Epoetin Alfa in Patients With Advanced-Stage Hodgkin's Lymphoma: Results of the Randomized Placebo-Controlled GHSG HD15EPO Trial

Engert, Andreas; Josting, Andreas; Haverkamp, Heinz; Villalobos, Matthias; Lohri, Andreas; Sökler, Martin; Zijlstra, Josée M.; Sturm, Isrid; Topp, Max S.; Rank, Andreas; Zenz, Thorsten; Vogelhuber, Martin; Nogová, Lucia; Borchmann, Peter; Fuchs, Michael; Flechtner, Hans‐Henning; Diehl, Volker

doi:10.1200/jco.2009.25.1835

Cited by 53 publications

(30 citation statements)

References 28 publications

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“…Moreover, the drug label and current ASH/ASCO guidelines [28,42] generally recommend not to use ESA in patients with curative intent, although convincing data are lacking that transfusions carry a lower risk in this patient group than ESA. By contrast, several recent prospective randomised trials using ESA with curative intent did not provide evidence of an impact on survival or relapse in patients with Hodgkin's lymphoma [46], aggressive lymphoma [47], cervical cancer [48] and early breast cancer [49]. Furthermore, several studies and 3 meta-analyses [20,21,50] have shown that transfusions rather increase the risk of complications such as cardiovascular disease [23], acute lung injury [19], haemolytic reactions [19], postoperative infection [19,20] and surgical re-intervention [20], as well as the risk of relapse [20,21,24], all-cause [19,20,22,23,24,51] and cancer-related mortality [20], and may induce malignant lymphomas [50].…”

Section: Discussionmentioning

confidence: 99%

Treatment of Cancer-Associated Anaemia: Results from a Two-Day Cross-Sectional Survey in Germany

Schmitz

2013

Oncol Res Treat

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Background: The aim was to re-evaluate the current prevalence and management of cancer-associated anaemia as defined by the World Health Organisation (WHO) and related risk factors. Patients and Methods: This was a prospective, 2-day web-based cross-sectional survey in cancer patients with non-myeloid malignancies in German outpatient clinics. Results: 89 centres collected data from 3,867 patients, of whom 74% received active cancer therapy. The median age was 65 years (range 19-99 years) and almost two-thirds were women; 68% of the patients had solid tumours (breast 34%, colorectal 17%, lung 8%), with 56% of them being metastatic; 73% had a WHO performance score of ≤ 1. The mean haemoglobin level was 12.0 ± 1.7 g/dl (± standard deviation; range 4.3-17.8 g/dl); the prevalence of levels below 12.0 g/dl was 49%. Two-thirds of these patients were not treated for anaemia; one-third received erythropoiesis-stimulating agents (12.6%), iron therapy (8.1%), transfusions (7.5%) or combinations thereof (8.0%) during the 4 weeks before evaluation. Chemotherapy, female sex, age and poor performance status were identified as significant anaemia-associated factors. Conclusions: The prevalence of untreated anaemia and the decreased performance status of cancer patients in Germany have hardly changed since the European Cancer Anaemia Survey (ECAS) in 2001. The treatment practice may not only be driven by guidelines and does not yet reflect new concepts of anaemia management.

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Section: Discussionmentioning

confidence: 99%

Treatment of Cancer-Associated Anaemia: Results from a Two-Day Cross-Sectional Survey in Germany

Schmitz

2013

Oncol Res Treat

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“…Positive findings from observational studies (Glaspy et al , 1997; Demetri et al , 1998; Gabrilove et al , 2001; Quirt et al , 2001; Cella et al , 2003) and clinical trials (Littlewood et al , 2001; Fallowfield et al , 2002; Chang et al , 2005; Wilkinson et al , 2006) have not been confirmed in more recent RCTs (Smith et al , 2008; Hoskin et al , 2009; Engert et al , 2010; Fujisaka et al , 2011; Nitz et al , 2011). Previous meta-analyses have demonstrated that ESAs effectively reduce fatigue-related symptoms in cancer patients (Minton et al , 2008, 2010; Tonelli et al , 2009).…”

