The impact of hypogonadism and autonomic dysfunction on fatigue, emotional function, and sexual desire in male patients with advanced cancer: a pilot study

BACKGROUND: The objective of this study was to determine whether hypogonadism and autonomic dysfunction contribute substantially to cancer-related fatigue, decreased sexual desire, and depression in male patients with advanced, incurable cancer. METHODS: Forty-eight patients who had received no major antineoplastic intervention for at least 2 weeks were tested for autonomic dysfunction by using Ewing tests. Total and free testosterone levels were measured. Multivariate analyses were performed to test the relation of these factors with the Functional Assessment of Cancer Therapy (FACT) (the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] scale and the Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] subscale), the Hospital Anxiety and Depression Scale (HADS), the Edmonton Symptom Assessment Scale, the Sexual Desire Inventory, and sexual function (Cancer Rehabilitation Evaluation System subscale). Common causes for fatigue (anemia, depression, malnutrition, symptom distress, and medications) also were considered. RESULTS: Thirty-eight of 47 patients (81%) had autonomic dysfunction, although it was not associated significantly with the other variables examined. Twenty-nine of 45 patients (64%) had a low level of free testosterone (hypogonadism), which was correlated with the HADS Anxiety score (P = .002), the FACT Emotional Well-Being score (P = .02), and the HADS Depression score (P = .04). Hypogonadal men also had lower scores on the FACT Functional Well-Being scale (P = .01) and the FACIT-F subscale (P = .05). Men who reported symptoms related to weight loss (FAACT scale) had significantly lower levels of free testosterone (r = 0.34; P = .02) but did not differ from the other group in actual weight loss (P = .22). The total testosterone level was not appropriate for screening of hypogonadism unless the patients had values <100 ng/ mL. Logistic regression analysis failed to reveal a distinct multivariate model of autonomic dysfunction or hypogonadism that predicted clinical outcomes. CONCLUSIONS: Hypogonadism is a frequent condition in patients with advanced, incurable cancer and is associated with negative mood, fatigue, and symptoms related to anorexia/cachexia.     

Fatigue, serum cytokine levels, and blood cell counts during radiotherapy of patients with breast cancer

PURPOSE: To assess the level of fatigue during the course of adjuvant radiotherapy (RT) of breast cancer patients and its relation to anxiety, depression, serum cytokines, and blood count levels. METHODS AND MATERIALS: Forty-one patients who received adjuvant RT after breast-conserving surgery were prospectively studied. All patients underwent RT without concomitant chemotherapy. Patients rated their fatigue with two standardized self-assessment instruments, the Fatigue Assessment Questionnaire and a visual analog scale on fatigue intensity, before RT, during weeks 1-5 of RT, and 2 months after RT completion. In addition, the anxiety and depression levels were assessed with the Hospital Anxiety and Depression Scale. A differential blood cell count and the serum levels of the cytokines interleukin (IL)-1beta, IL-6, and tumor necrosis factor-alpha were determined in parallel to the fatigue assessments. RESULTS: Fatigue intensity as assessed with the visual analog scale increased (p <0.001) until treatment week 4 and remained elevated until week 5. Two months after RT, the values had fallen to the pretreatment levels. Fatigue measured with the Fatigue Assessment Questionnaire did not increase significantly during treatment, but the subscores on physical (p = 0.035) and cognitive (p = 0.015) fatigue were elevated during treatment weeks 4 and 5. Affective fatigue did not change significantly. Anxiety, as rated with the Hospital Anxiety and Depression Scale, declined during RT (p = 0.002), but the Hospital Anxiety and Depression Scale depression score did not change significantly. IL-1beta, IL-6, and tumor necrosis factor-alpha levels did not change during therapy and did not correlate with fatigue. Peripheral blood cell levels declined significantly during therapy and were still low 2 months after treatment. Until treatment week 5, lymphocytes were reduced to almost 50% of their initial values. Hemoglobin levels did not correlate with fatigue. CONCLUSIONS: We observed an increase in fatigue during adjuvant RT of patients with breast cancer. Fatigue returned to pretreatment levels 2 months after treatment. No evidence was found that anxiety, depression, serum levels of IL-1beta, IL-6, tumor necrosis factor-alpha, or declining hemoglobin levels were responsible for the treatment-induced fatigue.     

