Recombinant Human Erythropoietin Therapy for Anemic Cancer Patients on Combination Chemotherapy

117

114

This open-label, prospective study was conducted to compare the impact of epoetin b vs standard care on quality of life (QoL) in anaemic patients with lymphoid or solid tumour malignancies. A total of 262 anaemic patients (haemoglobin [Hb]p11 g dl À1 ) were randomised to a 12-week treatment with s.c. epoetin b (initial dose 150 IU kg À1 three times weekly) or standard care. Transfusions were recommended for both groups at an Hb threshold of 8.5 g dl À1 . The primary efficacy variables were improvement in QoL as measured using the Short-Form-36 physical component summary (SF-36 PCS) score and the Functional Assessment of Cancer Therapy fatigue and anaemia subscales (FACT-F and FACT-An). A visual analogue scale (VAS) was also used as a global QoL measure. Clinical response was defined as a X2 g dl À1 increase in Hb level without need of transfusion after the initial 4 weeks of treatment. Baseline to final visit changes in SF-36 PCS, FACT-F and VAS scores were significantly greater with epoetin b than with standard care (Po0.05); changes in FACT-An subscale score tended to be greater with epoetin b (P ¼ 0.076). Epoetin b significantly increased Hb concentrations relative to standard care (responders: 47% vs 13%; Po0.001). Levels of endogenous erythropoietin o50 mIU ml À1 were significantly predictive of response (OR 2.496, 95% CI: 1.21 -5.13). Epoetin b therapy significantly improves QoL compared with standard care in anaemic patients with solid tumours and lymphoid malignancies.

Section: Discussionsupporting

confidence: 93%

Impact of epoetin β on quality of life in patients with malignant disease

Boogaerts¹,

Coiffier

Kainz³

2003

117

114

“…However, Lavey and Dempsey (1993) used 300 U kg-' three times only during the first week and then 150 U kg-' (three times a week) for the remainder of the RT. This dosing schedule is fairly close to that used in the two largest experiences of r-HuEPO in patients with cancer-related anaemia (Abels, 1992a(Abels, ,b, 1993Ludwig et al, 1993Ludwig et al, , 1994 including patients receiving combination chemotherapy (Case et al, 1993). Response rates in these studies are defined differently but are approximately in the 40 to 50% range of patients tested, which is similar to our results.…”

Section: Discussionsupporting

confidence: 86%

“…Nevertheless, this trend toward improved QOL in r-HuEPO-treated patients is reflected in the literature with most (Abels, 1992b(Abels, , 1993Case et al, 1993;Ludwig et al, 1993;Leitgeh et al, 1994) but not all (Dusenberg et al, 1994) series showing a benefit in various quality of life parameters over concurrent or historical controls.…”

Section: Discussionmentioning

confidence: 99%

“…Recombinant erythropoietin (r-HuEPO) has previously been shown to increase the haematocrit and reduce the transfusion requirement in patients with end-stage renal disease undergoing haemodialysis (Esbach et al, 1989) and in AIDS patients treated with zidovudine (Fischl et al, 1990). In addition, there are now a number of reports on the use of r-HuEPO to correct anaemia in cancer patients (Platanias et al, 1991;Abels, 1992aAbels, ,b, 1993Miller et al, 1992;Case et al, 1993;Lavey and Dempsey, 1993;Ludwig et al, 1993Ludwig et al, , 1994Vijayakumar et al, 1993;Dusenbery et al, 1994;Leitgeh et al, 1994;deCampos et al, 1995). In the largest randomized trial published to date, Abels (1993) demonstrated that r-HuEPO corrected anaemia and reduced transfusion requirements compared with a control group for patients with a variety of cancers undergoing chemotherapy.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Effect of subcutaneous recombinant human erythropoetin in cancer patients receiving radiotherapy: final report of a randomized, open-labelled, phase II trial

