Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level <10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial.
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Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level <10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. / Vansteenkiste, Johan; Hedenus, Michael; Gascon, Pere; Bokemeyer, Carsten; Ludwig, Heinz; Vermorken, Jan; Hamilton, Lisa; Bridges, Ken; Pujol, Beatriz.
In: BMC CANCER, Vol. 9, 2009, p. 311.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level <10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial.
AU - Vansteenkiste, Johan
AU - Hedenus, Michael
AU - Gascon, Pere
AU - Bokemeyer, Carsten
AU - Ludwig, Heinz
AU - Vermorken, Jan
AU - Hamilton, Lisa
AU - Bridges, Ken
AU - Pujol, Beatriz
PY - 2009
Y1 - 2009
N2 - ABSTRACT: BACKGROUND: Several studies have shown that darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), can reduce transfusions and increase hemoglobin (Hb) levels in patients with chemotherapy-induced anemia (CIA). Recent safety concerns, however, have prompted changes to ESA product information. In the European Union and United States, ESA therapy initiation for CIA is now recommended at a Hb level or = 10 g/dL baseline-Hb group (14% vs 21%) compared with the or = 10 g/dL baseline-Hb group, but not the or = 11 g/dL. The Kaplan-Meier estimate of percentage of patients (Q3W vs QW) who achieved Hb > or = 11 g/dL from week 1 to EOTP was 90% vs 85% in the > or = 10 g/dL baseline-Hb group and 54% vs 57% in the or = 10 g/dL baseline-Hb group reached the threshold Hb of > or = 13 g/dL. CONCLUSION: In this exploratory analysis, darbepoetin alfa Q3W and QW raised Hb levels and maintained mean Hb at or = 10 g/dL baseline-Hb group had fewer transfusions and faster anemia correction. Additional studies should prospectively evaluate the relationship between Hb levels at ESA initiation and outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00118638.
AB - ABSTRACT: BACKGROUND: Several studies have shown that darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), can reduce transfusions and increase hemoglobin (Hb) levels in patients with chemotherapy-induced anemia (CIA). Recent safety concerns, however, have prompted changes to ESA product information. In the European Union and United States, ESA therapy initiation for CIA is now recommended at a Hb level or = 10 g/dL baseline-Hb group (14% vs 21%) compared with the or = 10 g/dL baseline-Hb group, but not the or = 11 g/dL. The Kaplan-Meier estimate of percentage of patients (Q3W vs QW) who achieved Hb > or = 11 g/dL from week 1 to EOTP was 90% vs 85% in the > or = 10 g/dL baseline-Hb group and 54% vs 57% in the or = 10 g/dL baseline-Hb group reached the threshold Hb of > or = 13 g/dL. CONCLUSION: In this exploratory analysis, darbepoetin alfa Q3W and QW raised Hb levels and maintained mean Hb at or = 10 g/dL baseline-Hb group had fewer transfusions and faster anemia correction. Additional studies should prospectively evaluate the relationship between Hb levels at ESA initiation and outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00118638.
U2 - 10.1186/1471-2407-9-311
DO - 10.1186/1471-2407-9-311
M3 - SCORING: Zeitschriftenaufsatz
VL - 9
SP - 311
JO - BMC CANCER
JF - BMC CANCER
SN - 1471-2407
ER -
