A prospective observational study of anaemia management in cancer patients - results from the German Cancer Anaemia Registry

The use of erythropoiesis-stimulating agents (ESA) in cancer patients is still under debate. However, little is known about rationales, strategies, objectives, and effectiveness of anaemia treatments in common practice. The Cancer Anaemia Registry prospectively surveyed about 2000 cancer patients with anaemia throughout Germany. The main objectives of anaemia treatment regardless of modality were to improve quality of life (QOL) and to correct haemoglobin (Hb) levels. The Hb threshold for any anaemia treatment (means ± SD: 9.4 ± 1.2 g/dL) but not for blood transfusions (8.7 ± 1.0 g/dL) depended on cancer type and treatment strategy. Physicians preferred ESA as first-line treatment to prevent transfusions in patients with solid tumours, if they thought that chemotherapy caused the anaemia. If they suspected other causes or patients had lymphoproliferative malignancies, physicians preferred transfusions or attempted to correct underlying disorders; both mainly to improve QOL or prognosis. Effectiveness of all strategies was comparable. However, ESA most effectively prevented transfusions; primary transfusions appeared less suitable for correcting Hb or improving QOL. Using supportive treatments for QOL improvement was common whereas diagnostic measures and intravenous iron therapy were underused. Prospective clinical trials using QOL as end point and evaluating diagnostics in cancer-associated anaemia are warranted.     

Incidence of anaemia in breast cancer patients receiving adjuvant chemotherapy

Anaemia is frequent in breast cancer patients but often remains undiagnosed and untreated. To determine the incidence of anaemia a prospective survey of primary non-metastatic breast cancer patients who received at least four cycles of adjuvant, non-platinum multi-agent chemotherapy was conducted at 47 centres in Austria. Two hundred and forty seven patients were prospectively included between October 1999 and December 1999. Haemoglobin (Hb) levels were determined after surgery and prior to each cycle of chemotherapy. Treatment of anaemia (blood transfusion or epoetin alfa) during the observation period was at the physician's discretion. For the purpose of this study, patients were considered to be anaemic if their Hb was below 12 g/dl. At baseline (after surgery and before the first cycle of chemotherapy), 28.7% of all patients were anaemic. The only significant differentiating factor was the type of surgery. 37.9% of patients who underwent mastectomy were anaemic, whereas only 22.8% of patients who underwent breast conserving surgery were anaemic. Forty two percent of 176 patients with a Hb level of 12 g/dl at baseline developed anaemia during adjuvant chemotherapy. The only factor that significantly influenced the development of anaemia during chemotherapy was the Hb level at baseline. The total incidence of anaemia in patients with primary breast cancer who underwent surgery followed by adjuvant multi-agent chemotherapy was 58.7%. Forty nine patients (20.2%), 48 patients (19.2%) and 48 patients (19.2%) showed a decrease in Hb levels by 1 g/dl, 1–2 g/dl and >2 g/dl, respectively. Only 18.6% of the patients who were found to be anaemic received anaemia treatment. The two most important factors for developing anaemia are the kind of surgery and the Hb level prior to chemotherapy.     

Early intervention with epoetin beta prevents severe anaemia in patients with solid tumours receiving platinum-based chemotherapy: results of the NeoPrevent study

Background Anaemia is common during platinum-based chemotherapy. This study aimed to evaluate the efficacy and safety of epoetin beta in the prevention of severe anaemia in patients with solid tumours receiving concomitant platinum therapy.Patients and methods In this open-label, single-arm study, patients (n = 255) with solid tumours and haemoglobin (Hb) levels ≤ 13 g/dl (men) or ≤ 12 g/dl (women) received epoetin beta 450 IU/kg (∼30,000 IU) weekly until 4 weeks after their last platinum-based chemotherapy cycle.Results An anaemia prevention response [defined as patients with a Hb response (increase in Hb level > 1 g/dl from baseline) plus patients whose Hb levels remained ± 1 g/dl of baseline throughout the study] was observed in 234 patients (92%). Response to epoetin beta was rapid. Of the 159 patients achieving a Hb response, 139 (87%) had Hb levels > 1 g/dl of baseline within 4 weeks of treatment initiation. Mean Hb levels had improved from 10.8 ± 1.0 g/dl at baseline to 12.2 ± 1.8 g/dl by the final visit. Quality of life measured by linear analogue scale assessment significantly (P < 0.01) improved in patients achieving a Hb response (n = 159).Conclusions Epoetin beta effectively prevents anaemia in most patients with solid tumours receiving concurrent platinum-based chemotherapy.     

