Safety and efficacy outcomes with erythropoiesis-stimulating agents in patients with breast cancer: a meta-analysis

ABSTRACT A meta-analysis of trials of ESA use in patients with breast cancer receiving chemotherapy was conducted. Nine studies were analyzed (ESAn = 2346; controln = 2367). The overall stratified random-effects odds ratio (95% CI) was 1.17 (0.99–1.39) for death and 1.01 (0.87–1.16) for disease progression-related end points. Odds ratios remain consistent with prior data after including recent results. Background New data on erythropoiesis-stimulating agents (ESAs) regarding overall survival and disease progression-related outcomes in patients with breast cancer receiving chemotherapy are presented in a meta-analysis of controlled trials of ESA use (epoetin a, epoetin b, darbepoetin a, biosimilars). Patients and methods A literature search identified reports from January 1997 through March 2014. We used company databases for Amgen, Inc., or Janssen studies and published data for other studies. Random-effects odds ratios (ORs) were calculated to compare results for patients randomized to ESA with those randomized to control. Results Deaths were reported for 571 of 2346 patients (24%) in the ESA groups and 523 of 2367 patients (22%) in the control groups [OR, 1.20; 95% confidence interval (CI) 1.03–1.40]. Sensitivity analyses were conducted to explore the effects of individual studies and exclusion of one study (BEST) resulted in an OR for death of 1.12 (95% CI 0.94–1.34). In seven studies reporting progression-related end points (N = 4197; ESAn = 2088; controln = 2109), the OR was 1.01 (95% CI 0.87–1.16) for ESA compared with control. Conclusions After incorporating recent results of ESA use in patients with breast cancer, risks of survival and progression-free survival remain consistent with previously published data.