frederic J Reu  8 , Christopher M Reynolds  9 , Robert Z Orlowski #  10 , Bart Barlogie #
Affiliations
Clinical Trial

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)

Brian G M Durie et al. Blood Cancer J. .

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.

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Conflict of interest statement

B.G.M.D.: Johnson & Johnson: Consultancy; Takeda: Consultancy; Onyx: Consultancy; Celgene: Consultancy. M.H.A.: Millennium: Research Funding. J.E.: University of Arkansas for Medical Sciences: Employment. F.J.R.: Takeda/Millennium: Research Funding; Novartis: Research Funding; Celgene: Research Funding. R.Z.O: BioTheryX, Inc.: Membership on an entity’s Board of Directors or advisory committees; Janssen Pharmaceuticals: Membership on an entity’s Board of Directors or advisory committees; Celgene: Consultancy, Research Funding; Spectrum Pharmaceuticals: Research Funding; Onyx Pharmaceuticals: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Millennium Pharmaceuticals: Consultancy, Research Funding; Acetylon: Membership on an entity’s Board of Directors or advisory committees; Genentech: Consultancy; Forma Therapeutics: Consultancy; Array BioPharma: Consultancy, Research Funding. B.B.: Dana Farber Cancer Institute: Other: Travel Stipend; International Workshop on Waldenström’s Macroglobulinemia: Other: Travel Stipend; ComtecMed-World Congress on Controversies in Hematology: Other: Travel Stipend; European School of Hematology- International Conference on Multiple Myeloma: Other: Travel Stipend; Celgene: Consultancy, Research Funding; Millennium: Consultancy, Research Funding; Myeloma Health, LLC: Patents & Royalties: Co-inventor of patents and patent applications related to use of GEP in cancer medicine licensed to Myeloma Health, LLC; Multiple Myeloma Research Foundation: Other: Travel Stipend.

Figures

Fig. 1
Fig. 1. Outcomes for VRd and Rd.
a Progression-free survival (N = 460). b Response duration (N = 357). c Overall survival (N = 460). d Overall survival (OS) at 5 years.
Fig. 2
Fig. 2. Landmarked outcomes.
a Progression-free Survival by best response at 6 months. b Overall Survival by best response at 12 months.
See this image and copyright information in PMC

References

    1. Anonymous Revlimid® (lenalidomide) [prescribing information]. (Celgene Corporation, Summit, 2017).
    1. Lu G, et al. The myeloma drug lenalidomide promotes the cereblon-dependent destruction of Ikaros proteins. Science. 2014;343:305–309. doi: 10.1126/science.1244917. - DOI - PMC - PubMed
    1. Lopez-Girona A, et al. Cereblon is a direct protein target for immunomodulatory and antiproliferative activities of lenalidomide and pomalidomide. Leukemia. 2012;26:2326–2335. doi: 10.1038/leu.2012.119. - DOI - PMC - PubMed
    1. Richardson P, et al. Lenalidomide in multiple myeloma: an evidence-based review of its role in therapy. Core Evid. 2010;4:215–245. - PMC - PubMed
    1. Anonymous Velcade [package insert]. (Millenium Pharmaceuticals, Cambridge, MA, 2017).

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