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Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes.

Gabrilove J, Paquette R, Lyons RM, Mushtaq C, Sekeres MA, Tomita D, Dreiling L - Br. J. Haematol. (2008)

Bottom Line: Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters.Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported.In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Mt Sinai School of Medicine, New York, NY 10029, USA. janice.gabrilove@mssm.edu

ABSTRACT
Patients with myelodysplastic syndromes (MDS) often develop anaemia resulting in frequent transfusions and fatigue. Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia. This single-arm, phase 2 study examined the efficacy of darbepoetin alfa 500 microg every 3 weeks (Q3W) for treating anaemia in low-risk MDS patients (after 6 weeks, poor responders received darbepoetin alfa 500 microg every 2 weeks). The primary end-point was the incidence of erythroid responses (International Working Group criteria) after 13 weeks of therapy. Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters. Analyses were stratified by the patient's previous ESA therapy status [ESA-naïve (n = 144) vs. prior ESA-treated (n = 62)]. After 13 weeks of therapy, 49% of ESA-naïve patients and 26% of prior ESA-treated patients achieved a major erythroid response. After 53/55 weeks, 59% of ESA-naïve patients and 34% of prior ESA-treated patients achieved a major erythroid response; 82% of ESA-naïve patients and 55% of prior ESA-treated patients achieved target haemoglobin of 110 g/l. Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported. In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

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Change in haemoglobin from baseline to week 53/55. Data are presented from an analysis using the last-value-carried-forward (LVCF) approach and from an analysis using available data. The mean change in haemoglobin is shown by baseline haemoglobin category. Error bars indicate the upper and lower 95% CL. ESA, erythropoiesis-stimulating agent; CL, confidence limit.
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fig04: Change in haemoglobin from baseline to week 53/55. Data are presented from an analysis using the last-value-carried-forward (LVCF) approach and from an analysis using available data. The mean change in haemoglobin is shown by baseline haemoglobin category. Error bars indicate the upper and lower 95% CL. ESA, erythropoiesis-stimulating agent; CL, confidence limit.

Mentions: The mean baseline haemoglobin concentrations for ESA-naïve and prior ESA-treated patients are presented in Table I. Using the LVCF approach to impute missing values, the mean (95% CL) change in haemoglobin concentration from baseline to week 53/55 was 11 g/l (8, 13) in ESA-naïve patients and 3 g/l (−2, 8) in prior ESA-treated patients (Fig 4). Using the available data approach, the mean (95% CL) change in haemoglobin to week 53/55 was 14 g/l (11, 18) for ESA-naïve patients (n = 68) and 16 g/l (9, 22) for prior ESA-treated patients (n = 9).


Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes.

Gabrilove J, Paquette R, Lyons RM, Mushtaq C, Sekeres MA, Tomita D, Dreiling L - Br. J. Haematol. (2008)

Change in haemoglobin from baseline to week 53/55. Data are presented from an analysis using the last-value-carried-forward (LVCF) approach and from an analysis using available data. The mean change in haemoglobin is shown by baseline haemoglobin category. Error bars indicate the upper and lower 95% CL. ESA, erythropoiesis-stimulating agent; CL, confidence limit.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2654479&req=5

fig04: Change in haemoglobin from baseline to week 53/55. Data are presented from an analysis using the last-value-carried-forward (LVCF) approach and from an analysis using available data. The mean change in haemoglobin is shown by baseline haemoglobin category. Error bars indicate the upper and lower 95% CL. ESA, erythropoiesis-stimulating agent; CL, confidence limit.
Mentions: The mean baseline haemoglobin concentrations for ESA-naïve and prior ESA-treated patients are presented in Table I. Using the LVCF approach to impute missing values, the mean (95% CL) change in haemoglobin concentration from baseline to week 53/55 was 11 g/l (8, 13) in ESA-naïve patients and 3 g/l (−2, 8) in prior ESA-treated patients (Fig 4). Using the available data approach, the mean (95% CL) change in haemoglobin to week 53/55 was 14 g/l (11, 18) for ESA-naïve patients (n = 68) and 16 g/l (9, 22) for prior ESA-treated patients (n = 9).

Bottom Line: Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters.Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported.In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Mt Sinai School of Medicine, New York, NY 10029, USA. janice.gabrilove@mssm.edu

ABSTRACT
Patients with myelodysplastic syndromes (MDS) often develop anaemia resulting in frequent transfusions and fatigue. Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia. This single-arm, phase 2 study examined the efficacy of darbepoetin alfa 500 microg every 3 weeks (Q3W) for treating anaemia in low-risk MDS patients (after 6 weeks, poor responders received darbepoetin alfa 500 microg every 2 weeks). The primary end-point was the incidence of erythroid responses (International Working Group criteria) after 13 weeks of therapy. Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters. Analyses were stratified by the patient's previous ESA therapy status [ESA-naïve (n = 144) vs. prior ESA-treated (n = 62)]. After 13 weeks of therapy, 49% of ESA-naïve patients and 26% of prior ESA-treated patients achieved a major erythroid response. After 53/55 weeks, 59% of ESA-naïve patients and 34% of prior ESA-treated patients achieved a major erythroid response; 82% of ESA-naïve patients and 55% of prior ESA-treated patients achieved target haemoglobin of 110 g/l. Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported. In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

Show MeSH
Related in: MedlinePlus