M Aapro1, V Moebus2, U Nitz3, J O'Shaughnessy4, P Pronzato5, M Untch6, D Tomita7, C Bohac7, B Leyland-Jones8. 1. Clinique de Genolier, Multidisciplinary Oncology Institute, Genolier, Switzerland maapro@genolier.net. 2. Department of Gynecology and Obstetrics, Höchst Frankfurt Clinic, Academic Hospital of the Goethe University, Frankfurt. 3. Geriatric Breast Center, Evangelina Bethesda Hospital for Breast Diseases, Nordrhein-Westfalen, Germany. 4. Texas Oncology Baylor Sammons Cancer Center, US Oncology, Dallas, USA. 5. Department of Medical Oncology, National Institute for Cancer Research, IRCCS University Hospital San Martino - IST, Genova, Italy. 6. Department of Obstetrics and Gynecology, Helios Clinic Berlin-Buch, Berlin, Germany. 7. Global Biostatistical Sciences, Amgen Inc., Thousand Oaks. 8. Edith Sanford Breast Cancer Research, Sioux Falls, USA.
Abstract
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 α, epoetin β, darbepoetin α, 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; ESA n = 2088; control n = 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.
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 α, epoetin β, darbepoetin α, 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; ESA n = 2088; control n = 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.
Authors: N Maass; F Schütz; P A Fasching; T Fehm; W Janni; S Kümmel; H-C Kolberg; D Lüftner; M Wallwiener; M P Lux Journal: Geburtshilfe Frauenheilkd Date: 2015-02 Impact factor: 2.915