Erythropoietin Treatment under Polychemotherapy in Patients with Gynecologic Malignancies: A Prospective, Randomized, Double-Blind Placebo-Controlled Multicenter Study

Kurz, Ch.; Marth, Ch.; Windbichler, Gudrun; Lahousen, M; Medl, M.; Vavra, N.; Sevelda, P.

doi:10.1006/gyno.1997.4675

Cited by 53 publications

(69 citation statements)

References 16 publications

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“…For epoetin alfa-treated patients in our study, increased Hb levels resulted in reduced transfusion use; only 7.9% of these patients received transfusions compared with 30.5% of BST patients (Po0.001) -a 74% reduction in transfusion use. This result is comparable to results from previous studies enrolling gynaecologic and ovarian cancer patients in which epoetin treatment reduced the percentage of patients requiring transfusion by 67 -77% compared with controls (Kurz et al, 1997;ten Bokkel Huinink et al, 1998). In studies in patients with other malignancies, epoetin alfa treatment resulted in reductions of approximately 36 -62% in transfusion use, compared with controls (Dammacco et al, 2001;Littlewood et al, 2001;Pronzato et al, 2002;Janinis et al, 2003;Savonije et al, 2004;Chang et al, 2005;Witzig et al, 2005) (Table 4).…”

Section: Discussionsupporting

confidence: 84%

“…In two large studies with patients receiving platinum or nonplatinum chemotherapy, mean Hb increases were about 1 g dl À1 at week 4 and 2 g dl À1 at week 8 (Gabrilove et al, 2001;Littlewood et al, 2001). In a study of epoetin alfa in patients with gynaecologic malignancies receiving polychemotherapy (70% with epithelial ovarian cancer), mean Hb increases of 1.5 and 1.6 g dl À1 were observed at 4 and 6 weeks, respectively, with an overall mean Hb increase of 3 g dl À1 at 12 weeks (Kurz et al, 1997). The differences in rates of Hb increase may reflect differences in baseline Hb for the populations in the various studies; the mean baseline Hb of 10.7 g dl À1 for ovarian cancer patients in our study was somewhat higher than that for patients in two of the other studies (range: 9.5 -9.9 g dl À1 ).…”

Section: Discussionmentioning

confidence: 99%

“…Mean increases in QOL from baseline to final score were significant (Po0.001) for Energy Level, Ability to Do Daily Activities, and Overall Quality of Life. In a small double-blind, placebo-controlled trial (n ¼ 35) that enrolled anaemic (Hb o11 g dl À1 ) gynaecologic patients receiving polychemotherapy, epoetin alfa treatment increased Hb levels by 3 g dl À1 at study end and significantly (P ¼ 0.009) decreased transfusion use (Kurz et al, 1997). Quality of life, measured using a nonvalidated questionnaire, did not differ significantly between the groups; however, physical activity levels improved significantly from baseline in patients who responded to epoetin alfa.…”

Section: Discussionmentioning

confidence: 99%

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Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

Wilkinson

Antonopoulos²,

Lahousen

et al. 2006

Br J Cancer

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This multicentre, open-label, controlled clinical trial assessed the effects of epoetin alfa treatment on haematologic and quality of life (QOL) parameters in 182 anaemic (Hbp12 g dl À1 ) ovarian cancer patients receiving platinum chemotherapy. Patients were randomised 2 : 1 to receive epoetin alfa 10 000 -20 000 IU three times weekly plus best standard treatment (BST) or BST only. Main study end points were changes from baseline in haemoglobin (Hb) level, transfusion requirements, and QOL. For the epoetin alfa group, mean Hb increased by 1.8 g dl À1 by weeks 4 -6 and was significantly increased from baseline through study end (Po0.001). The mean change in Hb from baseline was significantly (Po0.001) greater for epoetin alfa than BST patients at all postbaseline evaluations. Significantly fewer epoetin alfa than BST patients required transfusion(s) after the first 4 weeks of treatment (7.9 vs 30.5%; Po0.001). Also, significant (Pp0.04) differences favouring the epoetin alfa group over the BST group were found for all three median CLAS scores (Energy Level, Ability to Do Daily Activities, Overall QOL) and the median average CLAS score during chemotherapy. These findings support use of epoetin alfa to increase Hb levels, reduce transfusion use, and improve QOL in anaemic ovarian cancer patients receiving platinum chemotherapy.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

Wilkinson

Antonopoulos²,

Lahousen

et al. 2006

Br J Cancer

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“…[58][59][60][61][62] In restricting eligibility to ESA treatments evaluated in accordance with their European marketing authorisation with respect to starting dose, 47 studies were excluded (a list of these studies together with the study characteristics can be found in Appendix 6). In total, 23 primary studies 17,48,[50][51][52][53][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77][78] reported in 34 publications 17,48,[50][51][52][53][58][59][60] were judged to meet the inclusion criterion for the review (Table 10); study characteristics are summarised in Appendix 7. Primary studies are linked to multiple secondary publications, as shown in Appendix 8.…”