Early Intervention with epoetin alfa during platinum-based chemotherapy: an analysis of quality-of-life results of a multicenter, randomized, controlled trial compared with population normative data

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.     

Chronic fatigue in Hodgkin lymphoma survivors and associations with anxiety,depression and comorbidity

Background:

Fatigue is a frequent and persistent problem among Hodgkin lymphoma (HL) survivors. We investigated the prevalence of clinically relevant fatigue in HL survivors and the relation between fatigue and anxiety and depression.

Methods:

Fatigue was measured through the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Fatigue Assessment Scale (FAS). Anxiety and depression were measured with the Hospital Anxiety and Depression Scale. Questionnaires were mailed to 267 HL survivors. Results were compared with a Dutch age-matched normative population.

Results:

Response rate was 68% (median age 46 years, mean time since diagnosis 4.6 years). Prevalence of fatigue was significantly higher among HL survivors than in the norm population (FAS 41% vs 23%, QLQ-C30 43% vs 28%), as were fatigue levels. There was a significant association between fatigue, anxiety and depression. Of the HL survivors with high symptom levels of depression, 97% also reported fatigue. In multivariate analysis, depression was strongly associated with high levels of fatigue and, to a lesser extent, anxiety and comorbidity.

Conclusions:

Prevalence rates of fatigue are significantly higher in HL survivors than in the general population and differences are clinically relevant. Depression and anxiety were strongly associated with high levels of fatigue. Reducing fatigue levels by treatment of depression and anxiety should be further explored.     

Double-blind,placebo-controlled,randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy

BACKGROUND: Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp(TM)) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy. METHODS: In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin or=25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P =.019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups. CONCLUSIONS: Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.     

The influence of erythropoietin on cognitive function in women following chemotherapy for breast cancer

Objective: 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‐alfa 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. Methods: 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. Results: Of 278 patients receiving adjuvant treatment in the primary study, 87 participated in the sub‐study: 45 had received epoetin‐alfa 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‐alfa group (not significant). There were no significant differences in the HVLT‐R, or in fatigue, but patients who had received epoetin‐alfa reported better quality‐of‐life. Conclusion: This study failed to demonstrate a protective effect of epoetin‐alfa against the development of delayed cognitive dysfunction after chemotherapy. Copyright © 2008 John Wiley & Sons, Ltd.     

Effectiveness of darbepoetin alfa versus epoetin alfa in patients with chemotherapy-induced anemia treated in clinical practice

PRIMARY PURPOSE: The objective of this retrospective observational cohort study was to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in patients with chemotherapy-induced anemia using data from noncontemporaneous chart audits conducted at a community-based oncology practice. MATERIALS AND METHODS: For the first chart audit, data were collected from consecutive patients with nonmyeloid malignancies with diagnoses of chemotherapy-induced anemia and hemoglobin levels < or = 10.5 g/dl who were receiving concurrent chemotherapy and had at least 5 weeks of visits from July-September 2000. After therapeutic substitution of darbepoetin alfa for epoetin alfa for all patients with chemotherapy-induced anemia, data were collected from consecutive darbepoetin alfa-treated patients with diagnoses of chemotherapy-induced anemia and at least 8 weeks of visits from June-October 2002 (darbepoetin alfa was approved in July 2002). RESULTS: Most (86%) of the 212 epoetin alfa-treated patients had received an initial dose of 40,000 U once weekly, and most (85%) of the 196 darbepoetin alfa-treated patients had received a fixed dose of either 100 microg once weekly (49%) or 200 microg every 2 weeks (36%). At 8 weeks, the mean change in hemoglobin level was 1.1 g/dl for the darbepoetin alfa patient group and 1.0 g/dl for the epoetin alfa patient group. DISCUSSION: Utilization, dose escalation rates, and clinical outcomes were considered comparable for the darbepoetin alfa and epoetin alfa patient groups. CONCLUSIONS: Darbepoetin alfa, 100 microg once weekly or 200 microg every 2 weeks, appears to be as effective as epoetin alfa, 40,000 U once weekly, for the treatment of chemotherapy-induced anemia in the clinical practice setting.     

Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks

The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95% CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95% CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy.The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84% (95% CI:81,86).Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26%) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2% of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.     

Fatigue, anxiety, and depression in long-term survivors of testicular cancer.

PURPOSE: To investigate the prevalence of chronic fatigue (CF), the levels of anxiety and depression, and the correlation between these conditions in long-term survivors of testicular cancer (TCSs). Occurrence of CF in TCSs is compared with findings in male survivors of Hodgkin's disease (HDSs) and in males from the general population (GenPop). METHODS: TCSs, HDSs, and two cohorts of the GenPop completed the Fatigue Questionnaire (FQ) and the Hospital Anxiety and Depression Scale (HADS) as part of a questionnaire survey. Cases of CF were identified according to published cut-offs, and the levels of anxiety (HADS-A) and depression (HADS-D) were calculated. RESULTS: Among 791 TCSs, 16% displayed CF (HDSs, 24%; GenPop, 10%). In the age group younger than 30 years, the prevalence of CF was higher in TCSs than in the GenPop (P <.01). In TCSs, age, anxiety, depression, and comorbidity were independent predictors of CF. The mean HADS-A score in TCSs was significantly above the comparable figure of the GenPop and similar to that of HDSs. The mean HADS-D score in TCSs was below that of the GenPop. The highest and lowest mean scores of HADS-A and HADS-D were observed in the youngest TCSs. CONCLUSION: The prevalence of CF is less in TCSs than in HDSs but exceeds that of the GenPop. Together with comorbidity and age, anxiety and depression predict CF in TCSs, warranting psychiatric intervention for cases of CF among TCSs. Anxiety is a larger problem in TCSs than depression, particularly among the youngest TCSs.     

Art therapy improved depression and influenced fatigue levels in cancer patients on chemotherapy

INTRODUCTION: Cancer patients are particularly vulnerable to depression and anxiety, with fatigue as the most prevalent symptom of those undergoing treatment. The purpose of this study was to determine whether improvement in depression, anxiety or fatigue during chemotherapy following anthroposophy art therapy intervention is substantial enough to warrant a controlled trial. MATERIAL AND METHODS: Sixty cancer patients on chemotherapy and willing to participate in once-weekly art therapy sessions (painting with water-based paints) were accrued for the study. Nineteen patients who participated in > or =4 sessions were evaluated as the intervention group, and 41 patients who participated in < or =2 sessions comprised the participant group. Hospital Anxiety and Depression Scale (HADS) and the Brief Fatigue Inventory (BFI) were completed before every session, relating to the previous week. RESULTS: BFI scores were higher in the participant group (p=0.06). In the intervention group, the median HADS score for depression was 9 at the beginning and 7 after the fourth appointment (p=0.021). The median BFI score changed from 5.7 to 4.1 (p=0.24). The anxiety score was in the normal range from the beginning. CONCLUSION: Anthroposophical art therapy is worthy of further study in the treatment of cancer patients with depression or fatigue during chemotherapy treatment.     

Efficacy and safety of every-2-week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open-label phase II trial

This randomized, controlled trial evaluated the effect of darbepoetin alfa on hospitalization days, transfusion requirements, hemoglobin levels, and fatigue in patients with anemia of cancer (AOC). Eligible patients were anemic (hemoglobin or=18 years old, and had not received chemotherapy or radiotherapy within 4 weeks of study screening. Patients were randomized 4:1 to receive darbepoetin alfa, 3.0 microg/kg every 2 weeks (Q2W) (n = 226), or observation only for 12 weeks (n = 59), followed by an optional 9 weeks of darbepoetin alfa, 3.0 microg/kg Q2W. Endpoints were compared between the two treatment arms at week 13. A planned interim analysis indicated that assumptions regarding hospitalization in the study design were incorrect, so the study was terminated early. Therefore, results for the primary endpoint should be interpreted cautiously. The hospitalization rate was similar (0.5 days) for both the darbepoetin alfa and observation groups (p = .73). Transfusion incidence (weeks 5-12) was significantly lower for darbepoetin alfa patients (8%) than for observation patients (22%) (p = .0092). By week 13, hemoglobin increased by 2.1 g/dl in patients receiving darbepoetin alfa, compared with 0.1 g/dl in the observation group p < .0001. Hemoglobin improvements were paralleled by an increase in Functional Assessment of Cancer Therapy-Fatigue score (mean change in score at week 13: darbepoetin alfa, 6.0; observation, 2.2; p < .05). Darbepoetin alfa Q2W can significantly improve hemoglobin levels and reduce transfusion requirements in patients with AOC, resulting in significant improvements in health-related quality of life.     

Fatigue in ovarian carcinoma patients: a neglected issue?

BACKGROUND: Although fatigue is a commonly reported symptom in cancer patients it is rarely investigated, especially in patients with ovarian carcinoma. The main focus of the current study was to assess fatigue in these patients and to investigate the impact of fatigue and other clinical and psychosocial variables on their quality of life (QOL). METHODS: Ninety-eight ovarian carcinoma survivors (average age of 57.4 +/- 12.5 years) were included in the study. All women had received cancer therapy but had not been treated for at least 6 months. The average time elapsed since first diagnosis was 5.7 +/- 5.5 years. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and QOL was measured with the Functional Assessment of Cancer Therapy (FACT)-ovarian carcinoma part and the European Organization for Research and Treatment of Cancer Care Questionnaire, including the ovarian carcinoma module. RESULTS: Thirty-two of 98 ovarian carcinoma patients (32.7%, 95% confidence interval, 23.5-42.9%) reported MFI-20 General Fatigue scores >/= 12.0 and therefore could be characterized as suffering from fatigue. This group of patients had a significantly lower QOL, had higher scores of anxiety and depression, and perceived that they had less social support. In a multiple regression model, mental adjustment, social support, anxiety, and depression as well as fatigue were significant predictors of QOL (FACT-generic part total score) whereas clinical and sociodemographic variables were not. CONCLUSION: A remarkably high proportion of ovarian carcinoma survivors suffered from fatigue. Because this symptom is a key predictor of QOL, it should be given more attention in aftercare programs.     

The physical and psychological symptoms experienced by patients with metastatic breast cancer before death

The present study explores the levels of anxiety and depression experienced by a sample of 44 patients with metastatic breast cancer 1–7 weeks before their death. In addition, relationships were examined between symptomatology (measured by the Rotterdam Symptom Checklist) and anxiety and depression (measured by the Hospital Anxiety and Depression Scale). Results suggested that a high proportion of patients scored in the case range for anxiety (66%) and depression (50%) using the cut-off scores suggested by the authors. Weak positive correlations between physical symptomatology and anxiety and depression were ascertained using scores from the Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale. The results of the present study are discussed in the context of previous research findings and further research avenues are highlighted.     

