Epoetin alfa 80,000 U Every Three Weeks (Q3W) in Anemic Cancer Patients (pts) Not Receiving Chemotherapy (CT) or Radiation Therapy (RT).

Anemia is reported at rates approaching 40% in cancer pts not receiving CT or RT. In two previous studies in anemic cancer pts not receiving CT or RT, epoetin alfa administered at 40,000 U sc once weekly¹ or 60,000 U sc every two weeks² was shown to be both safe and effective (hematopoietic response [HR] rates of 76.9% and 76.8%, respectively) in treating anemia. The primary objective of the current study was to evaluate the HR to epoetin alfa 80,000 U SC Q3W in this population; transfusions and quality of life were evaluated as well. Eligible pts had a non-myeloid malignancy, baseline hemoglobin (Hb) ≤ 11 g/dL, no CT administration within 8 weeks or RT within 4 weeks of study entry, and no plans to receive these therapies during the study period. Study drug was to be administered at Weeks 1, 4, 7, and 10, with follow-up continuing to Week 13. Epoetin alfa dose was reduced for Hb > 12 g/dL or Hb increase > 1.5 g/dL in any 3-week period; dose was withheld for Hb > 13 g/dL, then reduced when Hb ≤ 12 g/dL. All pts were to receive supplemental ferrous sulfate 325 mg po qd as tolerated. The primary efficacy endpoint was the proportion of pts achieving HR, defined as a ≥ 2 g/dL Hb increase and/or Hb ≥ 12 g/dL during the study, independent of transfusion within 28 days. 51 pts were enrolled (safety population) and 49 met the criteria for efficacy analyses (received ≥ 1 dose of epoetin alfa and had ≥ 1 post-baseline Hb value). Mean age was 71.0 ± 10.5 years, 53% of pts were female, 94% of pts had baseline ECOG status of 0 or 1, and mean baseline Hb was 10.3 ± 0.6 g/dL. The most common tumor types were breast (n=12, 24.5%) and prostate (n=12, 24.5%). HR was achieved in 37/49 (75.5%) pts. Mean time to first HR was 5.76 weeks. Hb change from baseline ≥ 1 g/dL was achieved in 39/49 (79.6%) pts, in a mean 3.77 weeks. 24 of 51 pts (47.1%) had at least one dose reduction or withhold. From Day 29 to end of study, 2/49 (4.1%) pts received PRBC transfusion. Statistically significant quality of life improvements from baseline in all 3 LASA scales (Energy Level, Daily Activities, and overall Quality of Life) were noted at Weeks 7 and 13/WD. Improvements were also seen with the FACT-An subscales, although not all changes were statistically significant at Weeks 7 and 13/WD. Adverse events occurring in ≥ 5% of the safety population were arthralgia (5 of 51 pts, 9.8%), back pain (3 of 51 pts, 5.9%), and vomiting (3 of 51 pts, 5.9%). One non-clinically relevant thrombotic vascular event of chest pain was reported. One pt died during the study, and 2 pts died during study follow-up; all deaths were considered unrelated to epoetin alfa therapy. In this population of cancer pts with anemia not receiving CT or RT, epoetin alfa 80,000 U sc administered Q3W safely increases Hb and improves pt quality of life. This extended dosing regimen further expands the flexible dosing options for epoetin alfa in this pt population.