Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double‐blind, placebo‐controlled study

Abstract

Summary. This phase 3, randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Patients (n ¼ 344) with lymphoma or myeloma received darbepoetin alfa 2AE25 lg/ kg or placebo s.c., once weekly for 12 weeks. The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group (60%) than in the placebo group (18%) (P < 0AE001), regardless of baseline endogenous erythropoietin level. However, increased responsiveness was observed in patients with lower baseline erythropoietin levels. Darbepoetin alfa also resulted in higher mean changes in haemoglobin than placebo from baseline to the last value during the treatment phase (1AE80 g/dl vs 0AE19 g/dl) and after 12 weeks of treatment (2AE66 g/dl vs 0AE69 g/dl). A significantly lower percentage of patients in the darbepoetin alfa group received red blood cell transfusions than in the placebo group (P < 0AE001). The efficacy of darbepoetin alfa was consistent for patients with lymphoma or myeloma. Improvements in quality of life were also observed with darbepoetin alfa. The overall safety profile of darbepoetin alfa was consistent with that expected for this patient population. Darbepoetin alfa significantly increased haemoglobin and reduced red blood cell transfusions in patients with lymphoproliferative malignancies receiving chemotherapy.

Correction of anaemia through the use of darbepoetin alfa improves chemotherapeutic outcome in a murine model of Lewis lung carcinoma

“…As the EpoR is redundant on the tumour cells, this verifies that the correction of anaemia is the explanation for the increased therapeutic outcome. This paper supports the reports from long-term follow-up in darbepoetin clinical trials that indicate no tumour-promoting or detrimental effect of darbepoetin on survival in patients with cancer (Vansteenkiste et al, 2002;Hedenus et al, 2003).…”

Efficacy and Safety of Every-2-Week Darbepoetin Alfa in Patients with Anemia of Cancer: A Controlled, Randomized, Open-Label Phase II Trial

“…The study was designed to enroll approximately 1,000 patients to detect a 23%-35% reduction in the mean number of days hospitalized in the darbepoetin alfa group compared with the observation group [13,18]. Because there were few AOC studies on which to base our estimations, we based our calculations on data available from patients with chemotherapy-induced anemia [13,18].…”

“…Because there were few AOC studies on which to base our estimations, we based our calculations on data available from patients with chemotherapy-induced anemia [13,18]. In previous phase II studies in this population, approximately 20% of the darbepoetin alfa-treated patients were hospitalized in each study, with a mean duration of stay across studies of approximately 2 days, and with a standard deviation of 5-6 days.…”

Iron Deficiency Anemia in Cancer Patients

“…However, several studies have reported a possibly decreased survival in cancer patients receiving ESAs, [32][33][34][35][36] and therefore physicians are advised to only administer ESAs to patients with cancer-related anemia during chemotherapy. There is conflicting evidence from five meta-analyses examining the mortality risk with the use of ESAs, with three studies indicating an increased risk [37][38][39] and two studies indicating no effect on mortality or disease progression.…”