epoetin-alfa and Fatigue

In gynaecology, anaemia treatment is indicated in extremely different situations. In cancer patients, treatment with epoetin can relieve fatigue and improve quality of life. In these patients, epoetin treatment can also have a positive influence on survival through increasing the efficacy of radiotherapy and chemotherapy. Recent data are presented. In gynaecological surgery, the use of epoetin--based on results in oncology and orthopaedic surgery--makes a constructive contribution to the improvement of quality of life and during patient recovery through rapid normalisation of perioperative anaemia, thus reducing the risk of a transfusion with donated blood. Encouraging data from recent publications concerning the prevention of PRCA under epoetin treatment are presented.

Topics: Adult; Anemia; Blood Transfusion; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Pregnancy; Pregnancy Complications; Quality of Life; Recombinant Proteins; Risk Factors

In patients with human immunodeficiency virus (HIV), anemia is a commonly encountered hematologic abnormality that has a significant impact on clinical outcomes and quality of life (QOL). This review describes the prevalence of anemia in several populations of patients with HIV and the effects of anemia on survival, morbidity, disease progression, transfusion requirements, and QOL. The prevalence of anemia in HIV disease varies considerably, ranging from 1.3% to 95%: it depends on several factors, including the stage of HIV disease, sex, age, pregnancy status, and injection-drug use as well as the definition of anemia used. In general, as HIV disease progresses, the prevalence and severity of anemia increase. Anemia is also more prevalent in HIV-positive women, children, and injection-drug users than in HIV-negative women, children, and injection-drug users. Anemia has been shown to be a statistically significant predictor of progression to the acquired immunodeficiency syndrome and is independently associated with an increased risk of death in patients with HIV. Treatment of anemia with epoetin-alpha has resulted in significantly fewer patients requiring transfusion as well as decreases in the mean number of units of blood transfused. Resolution of HIV-related anemia has been shown to improve QOL, physical functioning, energy, and fatigue in individuals with HIV. More recently, the use of highly active antiretroviral therapy has also been associated with a significant increase in hemoglobin concentrations and a decrease in the prevalence of anemia.

Topics: Activities of Daily Living; Adult; Anemia; Anti-HIV Agents; Blood Transfusion; CD4 Lymphocyte Count; Child; Comorbidity; Disease Progression; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; HIV Infections; Humans; Infant; Male; Outcome Assessment, Health Care; Pregnancy; Prevalence; Quality of Life; Recombinant Proteins; Severity of Illness Index; Substance Abuse, Intravenous; Survival Analysis

To determine the occurrence of cancer-related fatigue, the methods used to assess it, and the efficacy of the available treatments, we performed literature searches that identified English-language publications on these topics. Twenty-seven studies were identified in which the quantitative estimation of the occurrence of cancer-related fatigue was an end point. Fifty-six were judged to be relevant to the assessment of fatigue, and 10 randomized controlled clinical trials of treatments of cancer-related fatigue were retrieved. The occurrence of cancer-related fatigue was found to range from 4% to 91%, depending on the population studied and the methods of assessment. Few population-based studies and no longitudinal studies of cancer-related fatigue have been performed. The methods of fatigue assessment were highly variable. Exercise programs show promise to prevent or treat fatigue in some subsets of cancer patients, and the use of epoetin alfa for correction of anemia has been shown to ameliorate fatigue. The number of subjects in the treatment trials was small and their methodologic quality was inconsistent.

Topics: Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Evidence-Based Medicine; Exercise Therapy; Fatigue; Humans; Neoplasms; Palliative Care; Radiotherapy; Randomized Controlled Trials as Topic; Recombinant Proteins

To describe the management of fatigue and anemia in patients with cancer.. Published literature and clinical experience.. Anemia is a common cause of cancer-related fatigue. Epoetin alfa increases hemoglobin, decreases transfusion requirements, and improves energy and quality of life in patients with cancer-related anemia. Nonpharmacologic treatment options include exercise, nutrition optimization, and psychosocial interventions. Effective management of fatigue improves overall cancer treatment, quality of life, and functional status.. Fatigue and anemia are commonly undertreated complications of cancer and its treatment. Oncology nurses play a key role in identifying and managing these conditions.

Topics: Activities of Daily Living; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Male; Neoplasms; Nursing Assessment; Nursing Methodology Research; Oncology Nursing; Patient Care Planning; Quality of Life; Recombinant Proteins

Hysterectomy is the second-most-common surgical procedure among premenopausal women. The conditions that lead to the need for a hysterectomy often are accompanied by chronic blood loss that can lead to anemia. Moreover, hysterectomy and myomectomy may result in significant blood loss, which exacerbates the anemia. The presence of fatigue associated with anemia has a substantially negative impact on quality of life and the ability to perform activities of daily living. Options for alleviating perioperative anemia include minimizing surgical blood loss, blood transfusion, supplementation with hematinics, such as iron and folic acid, and treatment with recombinant human erythropoietin. Treating preoperative anemia is expected to help correct anemia prior to surgery and may have a positive impact on anemia-related symptoms and surgical outcomes.

