Results demonstrated that PROCRIT® therapy reduced the proportion of patients transfused in day 29 through week 16 of the study as compared to placebo. Twenty-five patients (14%) in the PROCRIT® group received transfusions compared to 48 patients (28%) in the placebo group (p = 0.0010) between day 29 and week 16 or the last day on study.

Comparable intensity of chemotherapy for patients enrolled in the two study arms was suggested by similarities in mean dose and frequency of administration for the 10 most commonly administered chemotherapy agents, and similarity in the incidence of changes in chemotherapy during the trial in the two arms.

Pediatric Patients

The safety and effectiveness of PROCRIT® were evaluated in a randomized, double ­blind, placebo-controlled, multicenter study in anemic patients ages 5 to 18 receiving chemotherapy for the treatment of various childhood malignancies. Two hundred twenty-two patients were randomized (1:1) to PROCRIT® or placebo. PROCRIT® was administered at 600 Units/kg (maximum 40,000 Units) intravenously once per week for 16 weeks. If hemoglobin had not increased by 1g/dL after the first 4-5 weeks of therapy, PROCRIT® was increased to 900 Units/kg (maximum 60,000 Units). Among the PROCRIT®-treated patients 60% required dose escalation to 900 Units/kg/week.

The effect of PROCRIT® on transfusion requirements is shown in the table below:

Percentage of Patients Transfused

There was no evidence of an improvement in health-related quality of life, including no evidence of an effect on fatigue, energy or strength, in patients receiving PROCRIT® as compared to those receiving placebo.

Surgery Patients

PROCRIT® has been studied in a placebo-controlled, double-blind trial enrolling 316 patients scheduled for major, elective orthopedic hip or knee surgery who were expected to require ≥ 2 units of blood and who were not able or willing to participate in an autologous blood donation program. Based on previous studies which demonstrated that pretreatment hemoglobin is a predictor of risk of receiving transfusion,^19,26 patients were stratified into one of three groups based on their pretreatment hemoglobin [ ≤ 10 (n = 2), > 10 to 13 (n = 96), and > 13 to ≤ 15 g/dL (n = 218)] and then randomly assigned to receive 300 Units/kg PROCRIT® , 100 Units/kg PROCRIT® or placebo by SC injection for 10 days before surgery, on the day of surgery, and for 4 days after surgery.¹⁷ All patients received oral iron and a low-dose post-operative warfarin regimen.¹⁷

Treatment with PROCRIT® 300 Units/kg significantly (p = 0.024) reduced the risk of allogeneic transfusion in patients with a pretreatment hemoglobin of > 10 to ≤ 13; 5/31 (16%) of PROCRIT® 300 Units/kg, 6/26 (23%) of PROCRIT® 100 Units/kg, and 13/29 (45%) of placebo-treated patients were transfused.¹⁷ There was no significant difference in the number of patients transfused between PROCRIT® (9% 300 Units/kg, 6% 100 Units/kg) and placebo (13%) in the > 13 to ≤ 15 g/dL hemoglobin stratum. There were too few patients in the ≤ 10 g/dL group to determine if PROCRIT® is useful in this hemoglobin strata. In the > 10 to ≤ 13 g/dL pretreatment stratum, the mean number of units transfused per PROCRIT®-treated patient (0.45 units blood for 300 Units/kg, 0.42 units blood for 100 Units/kg) was less than the mean transfused per placebo-treated patient (1.14 units) (overall p = 0.028). In addition, mean hemoglobin, hematocrit, and reticulocyte counts increased significantly during the presurgery period in patients treated with PROCRIT®.¹⁷

Bookmark this page: