Evaluation of clinical use and effectiveness of darbepoetin alfa in cancer patients with chemotherapy-induced anemia.

PURPOSE: To investigate the patterns of use of darbepoetin alfa in Spanish centers, and to evaluate its effectiveness in the treatment of chemotherapy-induced anemia under clinical practice conditions. METHODS: This was an observational, retrospective, multicenter study in adult patients with non-myeloid malignancies who initiated chemotherapy and darbepoetin alfa. Data was collected for up to 16 weeks or until treatment discontinuation. RESULTS: A total of 685 patients (72.7% with solid tumors and 27.3% with hematologic malignancies) were included in the study. Median age was 64.7 years (range 18.5-88.9 years), 50.7% were women, 82.4% had ECOG status 0-1 and 80.5% had stage III/IV cancer. At darbepoetin initiation, mean hemoglobin (Hb) was 100 g/L (SD 10), with 11.0% and 23.1% of patients below 90 g/L in solid and hematologic malignancies, respectively. A decrease in transfusion requirements was observed between weeks 5-16 with respect to weeks 0-16 (13.3% [95% CI: 10.7 to 15.9] versus 19.0% [95% CI: 16.0 to 22.0]). Hb levels were significantly increased during the treatment (mean change of 10.4 g/L for solid tumors [p < 0.001], and 16.6 g/L for hematologic malignancies [p < 0.001]). The percentage of patients with baseline Hb level <110 g/L who achieved an Hb level ≥110 g/L during the study was 66.5% (95% CI: 62.5% to 70.5%). Six serious adverse reactions were considered related to darbepoetin alfa (thromboembolic events, 1.0%). CONCLUSIONS: With the limitation of a retrospective design, our results suggest that darbepoetin alfa is a well tolerated treatment that increases hemoglobin levels and reduces the need for transfusion in cancer patients receiving chemotherapy in clinical practice.

Psychometric properties of the Perform Questionnaire: a brief scale for assessing patient perceptions of fatigue in cancer.

PURPOSE: Fatigue is a symptom with a relevant impact on the daily lives of cancer patients and is gaining importance as an outcome measure. The Perform Questionnaire (PQ) is a new scale originally developed among Spanish-speaking patients for the assessment of perception and beliefs about fatigue in cancer patients. METHODS: An observational longitudinal multicenter study was carried out on cancer patients with fatigue. Fatigue-specific measures (FACT-F), generic health-related quality-of-life measures (NHP), and PQ were gathered at baseline and 3 months later. Feasibility, reliability (internal consistency and test-retest), validity, sensitivity to change, and minimally important differences were analysed. RESULTS: Four hundred thirty-seven patients were included in the study: 60.5% were women, the mean age was 59.1 years, the mean time from diagnosis was 2.2 years, 33.6% of patients had breast cancer, and 29.1% had anaemia (haemoglobin (Hb) <11 g/dL). Low levels of missing items and ceiling/floor effects (<10%) were found. The overall Cronbach's alpha and intraclass correlation coefficient were 0.94 and 0.83, respectively. The PQ score was associated with fatigue intensity, the need for a caregiver, and the Hb level. Its association was stronger with the FACT-F than with non-specific health measures (NHP). The PQ showed good sensitivity to change for improved and worsening health status. A minimally important difference of 3.5 was estimated in patients whose Hb level had improved by at least 1 g/dL. CONCLUSIONS: The PQ measured the attitudes and beliefs about fatigue among cancer patients in clinical practice and showed good psychometric properties among Spanish-speaking patients.

Development of a new questionnaire to assess patient perceptions of cancer-related fatigue: item generation and item reduction.

OBJECTIVES: Existing instruments that measure the impact of cancer-related fatigue on health-related quality of life do not usually incorporate the attitudes, beliefs and perspectives of patients. This study aimed to develop an instrument to measure the impact of cancer-related fatigue on the health-related quality of life of cancer patients. METHODS: Items were generated from a literature review, focus groups of cancer patients and meetings with oncologists. Potential items were administered to cancer patients to facilitate item reduction, which was based on clinimetric and psychometric analyses and qualitative criteria. A preliminary assessment of feasibility, reliability and validity of the retained items was performed. RESULTS: An initial pool of 75 items was administered to 238 cancer patients. Fifty items were eliminated after statistical analysis and 13 in response to expert opinion, resulting in a provisional instrument with 12 items in 3 dimensions. These displayed acceptable internal consistency (Cronbach's alpha, 0.78-0.92) and their overall score was associated with fatigue intensity, extent of disease, intention of treatment and need of caregivers. CONCLUSION: The newly developed questionnaire, which measures the impact of cancer-related fatigue on oncology patients, has shown satisfactory feasibility, reliability and validity.

Darbepoetin alpha for the treatment of anemia in patients with myelodysplastic syndromes.

BACKGROUND: Anemia occurs as a comorbidity in from 80% to 85% of patients with myelodysplastic syndromes (MDS): It causes fatigue, increases transfusion needs, and reduces quality of life. Darbepoetin alpha (DA) is an erythropoiesis-stimulating protein (ESP) that is more highly glycosylated and has a longer half-life relative to recombinant human erythropoietin (rHuEPO), thus, allowing less frequent administration, increased convenience, and better compliance. METHODS: This retrospective analysis included 81 patients with MDS who were enrolled at 9 Spanish centers and who received once-weekly, subcutaneous DA (75-300 microg) for 16 weeks. RESULTS: Fifty-five percent of all patients (38 of 69 evaluable patients) achieved responses; 30.4% of were major responses, and 24.6% were minor responses; 64.7% of rHuEPO-naive patients and 45.7% rHuEPO-treated patients responded; and 43.2% had received previous rHuEPO. Most responses (65.8%) occurred at or before Week 8. The median age at diagnosis was 70 years (range, 38-87 years), the median age at the initiation of DA treatment was 75 years (range, 39-91 years), and 56.8% of patients were women. The median time from last ESP dose to DA initiation was 16.8 weeks (range, 0.0-159.0 weeks; <1 week in 53.1% of patients). According to the French-American-British classification system (n = 81 patients), 39.5% had refractory anemia (RA), 46.9% had RA with ringed sideroblasts, 9.9% had RA with excess blasts (RAEB), 1.2% had RAEB in transformation, and 2.5% had chronic myelomonocytic leukemia. According to the International Prognostic Scoring System (n = 47 patients), 55.3% of patients were in the low-risk group, and 36.2% of patients were in the intermediate-1-risk group. The median baseline hemoglobin level was 8.9 g/dL (range, 8.4-9.1 g/dL). The Starting DA dose was 75 microg per week in 3.7% of patients, 150 microg per week in 65.4% of patients, and 300 microg per week in 29.6% of patients (the dose was increased in 18.5% of patients and reduced in 9.9% of patients; median time to dose adjustment, 8 weeks). Five patients received granulocyte colony-stimulating factors. No DA-related adverse reactions occurred. CONCLUSIONS: In the current study, 55% of evaluable patients with MDS safely achieved an erythroid response.

Los servicios farmacéuticos desde la perspectiva asistencial. Análisis de situación y líneas estratégicas / The pharmaceutical services from an assistance perspective. Analysis of situation and strategics lines

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