PURPOSE: The Breast Cancer-Anemia and the Value of Erythropoietin (BRAVE) study evaluated whether epoetin beta would improve survival in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: BRAVE was an open-label, randomized, multicenter study in patients with MBC treated withanthracycline- and/or taxane-based chemotherapy. Patients (hemoglobin [Hb] < 12.9 g/dL) were randomly assigned (1:1) to epoetin beta 30,000 U subcutaneously once weekly or control for 24 weeks. The primary efficacy variable was overall survival. Secondary efficacy outcomes included progression-free survival, transfusion- and severe anemia-free survival, Hb response, safety, and quality of life (QoL). RESULTS: After 18 months of follow-up, 62 (27%) of 231 patients survived withepoetin beta therapy and 63 (27%) of 232 with control. No difference was detected in overall survival (hazard ratio [HR] = 1.07; 95% CI, 0.87 to 1.33, P = .522) or progression-free survival (HR = 1.07; 95% CI, 0.89 to 1.30, P = .448). There was a statistically significant benefit on transfusion- and severe anemia-free survival compared with control (HR = 0.59; P = .0097). Median Hb level increased with epoetin beta (11.7 g/dL at baseline to 13.3 g/dL at 24 weeks) but did not change with control (11.5 v 11.4 g/dL). Patients receiving epoetin beta experienced more thromboembolic events (TEEs) compared with controls (13% v 6%; P = .012) with no difference in serious TEEs (4% v 3%). Epoetin beta did not significantly improve QoL in this study where patients had a high baseline Hb value. CONCLUSION: In patients with MBC receiving chemotherapy and initial Hb less than 12.9 g/dL, epoetin beta increased Hb. No difference was detected in overall survival. Because of its superiority design, this study cannot, however, exclude clinically important differences in survival with absolute certainty.
RCT Entities:
PURPOSE: The Breast Cancer-Anemia and the Value of Erythropoietin (BRAVE) study evaluated whether epoetin beta would improve survival in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: BRAVE was an open-label, randomized, multicenter study in patients with MBC treated with anthracycline- and/or taxane-based chemotherapy. Patients (hemoglobin [Hb] < 12.9 g/dL) were randomly assigned (1:1) to epoetin beta 30,000 U subcutaneously once weekly or control for 24 weeks. The primary efficacy variable was overall survival. Secondary efficacy outcomes included progression-free survival, transfusion- and severe anemia-free survival, Hb response, safety, and quality of life (QoL). RESULTS: After 18 months of follow-up, 62 (27%) of 231 patients survived with epoetin beta therapy and 63 (27%) of 232 with control. No difference was detected in overall survival (hazard ratio [HR] = 1.07; 95% CI, 0.87 to 1.33, P = .522) or progression-free survival (HR = 1.07; 95% CI, 0.89 to 1.30, P = .448). There was a statistically significant benefit on transfusion- and severe anemia-free survival compared with control (HR = 0.59; P = .0097). Median Hb level increased with epoetin beta (11.7 g/dL at baseline to 13.3 g/dL at 24 weeks) but did not change with control (11.5 v 11.4 g/dL). Patients receiving epoetin beta experienced more thromboembolic events (TEEs) compared with controls (13% v 6%; P = .012) with no difference in serious TEEs (4% v 3%). Epoetin beta did not significantly improve QoL in this study where patients had a high baseline Hb value. CONCLUSION: In patients with MBC receiving chemotherapy and initial Hb less than 12.9 g/dL, epoetin beta increased Hb. No difference was detected in overall survival. Because of its superiority design, this study cannot, however, exclude clinically important differences in survival with absolute certainty.
Authors: Peter L Greenberg; Zhuoxin Sun; Kenneth B Miller; John M Bennett; Martin S Tallman; Gordon Dewald; Elisabeth Paietta; Richard van der Jagt; Jessie Houston; Mary L Thomas; David Cella; Jacob M Rowe Journal: Blood Date: 2009-06-29 Impact factor: 22.113
Authors: Mariana Chavez-MacGregor; Hui Zhao; Shenying Fang; Tomasz P Srokowski; Gabriel N Hortobagyi; Sharon H Giordano Journal: Cancer Date: 2011-02-24 Impact factor: 6.860
Authors: Thomas Thomaidis; Arndt Weinmann; Martin Sprinzl; Stephan Kanzler; Jochen Raedle; Matthias Ebert; Carl Cristoph Schimanski; Peter Robert Galle; Thomas Hoehler; Markus Moehler Journal: Int J Clin Oncol Date: 2013-03-27 Impact factor: 3.402
Authors: Marcello Tonelli; Brenda Hemmelgarn; Tony Reiman; Braden Manns; M Neil Reaume; Anita Lloyd; Natasha Wiebe; Scott Klarenbach Journal: CMAJ Date: 2009-04-30 Impact factor: 8.262
Authors: J Glaspy; J Crawford; J Vansteenkiste; D Henry; S Rao; P Bowers; J A Berlin; D Tomita; K Bridges; H Ludwig Journal: Br J Cancer Date: 2010-01-05 Impact factor: 7.640