EOTP = end of trial period; QW = once weekly.
Data from a randomized, double-blind, placebo-controlled trial of 314 patients with hemoglobin (Hb) ≤ 11 g/dL who had lung cancer and were receiving platinum-containing chemotherapy. Patients received once-weekly treatment with either Aranesp® (2.25 mcg/kg) or placebo, administered by subcutaneous injection, for up to 12 weeks. Per the pivotal trial protocol, doses were withheld if Hb exceeded 14 g/dL in women or 15 g/dL in men—the P value is based on Kaplan-Meier (K-M) proportions.1,2
Adverse reactions were based on data from a randomized, double-blind, placebo-controlled study of Aranesp in 597 patients (Aranesp 301, placebo 296) with extensive-stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. Patients received Aranesp at a dose of 300 mcg or placebo weekly for 4 weeks, then every 3 weeks for a total of 24 weeks, and the median duration of exposure was 19 weeks (range: 1 to 26 weeks).
Adverse reactions were also based on data from 7 randomized, double-blind, placebo-controlled studies, including the SCLC study described above, that enrolled 2,112 patients (Aranesp 1,203, placebo 909) with non-myeloid malignancies. Dosing and schedules varied by study from once weekly to once every 4 weeks, and the median duration of exposure was 12 weeks (range: 1 to 27 weeks).
In addition to the thrombovascular adverse reactions, abdominal pain and edema occurred at a higher incidence in patients taking Aranesp compared to patients on placebo. Among all placebo-controlled studies, abdominal pain (13.2% vs 9.4%) and edema (12.8% vs 9.7%) were reported more frequently in patients receiving Aranesp compared to the placebo group. In the SCLC study, the incidence of abdominal pain (10.3% vs 3.4%) and edema (5.6% vs 5.1%) in the Aranesp-treated patients compared to those receiving placebo.