Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens
| Autor: | Thomas A. Warr, Rachel Neuwirth, Robert M. Rifkin, Ian W. Flinn, Yousuf Gaffar, James A. Reeves, Veena Charu, James Essell, Yanyan Zhu, Ruben Niesvizky, Billy Clowney, Nashat Y. Gabrail, Dixie-Lee Esseltine, Liviu Niculescu, Jennifer Elliott |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Melphalan Cancer Research medicine.medical_specialty Kaplan-Meier Estimate Risk Assessment Severity of Illness Index Gastroenterology Disease-Free Survival Drug Administration Schedule law.invention Bortezomib Randomized controlled trial Adrenal Cortex Hormones law Prednisone Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Community Health Services Prospective Studies Dexamethasone Aged Proportional Hazards Models Dose-Response Relationship Drug business.industry Phase IIIb Trial Middle Aged Prognosis Survival Analysis Thalidomide Surgery Treatment Outcome Oncology Multivariate Analysis Female Multiple Myeloma business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 33:3921-3929 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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/m2, 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/m2 and oral prednisone 60 mg/m2, days 1 to 4, every other cycle), followed by 25 weeks (five 35-day cycles) of bortezomib maintenance (1.6 mg/m2, 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. |
| Databáze: | OpenAIRE |
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