Section: Studies Identifiedmentioning

confidence: 99%

The effectiveness and cost-effectiveness of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer treatment-induced anaemia (including review of technology appraisal no. 142): a systematic review and economic model

Crathorne

Huxley

Haasova

et al. 2016

Health Technol Assess

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BackgroundAnaemia is a common side effect of cancer treatments and can lead to a reduction in quality of life. Erythropoiesis-stimulating agents (ESAs) are licensed for use in conjunction with red blood cell transfusions to improve cancer treatment-induced anaemia (CIA).ObjectiveTo investigate the effectiveness and cost-effectiveness of ESAs in anaemia associated with cancer treatment (specifically chemotherapy).Data sourcesThe following databases were searched from 2004 to 2013: The Cochrane Library, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Web of Science, Cumulative Index to Nursing and Allied Health Literature, British Nursing Index, Health Management Information Consortium, Current Controlled Trials and ClinicalTrials.gov. The US Food and Drug Administration and European Medicines Agency websites were also searched. Bibliographies of included papers were scrutinised for further potentially includable studies.Review methodsThe clinical effectiveness review followed principles published by the NHS Centre for Reviews and Dissemination. Randomised controlled trials (RCTs), or systematic reviews of RCTs, of ESAs (epoetin or darbepoetin) for treating people with CIA were eligible for inclusion in the review. Comparators were best supportive care, placebo or other ESAs. Anaemia- and malignancy-related outcomes, health-related quality of life (HRQoL) and adverse events (AEs) were evaluated. When appropriate, data were pooled using meta-analysis. An empirical health economic model was developed comparing ESA treatment with no ESA treatment. The model comprised two components: one evaluating short-term costs and quality-adjusted life-years (QALYs) (while patients are anaemic) and one evaluating long-term QALYs. Costs and benefits were discounted at 3.5% per annum. Probabilistic and univariate deterministic sensitivity analyses were performed.ResultsOf 1457 titles and abstracts screened, 23 studies assessing ESAs within their licensed indication (based on start dose administered) were included in the review. None of the RCTs were completely aligned with current European Union licenses. The results suggest a clinical benefit from ESAs for anaemia-related outcomes and an improvement in HRQoL scores. The impact of ESAs on AEs and survival remains highly uncertain, although point estimates are lower, confidence intervals are wide and not statistically significant. Base-case incremental cost-effectiveness ratios (ICERs) for ESA treatment compared with no ESA treatment ranged from £19,429 to £35,018 per QALY gained, but sensitivity and scenario analyses demonstrate considerable uncertainty in these ICERs, including the possibility of overall health disbenefit. All ICERs were sensitive to survival and cost.LimitationsThe relative effectiveness of ESAs was not addressed; all ESAs were assumed to have equivalent efficacy. No studies were completely aligned with their European labelling beyond the starting dose evaluated. There is questionable generalisability given that the included trials were published > 20 years ago and there have been many changes to chemotherapy as well as to the quality of supportive treatment. Trial quality was moderate or poor and there was considerable unexplained heterogeneity for a number of outcomes, particularly survival, and evidence of publication bias. Adjustments were not made to account for multiple testing.ConclusionsESAs could be cost-effective when used closer to licence, but there is considerable uncertainty, mainly because of unknown impacts on overall survival.Study registrationThis study is registered as PROSPERO CRD42013005812.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…For these reasons, many practitioners rely on growth factors, including epoetin alfa (rHuEPO; Epogen or Procrit ® ) or darbepoetin alfa (Aranesp ® ) to treat anemia (FIGURE 2) [47]. Kurz et al concluded that rHuEPO increases hemoglobin levels and decreases transfusions in patients with gynecologic malignancies undergoing polychemotherapy, without compromising QoL [48]. It has even been suggested that rHuEPO may be given prophylactically in older patients (>65 years) and those with baseline hemoglobin of less than 10.5 who are going to be given chemotherapy consisting of carboplatin and paclitaxel [49,50].…”

Section: Anemia and Fatiguementioning

confidence: 99%

Supportive care for women with gynecologic cancers

Chase¹,

Monk²,

Wenzel³

et al. 2008

Expert Review of Anticancer Therapy

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Erythropoietin Treatment under Polychemotherapy in Patients with Gynecologic Malignancies: A Prospective, Randomized, Double-Blind Placebo-Controlled Multicenter Study

Cited by 53 publications

References 16 publications

Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

The effectiveness and cost-effectiveness of erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating cancer treatment-induced anaemia (including review of technology appraisal no. 142): a systematic review and economic model

Supportive care for women with gynecologic cancers

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