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).

التفاصيل البيبلوغرافية
العنوان:	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).
المؤلفون:	Durie BGM; Cedars Sinai Cancer Center, Los Angeles, CA, USA. BDurie@myeloma.org., Hoering A; SWOG Statistical Center, Seattle, WA, USA., Sexton R; SWOG Statistical Center, Seattle, WA, USA., Abidi MH; Michigan State University/Spectrum Health Cancer Center, Grand Rapids, MI, USA., Epstein J; Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Rajkumar SV; Division of Hematology, Mayo Clinic, Rochester, MN, USA., Dispenzieri A; Division of Hematology, Mayo Clinic, Rochester, MN, USA., Kahanic SP; Sanford NCORP of the North Central Plains/ Siouxland Regional Cancer Center, Sioux City, IA, USA., Thakuri MC; Cancer Care Western NC, Asheville, NC, USA., Reu FJ; Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA., Reynolds CM; Michigan Cancer Research Consortium NCORP, St. Joseph Mercy Hospital, Ann Arbor, MI, USA., Orlowski RZ; Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Barlogie B
المصدر:	Blood cancer journal [Blood Cancer J] 2020 May 11; Vol. 10 (5), pp. 53. Date of Electronic Publication: 2020 May 11.
نوع المنشور:	Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: Nature Pub. Group Country of Publication: United States NLM ID: 101568469 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-5385 (Electronic) Linking ISSN: 20445385 NLM ISO Abbreviation: Blood Cancer J Subsets: MEDLINE
أسماء مطبوعة:	Original Publication: New York, NY : Nature Pub. Group
مواضيع طبية MeSH:	Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bortezomib/therapeutic use , Dexamethasone/therapeutic use , Lenalidomide/therapeutic use , Multiple Myeloma/drug therapy, Aged ; Female ; Follow-Up Studies ; Humans ; Male ; Survival Analysis ; Transplantation, Autologous ; Treatment Outcome
مستخلص:	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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معلومات مُعتمدة:	UG1 CA189821 United States CA NCI NIH HHS; U10 CA046113 United States CA NCI NIH HHS; UG1 CA189825 United States CA NCI NIH HHS; N01 CA013612 United States CA NCI NIH HHS; U10 CA013612 United States CA NCI NIH HHS; U10 CA180821 United States CA NCI NIH HHS; U10 CA139519 United States CA NCI NIH HHS; UG1 CA189830 United States CA NCI NIH HHS; U10 CA045450 United States CA NCI NIH HHS; U10 CA073590 United States CA NCI NIH HHS; UG1 CA189853 United States CA NCI NIH HHS; U10 CA180820 United States CA NCI NIH HHS; UG1 CA189808 United States CA NCI NIH HHS; UG1 CA189957 United States CA NCI NIH HHS; U10 CA180888 United States CA NCI NIH HHS; U10 CA068183 United States CA NCI NIH HHS; N01 CA004919 United States CA NCI NIH HHS; UG1 CA189829 United States CA NCI NIH HHS; U10 CA022433 United States CA NCI NIH HHS; UG1 CA189804 United States CA NCI NIH HHS; UG1 CA189856 United States CA NCI NIH HHS; UG1 CA189971 United States CA NCI NIH HHS; U10 CA012644 United States CA NCI NIH HHS; U10 CA016385 United States CA NCI NIH HHS; U10 CA037981 United States CA NCI NIH HHS; U10 CA004919 United States CA NCI NIH HHS; UG1 CA189872 United States CA NCI NIH HHS; UG1 CA189952 United States CA NCI NIH HHS; UG1 CA189858 United States CA NCI NIH HHS; UG1 CA189860 United States CA NCI NIH HHS; U10 CA046282 United States CA NCI NIH HHS; UG1 CA189854 United States CA NCI NIH HHS; U10 CA180819 United States CA NCI NIH HHS; UG1 CA189953 United States CA NCI NIH HHS
المشرفين على المادة:	0 (Antineoplastic Agents) 69G8BD63PP (Bortezomib) 7S5I7G3JQL (Dexamethasone) F0P408N6V4 (Lenalidomide)
تواريخ الأحداث:	Date Created: 20200513 Date Completed: 20210504 Latest Revision: 20210511
رمز التحديث:	20231215
مُعرف محوري في PubMed:	PMC7214419
DOI:	10.1038/s41408-020-0311-8
PMID:	32393732
قاعدة البيانات:	MEDLINE

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تدمد:	2044-5385
DOI:	10.1038/s41408-020-0311-8