Relationship of psychological characteristics and self‐efficacy in gastrointestinal cancer survivors

To characterize gastrointestinal cancer survivors' ability to psychologically adjust, we examined the relationship between psychological characteristics (quality of life (QOL), anxiety, depression, and post‐traumatic stress symptoms) and self‐efficacy (perceived ability to initiate coping strategies). Forty‐seven subjects (32 males and 15 females) were recruited from outpatient clinics or general surgical wards after readmission for therapy unrelated to cancer. All had undergone treatment for gastrointestinal cancer. Japanese version of the Functional Assessment of Cancer Therapy—General (FACT‐G), Japanese version of Hospital Anxiety and Depression Scale (HADS), Japanese version of Impact of Event Scale—Revised (IES‐R), and The Self‐Efficacy Scale for Advanced Cancer (SEAC) were administered. Correlation analyses revealed a statistically significant positive correlation between three subscales of SEAC and QOL (total of FACT‐G value) and a significant negative correlation between anxiety, depression (the total of HADS value), post‐traumatic stress symptoms (the total of IES‐R value), and SEAC. In multiple regression analysis, the influence from Affect Regulation Efficacy (subscale of SEAC) was the largest in anxiety and post‐traumatic stress symptoms while the influence from Activities of Daily Living Efficacy (subscale of SEAC) was the largest in QOL and depression. Our findings revealed that a strong relationship between self‐efficacy and psychological adjustment, and that there should be several psychological intervention forms performed at various treatment stages to enhance self‐efficacy in this population of gastrointestinal cancer survivors. These results also imply the effectiveness of interventions on self‐efficacy for gastrointestinal cancer survivors and the influence of psychological factors such as QOL, anxiety, depression, and post‐traumatic stress symptoms. Copyright © 2009 John Wiley & Sons, Ltd.     

Predicting delayed anxiety and depression in patients with gastrointestinal cancer

The aim of this study was to examine the possibility of predicting anxiety and depression 6 months after a cancer diagnosis on the basis of measures of anxiety, depression, coping and subjective distress associated with the diagnosis and to explore the possibility of identifying individual patients with high levels of delayed anxiety and depression associated with the diagnosis. A consecutive series of 159 patients with gastrointestinal cancer were interviewed in connection with the diagnosis, 3 months (non-cured patients only) and 6 months later. The interviews utilized structured questionnaires assessing anxiety and depression [Hospital Anxiety and Depression (HAD) scale], coping [Mental Adjustment to Cancer (MAC) scale] and subjective distress [Impact of Event (IES) scale]. Patient anxiety and depression close to the diagnosis were found to explain approximately 35% of the variance in anxiety and depression that was found 6 months later. The addition of coping and subjective distress measures did little to improve that prediction. A model using (standardized) cut-off scores of moderate to high anxiety, depression (HAD) and intrusive thoughts (IES subscale) close to the diagnosis to identify patients at risk for delayed anxiety and depression achieved a sensitivity of 75% and a specificity of 98%. Levels of anxiety and depression at diagnosis predicted a similar status 6 months later. The results also indicated that the HAD scale in combination with the IES intrusion subscale may be used as a tool for detecting patients at risk of delayed anxiety and depression.     

Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study

Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anemia. This phase II, double-blind, placebo-controlled study examined the efficacy of darbepoetin alfa for treating anemia of cancer (AoC) in patients not receiving chemotherapy or radiotherapy. Patients were randomized 3:1 to receive darbepoetin alfa (6.75 microg/kg) or placebo every 4 weeks; the end of the study was at week 17. The primary endpoint was the percentage of patients with a hematopoietic response. Secondary endpoints included transfusion incidence and safety parameters. Efficacy analyses were performed on 162 patients in the darbepoetin alfa group and 56 patients in the placebo group. The Kaplan-Meier percentages of patients who achieved a hematopoietic response (darbepoetin alfa, 69%; placebo, 24%) or achieved the target hemoglobin (darbepoetin alfa, 85%; placebo, 50%) differed significantly between treatment groups. The transfusion incidence did not differ between treatment groups probably because of the low baseline transfusion rates in AoC patients. The incidence of adverse events (including on-study deaths) was similar in both groups. In conclusion, darbepoetin alfa appeared to be well tolerated and significantly increased hemoglobin levels in these AoC study patients.     

