Pre-transfusion hemoglobin (PT-Hb) levels in erythropoiesis-stimulating agent (ESA)-treated patients with chemotherapy-induced anemia (CIA): Results from randomized controlled trial (RCT) and observational data.

Abstract

e16559 Background: Cancer patients often experience CIA and may be treated with ESAs. Recent observational data on PT-Hb levels in ESA-treated patients with CIA have not been reported. This analysis evaluated PT-Hb levels for this population from RCTs and the DOSE registry, a prospective, observational study of real-world ESA treatment patterns and hematologic outcomes. Methods: Data from ESA-treated cancer patients with CIA were obtained from 3 RCTs (Waltzman/Oncologist 2005; Henry/Curr Med Res Opin 2006; Glaspy/Cancer 2009) and from the DOSE registry (Larholt/Clin Drug Inv 2008). Transfused patients with PT-Hb measurements were identified. PT-Hb levels were defined according to RCT protocols or as the most recent Hb value 7 days before the transfusion episode (DOSE registry). Descriptive statistics summarize the analyses. Results: Of the 834 ESA-treated CIA patients from RCTs, 150 received a total of 257 transfusions, of which 245 (95.3%) had PT-Hb levels available. Of 1,810 ESA-treated CIA registry patients (enrolled 12/2003-5/2009), 364 received a total of 596 transfusions, of which 508 (85.2%) had PT-Hb levels available. The PT-Hb was significantly lower in RCT patients compared to registry patients (mean±sd: RCT 8.0±1.0 g/dL, registry 8.9±1.1 g/dL, p<0.0001). The PT-Hb range was wide for both groups (RCT: 4.7-13.1 g/dL; registry: 5.1-12.9 g/dL). In RCT patients, 42.4% of transfusions occurred at PT-Hb levels <8.0 g/dL and 1.9% at ≥10.0 g/dL. In registry patients, 15.8% of transfusions occurred at PT-Hb levels of <8.0 g/dL and 13.1% at ≥10.0 g/dL. Conclusions: Wide variance of PT-Hb levels in ESA-treated patients with CIA was reported from RCT and observational data. Mean PT-Hb was significantly lower in the RCT compared to observational data. Patient characteristics or site-specific transfusion policies that may contribute to the latter represent an area of future research. Group Transfusions based on PT-Hb range (g/dL), n (%) <7.0 7.0-7.9 8.0-8.9 9.0-9.9 >10.0 Missing RCTs 21 (8.2) 88 (34.2) 105 (40.9) 26 (10.1) 5 (1.9) 12 (4.7) Registry 13 (2.2) 81 (13.6) 192 (32.2) 144 (24.2) 78 (13.1) 88 (14.8) Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Centocor Ortho Biotech Centocor Ortho Biotech Johnson & Johnson Centocor Ortho Biotech