Topics: Anemia; Blood Loss, Surgical; Blood Transfusion; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Gonadotropin-Releasing Hormone; Gonadotropins; Hematinics; Hematocrit; Humans; Hysterectomy; Preoperative Care; Recombinant Proteins

Recombinant human erythropoietin (r-HuEPO, epoetin alfa) is used for treatment of anemia associated with chemotherapy for non-myeloid malignancies, chronic renal failure and zidovudine treatment in patients infected with the human immunodeficiency virus and for anemic patients undergoing elective, noncardiac, nonvascular surgery. Epoetin alfa has been shown to safely increase preoperative hemoglobin (Hb) levels in anemic patients undergoing elective noncardiac, nonvascular surgery and is more effective than preoperative autologous blood donation in reducing the need for perioperative blood transfusions in orthopedic surgery patients. Epoetin alfa was shown to significantly increase Hb levels and decrease transfusion requirements in gynecologic cancer patients undergoing chemotherapy. A once-weekly regimen of 40,000 IU per dose was effective in these patients. In addition to decreasing transfusion requirements and increasing Hb, epoetin alfa for relieving anemia-related fatigue and improving quality of life was demonstrated in clinical trials in anemic cancer patients receiving chemotherapy. With regard to quality of life in orthopedic surgery patients, a novel instrument to measure the effect of Hb management on postoperative recuperative power (i.e., vigor, functional ability) has been validated and may prove to be useful in optimizing rehabilitation and discharge planning. Extensive clinical experience with epoetin alfa in anemic patients undergoing major elective orthopedic surgery or those with gynecologic cancer provides a strong basis for its use in gynecologic surgery.

Topics: Anemia; Blood Transfusion; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Gynecologic Surgical Procedures; Hematinics; Hemoglobins; Humans; Neoplasms; Orthopedics; Quality of Life; Recombinant Proteins; Safety; Treatment Outcome

Perioperative anemia is a common complication of major surgery that may lead to prolonged and debilitating fatigue and reduction in health-related quality of life (QOL). Treatment with recombinant human erythropoietin (r-HuEPO, epoetin alfa) has been shown to increase perioperative hemoglobin (Hb) and hematocrit (HCT) levels, thereby facilitating postoperative recovery in orthopedic surgery patients. Treatment with epoetin alfa has also been shown to increase Hb and HCT levels and improve QOL in anemic cancer patients undergoing chemotherapy. The clinical and QOL benefit of using epoetin alfa in these patient populations provides the rationale for its use in patients undergoing gynecologic surgery. Because persistent fatigue is the most common complaint of patients following hysterectomy, the use of epoetin alfa should be considered to preoperatively correct anemia in this patient population. Research has been initiated to increase our understanding of the role of epoetin alfa in treating anemic patients (Hb levels < or = 13 g/dL) undergoing surgery for benign gynecologic disease, especially as it relates to postoperative QOL. Future studies should investigate the use of epoetin alfa in patients with gynecologic cancers. These studies should confirm the role of epoetin alfa in combination with iron supplementation to improve perioperative Hb/HCT levels and overall QOL in patients undergoing gynecologic surgery.

Topics: Anemia; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Forecasting; Gynecologic Surgical Procedures; Hematinics; Humans; Perioperative Care; Quality of Life; Recombinant Proteins; Safety; Treatment Outcome

Topics: Adult; Anemia; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Recombinant Proteins

Hematologic toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematologic parameters and fatigue in patients with breast cancer during chemotherapy.. In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 × 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 × epirubicin and cyclophosphamide followed by 4 × docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after one-half of the chemotherapy.. In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41; P < .001) were affected by treatment regimen. Fatigue during chemotherapy was mostly affected by the level of fatigue before the start of chemotherapy (B = 0.41; P < .001). Patients with G-CSF application in the preceding cycle showed an increased fatigue score (B = 5.43; P = .02).. We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.

Topics: Adolescent; Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Chemotherapy, Adjuvant; Epoetin Alfa; Fatigue; Female; Granulocyte Colony-Stimulating Factor; Hemoglobins; Humans; Leukocyte Count; Leukopenia; Middle Aged; Neoplasm Staging; Prospective Studies; Quality of Life; Severity of Illness Index; Young Adult

To compare usual care with a home-based individualized exercise program (HBIEP) in patients receiving intensive treatment for multiple myeloma (MM)and epoetin alfa therapy.. Randomized trial with repeated measures of two groups (one experimental and one control) and an approximate 15-week experimental period.. Outpatient setting of the Myeloma Institute for Research and Therapy at the Rockfellow Cancer Center at the University of Arkansas for Medical Sciences.. 187 patients with newly diagnosed MM enrolled in a separate study evaluating effectiveness of the Total Therapy regimen, with or without thalidomide.. Measurements included the Profile of Mood States fatigue scale, Functional Assessment of Cancer Therapy-Fatigue, ActiGraph® recordings, 6-Minute Walk Test, and hemoglobin levels at baseline and before and after stem cell collection. Descriptive statistics were used to compare demographics and treatment effects, and repeated measures analysis of variance was used to determine effects of HBIEP.. Fatigue, nighttime sleep, performance (aerobic capacity) as dependent or outcome measures, and HBIEP combining strength building and aerobic exercise as the independent variable.. Both groups were equivalent for age, gender, race, receipt of thalidomide, hemoglobin levels, and type of treatment regimen for MM. No statistically significant differences existed among the experimental and control groups for fatigue, sleep, or performance (aerobic capacity). Statistically significant differences (p < 0.05) were found in each of the study outcomes for all patients as treatment progressed and patients experienced more fatigue and poorer nighttime sleep and performance (aerobic capacity).. The effect of exercise seemed to be minimal on decreasing fatigue, improving sleep, and improving performance (aerobic capacity).. Exercise is safe and has physiologic benefits for patients undergoing MM treatment; exercise combined with epoetin alfa helped alleviate anemia.

