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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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Major and minor erythroid responses during the 13-week test period by IPSS classification. The percentage of patients achieving an erythroid response during the 13-week test period is shown for patients with Low and Intermediate-1 (Int-1) IPSS classifications, and stratified by prior ESA treatment status. IPSS, International Prognostic Scoring System; ESA, erythropoiesis-stimulating agent; CL, confidence limit.
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fig05: Major and minor erythroid responses during the 13-week test period by IPSS classification. The percentage of patients achieving an erythroid response during the 13-week test period is shown for patients with Low and Intermediate-1 (Int-1) IPSS classifications, and stratified by prior ESA treatment status. IPSS, International Prognostic Scoring System; ESA, erythropoiesis-stimulating agent; CL, confidence limit.

Mentions: For patients classified as low risk according to the IPSS, the crude percentage (95% CL) that experienced major erythroid responses during the 13-week test period was 55% (45, 65) for ESA-naïve patients and 32% (18, 46) for prior ESA-treated patients. Patients classified in the Intermediate-1 IPSS risk class had lower rates of response [32% (18, 46) for ESA-naïve and 14% (0, 33) for prior ESA-treated] (Fig 5).


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)

Major and minor erythroid responses during the 13-week test period by IPSS classification. The percentage of patients achieving an erythroid response during the 13-week test period is shown for patients with Low and Intermediate-1 (Int-1) IPSS classifications, and stratified by prior ESA treatment status. IPSS, International Prognostic Scoring System; ESA, erythropoiesis-stimulating agent; CL, confidence limit.
© Copyright Policy
Related In: Results  -  Collection

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

fig05: Major and minor erythroid responses during the 13-week test period by IPSS classification. The percentage of patients achieving an erythroid response during the 13-week test period is shown for patients with Low and Intermediate-1 (Int-1) IPSS classifications, and stratified by prior ESA treatment status. IPSS, International Prognostic Scoring System; ESA, erythropoiesis-stimulating agent; CL, confidence limit.
Mentions: For patients classified as low risk according to the IPSS, the crude percentage (95% CL) that experienced major erythroid responses during the 13-week test period was 55% (45, 65) for ESA-naïve patients and 32% (18, 46) for prior ESA-treated patients. Patients classified in the Intermediate-1 IPSS risk class had lower rates of response [32% (18, 46) for ESA-naïve and 14% (0, 33) for prior ESA-treated] (Fig 5).

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