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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

Proportion of patients with haematopoietic response.
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fig2: Proportion of patients with haematopoietic response.

Mentions: Change from baseline calculated using last available haemoglobin value not within 28 days of a transfusion (imputed analysis), and for patients with haemoglobin value at week 13 not within 28 days of a transfusion (alternate analysis). QW=once weekly; Q3W=once every 3 weeks; Q4W=once every 4 weeks; N=number in cohort; CI=confidence interval; RBC=red blood cell; EOTP=end of treatment period; n=number in subset; NE=not estimable (median not reached).


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)

Proportion of patients with haematopoietic response.
© Copyright Policy
Related In: Results  -  Collection

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

fig2: Proportion of patients with haematopoietic response.
Mentions: Change from baseline calculated using last available haemoglobin value not within 28 days of a transfusion (imputed analysis), and for patients with haemoglobin value at week 13 not within 28 days of a transfusion (alternate analysis). QW=once weekly; Q3W=once every 3 weeks; Q4W=once every 4 weeks; N=number in cohort; CI=confidence interval; RBC=red blood cell; EOTP=end of treatment period; n=number in subset; NE=not estimable (median not reached).

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