Prise en charge de l’anémie en oncologie: modalités pratiques, efficacité des agents stimulant l’érythropo?èse (ASE) [darbépoétine alpha] et place de la transfusion

Patients andmethod

An observational study was carried out in an oncology department that had initiated an active anaemia management strategy using ESA (darbepoetin-alpha) in order to observe the resulting changes seen in the use of transfusions and to assess the effectiveness of this strategy in controlling anaemia in clinical practice. Data were gathered from medical files of all patients treated with ESA for anaemia during two successive periods of a year. The first period corresponded to the implementation of this strategy within the unit (from September 2006), and the second period (from April 2008) could be regarded as a phase of stable practice.

Results

The percentage of patients treated with ESA increased slightly, from 23.3 to 26.8%, for the active group, which remained almost identical during the two periods (897?C899 patients). The average number of ESA injections per patient decreased (3.21 compared to 2.88, NS). The number of transfusions reduced by about 19% across the two periods. Analysis of the effectiveness of treatment was carried out on a cumulative number of 339 patients, who received a continuous sequence of ESA injections during the same course of chemotherapy, with at least three injections of ESA. This corresponded to 205 patients in period one and 134 patients in period two. Effectiveness was defined as a function of the changes in Hb level (??Hb) in three categories: 39.8% of patients were judged to have responded well (??Hb ?? 1 g/dl), 36.9% as having had an intermediate response (0 ?? ??Hb < 1 g/dl) and if ??Hb < 0, they were classified as not responded (33.3%). Improvements in Hb levels during successive ESA injections were more significant for patients presenting with initially low Hb levels.

Conclusions

The results obtained show that the effectiveness of darbepoetin-alpha observed in clinical practice is in agreement with that demonstrated in clinical trials, and confirms that treatment with darbepoetin-alpha substantially decreases the need for transfusions.     

European guidelines for the management of chemotherapy-induced anaemia and health economic aspects of treatment

Patients with cancer receiving myelosuppressive chemotherapy frequently develop anaemia; platinum-based chemotherapy, in particular, leads to reduced production of the bone marrow-stimulating hormone erythropoietin. The European Cancer Anaemia Survey showed that many patients do not receive erythropoiesis-stimulating agent (ESA) therapy and highlighted the need for clear guidelines for the diagnosis and treatment of anaemia in cancer patients. In response to a fast-moving therapeutic environment and guidelines produced in the USA, the European Organisation for Research and Treatment of Cancer established an independent task force to develop evidence-based guidelines for the use of ESAs in European anaemic cancer patients that were first published in 2004. The guidelines recommend that, in patients receiving chemotherapy/radiotherapy, ESA therapy should be initiated at haemoglobin levels of 9-11 g/dL based on the severity of symptoms (target haemoglobin concentration: 12-13 g/dL) to improve quality of life and prevent the need for red blood cell transfusions. Treatment should be maintained as long as Hb levels remain <12-13 g/dL and patients continue to show symptomatic improvement, and should be discontinued, due to marginally elevated risks of thromboembolic events, when haemoglobin levels exceed 14 g/dL. Treatment of anaemia with ESAs is cost-effective and is associated with long-term gains in quality-adjusted life years.     

Spanish Society of Medical Oncology consensus on the use of erythropoietic stimulating agents in anaemic cancer patients

Treatment of anaemia is a very important aspect in the management of cancer patients. In order to carry out a consensus process about the use of erythropoietic stimulating agents (ESAs) in cancer patients, the Spanish Society of Medical Oncology (SEOM) elaborated a working group which coordinated a panel of medical oncology specialists. This working group has reviewed the main issues about the use of ESAs. In addition a consensus meeting was held in Madrid on 25 April 2007. The following conclusions were made: Since ESA treatment increases the haemoglobin (Hb) level and decreases the red blood cell (RBC) transfusion requirements, ESAs should be used within the approved indications in patients undergoing chemotherapy treatment, beginning at a Hb level below 11 g/dl and maintaining it around 12 g/dl, with iron supplements if necessary. Neither increasing the ESA dose in non-responders nor the use of ESAs in the treatment of chronic cancer-related anaemia is recommended.     