Topics: Adult; Affect; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Epoetin Alfa; Erythropoietin; Exercise; Fatigue; Female; Home Care Services; Humans; Male; Middle Aged; Models, Biological; Motor Activity; Multiple Myeloma; Muscular Atrophy; Peripheral Blood Stem Cell Transplantation; Polysomnography; Recombinant Proteins; Resistance Training; Sleep Disorders, Intrinsic; Thalidomide; Walking

To determine whether epoetin alfa reduces anemia-related fatigue, improves other aspects of health-related patient-recorded outcomes (PROs), reduces the number of RBC transfusions, and has an impact on freedom from treatment failure (FFTF) and overall survival (OS) in patients with advanced-stage Hodgkin's lymphoma (HL).. The prospectively randomized HD15EPO study performed by the German Hodgkin Study Group investigated epoetin alfa administered at doses of 40,000 U weekly during and after chemotherapy (six to eight cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone [BEACOPP]) in a double-blind, placebo-controlled setting. The study accrued 1,379 patients, of whom 1,328 were assessable for safety, 1,303 were assessable for clinical outcome, and 930 were assessable for PROs.. PROs were not different in patients receiving placebo or epoetin alfa, both after the end of chemotherapy and 6 months thereafter. There was no difference between patients treated with epoetin alfa or placebo with respect to FFTF and OS. There were also no differences in the numbers of deaths, progressions, relapses, and thromboembolic events. The median number of RBC transfusions was reduced from four per patient in the placebo group to two per patient in the epoetin alfa group (P < .001), with 27.4% of patients needing no RBC transfusion in the placebo group compared with 36.7% of patients in the epoetin alfa group (P < .001).. 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.

Topics: Adolescent; Adult; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Cyclophosphamide; Double-Blind Method; Doxorubicin; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Etoposide; Fatigue; Female; Germany; Hematinics; Hodgkin Disease; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Staging; Prednisone; Procarbazine; Proportional Hazards Models; Prospective Studies; Recombinant Proteins; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vincristine; Young Adult

The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial, and predictors of change in quality of life in endstage renal disease have not been well characterized.. Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were randomly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks, using epoetin_alfa as primary therapy. Patients and attending physicians were masked to treatment assignment. Quality of life, a secondary outcome, was prospectively recorded using the Kidney Disease Quality of Life (KDQoL) questionnaire at weeks 0, 24, 36, 48, 60, 72, 84, and 96, with prespecified outcomes being fatigue and quality of social interaction.. The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr. Mortality was low, reflecting the relatively healthy group enrolled. Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups. Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time (P = 0.007) compared with change in the low-target group. Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains.. In relatively healthy hemodialysis patients, normal hemoglobin targets may have beneficial effects on fatigue. Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements.

Topics: Anemia; Body Mass Index; Canada; Epoetin Alfa; Erythropoietin; Europe; Fatigue; Female; Hematinics; Hemoglobins; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Quality of Life; Recombinant Proteins; Renal Dialysis; Social Behavior; Surveys and Questionnaires; Time Factors; Treatment Outcome

To evaluate the effect of epoetin alfa on local disease-free survival (DFS), overall survival (OS), and cancer treatment-related anemia and fatigue in patients with head and neck cancer receiving radical radiotherapy with curative intent.. Patients (N = 301) with hemoglobin (Hb) less than 15 g/dL were randomly assigned in a ratio of 1:1 to receive radiotherapy plus epoetin alfa (10,000 U subcutaneously [SC] three times weekly if baseline Hb was < 12.5 g/dL; 4,000 U SC three times weekly if baseline Hb > or = 12.5 g/dL) or radiotherapy alone. Hb levels were monitored weekly. The primary end point was local DFS, defined as the time from random assignment to local disease recurrence or death. Secondary efficacy end points included OS, local tumor response, and local tumor control. Patients were followed at 1, 4, 8, and 12 weeks postradiotherapy and annually for 5 years. Cancer treatment-related anemia and fatigue were evaluated with the Functional Assessment of Cancer Therapy-Anemia and Functional Assessment of Cancer Therapy-Head and Neck. Adverse events were recorded up to 12 weeks postradiotherapy.. Hb levels increased from baseline with epoetin alfa. The median duration of local DFS was not statistically different between groups (observation, 35.42 months; epoetin alfa, 31.47 months; hazard ratio, 1.04; 95% CI, 0.77 to 1.41). Groups did not significantly differ in DFS, OS, tumor outcomes, or cancer treatment-related anemia or fatigue. No new or unexpected adverse events were observed.. Addition of epoetin alfa to radical radiotherapy did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in patients with head and neck cancer.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Carcinoma, Squamous Cell; Disease Progression; Disease-Free Survival; Epoetin Alfa; Erythropoietin; Fatigue; Female; Head and Neck Neoplasms; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Recombinant Proteins; Survival Rate

To determine the effect of aerobic and strength resistance training and epoetin alfa (EPO) therapy on transfusions, stem cell collections, transplantation recovery, and multiple myeloma treatment response.. Randomized clinical trial.. A myeloma research and therapy center in the south central United States.. 135 patients with multiple myeloma, 120 evaluable.. Random assignment to exercise or usual care groups. All patients received EPO based on an algorithm. Aerobic capacity, using the six-minute walk test, was assessed prior to induction chemotherapy, prior to stem cell mobilization, and following stem cell collection for all patients and before and after transplantation for patients continuing in the study. Data analysis included analysis of variance to compare other outcome variables by groups.. Number of red blood cell and platelet transfusions during transplantation, number of attempts at and total number of days of stem cell collection, time to recovery after transplantation, and response to intensive therapy for multiple myeloma.. Recovery and treatment response were not significantly different between groups after transplantation. The exercise group had significantly fewer red blood cell transfusions and fewer attempts at stem cell collection. Serious adverse events were similar in each group.. Exercise with prophylactic EPO therapy reduces the number of RBC transfusions and attempts at stem cell collection for patients receiving intensive treatment for multiple myeloma.. Exercise is safe and has many physiologic benefits for patients receiving multiple myeloma treatment.

