Development and psychometric validation of a brief comprehensive health status assessment scale in older patients with hematological malignancies: The GAH Scale.

OBJECTIVES: The purpose of this study was to develop a new brief, comprehensive geriatric assessment scale for older patients diagnosed with different hematological malignancies, the Geriatric Assessment in Hematology (GAH scale), and to determine its psychometric properties. MATERIALS AND METHODS: The 30-item GAH scale was designed through a multi-step process to cover 8 relevant dimensions. This is an observational study conducted in 363 patients aged≥65years, newly diagnosed with different hematological malignancies (myelodysplasic syndrome/acute myeloblastic leukemia, multiple myeloma, or chronic lymphocytic leukemia), and treatment-naïve. The scale psychometric validation process included the analyses of feasibility, floor and ceiling effect, validity and reliability criteria. RESULTS: Mean time taken to complete the GAH scale was 11.9±4.7min that improved through a learning-curve effect. Almost 90% of patients completed all items, and no floor or ceiling effects were identified. Criterion validity was supported by reasonable correlations between the GAH scale dimensions and three contrast variables (global health visual analogue scale, ECOG and Karnofsky), except for comorbidities. Factor analysis (supported by the scree plot) revealed nine factors that explained almost 60% of the total variance. Moderate internal consistency reliability was found (Cronbach's α: 0.610), and test-retest was excellent (ICC coefficients, 0.695-0.928). CONCLUSION: Our study suggests that the GAH scale is a valid, internally reliable and a consistent tool to assess health status in older patients with different hematological malignancies. Future large studies should confirm whether the GAH scale may be a tool to improve clinical decision-making in older patients with hematological malignancies.

Darbepoetin alfa for anemia in patients with low or intermediate-1 risk myelodysplastic syndromes and positive predictive factors of response.

BACKGROUND: Current guidelines support the use of erythropoiesis-stimulating agents for the treatment of anemia associated with low-risk myelodysplastic syndromes (MDS). DESIGN AND METHODS: Single-arm, open-label, multi-center, phase 2 trial that evaluated the efficacy and safety of darbepoetin alfa (DA) in patients with low or intermediate-risk MDS, hemoglobin <100 g/L, erythropoietin (EPO) levels <500 IU/L and transfusion requirements <2 units/month over the preceding 2 months. Erythroid response (major [MaR] or minor [MiR]) and fatigue (Functional Assessment of Cancer Therapy-Fatigue [FACT-F]) were evaluated at 8, 16 and 24 weeks. DA was initiated at 300 µg weekly. For patients who did not achieve MaR by 8 weeks, filgrastim 300 µg weekly was added. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01039350. RESULTS: Forty-four patients (72.7% transfusion independent) were included. Median age was 76.0 years (range 41.3-92.4), 54.5% were male, and 90.9% presented ECOG Status (0-1). Eighteen patients received filgrastim. An erythroid response was achieved by 31 of 44 patients (70.5%) at week 8 (47.7% MaR, 22.7% MiR), 31 of 44 patients (70.5%) at week 16 (61.4% MaR, 9.1% MiR), and 32 of 44 patients (72.7%) at week 24 (61.3% MaR, 11.4% MiR). Mean (95% CI) change in FACT-F at week 24 was 3.61 (0.72 to 6.51). Baseline EPO levels <100 IU/L were a predictive factor of response. DA was well tolerated. Four mild (two iron deficiencies, flu syndrome and headache) and one fatal (thromboembolic event) adverse events were considered related to darbepoetin alfa. CONCLUSIONS: A fixed dose of 300 µg of darbepoetin alfa weekly (with or without filgrastim) seems to be an effective and safe treatment for anemic patients with low or intermediate-risk MDS, low transfusion burden and EPO levels <500 IU/L. Results may not be extrapolable to unselected MDS patients.

[New indications for erythropoietin in clinical practice]. / Nuevas indicaciones de la eritropoyetina en la práctica clínica.

The utilization of rHuEp changed definitively the treatment and the natural history of anemia in patients with chronic renal insufficiency (CRI), and now is modifying the treatment of anemia of other non-renal patients as anemia of premature, anemia in onco-hematological illnesses, anemia in human immunodeficiency virus (HIV) infection, and for reduction of allogenic blood transfusions in surgery. We analyze briefly the clinical indications of rHuEpo and the possible complications secondary to its use.

Nuevas indicaciones de la eritropoyetina en la práctica clínica / New indications for erythropoietin in clinical practice

El empleo de la eritropoyetina recombinante (rHuEp) modificó definitivamente el tratamiento y el curso evolutivo de la anemia del paciente con insuficiencia renal crónica (IRC) y está modificando el tratamiento de la anemia de otros pacientes no renales como anemias del prematuro, padecimientos oncohematológicos, infección por el virus de la inmunodeficiencia humana (VIH) y reducción de las transfusiones de sangre alogénica en cirugía. En el presente trabajo analizamos brevemente las indicaciones clínicas de la rHuEpo y las posibles complicaciones derivadas de su empleo

The utilization of rHuEp changed definitively the treatment and the natural history of anemia in patients with chronic renal insufficiency (CRI), and now is modifying the treatment of anemia of other non-renal patients as anemia of premature, anemia in onco-hematological illnesses, anemia in human immunodeficiency virus (HIV) infection, and for reduction of allogenic blood transfusions in surgery. We analyze briefly the clinical indications of rHuEpo and the possible complications secondary to its use

Dry eye in Waldenström's macroglobulinemia. Improvement after systemic chemotherapy.

Waldenström's macroglobulinemia is an uncommon cause of dry eye. We describe a case of dry eye associated with Waldenström's macroglobulinemia that responded poorly to substitutive topical treatment but improved spectacularly in response to systemic chemotherapy. As far as we know, no similar case has been reported.