Darbepoetin alfa for the treatment of cancer-related anemia: an update

Anemia is a common and potentially debilitating complication of cancer. Darbepoetin alfa (Aranesp, Amgen) has been in routine clinical use for the treatment of chemotherapy-induced anemia since 2002. The extended half-life of darbepoetin alfa permits less frequent and consequently more flexible dosing than other erythropoietic therapies. Data suggest that hemoglobin levels can be effectively and safely increased with darbepoetin alfa in cancer patients who are receiving chemotherapy (patients with treatment-induced anemia), and in those who are not receiving chemotherapy (patients with tumor-induced anemia). This review provides an overview of clinical trial results, particularly those exploring flexible, extended dosing schedules.     

Darbepoetin alfa: potential role in managing anemia in cancer patients

Anemia in cancer patients is frequent but often under-recognized and under-treated. This may be related to misconceptions about the impact of anemia on cancer patients and ill-defined guidelines for treatment, as well as the inadequacies of current therapy. Darbepoetin alfa, a novel erythropoiesis-stimulating protein with a longer serum half-life than epoetin (alpha and beta), is approved to treat anemia in patients with chronic kidney disease. Most recently darbepoetin alfa has received approval by the FDA in USA for the treatment of anemia associated with myelosuppressive chemotherapy and approval in the EU is expected soon. Clinical trials in cancer patients indicate that darbepoetin alfa effectively and safely alleviates anemia in patients receiving chemotherapy. A Phase II trial also indicates that darbepoetin alfa is effective in patients who are not receiving chemotherapy. Thus, darbepoetin alfa has the potential to improve supportive care and thereby, cancer patients' quality of life, and might also impact on treatment outcome.     

Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center

BACKGROUND: The correlation of fatigue levels with functional interference, symptom distress, and quality of life may help determine clinically significant fatigue levels. METHODS: One hundred eighty consecutive patients with cancer completed the Functional Assessment of Cancer Therapy (FACT) General and Fatigue subscales (FACT-G and FACT-F, respectively), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), the Depression Scale (Zung), and the Brief Fatigue Inventory (BFI). The Karnofsky performance status (KPS) was determined for each patient. Multivariate analyses of variance were performed to compare fatigue models with different cut-off points to categorize fatigue levels. Cox proportional hazards analysis was performed to assess the association between fatigue severity and survival. RESULTS: Increased fatigue levels were associated with greater symptom distress and decreased quality of life. A model with usual fatigue cut-off points of 0 (no fatigue), 1-2 (mild fatigue), 3-6 (moderate fatigue), and 7-10 (severe fatigue) was optimal in relation to functional interference items (Wilks lambda, 0.36; F = 11.61; P < 0.0001), symptom distress scores (Wilks lambda, 0.52; F = 10.41; P < 0.0001), and quality-of-life scores (Wilks lambda, 0.50; F = 0.50; P < 0.0001). Fatigue severity predicted survival in univariate analysis (chi-square test, 25.42; P < 0.0001). The KPS, stage of disease, and number of symptoms independently predicted survival in patients with fatigue. CONCLUSIONS: Clinically relevant fatigue levels are correlated with symptom and quality-of-life measurements. Patients with a usual fatigue severity > 3 or a worst fatigue severity > 4 on a 1-10 scale may require further assessment.     

Darbepoetin alfa for the treatment of cancer-related anemia: an update

Anemia is a common and potentially debilitating complication of cancer. Darbepoetin alfa (Aranesp^®, Amgen) has been in routine clinical use for the treatment of chemotherapy-induced anemia since 2002. The extended half-life of darbepoetin alfa permits less frequent and consequently more flexible dosing than other erythropoietic therapies. Data suggest that hemoglobin levels can be effectively and safely increased with darbepoetin alfa in cancer patients who are receiving chemotherapy (patients with treatment-induced anemia), and in those who are not receiving chemotherapy (patients with tumor-induced anemia). This review provides an overview of clinical trial results, particularly those exploring flexible, extended dosing schedules.