Topics: Adult; Aged; Analysis of Variance; Anemia; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Combined Modality Therapy; Cyclophosphamide; Dexamethasone; Doxorubicin; Epoetin Alfa; Erythropoietin; Etoposide; Exercise Test; Exercise Therapy; Fatigue; Female; Hematinics; Humans; Male; Middle Aged; Multiple Myeloma; Nurse's Role; Nursing Evaluation Research; Oncology Nursing; Peripheral Blood Stem Cell Transplantation; Recombinant Proteins; Treatment Outcome; Vincristine

To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia.. An exploratory, 32 week, randomized, double-blind, crossover treatment trial.. Sixty-two community-dwelling individuals aged 65 and older with chronic anemia (Hb < or =11.5 g/dL).. Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II).. Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test.. Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age+/-standard deviation of 76.1+/-7.2. Mean baseline Hb was 10.5+/-0.9 g/dL (7.3-11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo (P<.001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P<.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated.. In this trial involving predominantly older African-American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.

Topics: Aged; Anemia; Chicago; Comorbidity; Cross-Over Studies; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Mobility Limitation; Quality of Life; Recombinant Proteins; Treatment Outcome

To evaluate the effect of epoetin alfa on quality of life (QOL) in patients with solid tumors and mild-to-moderate anemia receiving platinum-based chemotherapy relative to population norms.. In the original study, patients (n = 316) with hemoglobin (Hb) levels < or =12.1 g/dl were randomized 2:1 to receive either epoetin alfa at a dose of 10,000 U thrice weekly s.c. or best supportive care (BSC) to compare the effects on transfusion use, hematologic response, and QOL (measured by the Functional Assessment of Cancer Therapy-Anemia [FACT-An]and Cancer Linear Analogue Scale [CLAS]). The QOL data from this previously reported trial were reanalyzed here relative to population norms.. Mean baseline QOL scores were similar between groups. At study completion, mean CLAS, FACT-An, FACT-An Anemia subscale, and FACT-An Fatigue subscale scores were significantly higher for patients given epoetin alfa than for those treated with BSC. Compared with population norms, both groups had impaired QOL at baseline. Differences in mean QOL change scores from baseline to study end for epoetin alfa versus BSC were 3.17 points for the FACT-General Total, 9.90 for the FACT-An Fatigue subscale, and 7.30 for the FACT-An Anemia subscale. This was equivalent to corrections in QOL deficits attributable to epoetin alfa of 97.3%, 40.7%, and 38.0% for the FACT-General Total, FACT-An Fatigue, and FACT-An Anemia subscale scores, respectively, versus BSC. A somewhat greater QOL benefit was observed for the FACT-An Fatigue and FACT-An Anemia subscales in the subset of patients with baseline Hb levels >10.5 g/dl.. Patients in this study had impaired QOL compared with population norms. Early treatment with epoetin alfa to correct anemia improved QOL in a statistically significant and clinically meaningful way, and improvements were greater in patients with baseline Hb levels >10.5 g/dl.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Platinum Compounds; Quality of Life; Recombinant Proteins; Reference Values; Sickness Impact Profile; Treatment Outcome

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.. 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.. 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.. 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.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Blood Transfusion; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Platinum Compounds; Quality of Life; Recombinant Proteins; Sickness Impact Profile; Treatment Outcome

Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL).. Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for > or = 4 months of myelosuppressive chemotherapy were randomized to receive < or = 16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to < 9 g/dL (late). Those patients with a hemoglobin level > 12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total.. In all, 269 patients with a hemoglobin level < or = 12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21-7.46) in early patients and decreased 4.37 (95% CI, -7.99 to -0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98-1.46) in early patients but decreased 0.2 g/dL (95% CI, -0.32-0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients.. Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to < 9.0 g/dL.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematologic Neoplasms; Hemoglobins; Humans; Male; Middle Aged; Quality of Life; Recombinant Proteins; Work Capacity Evaluation

Epoetin alfa administered at 40,000 U once weekly (qw) to anemic cancer patients receiving chemotherapy increases hemoglobin levels, improves quality of life (QOL), and reduces transfusions. The benefit of epoetin alfa in maintaining hemoglobin levels in cancer patients with hemoglobin less than 12 g/dL has not been evaluated.. Breast cancer patients (N = 354) receiving chemotherapy were randomly assigned in 1:1 ratio to epoetin alfa (40,000 U qw) or standard of care (SOC). QOL was assessed at baseline and week 12. Hemoglobin responses, transfusion requirements, and prognostic factors for responses were measured.. At week 12, Functional Assessment of Cancer Therapy-Anemia (FACT-An; mean, 2.16 +/- 12.84 for epoetin alfa v -4.43 +/- 13.42 for SOC) and FACT-An fatigue (mean, 1.85 +/- 10.52 for epoetin alfa v -3.55 +/- 11.14 for SOC) change scores were significantly higher in the epoetin alfa group (P < .0001). Hemoglobin responses defined as mean hemoglobin > or = 12 g/dL or a > or = 2 g/dL increase compared with baseline were significantly higher in the epoetin alfa group versus SOC: 52.0% v 5.1% and 65.7% v 6.3%, respectively (P < .0001 for both comparisons). Percentage transfused was significantly lower in the epoetin alfa group compared with SOC (8.6% v 22.9%). More than 90% of patients did not require a dose increase and 28.7% had a dose reduction.. Epoetin alfa administered at 40,000 U qw is effective in improving QOL, maintaining hemoglobin level, and reducing transfusion requirements in breast cancer patients. The high effectiveness observed could be attributed in part to early treatment with epoetin alfa.

Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Blood Transfusion; Breast Neoplasms; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Middle Aged; Quality of Life; Recombinant Proteins; Treatment Outcome

Impaired cognition, fatigue, and diminished quality of life (QOL) are commonly associated with breast cancer chemotherapy. This randomized, double-blind, placebo-controlled pilot trial assessed the feasibility of quantifying the effects of epoetin alfa on cognitive function and mood, and evaluated its effects on fatigue and QOL in patients with breast cancer treated with anthracycline-based adjuvant or neoadjuvant chemotherapy. Patients were randomized to receive epoetin alfa 40,000 U subcutaneously once weekly or placebo at the beginning of 4 cycles of chemotherapy administered over 12 weeks. Cognitive function was assessed by Executive Interview (EXIT25) and Clock Drawing Tasks; mood by Profile of Mood States; anemia-related symptoms, including fatigue, by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) subscale; and QOL by Linear Analog Scale Assessment. Ninety-four patients were evaluable for efficacy and safety. Mean change in EXIT25 scores from baseline to cycle 4 in the epoetin alfa group was 1.3 +/- 3.3; the mean change was 0.3 +/- 2.4 in the placebo group (a negative change indicates improved executive function). There was no difference between groups in mean change in EXIT25 score from baseline to 6-month follow-up assessment. Mean hemoglobin levels were higher in the epoetin alfa group compared with the placebo group after 4 cycles of chemotherapy. Epoetin alfa recipients had less of a decrease in FACT-An subscale scores from baseline to cycle 4 and improvement in FACT-An subscale scores at 6-month follow-up assessment compared with placebo. Epoetin alfa therapy was well tolerated. These data suggest that epoetin alfa may have attenuated the cognitive impairment and fatigue that occurred during adjuvant breast cancer chemotherapy.

Topics: Adult; Affect; Aged; Breast Neoplasms; Chemotherapy, Adjuvant; Cognition Disorders; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Injections, Subcutaneous; Middle Aged; Neoadjuvant Therapy; Placebos; Quality of Life; Recombinant Proteins; Treatment Outcome

This prospective, open-label, multicenter study was undertaken to determine the safety and efficacy of epoetin alfa in increasing hemoglobin levels and improving quality of life (QOL), specifically fatigue, in cancer patients receiving chemotherapy with or without radiotherapy (n=702). Epoetin alfa, 10,000 IU three times a week s.c. for 8-18 weeks, increased the mean hemoglobin level relative to baseline (1.0 +/- 1.5 g/dl by week 4 and > or =1.7 g/dl from week 10 through the end of the trial), with 63.4% of patients experiencing > or =2 g/dl increases in hemoglobin above baseline at some time during the study. Fatigue is an important component of QOL. Physicians, nurses, and patients independently assessed patient fatigue level on a linear-analogue scale. Although all three groups reported improvements in patient fatigue over the course of the study (p <.0001), the magnitude of fatigue ratings and their relationship to tumor response and to hemoglobin level varied by group. Overall, epoetin alfa was well tolerated and effective in improving hemoglobin levels and decreasing fatigue in patients undergoing chemotherapy.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Prospective Studies; Quality of Life; Recombinant Proteins; Treatment Outcome

Fatigue can be a major problem for cancer patients receiving chemotherapy, and anaemia is known to be an important contributory factor. Several studies have shown that treatment with epoetin alfa raises haemoglobin levels, reduces fatigue and improves health-related quality of life (HrQoL). However, it is often difficult for clinicians to relate reported HrQoL improvements from clinical trials to meaningful benefits for their patients. Results from a large-scale, placebo-controlled study were used to determine the minimally important difference in HrQoL, defined as the 'smallest difference in score...which patients perceive as beneficial and which would mandate...a change in the patient's management'. This analysis confirmed that, for the five QoL scales used, epoetin alfa conferred not only a statistically significant but also a clinically significant benefit in terms of QoL compared to placebo, since, in each case, the benefit associated with epoetin alfa use was considerably higher than the minimally important difference.

Topics: Adult; Anemia; Antineoplastic Agents; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Humans; Male; Neoplasms; Placebos; Quality of Life; Recombinant Proteins

Anemia, fatigue, and diminished quality of life (QOL) often are associated with chemotherapy. In a previous study of patients with early-stage breast cancer and a mean baseline hemoglobin (Hb) level of 12.1 g/dL, Hb decreased by 2.0 g/dL after 4 cycles of adjuvant chemotherapy. The current open-label, nonrandomized, multicenter, prospective, community-based study evaluated the effects of 12-24 weeks of epoetin alfa (40,000 U subcutaneously once weekly initiated at the start of standard adjuvant chemotherapy) in patients with stage I-III breast cancer and baseline Hb levels > or =10 g/dL to < or =14 g/dL on Hb level, transfusions, and QOL.. Of 1792 patients enrolled, 1785 were evaluable for safety and 1632 for efficacy. Mean age was 53 years +/- 10.7 and mean baseline Hb level was 12.3 g/dL +/- 1.0. From baseline levels, epoetin alfa significantly increased Hb (1.3 g/dL +/- 1.5; P < 0.05) and improved QOL according to the Linear Analog Scale Assessment (LASA) of energy (5.1 mm +/- 27.7), LASA activity (5.1 mm +/- 28.2), LASA overall QOL (4.3 mm +/- 26.7), and Functional Assessment of Cancer Therapy-Anemia (1.7 points +/- 14.0; P < 0.05 in each case). Patients with baseline mild anemia (Hb level >10 g/dL to < or =12 g/dL) also had significant improvements from baseline levels in all 3 LASA parameters (P < 0.05). Epoetin alfa was well tolerated; clinically relevant thrombovascular events were reported in 4.3% of patients.. In this study, epoetin alfa significantly improved Hb and QOL in mildly anemic patients with early-stage breast cancer receiving adjuvant chemotherapy. However, based on recent studies showing an increased risk of thrombovascular events in patients with cancer treated with erythropoietic agents beyond correction of anemia, treatment with epoetin alfa is not indicated or recommended in patients with cancer and Hb levels > 12 g/dL.. Controlled studies are warranted to confirm the safety and efficacy of epoetin alfa therapy in patients with mild anemia receiving chemotherapy.

