Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma

作者：Paul Gerard Guy Richardson, Pieter Sonneveld, Michael W. Schuster, David H. Irwin, Edward Allen Stadtmauer, Thierry T.F. Facon, Jean‐Luc Harousseau, Dina Ben‐Yehuda, Sagar Lonial, Hartmut Goldschmidt, Donna Ellen Reece, Jesús F. San Miguel, Joan Bladé, Mario Boccadoro, Jamie D. Cavenagh, William S. Dalton, Anthony L. Boral, Dixie L. Esseltine, Jane Porter, David P. Schenkein, Kenneth Carl Anderson · 发表于：New England Journal of Medicine · 年份：2005 · DOI：10.1056/nejmoa043445 · 被引用次数：2513 · 研究领域：Multiple Myeloma Research and Treatments、Radiopharmaceutical Chemistry and Applications、Cancer Treatment and Pharmacology

BACKGROUND: This study compared bortezomib with high-dose dexamethasone in patients with relapsed multiple myeloma who had received one to three previous therapies. METHODS: We randomly assigned 669 patients with relapsed myeloma to receive either an intravenous bolus of bortezomib (1.3 mg per square meter of body-surface area) on days 1, 4, 8, and 11 for eight three-week cycles, followed by treatment on days 1, 8, 15, and 22 for three five-week cycles, or high-dose dexamethasone (40 mg orally) on days 1 through 4, 9 through 12, and 17 through 20 for four five-week cycles, followed by treatment on days 1 through 4 for five four-week cycles. Patients who were assigned to receive dexamethasone were permitted to cross over to receive bortezomib in a companion study after disease progression. RESULTS: Patients treated with bortezomib had higher response rates, a longer time to progression (the primary end point), and a longer survival than patients treated with dexamethasone. The combined complete and partial response rates were 38 percent for bortezomib and 18 percent for dexamethasone (P<0.001), and the complete response rates were 6 percent and less than 1 percent, respectively (P<0.001). Median times to progression in the bortezomib and dexamethasone groups were 6.22 months (189 days) and 3.49 months (106 days), respectively (hazard ratio, 0.55; P<0.001). The one-year survival rate was 80 percent among patients taking bortezomib and 66 percent among patients taking dexamethas...