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).
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
Journal
Blood cancer journal
ISSN: 2044-5385
Titre abrégé: Blood Cancer J
Pays: United States
ID NLM: 101568469
Informations de publication
Date de publication:
11 05 2020
11 05 2020
Historique:
received:
22
11
2019
accepted:
12
03
2020
revised:
21
02
2020
entrez:
13
5
2020
pubmed:
13
5
2020
medline:
5
5
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 32393732
doi: 10.1038/s41408-020-0311-8
pii: 10.1038/s41408-020-0311-8
pmc: PMC7214419
doi:
Substances chimiques
Antineoplastic Agents
0
Bortezomib
69G8BD63PP
Dexamethasone
7S5I7G3JQL
Lenalidomide
F0P408N6V4
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
53Subventions
Organisme : NCI NIH HHS
ID : UG1 CA189821
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA046113
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189825
Pays : United States
Organisme : NCI NIH HHS
ID : N01 CA013612
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA013612
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180821
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA139519
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189830
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA045450
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA073590
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189853
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180820
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189808
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189957
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180888
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA068183
Pays : United States
Organisme : NCI NIH HHS
ID : N01 CA004919
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189829
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA022433
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189804
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189856
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189971
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA012644
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA016385
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA037981
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA004919
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189872
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189952
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189858
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189860
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA046282
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189854
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180819
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189953
Pays : United States
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