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J Clin Oncol ; 33(33): 3921-9, 2015 Nov 20.
Article in English | MEDLINE | ID: mdl-26056177

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.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bortezomib/administration & dosage , Multiple Myeloma/drug therapy , Multiple Myeloma/mortality , 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
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