Weekly Administration of Epoetin Beta for Chemotherapy-induced Anemia in Cancer Patients: Results of a Multicenter, Phase III, Randomized, Double-blind, Placebo-controlled Study

Abstract

Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.

Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: systematic review and meta-analyses of published and unpublished data

“…Of the 58 eligible RCTs, we excluded 21 RTCs for the following reasons: QoL data were not reported because of premature closure of the trials (Machtay et al , 2007; Thomas et al , 2008; AGO-OVAR 2.7; CR002305); or data reporting was too incomplete to allow any analysis (Rose et al , 1994; Dammacco et al , 2001; Quirt et al , 2001; Thomas et al , 2002; INT-1; INT-3; Leyland-Jones et al , 2005; Goss et al , 2005; Aapro et al , 2008a; Suzuki et al , 2008; EPO-GER-20; Gupta et al , 2009; Ray-Coquard et al , 2009; Yoshizaki et al , 2010; Untch et al , 2011; CDR0000069148; Moebus et al , 2013) (Figure 1). Finally, we included 37 studies with 10 581 patients randomised (Abels, 1993; Case et al , 1993; Henry and Abels, 1994; Thatcher et al , 1999; Littlewood et al , 2001; Huddart et al , 2002; Kotasek et al , 2002, 2003; Osterborg et al , 2002; Vansteenkiste et al , 2002; Boogaerts et al , 2003; Hedenus et al , 2003; Iconomou et al , 2003; Milroy et al , 2003; P-174; Chang et al , 2005; Debus et al , 2005; Mystakidou et al , 2005; O'Shaughnessy et al , 2005; Savonije et al , 2005; Witzig et al , 2005; Wilkinson et al , 2006; Charu et al , 2007; Wright et al , 2007; Gordon et al , 2008; Krzakowski, 2008; Pirker et al , 2008; Smith et al , 2008; Strauss et al , 2008; Christodoulou et al , 2009; Hernandez et al , 2009; Hoskin et al , 2009; OBE/EPO-INT-03; Tsuboi et al , 2009; Winquist et al , 2009; Engert et al , 2010; Pronzato et al , 2010). …”

American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer

“…[40][41][42][43][44][45][46][47][48][49][50][51][52] Characteristics of these trials are provided in Data Supplement DS2.…”

“…Since the 2007 guideline update, one individual patient data meta-analysis, 9,27 four literature-based or study-level metaanalyses, 8,28,31,33,34 one systematic review of RCTs without a meta-analysis, 29 and two individual placebo-controlled RCTs 46,48 have published evidence relevant to the effects of ESA therapy on risk of mortality. Literature update and discussion: new evidence on potential harms.…”

“…Since the last guideline update, several clinical trials 35,42,48 and one meta-analysis 31 have included QOL as an end point for patients with chemotherapy-induced anemia randomly assigned to treatment with ESAs or placebo. The Update Committee does not find this evidence conclusive to show that ESA use, particularly at higher levels of Hb initiation, leads to substantial improvements in QOL (ie, perceived and valued by patients) as measured by the Functional Assessment of Cancer Therapy instruments, 35,42 even when the Hb increases and transfusion decreases are statistically significant.…”

“…36,37,46,48,49 However, one study (N ϭ 120) reported no thromboembolic events of any grade in either arm. 43 A fixed effects meta-analysis of 30 RCTs in the AHRQ comparative effectiveness review found that thromboembolic events were statistically significantly more likely to occur in patients administered epoetin compared with controls (RR, 1.69; 95% CI, 1.36 to 2.10; P Ͻ .001).…”