Phase III Study of Two Different Dosing Schedules of Erythropoietin in Anemic Patients With Cancer

Abstract

After three weekly doses of epoetin alfa 40,000 U, a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL. The Hb increment is somewhat greater with continued weekly epoetin alfa. Lack of blinding as a result of different treatment schedules may have confounded results.

An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy

“…In a small pilot study in anemic patients receiving chemotherapy, epoetin alfa at an initial dosage regimen of 60,000 U SC QW, followed by a maintenance regimen of 120,000 U SC every 3 weeks (Q3W), increased and maintained Hb levels and resulted in low transfusion requirements [21]. A recent study conducted by Steensma et al [31] compared transfusion requirements, Hb levels, and quality of life for two epoetin alfa dosage regimens (three doses of 40,000 U SC QW followed by 18 additional weeks of either 40,000 U SC QW or 120,000 U SC Q3W). The authors reported that efficacy results were similar for the two regimens in terms of transfusion requirements and quality of life, although mean Hb change during the study was slightly higher in the group receiving 40,000 U SC QW throughout compared with the group receiving 120,000 U SC Q3W (1.8 vs 1.4 g/dl, respectively) [31].…”

A randomized comparison of once weekly epoetin alfa to extended schedule epoetin or darbepoetin in chemotherapy‐associated anemia

“…A CONSORT flow diagram is displayed in Fig. 1; 62% of enrolled patients completed all study interventions, similar to prior ESA studies in the CAA population [15,24].…”

“…Because the contracted cost for DA and EA varies from site to site, no direct economic comparison of EA to DA in the schedules used in this trial was possible. An induction phase of weekly EA followed by less frequent maintenance dosing once a Hb increment is achieved, as previously reported [15], might allow maintenance of Hb levels above the range associated with need for RBC transfusion requirements, while using lower total EA doses and a more convenient patient schedule. It is also possible that extended schedules of DA longer than once every 3 weeks might be effective, and this could be tested in future studies.…”

“…In a previous cooperative group study (N02C2), we had compared maintenance EA administered once every 3 weeks with continued weekly EA in the CAA setting [15]. In that study, 365 patients received three weekly SC doses of EA 40,000 U, and were then randomized 1:1 to receive either standard weekly EA 40,000 or 120,000 U of EA every 3 weeks for 18 additional weeks.…”

“…However, a previous cooperative group study of the North Central Cancer Treatment Group (NCCTG) suggested that EA can also be given less often than the FDAapproved once weekly schedule with similar results [15]. In addition, a nonhuman primate study suggested EA could be given every 2 weeks with comparable erythropoietic benefit to more frequent dosing, and a human pilot study suggested that every 3 week dosing of EA might be effective as a maintenance strategy after an initial period of weekly dosing [16,17].…”