Clinical experience with ferric carboxymaltose in the treatment of cancer- and chemotherapy-associated anaemia

BackgroundIntravenous (i.v.) iron can improve anaemia of chronic disease and response to erythropoiesis-stimulating agents (ESAs), but data on its use in practice and without ESAs are limited. This study evaluated effectiveness and tolerability of ferric carboxymaltose (FCM) in routine treatment of anaemic cancer patients.Patients and methodsOf 639 patients enrolled in 68 haematology/oncology practices in Germany, 619 received FCM at the oncologist's discretion, 420 had eligible baseline haemoglobin (Hb) measurements, and 364 at least one follow-up Hb measurement. Data of transfused patients were censored from analysis before transfusion.ResultsThe median total iron dose was 1000 mg per patient (interquartile range 600–1500 mg). The median Hb increase was comparable in patients receiving FCM alone (1.4 g/dl [0.2–2.3 g/dl; N = 233]) or FCM + ESA (1.6 g/dl [0.7–2.4 g/dl; N = 46]). Patients with baseline Hb up to 11.0 g/dl and serum ferritin up to 500 ng/ml benefited from FCM treatment (stable Hb ≥11.0 g/dl). Also patients with ferritin >500 ng/ml but low transferrin saturation benefited from FCM treatment. FCM was well tolerated, 2.3% of patients reported putative drug-related adverse events.ConclusionsThe substantial Hb increase and stabilisation at 11–12 g/dl in FCM-treated patients suggest a role for i.v. iron alone in anaemia correction in cancer patients.     

Anaemia management with epoetin alfa in lung cancer patients in The Netherlands

Anaemia seriously threatens the quality of life (QOL) in cancer patients receiving chemotherapy. In this article results are presented on the lung cancer population from a Dutch observational study. This study addressed the real-life situation of recombinant human erythropoietin (r-Hu-EPO or epoetin alfa) treatment in anaemic cancer patients receiving chemotherapy, with a focus on efficacy. In total 781 patients were enrolled in the observational study, including 382 patients with lung cancer. At enrolment patients were receiving epoetin alfa treatment and/or patients had a haemoglobin (Hb) level 11.3g/dl) was especially effective for NSCLC patients where it resulted in a stabilization of Hb at baseline level. For SCLC patients this strategy was less effective. Furthermore, early intervention seemed to diminish the need for a blood transfusion, i.e., the higher the Hb at epoetin initiation the more patients did not receive any blood transfusion. Results from this observational study demonstrate that epoetin alfa treatment corrects chemotherapy-related anaemia in both NSCLC as well as SCLC patients. Early epoetin alfa intervention seems advantageous for lung cancer patients both in terms of maintaining adequate Hb levels during chemotherapy as well as reducing transfusions.     

Treatment patterns and outcomes in the management of anaemia in cancer patients in Europe: Findings from the Anaemia Cancer Treatment (ACT) study

ObjectivesTo examine anaemia management in cancer patients treated with erythropoiesis-stimulating agents (ESAs) in Europe.MethodsRetrospective pharmacoepidemiologic study of 2192 patients from 307 centres. Minimum of 3 visits over 8–10 weeks with ESA treatment initiated at visit 1.ResultsMost patients were treated per guidelines, except for low iron supplementation rates. Mean Hb rose from 9.54 ± 0.95 g/dl to 10.88 ± 1.49 g/dl at visit 3, without concomitant rise in WHO/ECOG score. Response rates were 65.0% (Hb increase ↑ ? 1 g/dl); 54.3% (Hb increase ↑ ? 1 g/dl in 8 weeks); 38.9% (haematopoietic response); 33.7% (Hb increase ↑ ? 2 g/dl) and 18.8% (Hb between12.0 and 12.9 g/dl)ConclusionsTreatment patterns were guideline congruent, except for (intravenous) iron supplementation. Hb increased by 1.34 g/dl. A net erythropoiesis boost of Hb ? 1 g/dl is attainable in two-thirds of patients and should be condensed to 8 weeks on an individual patient basis. Anaemia management in Europe has improved significantly. The general effectiveness and relative safety of judicious ESA treatment are evident.     

