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Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2015 Nov 20; Vol. 33 (33), pp. 3921-9. Date of Electronic Publication: 2015 Jun 08. - Publication Year :
- 2015
-
Abstract
- Purpose: The US community-based, phase IIIB UPFRONT trial was designed to compare three frontline bortezomib-based regimens in transplantation-ineligible patients with myeloma.<br />Patients and Methods: Patients (N = 502) were randomly assigned 1:1:1 to 24 weeks (eight 21-day cycles) of induction with bortezomib-dexamethasone (VD; n = 168; intravenous bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11 plus oral dexamethasone 20 mg, days 1, 2, 4, 5, 8, 9, 11, and 12 [cycles 1 to 4], or 1, 2, 4, and 5 [cycles 5 to 8]), bortezomib-thalidomide-dexamethasone (VTD; n = 167; bortezomib and dexamethasone as before plus oral thalidomide 100 mg, days 1 to 21), or bortezomib-melphalan-prednisone (VMP; n = 167; bortezomib as before plus oral melphalan 9 mg/m(2) and oral prednisone 60 mg/m(2), days 1 to 4, every other cycle), followed by 25 weeks (five 35-day cycles) of bortezomib maintenance (1.6 mg/m(2), days 1, 8, 15, and 22). The primary end point was progression-free survival.<br />Results: After 42.7 months' median follow-up, median progression-free survival with VD, VTD, and VMP was 14.7, 15.4, and 17.3 months, respectively; median overall survival was 49.8, 51.5, and 53.1 months, with no significant differences among treatments for either end point (global P = .46 and P = .79, respectively, Wald test). Overall response rates were 73% (VD), 80% (VTD), and 70% (VMP). Adverse events were more common with VTD than VD or VMP. Bortezomib maintenance was feasible without producing cumulative toxicity.<br />Conclusion: Although all bortezomib-containing regimens produced good outcomes, VTD and VMP did not appear to offer an advantage over VD in transplantation-ineligible patients with myeloma treated in US community practice.<br /> (© 2015 by American Society of Clinical Oncology.)
- Subjects :
- Adrenal Cortex Hormones administration & dosage
Adrenal Cortex Hormones adverse effects
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bortezomib adverse effects
Community Health Services
Disease-Free Survival
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Multiple Myeloma pathology
Multivariate Analysis
Prognosis
Proportional Hazards Models
Prospective Studies
Risk Assessment
Severity of Illness Index
Survival Analysis
Thalidomide administration & dosage
Thalidomide adverse effects
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Bortezomib administration & dosage
Multiple Myeloma drug therapy
Multiple Myeloma mortality
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 33
- Issue :
- 33
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 26056177
- Full Text :
- https://doi.org/10.1200/JCO.2014.58.7618