Topics: Adult; Anemia; Breast Neoplasms; Chemotherapy, Adjuvant; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Middle Aged; Prospective Studies; Quality of Life; Recombinant Proteins; Severity of Illness Index; Treatment Outcome

Anemia, highly common among cancer patients, is often an underlying cause of cancer-related fatigue and other quality-of-life (QOL) deficits. Although randomized clinical trials have shown that treatment with epoetin alfa increases hemoglobin levels, reduces fatigue, lessens transfusion requirements, and improves overall QOL, cancer-related anemia and fatigue remain undertreated. This is, in part, because scales and measures of QOL are still relatively unfamiliar to most clinicians and because population-based reference ranges are lacking, thus making clinical trial results difficult to interpret.. To aid in the interpretation of QOL results from clinical trials, we administered the Functional Assessment of Cancer Therapy-Anemia (FACT-An) QOL instrument to a nationally representative sample of 1,400 people using an Internet survey panel in the United States. We then compared the FACT-An data from the Internet survey with the QOL data of a 375-patient randomized, double-blind clinical trial evaluating epoetin alfa versus placebo in anemic cancer patients.. FACT-An, as administered to the survey population, displayed good psychometric properties and was able to discriminate between respondents with histories of specified illnesses, including anemia and cancer, and those without. Comparison of the population norm and clinical trial data showed that treatment with epoetin alfa resulted in clinically meaningful as well as statistically significant improvements in QOL (P <.01).. Reliable population norm data are now available to aid in the interpretation of clinical trial results where the FACT-An questionnaire is administered. In the clinical trial, treatment with epoetin alfa overcame much of the QOL deficit seen in anemic cancer patients compared with the norm population sample.

Topics: Adolescent; Anemia; Blood Transfusion; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Health Status Indicators; Hematinics; Hemoglobins; Humans; Neoplasms; Quality of Life; Recombinant Proteins; Surveys and Questionnaires; Treatment Outcome

This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival.. Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL, or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study.. Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P =.0057) and increased hemoglobin (P <.001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P <.01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P =.13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P =.052) favoring epoetin alfa. Adverse events were comparable between groups.. Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.

Topics: Activities of Daily Living; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Placebos; Quality of Life; Recombinant Proteins; Survival Analysis; Treatment Outcome

To prospectively evaluate the effectiveness, safety, and clinical benefits of once-weekly epoetin alfa therapy as an adjunct to chemotherapy in anemic cancer patients.. A total of 3,012 patients with nonmyeloid malignancies who received chemotherapy were enrolled onto this multicenter, open-label, nonrandomized study conducted in 600 United States community-based practices. Patients received epoetin alfa 40,000 U once weekly, which could be increased to 60,000 U once weekly after 4 weeks dependent on hemoglobin response. Treatment was continued for a maximum of 16 weeks.. Among the 2,964 patients assessable for efficacy, epoetin alfa therapy resulted in significant increases in hemoglobin levels, decreases in transfusion requirements, and improvements in functional status and fatigue as assessed by the linear analog scale assessment (energy level, ability to perform daily activities, and overall quality of life) and the anemia subscale of the Functional Assessment of Cancer Therapy-Anemia questionnaire. Improvements in quality-of-life parameters correlated significantly (P <.001) with increased hemoglobin levels. The direct relationship between hemoglobin and quality-of-life improvement was sustained during the 16-week study period, which is similar to findings of large community-based trials of three-times-weekly dosing. Once-weekly epoetin alfa was well tolerated, with most adverse events attributed to the underlying disease or concomitant chemotherapy.. The results from this large, prospective, community-based trial suggest that once-weekly epoetin alfa therapy increases hemoglobin levels, decreases transfusion requirements, and improves quality of life in patients with cancer and anemia who undergo concomitant chemotherapy. Based on the results of this study, the clinical benefits and the adverse event profile of once-weekly epoetin alfa therapy in community-based practice are similar to those observed in the historical experience with the three-times-weekly dosage schedule.

Topics: Activities of Daily Living; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Drug Administration Schedule; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Male; Middle Aged; Neoplasms; Prospective Studies; Quality of Life; Recombinant Proteins; Treatment Outcome

The cost of managing anemia with prophylactic epoetin alfa therapy versus blood transfusions in breast cancer patients receiving combination chemotherapy was studied. A retrospective study of anemia in breast cancer patients treated with four cycles of cyclophosphamide and doxorubicin with fluorouracil (CAF) or without fluorouracil (CA) was conducted. For each cycle of chemotherapy, patients were assessed for fatigue, subsequent blood transfusions administered, and potential response to and adverse effects of blood transfusions. Transfusions were given at the prescriber's discretion rather than in accordance with standard guidelines. The lowest hemoglobin concentration and hematocrit of each patient per cycle were reported. Data on these patients, along with data from published studies of prophylactic use of epoetin alfa, were used in a decision analysis of the costs associated with using epoetin alfa versus red blood cell transfusions to manage anemia. The charts of 50 patients were reviewed. In the study group, the percentage of patients with anemia and the frequency of fatigue rose with each chemotherapy cycle. In general, blood transfusions were not used. The cost of using epoetin alfa prophylactically for all four cycles was estimated at $6483 per patient for the literature-based group versus $169 for the study group. The cost of managing anemia in breast cancer patients was substantially lower when blood transfusions were used than when epoetin alfa was given prophylactically throughout four cycles of therapy with CAF or CA; the absence of standard guidelines for transfusion might have exaggerated the difference in costs.