Management of anaemia in patients with breast cancer: role of epoetin

Many patients with breast cancer suffer from anaemia, as a consequenceof the disease itself or its treatment. Anaemia has a negativeimpact on treatment outcome and overall survival, and affectsthe quality of life (QoL) of patients with cancer. Previously,cancer-related anaemia was treated with blood transfusion, butthis is inconvenient, offers only temporary improvement in haemoglobin(Hb) level and is associated with several risks. Consequently,blood transfusion is usually reserved for patients with severeanaemia (Hb levels <8 g/dl). Recombinant human erythropoietin(epoetin) is an effective and convenient treatment for cancer-relatedanaemia without the risks associated with red blood cell transfusion.Epoetin therapy effectively increases Hb levels, thereby reducingthe need for emergency blood transfusion and improving the QoLof patients with anaemia and breast cancer. Epoetin beta isalso effective for the prevention of anaemia and reduction oftransfusion requirements in patients with a high risk of developinganaemia during chemotherapy. With the increased use of dose-intensifiedchemotherapy in an attempt to improve response rates, administrationof epoetin to prevent anaemia could potentially benefit manypatients with breast cancer. Key words: anaemia, anaemia prevention, breast cancer, dose-dense chemotherapy, erythropoietin     

Once-weekly dose of epoetinum alfa in cancer patients with anemia receiving radiotherapy

Introduction Anaemia is present in 30%–90% of all patients with cancer, and its origin is multifactorial. Human recombinant erythropoietin has been shown to be useful in treating anemia in patients with cancer. The aim of this study was to evaluate the effectiveness of treatment of anaemia with epoetin alfa (EPO) given as a single weekly dose, and its repercussions on quality of life (QoL). Materials and methods From January to October 2002, a total of 139 patients referred to our service for radiotherapy (RT) had anemia and received treatment with EPO as a single weekly dose of 40,000 IU subcutaneously, with oral iron supplement. If haemoglobin (Hb) values after 1 month of treatment did not increase by≥1 g/dl, the dose was increased to 60,000 IU/week. Treatment with EPO ended when Hb values reached ≥14 g/dl or one month after the end of RT regardless of Hb values. QoL was evaluated with the Functional Assessment of Cancer Therapy-Anaemia subscale (FACT-An) and the Cancer Linear Analogue Scale (CLAS). Results Mean Hb at the start of treatment with EPO was 11.49±1.08 g/dl, and the mean value at the end of treatment was 14.52±1.41 g/dl (p<0.001). The mean increase in Hb was 2.97±2.91 weeks. In 11 patients (7.9%) the dose was increased after 4 weeks. In 84 patients (60.4%) EPO treatment was implemented before the commencing of RT. Mean Hb values in this group was 11.34±1.11 g/dl at the start of EPO treatment, 12.69±1.56 g/dl at the start of RT, 13.96±1.54 g/dl at the end of RT and 14.68±1.3 g/dl at the end of EPO treatment (p<0.001). In 55 patients (39.6%) anaemia developed during RT and, therefore, EPO treatment was implemented after commencing of RT. In this group the mean Hb values were 12.29±1.6 g/dl at the start of RT, 11.72±1.01 g/dl at the start of EPO treatment, 13.97±1.53 g/dl at the end of RT and 14.28±1.54 g/dl at the end of EPO treatment (p<0.001). Hemoglobin levels at the start of EPO were lower in patients who commenced EPO before RT (p<0.05). In 60 patients who received combined RT and chemotherapy, mean Hb values were 11.42±1.16 g/dl at the start of EPO and 13.98±1.55 g/dl at the end of EPO (p<0.005). In 75 patients who had received RT alone, the mean Hb values was 11.53±1.05 g/dl at the start of EPO and 14.98±1.17 g/dl at the end of treatment (p<0.001). Patients treated with RT alone had higher Hb levels at the end of RT and at the end of EPO treatment than did patients who had received combined treatment (p<0.005). The duration of EPO treatment was shorter in the group treated with RT alone than in the combined treated group (6.41±2.99 weeks versus 7.96±2.67 weeks; p<0.005). No significant differences were observed in FACT-An and CLAS scores at the beginning and the end of the study. Conclusions Treatment with epoetin alfa as a single weekly dose significantly increased Hb levels in patients with cancer who were undergoing radiotherapy. The response was greater in patients treated with radiotherapy alone than in those receiving combined therapy. The duration of EPO treatment was shorter in the group treated with radiotherapy alone than in the combined treatment group.     