Sweeney

Nicolae²,

Ignacio³

et al. 1998

Summary The purpose of this study was to determine the safety, efficacy and impact on quality of life of recombinant human erythropoietin (r-HuEPO) for cancer patients undergoing radiotherapy (RT). An open-labelled randomized design was used, with patients randomized to either treatment or control arms. Patients in the treatment arm received r-HuEPO given by subcutaneous injection at a dose of 200 units kg-' day-' plus oral iron supplements (ferrous sulphate 325 mg p.o. t.i.d.). Entry was restricted to patients with carcinoma of the lung, uterine cervix, prostate or breast who presented for RT with anaemia parameters reflective of 'the anaemia of chronic disease'. Radiotherapy policies (portals, doses, fraction size, etc.) were determined by the site and stage of disease. Complete blood counts (CBCs) were obtained weekly. The target level of haemoglobin was 15 g dl-1 for men and 14 g dl-1 for women. Quality of life (QOL) was assessed weekly by using an analogue scale to judge energy, activities of daily living and overall quality of life. Forty-eight patients were entered in the study, 24 in the treatment arm and 24 in the control arm. The prerandomization demographic characteristics and mean laboratory values were comparable in both arms. The mean haemoglobin at completion was 13.6 g dl-1 for r-HuEPO-treated patients compared with 11.0 g dl-1 for control subjects (P= 0.0012). Patients who received r-HuEPO demonstrated a mean weekly haemoglobin increase of 0.41 g dl-1 compared with a decrease in mean haemoglobin level in controls for 6 of the 7 weeks of the study (mean weekly decrease of 0.073 g dl-'). Target levels of haemoglobin were achieved by 41.6% of r-HuEPO-treated patients compared with none of the control subjects. The mean platelet count declined in both arms of the study with RT but the decline from pretreatment was less rapid in r-HuEPO-treated patients (11.2% decrease) compared with controls (26.3% decrease) and was statistically significant during weeks 4-6. Toxicity was minor with only mild irritation at the injection site. Mean quality of life end points were superior in the treatment arm but not statistically significant. r-HuEPO had a beneficial effect on weekly haemoglobin levels in patients undergoing RT with response rates similar to other studies. There was also a less rapid decline in weekly platelet counts in r-HuEPO-treated patients compared with control subjects. Further studies are needed to address the optimum dose and scheduling as well as the impact of r-HuEPO on clinical outcomes.

“…Numerous studies, both placebo-controlled and open-label, have consistently shown that increasing haemoglobin values has a measurable and significant effect on QOL parameters in cancer patients whether they are receiving (Abels, 1993;Case et al, 1993;Henry and Abels, 1994;Leitgeb et al, 1994;Glaspy et al, 1997;Demetri et al, 1998) or not receiving concurrent chemotherapy (Ludwig et al, 1995). In all of these studies, haemoglobin was increased by the administration of recombinant human erythropoietin (rHuEPO, epoetin alfa).…”

Section: Improved Quality Of Lifementioning

confidence: 99%

Anaemia and its functional consequences in cancer patients: current challenges in management and prospects for improving therapy

Demetri

2001

100

Anaemia is a common occurrence in patients with cancer and contributes to the clinical symptomatology and reduced quality of life (QOL) seen in cancer patients. Many aspects of reduced QOL, including fatigue, are known to be associated with suboptimally low levels of haemoglobin. Even mild-to-moderate anaemia adversely affects patient-reported QOL parameters. Red blood cell transfusions are associated with many real and perceived risks, inconveniences, costs, and only temporary benefits. Recombinant human erythropoietin (rHuEPO) is an effective therapy to increase haemoglobin values in over half of anaemic cancer patients receiving concurrent chemotherapy. These increased haemoglobin values are closely correlated with improvements in QOL. Despite these objectively defined benefits, less than 50% of anaemic patients undergoing cytotoxic chemotherapy receive rHuEPO, in contrast to patients with chronic renal failure on dialysis, where anaemia is universally and aggressively treated to more optimal haemoglobin values. However, there are several barriers that may limit more widespread use of rHuEPO. These include inconvenience associated with frequent dosing; failure of a large proportion (40 to 50%) of patients to respond; relatively slow time to response; absence of reliable early indicators of response; and current lack of rigorous pharmacoeconomic data demonstrating cost-effectiveness. Darbepoetin alfa is a novel erythropoiesis stimulating protein (NESP) that is biochemically distinct from rHuEPO, and which has been proven to stimulate red blood cell production. The molecule has a 3-fold longer half-life and increased biological activity that will allow less frequent dosing, facilitating improved management of the anaemia of cancer. With this new option for therapy, further avenues of investigation should lead to renewed interest in the clinical benefits of optimal haemoglobin levels for patients with cancer. © 2001 Cance Cancer Research Campaign