Artikel ; Online: Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
2015 Band 33, Heft 33, Seite(n) 3921–3929
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.: Patients and methods: Patients (N = 502) were randomly assigned 1:1:1 to ...
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. 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. 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. 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. |
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Mesh-Begriff(e) | Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/adverse effects ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bortezomib/administration & dosage ; 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/drug therapy ; Multiple Myeloma/mortality ; 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 |
Chemische Substanzen | Adrenal Cortex Hormones ; Thalidomide (4Z8R6ORS6L) ; Bortezomib (69G8BD63PP) |
Sprache | Englisch |
Erscheinungsdatum | 2015-11-20 |
Erscheinungsland | United States |
Dokumenttyp | Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't |
ZDB-ID | 604914-x |
ISSN | 1527-7755 ; 0732-183X |
ISSN (online) | 1527-7755 |
ISSN | 0732-183X |
DOI | 10.1200/JCO.2014.58.7618 |
Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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