Anämie bei Krebs

Anaemia occurs in 50% of tumour patients which should be clarified by differential diagnosis and treated in accordance with the underlying causes. The quality of life of anaemic tumour patients can be improved by correction of the anaemia. Anaemia is often caused by activation of the immune system in chronic diseases (ACD anaemia of chronic disease). In the forefront are disorders due to inflammatory cytokines, i.e. increased uptake of iron by the reticulo-endothelial system (RES) and reduced release from the RES, reduced proliferation of erythrocyte precursor cells, with insufficient synthesis of and reduced reaction to erythropoietin (EPO) in relation to the anaemia, as well as reduced survival of erythrocytes. Hepcidin, a type II acute phase peptide produced in the liver, also inhibits intestinal iron resorption and iron mobilization from the RES. Additionally, medicinal chemotherapy or radiation therapy often suppresses bone marrow activity leading to anaemia requiring treatment. Typical causes of anaemia, such as haemorrhaging, iron deficiency, vitamin deficiency, haemolysis and alcohol-linked toxic bone marrow damage can also occur. An effective therapy of ACD is possible with erythrocyte transfusion and after chemotherapy also with erythropoiesis-stimulating agents (ESA), such as erythropoietin and darbepoietin. The EORTC, ASCO and ASH have developed guidelines for the therapy of anaemia with ESA for tumour patients under chemotherapy. The HB-value should be kept below 12g/dl to avoid complications. Current studies have shown that the effectiveness of ESA can be significantly improved if accompanied by intravenous iron substitution even if a functional or absolute iron deficiency does not primarily exist.     

Early intervention with epoetin beta prevents severe anaemia in lung cancer patients receiving platinum-based chemotherapy: a subgroup analysis of the NeoPrevent study

The NeoPrevent study showed that early intervention with epoetin beta could prevent severe anaemia in patients with solid tumours receiving platinum-based chemotherapy. An early intervention strategy may be particularly warranted in patients with lung cancer, as anaemia is very common in these patients and can be severe. The purpose of this study was to examine the efficacy and safety of epoetin beta in the subpopulation of patients with lung cancer included in the NeoPrevent study. Patients were enrolled if baseline haemoglobin (Hb) levels were 1g/dl) plus the proportion whose Hb was maintained at +/-1g/dl of baseline. Quality of life (QoL) was measured using the linear analogue scale assessment. The NeoPrevent study included 255 patients in total, and the results for the 102 patients with lung cancer (non-small-cell lung cancer 64%; small-cell lung cancer 36%) are presented here. The overall anaemia prevention response was 90%, with Hb response in 60% of patients and maintenance of baseline Hb level in 30%. Only 9% of patients required transfusions. QoL improved significantly in patients with Hb response (p<0.01) and was maintained in non-responders (p>or=0.578). Epoetin beta was effective in preventing severe anaemia in lung cancer patients receiving platinum-based chemotherapy.     

The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients

The European Cancer Anaemia Survey (ECAS) was conducted to prospectively evaluate the prevalence, incidence and treatment of anaemia (haemoglobin <12.0 g/dL) in European cancer patients, including the relationship of mild, moderate and severe anaemia to performance status. Patients were evaluated for up to 6 months. Data (N=15367) included demographics, tumour type, performance status, haemoglobin levels, cancer treatments and anaemia treatments. Prevalence of anaemia at enrollment was 39.3% (haemoglobin <10.0 g/dL, 10%), and 67.0% during the survey (haemoglobin <10.0 g/dL, 39.3%). Low haemoglobin levels correlated significantly with poor performance status. Incidence of anaemia was 53.7% (haemoglobin <10.0 g/dL, 15.2%). Anaemia was treated in 38.9% of patients (epoetin, 17.4%; transfusion, 14.9%; and iron, 6.5%). Mean haemoglobin to initiate anaemia treatment was 9.7 g/dL. Anaemia prevalence and incidence in cancer patients are high. Anaemia significantly correlates with poor performance status and many anaemic patients are not treated.     

Erythropoietic agents in anaemic patients with cancer: a retrospective observational survey of epoetin alpha, epoetin beta and darbepoetin alpha use in routine clinical practice

This retrospective observational survey assessed, in a routine clinical practice setting, the modalities of treatment with recombinant erythropoietic agents: alpha erythropoietic agents [epoetin alpha (Eprex) and darbepoetin alpha (Aranesp)] and epoetin beta (NeoRecormon). Evolution of haematological response parameters such as haemoglobin (Hb) during treatment of anaemic patients with cancer were contrasted for the different agents. Records of 125 consecutive adult cancer patients (42 epoetin alpha, 40 epoetin beta, 43 darbepoetin alpha) receiving chemotherapy and erythropoietic treatment for anaemia, and treated between September 2003 and February 2004, were analysed. Mean periods of observation of treatment were 103 days (epoetin alpha), 114 days (epoetin beta) and 95 days (darbepoetin alpha). The mean changes in maximum Hb level during treatment were 2.8 g/dl (epoetin alpha), 3.3 g/dl (epoetin beta) and 2.1 g/dl (darbepoetin alpha) (P=0.02, epoetin beta versus darbepoetin alpha). The proportions of patients achieving > or =1 g/ dl Hb increases were 85.7% (epoetin alpha), 87.5% (epoetin beta) and 79.1% (darbepoetin alpha). The mean cumulative doses administered to achieve these increases were 284, 722 IU; 201, 428 IU; and 208, 823 IU [dose calculated (based on equivalent peptide mass) using 1 microg darbepoetin alpha is equivalent to 200 IU epoetin], respectively. The proportions of patients achieving > or =2 g/dl Hb increases were 66.7% (epoetin alpha), 77.5% (epoetin beta) and 58.1% (darbepoetin alpha). This survey suggests that in real-life clinical conditions the available erythropoietic agents increase Hb effectively in anaemic patients with cancer, and that epoetin beta therapy may have therapeutic advantages over the other agents assessed.     

Modeling of treatment response to erythropoiesis-stimulating agents as a function of center- and patient-related variables: results from the Anemia Cancer Treatment (ACT) study

BackgroundIn anemic cancer patients treated with erythropoiesis-stimulating agent (ESA), (i) to examine the proportion of variance in hemoglobin (Hb) outcomes attributable to patients versus center, country, and region and (ii) to develop predictive models of treatment response.MethodsRetrospective study with a minimum of three visits at 1-month intervals. Three hundred and seven centers in 13 European countries contributed 2192 anemic ESA-treated cancer patients. Treatment response criteria included: Hb↑≥1 g/dl, Hb↑≥1 g/dl within 8 weeks, hematopoietic response (Hb↑≥2 g/dl or Hb ≥ 12 g/dl), Hb↑≥2 g/dl, and Hb between 12 and 13 g/dl.ResultsHb increased from 9.54 ± 0.95 g/dl (baseline) to 10.88 ± 1.49 g/dl (visit 3). Hb change from visits 1 to 2 (index of relative immediacy of response to ESA) averaged 0.81 ± 1.17 g/dl. The proportion of variance in Hb outcomes attributable to center was 11.8%–34.3%, country 2.9%–20.7%, and region 0.0%–7.6%. Immediacy of response to ESA was the most prevalent predictor of treatment response, followed by diagnosis of hematological malignancy and age <70 years.ConclusionsHb outcomes are determined significantly by the treating center and less so by country or region. The remaining majority variance was attributable to patient-related factors. Immediacy of response to ESA is the single most important predictor of treatment. When used according to guidelines, ESAs are effective in managing anemia in cancer patients and improving treatment outcomes.     

Once-weekly epoetin beta therapy in patients with solid tumours and chemotherapy-induced anaemia: a randomized, double-blind, dose-finding study

Anaemia is common in patients receiving chemotherapy, causing symptoms that have a major impact on quality of life (QoL). Epoetin beta rapidly increases haemoglobin (Hb) levels and improves QoL in anaemic patients with a variety of tumours. This was a randomized, double-blind, parallel-group, dose-finding study assessing the efficacy and safety of once-weekly epoetin beta in patients with solid tumours receiving chemotherapy. Adult patients with anaemia (Hb < 11 g/dL) were randomized to receive epoetin beta 30,000 IU or 20,000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Haemoglobin levels, transfusion need and QoL [Functional Assessment of Cancer Therapy-fatigue (FACT-F) subscale score] were assessed at regular intervals. Fifty patients were randomized; 30 patients received epoetin beta 30,000 IU once weekly and 20 received 20,000 IU once weekly. Mean (+/- SD) increase in Hb from baseline to week 12 was 1.75 +/- 2.15 g/dL in the 30,000 IU group (P = 0.008 vs. baseline) and 1.04 +/- 1.75 g/dL in the 20,000 IU group (non-significant). Haemoglobin response (increase in Hb >or=2 g/dL from baseline) was observed in 78.3% of patients receiving epoetin beta 30,000 IU and 66.7% receiving epoetin beta 20,000 IU. Improvements in FACT-F subscale score were significantly (P < 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both epoetin beta regiments were well tolerated and there were no dose-dependent adverse events. Epoetin beta 30,000 IU once weekly is an effective and well-tolerated treatment of anaemia in patients with solid tumours.     

