Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens

被引:128
作者
Niesvizky, Ruben [1 ]
Flinn, Ian W. [2 ,3 ]
Rifkin, Robert [4 ]
Gabrail, Nashat [5 ]
Charu, Veena [6 ]
Clowney, Billy [7 ]
Essell, James [8 ,9 ]
Gaffar, Yousuf [10 ]
Warr, Thomas [11 ]
Neuwirth, Rachel [12 ]
Zhu, Yanyan [12 ]
Elliott, Jennifer [12 ]
Esseltine, Dixie-Lee [12 ]
Niculescu, Liviu [12 ]
Reeves, James [13 ,14 ]
机构
[1] New York Presbyterian Hosp, Weill Cornell Med Coll, New York, NY 10021 USA
[2] Sarah Cannon Res Inst, Nashville, TN USA
[3] Tennessee Oncol, Nashville, TN USA
[4] McKesson Specialty Hlth, US Oncol Res, The Woodlands, TX USA
[5] Gabrail Canc Ctr, Canton, OH USA
[6] Pacific Canc Med Ctr, Anaheim, CA USA
[7] Santee Hematol Oncol, Sumter, SC USA
[8] Sarah Cannon Res Ins, Cincinnati, OH USA
[9] Oncol Hematol Care, Cincinnati, OH USA
[10] Univ Maryland, St Joseph Med Ctr, Towson, MD USA
[11] Clin Canc Care, Great Falls, MT USA
[12] Millennium Pharmaceut Inc, Cambridge, MA USA
[13] Sarah Cannon Res Inst, Ft Myers, FL USA
[14] Florida Canc Specialists, Ft Myers, FL USA
关键词
DIAGNOSED MULTIPLE-MYELOMA; STEM-CELL TRANSPLANTATION; MELPHALAN-PREDNISONE; PLUS DEXAMETHASONE; INITIAL TREATMENT; THALIDOMIDE; INDUCTION; SURVIVAL; THERAPY; LENALIDOMIDE;
D O I
10.1200/JCO.2014.58.7618
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. (C) 2015 by American Society of Clinical Oncology
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页码:3921 / +
页数:11
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