Topics: Anemia; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Decision Trees; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Hematinics; Humans; MEDLINE; Recombinant Proteins; Retrospective Studies

The health-related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo-controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months, who had a hemoglobin <9.0 g/dL, and did not have coronary artery disease or diabetes mellitus, were randomized to either receive placebo (n=40), or receive intravenous Epoetin alfa to achieve a target hemoglobin of 9.5-11.0 g/dL (n=40) or a target of 11.5-13.0 g/dL (n=38). Patients were followed for 6 months. The two Epoetin alfa-treatment groups were combined for all analyses performed. This post hoc analysis was conducted using an intent-to-treat repeated measures mixed model analysis of variance using Bonferroni's multiplicity correction. The Epoetin alfa-treated group showed a statistically significant improvement in the Kidney Disease Questionnaire symptom of fatigue in comparison with placebo. Additionally, the change in hemoglobin at 2 months was correlated with change in fatigue, energy, shortness of breath, and weakness, but had minimal effect on depression. These analyses confirm previously reported results, which indicate that treating hemodialysis patients with an erythropoiesis-stimulating agent improves HRQOL.

Topics: Adult; Aged; Anemia; Canada; Data Interpretation, Statistical; Epoetin Alfa; Erythropoietin; Fatigue; Female; Health Status; Hematinics; Humans; Kidney Failure, Chronic; Male; Middle Aged; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Renal Dialysis

Cognitive dysfunction is a potential side effect of chemotherapy, and erythropoietin might be protective. A previously reported study compared quality-of-life in women undergoing chemotherapy for breast cancer who were randomized to receive epoetin-alpha or standard care. Here, we report a non-randomized sub-study in which cognitive function of participants was evaluated at 12-30 months after chemotherapy.. The primary endpoint was the proportion of women with moderate-severe cognitive impairment, as measured by the High Sensitivity Cognitive Screen (HSCS). Subjects also completed the Revised Hopkins Verbal Learning Test (HVLT-R), the Functional Assessment of Cancer Therapy--Fatigue (FACT-F) and FACT-G self-report questionnaires for fatigue and quality-of-life, and the Hospital Anxiety and Depression Scale.. Of 278 patients receiving adjuvant treatment in the primary study, 87 participated in the sub-study: 45 had received epoetin-alpha and 42 standard care. Groups were well matched for age and type of chemotherapy. Eight patients (9%) had moderate-severe cognitive dysfunction by the HSCS: six of them in the epoietin-alpha group (not significant). There were no significant differences in the HVLT-R, or in fatigue, but patients who had received epoetin-alpha reported better quality-of-life.. This study failed to demonstrate a protective effect of epoetin-alpha against the development of delayed cognitive dysfunction after chemotherapy.

Topics: Antineoplastic Agents; Breast Neoplasms; Case-Control Studies; Cognition Disorders; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Matched-Pair Analysis; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins

The primary aim of this study was to assess whether epoetin alpha (Ea) would improve cognitive performance in a group of anaemic cancer patients receiving chemotherapy. The secondary aim was to confirm the positive impact of Ea on haematological parameters, and quality of life (QOL). Fifty patients with solid tumours and haemoglobin (Hb) <11.0 g/dL received Ea 40,000 units once weekly for 12 weeks and were administered the Mini-Mental State Examination and the European Organization for Research and Treatment of Cancer (QLQ-C30) questionnaire prior to Ea therapy and at study completion. No clinically significant alterations were observed on cognitive function during Ea treatment. Changes in cognitive function were unrelated to Hb change and there were no significant differences in cognitive performance between Ea responders and non-responders. The analyses revealed clinically significant improvements in Hb levels, physical and role function, and clinically meaningful reductions in fatigue. Hb changes were significantly associated with the magnitude of improvement in QOL parameters. The lack of a clinical benefit in cognition observed in this study during Ea treatment may redirect the focus of research from enhancing to maintaining cognitive function, since stability in cognitive performance through time may be as well clinically important.

Topics: Adolescent; Adult; Aged; Anemia; Antineoplastic Agents; Chemotherapy, Adjuvant; Cognition Disorders; Drug Administration Schedule; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Recombinant Proteins; Treatment Outcome; Young Adult

Despite the clinical importance of health-related quality of life (QOL) in patients suffering from myelodysplastic syndromes (MDS), few data exist on the prevalence of key MDS-associated symptoms, or the correlation of those symptoms with specific disease features such as hemoglobin level. In order to better understand the burden of disease-associated symptoms in patients with MDS, we designed a 120-question Internet-based survey of QOL appropriate for patients with MDS, incorporating validated QOL measurement instruments and questions about specific therapies. The 359 survey respondents were typical of MDS patients in terms of demographics, blood counts, and disease subtype. Patients reported high levels of excessive fatigue and poor scores on QOL assessments such as the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and the Brief Fatigue Inventory (BFI). Patients' debilitating fatigue correlated poorly with hemoglobin level, and fatigue was associated with significant impairment of both health-related QOL and ability to work or participate in desired activities. Within the limitations of self-reported data, these results provide a benchmark for future interventions to improve QOL in patients with MDS.