Impact of haemoglobin levels during adjuvant chemotherapy on the survival of patients with primary breast cancer

Tumour anaemia is a common symptom in cancer patients, particularly in those receiving chemotherapy. The aim of the current study was to analyse the impact of haemoglobin levels on the prognosis of patients with primary breast cancer receiving adjuvant chemotherapy. A total of 129 patients were available for analysis. The estimated median five-year overall survival rate was 76.6%. Mean Hb prior to primary surgery was 13.8 g/dl (SD 1.09), pre-chemotherapy Hb 12.8 g/dl (SD 1.2), and nadir Hb during chemotherapy 11.0 g/dl (SD1.1), respectively. Hb values were analysed as continuous variables in the Cox model. Survival analyses did not show a correlation between preoperative and pre-chemotherapy Hb levels with patient outcome. However, univariate analysis identified low nadir Hb (p=0.008), larger tumours (p=0.042), and hormone-receptor-negative tumours (p=0.022) to be significantly associated with poor patient survival. This result was persistent when analysis was adjusted for relevant prognostic factors in a multivariate Cox proportional hazards model. Nadir Hb, 1.54-fold increased risk for death (95% CI 1.03-2.32), and tumour size, 3.2-fold increased risk (95% CI 1.17-8.77) remained as independent variables, whereas hormone-receptor status failed to retain significance. The present data showed anaemia during adjuvant chemotherapy to be associated with poor survival in patients with primary breast cancer. Prospective randomized trials are warranted to examine the value of correcting anaemia with regard to improve disease control and survival.     

Diagnosis and management of anaemia and iron deficiency in patients with haematological malignancies or solid tumours in France in 2009-2010: the AnemOnHe study

Objective

To describe the management of anaemia in 2009-2010 in France in patients with haematological malignancies (HM) or solid tumours (ST).

Methods

Retrospective observational study in 57 centres, enrolling adult patients with HM or ST treated for an episode of anaemia (duration of the episode ?3 months occurring in the last 12 months).

Results

220 patients with ST (breast, 18%; lung, 18%) and 56 with HM (lymphoma, 60%) were included (median age, 68 years; female, 53%). Mean haemoglobin level at anaemia diagnosis was 9.3 ± 1.4 g/dL (<8 g/dL for 16%) and 9.8 ± 1.1 g/dL (<8 g/dL for 6%) in HM and ST patients, respectively. At least one parameter of iron deficiency (ferritin, transferrin saturation) was assessed in 26% of HM and 19% of ST patients. Treatment of anaemia included erythropoiesis-stimulating agents (ESA) for 98% of HM and 89% of ST patients. Iron was prescribed to 14% (oral, 12%; intravenous, 2%) of HM patients and to 42% (oral, 17%; intravenous, 25%) of ST patients. The rates of blood transfusions were high: 70% in HM and 46% in ST patients; transfusions alone or administrated with ESA were more frequent in patients with Hb <8 g/dL.

Conclusion

Although recent guidelines recommend evaluating iron deficiency and correcting anaemia by using intravenous iron, our study in cancer patients evidenced that ESA and blood transfusions are still frequently used as the treatment of anaemia in cancer patients. Iron deficiency is insufficiently assessed (only one patient among five) and as a consequence iron deficiency is most likely insufficiently treated.     

Early intervention with epoetin alfa during platinum-based chemotherapy: an analysis of the results of a multicenter, randomized, controlled trial based on initial hemoglobin level

OBJECTIVE: This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes. METHODS: Patients with Hb levels < or =12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (< or =9.7 g/dl, >9.7 g/dl to < or =10.5 g/dl, >10.5 g/dl to < or =11.3 g/dl, and >11.3 g/dl to < or =12.1 g/dl), and study results were reanalyzed. RESULTS: Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to < or =12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to < or =12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group. CONCLUSION: In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.