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A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer.

Smith RE, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J - Br. J. Cancer (2003)

Bottom Line: Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety.Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W.Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

View Article: PubMed Central - PubMed

Affiliation: South Carolina Oncology Associates, 1301 Taylor, Suite 1A, Columbia, SC 29201, USA. rsmith@sconcology.net

ABSTRACT
A multicentre study evaluated the efficacy and safety of darbepoetin alpha administered weekly (QW), every 3 weeks (Q3W), and every 4 weeks (Q4W) to anaemic patients with cancer not concurrently receiving chemotherapy or radiotherapy. The QW portion (n=102) was an open-label, sequential, dose-escalation design; cohorts received darbepoetin alpha QW by subcutaneous (s.c.) injection at 0.5, 1.0, 2.25, or 4.5 micro g kg(-1) week(-1) for 12 weeks. The 12-week placebo-controlled, double-blind Q3W (6.75 micro g kg(-1)) and Q4W (6.75 or 10.0 micro g kg(-1)) schedules (n=86), which enrolled different patients, took place after the QW schedule and were followed by a 12-week, open-label phase. Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety. Selected domains of health-related quality of life (HRQOL) were measured. With QW dosing, at least 70% of each cohort had a haemoglobin increase from baseline of > or =2 g dl(-1) or a concentration > or =12 g dl(-1) (haematopoietic response). In the 4.5 micro g kg(-1) QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (CI)=100, 100). In the Q3W and Q4W schedules, all cohorts had at least 60% of patients who achieved a haematopoietic response. Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W. Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

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Related in: MedlinePlus

Disposition of patients.
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fig1: Disposition of patients.

Mentions: A total of 102 patients in the QW schedule and 86 patients in the Q3W/Q4W schedules (64 darbepoetin alpha and 22 placebo) received at least one dose of study drug (Figure 1Figure 1


A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer.

Smith RE, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J - Br. J. Cancer (2003)

Disposition of patients.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2741110&req=5

fig1: Disposition of patients.
Mentions: A total of 102 patients in the QW schedule and 86 patients in the Q3W/Q4W schedules (64 darbepoetin alpha and 22 placebo) received at least one dose of study drug (Figure 1Figure 1

Bottom Line: Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety.Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W.Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

View Article: PubMed Central - PubMed

Affiliation: South Carolina Oncology Associates, 1301 Taylor, Suite 1A, Columbia, SC 29201, USA. rsmith@sconcology.net

ABSTRACT
A multicentre study evaluated the efficacy and safety of darbepoetin alpha administered weekly (QW), every 3 weeks (Q3W), and every 4 weeks (Q4W) to anaemic patients with cancer not concurrently receiving chemotherapy or radiotherapy. The QW portion (n=102) was an open-label, sequential, dose-escalation design; cohorts received darbepoetin alpha QW by subcutaneous (s.c.) injection at 0.5, 1.0, 2.25, or 4.5 micro g kg(-1) week(-1) for 12 weeks. The 12-week placebo-controlled, double-blind Q3W (6.75 micro g kg(-1)) and Q4W (6.75 or 10.0 micro g kg(-1)) schedules (n=86), which enrolled different patients, took place after the QW schedule and were followed by a 12-week, open-label phase. Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety. Selected domains of health-related quality of life (HRQOL) were measured. With QW dosing, at least 70% of each cohort had a haemoglobin increase from baseline of > or =2 g dl(-1) or a concentration > or =12 g dl(-1) (haematopoietic response). In the 4.5 micro g kg(-1) QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (CI)=100, 100). In the Q3W and Q4W schedules, all cohorts had at least 60% of patients who achieved a haematopoietic response. Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W. Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

Show MeSH
Related in: MedlinePlus