Topics: Adult; Aged; Aged, 80 and over; Darbepoetin alfa; Epoetin Alfa; Erythropoietin; Exanthema; Fatigue; Female; Hemoglobins; Humans; Male; Middle Aged; Myelodysplastic Syndromes; Quality of Life; Recombinant Proteins

Epoetin alpha is known to produce a hematological response in anemic cancer patients. A concomitant reduction in fatigue as well as an improvement of depression and anxiety and of quality of life has been reported. However, these effects are discussed controversially. Psychological variables may have a moderating effect on fatigue reduction.. Fifty-four anemic cancer outpatients were treated with epoetin alpha over 26 weeks with an initial dose of 3 x 10,000 IU/week and further individually adapted dosage. Hemoglobin level, fatigue, depression, anxiety, and health-related quality of life were measured every 4 weeks.. The hematological response rate was 50%, with 1/3 occurring after more than 8 weeks of treatment. Fatigue, depression, and quality of life improved significantly. Reduction in fatigue was associated with response, but the correlations between fatigue and hemoglobin were weak. Less depression and higher quality of life before treatment correlated with a better fatigue reduction when controlling for hemoglobin increase and initial fatigue level.. Psychological variables influence the reduction of fatigue during therapy with epoetin alpha in anemic cancer patients and should therefore be assessed at the beginning of treatment.

Topics: Adult; Aged; Anemia; Anxiety; Biomarkers; Case-Control Studies; Depression; Epoetin Alfa; Erythropoietin; Fatigue; Female; Germany; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Predictive Value of Tests; Psychology; Quality of Life; Recombinant Proteins; Surveys and Questionnaires; Time Factors; Treatment Outcome

An anti-anemia drug may improve self-reported quality of life (QOL) partly because patients know their hemoglobin level is rising. In the absence of any published studies on this topic, the authors investigated the association between knowledge of hemoglobin levels and self-reported QOL.. The study analyzed health-related QOL (HRQOL) data from five randomized clinical trials of erythropoietic therapy in patients with cancer-related anemia. Patients were asked whether they knew their hemoglobin level and, if so, to report its value. Patients (n=1007) were grouped into three categories depending on the extent and accuracy of hemoglobin level knowledge. HRQOL scale scores were compared between categories.. Only 23.2% of patients reported knowing their hemoglobin level at the end of the study; however, the value was accurate (within 1 g/dl) in 88.0% of these patients. On five of the 11 HRQOL scales studied, there was a significant association between knowledge of hemoglobin level and HRQOL score. However, the magnitude of the mean difference between those who knew vs. those who did not know their hemoglobin was generally below scale thresholds for minimally important differences.. Patient knowledge of hemoglobin level has a modest association with some aspects of self-reported HRQOL. The magnitude of this association, where it exists, would be unlikely to explain large group differences in HRQOL reports over time, even for patients who know their hemoglobin level.

Topics: Aged; Anemia; Darbepoetin alfa; Epoetin Alfa; Erythropoietin; Fatigue; Female; Health Knowledge, Attitudes, Practice; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Sickness Impact Profile

In a large, 16-week, prospective study of 2,964 anemic patients with various cancers undergoing chemotherapy, once-weekly subcutaneous administration of 40,000 U of epoetin alfa,with potential escalation to 60,000 U, increased hemoglobin (Hgb) levels, decreased transfusion requirements, and improved quality of life (QOL) as assessed using the Linear Analog Scale Assessment (LASA) for energy, activity, and overall QOL and the Functional Assessment in Cancer Therapy-Anemia (FACT-An) QOL instrument. A retrospective subset analysis conducted in 244 colorectal cancer patients enrolled in the study showed statistically significant improvements from baseline to final readings in LASA energy, activity, and overall QOL and FACT-An Anemia Symptoms and Fatigue subscale scores (P < 0.02). Moreover, patients who achieved larger improvements in Hgb levels also demonstrated greater percentage improvements in QOL over baseline measurements. Mean Hgb levels increased by 1.2 g/dL after 4 weeks of treatment and by 1.6 g/dL by study end, independent of red blood cell transfusion within 28 days prior to the Hgb assessment. Hematopoietic response (Hgb level > or = 12 g/dL and/or increase in Hgb level > or = 2 g/dL, independent of transfusion) was observed in 61% of patients (139/229). Additionally, the proportion of patients receiving transfusions decreased from 17% at baseline to 4% during the final month of therapy. Epoetin alfa was well tolerated, with no evidence of unexpected adverse events. Except for significantly higher QOL scores at baseline, results for the cohort of colorectal cancer patients were similar to those for patients with other cancer types in the main study population.

Topics: Adenocarcinoma; Adult; Anemia; Antineoplastic Agents; Clinical Trials as Topic; Colorectal Neoplasms; Epoetin Alfa; Erythropoietin; Fatigue; Hemoglobins; Humans; Quality of Life; Recombinant Proteins; Retrospective Studies

Strategies for managing antineoplastic therapy-associated hematopoietic toxicity (thrombocytopenia, neutropenia, and anemia) are discussed. Hemorrhage secondary to decreases in platelets is the major risk posed by chemotherapy-induced thrombocytopenia. Patients with < 20,000 platelets per microliter are at increased risk of bleeding, particularly if they have a history of bleeding associated with this condition. The risks of infection and complications are related to both the severity and duration of neutropenia. The rate of febrile neutropenia with most antineoplastic regimens is < 40%, and routine use of cytokine therapy is probably not cost-effective. The frequency of cancer-related anemia is dependent on the type, stage, and duration of disease. Chemotherapy-induced anemia is affected by the types of agents used, the schedule of drug administration, and the intensity of the regimen. Fatigue is the most common symptom of anemia, being reported by 80-100% of patients undergoing chemotherapy. Although fatigue is a major factor in patients' quality of life, it has often not been treated systematically and aggressively. Anemia used to be treated with transfusions, but therapy with epoetin alfa is showing promise as an alternative. The introduction of epoetin alfa has led to more aggressive treatment. Chemotherapy-induced hematopoietic toxicity is a multifactorial challenge that affects the treatment of oncology patients.

Topics: Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Hematinics; Humans; Neutropenia; Practice Guidelines as Topic; Recombinant Proteins; Severity of Illness Index; Thrombocytopenia