BACKGROUND: The effect of using fixed versus weight-based doses for erythropoietic agents has not been reported previously. To investigate this issue, the authors conducted a randomized Phase II study of darbepoetin alfa administered as either a fixed dose or a weight-based dose using an accelerated correction and maintenance dosing regimen (front-loading). METHODS: During the correction phase, patients with anemia (hemoglobin < 11.0 g/dL) who had nonmyeloid malignancies and who were receivingchemotherapy were given darbepoetin alfa at a fixed dose of 325 microg (n = 122) or at a weight-based dose of 4.5 microg/kg (n = 120) once weekly until they achieved a hemoglobin concentration > or = 12.0 g/dL. Patients then received darbepoetin alfa (325 microg or 4.5 microg/kg) once every 3 weeks for the remainder of the 16-week treatment period (maintenance phase). RESULTS:Darbepoetin alfa resulted in high Kaplan-Meier rates of hematopoietic response (> or = 2 g/dL increase from the baseline level or a hemoglobin level > or = 12 g/dL) in both the fixed-dose group (86%; 95% confidence interval [95% CI], 78- 94%) and the weight-based dose group (84%; 95% CI, 76-92%). The median time to hematopoietic response was 34 days (95% CI, 28-44 days) for the fixed-dose group and 36 days (95% CI, 30-45 days) for the weight-based dose group. Hemoglobin concentrations were maintained at target levels for up to 16 weeks in both groups. Darbepoetin alfa was well tolerated, and no clinically significant differences between fixed doses and weight-based doses were observed. CONCLUSIONS:Darbepoetin alfa was effective when administered as either a fixed dose or a weight-based dose using a front-loading approach to rapidly correct anemia and effectively maintain hemoglobin levels in patients with anemia who had malignant disease. Copyright 2004 American Cancer Society.
RCT Entities:
BACKGROUND: The effect of using fixed versus weight-based doses for erythropoietic agents has not been reported previously. To investigate this issue, the authors conducted a randomized Phase II study of darbepoetin alfa administered as either a fixed dose or a weight-based dose using an accelerated correction and maintenance dosing regimen (front-loading). METHODS: During the correction phase, patients with anemia (hemoglobin < 11.0 g/dL) who had nonmyeloid malignancies and who were receiving chemotherapy were given darbepoetin alfa at a fixed dose of 325 microg (n = 122) or at a weight-based dose of 4.5 microg/kg (n = 120) once weekly until they achieved a hemoglobin concentration > or = 12.0 g/dL. Patients then received darbepoetin alfa (325 microg or 4.5 microg/kg) once every 3 weeks for the remainder of the 16-week treatment period (maintenance phase). RESULTS: Darbepoetin alfa resulted in high Kaplan-Meier rates of hematopoietic response (> or = 2 g/dL increase from the baseline level or a hemoglobin level > or = 12 g/dL) in both the fixed-dose group (86%; 95% confidence interval [95% CI], 78- 94%) and the weight-based dose group (84%; 95% CI, 76-92%). The median time to hematopoietic response was 34 days (95% CI, 28-44 days) for the fixed-dose group and 36 days (95% CI, 30-45 days) for the weight-based dose group. Hemoglobin concentrations were maintained at target levels for up to 16 weeks in both groups. Darbepoetin alfa was well tolerated, and no clinically significant differences between fixed doses and weight-based doses were observed. CONCLUSIONS: Darbepoetin alfa was effective when administered as either a fixed dose or a weight-based dose using a front-loading approach to rapidly correct anemia and effectively maintain hemoglobin levels in patients with anemia who had malignant disease. Copyright 2004 American Cancer Society.
Authors: Vicente Alberola Candel; Alfredo Carrato Mena; Eduardo Díaz-Rubio García; Pere Gascón Vilaplana; Manuel González Barón; Miguel Martín Jiménez; Emilio Alba Conejo; Javier Cassinello Espinosa; Ramon Colomer; Juan Jesús Cruz Hernández; Agustí Barnadas i Molins; Carlos Camps Herrero; Ana Ma Casas Fernández de Tejerina; Joan Carulla Torrent; Manuel Constenla Figueiras; Joaquin Gavilá Gregori; Ma Dolores Isla Casado; Bartomeu Massuti Sureda; Mariano Provencio Pulla; César Augusto Rodríguez Sánchez; Jaime Sanz Ortiz Journal: Clin Transl Oncol Date: 2009-11 Impact factor: 3.405
Authors: Julia Bohlius; Kurt Schmidlin; Corinne Brillant; Guido Schwarzer; Sven Trelle; Jerome Seidenfeld; Marcel Zwahlen; Mike J Clarke; Olaf Weingart; Sabine Kluge; Margaret Piper; Maryann Napoli; Dirk Rades; David Steensma; Benjamin Djulbegovic; Martin F Fey; Isabelle Ray-Coquard; Volker Moebus; Gillian Thomas; Michael Untch; Martin Schumacher; Matthias Egger; Andreas Engert Journal: Cochrane Database Syst Rev Date: 2009-07-08
Authors: Kay Larholt; Chris L Pashos; Qin Wang; Brahim Bookhart; R Scott McKenzie; Catherine Tak Piech Journal: Clin Drug Investig Date: 2008 Impact factor: 2.859