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confidence: 94%

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

et al. 2014

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Background:Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The impact of ESAs on quality of life (QoL) is controversial and led to different recommendations of medical societies and authorities in the USA and Europe. We aimed to critically evaluate and quantify the effects of ESAs on QoL in cancer patients.Methods:We included data from randomised controlled trials (RCTs) on the effects of ESAs on QoL in cancer patients. Randomised controlled trials were identified by searching electronic data bases and other sources up to January 2011. To reduce publication and outcome reporting biases, we included unreported results from clinical study reports. We conducted meta-analyses on fatigue- and anaemia-related symptoms measured with the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) and FACT-Anaemia (FACT-An) subscales (primary outcomes) or other validated instruments.Results:We identified 58 eligible RCTs. Clinical study reports were available for 27% (4 out of 15) of the investigator-initiated trials and 95% (41 out of 43) of the industry-initiated trials. We excluded 21 RTCs as we could not use their QoL data for meta-analyses, either because of incomplete reporting (17 RCTs) or because of premature closure of the trial (4 RCTs). We included 37 RCTs with 10 581 patients; 21 RCTs were placebo controlled. Chemotherapy was given in 27 of the 37 RCTs. The median baseline haemoglobin (Hb) level was 10.1 g dl–1; in 8 studies ESAs were stopped at Hb levels below 13 g dl–1 and in 27 above 13 g dl–1. For FACT-F, the mean difference (MD) was 2.41 (95% confidence interval (95% CI) 1.39–3.43; P<0.0001; 23 studies, n=6108) in all cancer patients and 2.81 (95% CI 1.73–3.90; P<0.0001; 19 RCTs, n=4697) in patients receiving chemotherapy, which was below the threshold (⩾3) for a clinically important difference (CID). Erythropoiesis-stimulating agents had a positive effect on anaemia-related symptoms (MD 4.09; 95% CI 2.37–5.80; P=0.001; 14 studies, n=2765) in all cancer patients and 4.50 (95% CI 2.55–6.45; P<0.0001; 11 RCTs, n=2436) in patients receiving chemotherapy, which was above the threshold (⩾4) for a CID. Of note, this effect persisted when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy. There was some evidence that the MDs for FACT-F were above the threshold for a CID in RCTs including cancer patients receiving chemotherapy with Hb levels below 12 g dl–1 at baseline and in RCTs stopping ESAs at Hb levels above 13 g dl–1. However, these findings for FACT-F were not confirmed when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy.Conclusions:In cancer patients, particularly those receiving chemotherapy, we found that ESAs provide a small but clinically important improvement in anaemia-related symptoms (FACT-An). For fatigue-related symptoms (FACT-F), the overall effect did not reach the threshold for a CID.

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“…In addition, American guidelines encourage a risk benefit evaluation prior to the use of ESAs, which appears difficult on the basis of the individual patient, in particular given the lack of reliable predictors of response. However, as there is good evidence that the risks associated with the use of ESAs according to current guidelines are low [30][31][32][33]47,48 , minor benefits may already outweigh those. Interestingly, we found the most striking differences in QoL improvements using the response criterion of any Hb increase.…”

Section: Discussionmentioning

confidence: 83%

“…As a consequence, the ESA drug label has changed and official treatment guidelines have been revised several times [24][25][26][27][28][29] . However, evidence of such a risk in daily practice is lacking, and recent safety trials have provided data suggesting that use of ESAs according to guidelines is not associated with any decrease of survival in patients with Hodgkin's lymphoma 30 , aggressive lymphoma 31 , cervical cancer 32 , and early breast cancer 33 .…”

Section: Introductionmentioning

confidence: 98%

A prospective cohort study on the impact of darbepoetin alfa on quality of life in daily practice following anemia treatment guideline revisions

Steinmetz

Kindler

Lange

et al. 2014

Current Medical Research and Opinion

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Epoetin Alfa in Patients With Advanced-Stage Hodgkin's Lymphoma: Results of the Randomized Placebo-Controlled GHSG HD15EPO Trial

Abstract: Epoetin alfa administered at 40,000 U weekly parallel to BEACOPP chemotherapy was safe in patients with advanced-stage HL and reduced the number of RBC transfusions but had no impact on fatigue and other PRO domains.

Cited by 53 publications

References 28 publications

Treatment of Cancer-Associated Anaemia: Results from a Two-Day Cross-Sectional Survey in Germany

Treatment of Cancer-Associated Anaemia: Results from a Two-Day Cross-Sectional Survey in Germany

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

A prospective cohort study on the impact of darbepoetin alfa on quality of life in daily practice following anemia treatment guideline revisions

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