Biosimilar Epoetin Alfa Improves Both Hemoglobin Levels and Quality of Life

Anemia is a common complication for patients who are undergoing chemotherapy, and one that has implications for patients’ quality of life, especially with respect to fatigue. During the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, Jérôme Desrame, MD, reported on results of the CIROCO study, which assessed fatigue in patients with chemotherapy-induced anemia who were treated with biosimilar epoetin alfa.

The CIROCO study, funded by Sandoz, is a noninterventional, prospective, multicenter study of 538 adult patients who had 2 or more planned cycles of chemotherapy. The patients all had chemotherapy-induced anemia, and were receiving Sandoz’s biosimilar epoetin alfa (approved in the European Union under the brand names Epoetin Alfa Hexal, Abseamed, and Binocrit). Data were collected at inclusion, after a 2- to 3-month follow-up period, and after 4 to 6 cycles of chemotherapy.

Patients and their physicians separately assessed fatigue using a visual analogue scale (VAS) on a scale of 0 to 10; additionally, patients assessed their quality of life using the European Organization for the Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ C30).

Desrame and colleagues reported data for the subgroup of 434 patients with solid tumors. At baseline, mean hemoglobin was 9.7 (±0.8) g/dL. The mean increase in hemoglobin was 1.2 (±1.4) g/dL at 2 to 3 months of followup, and 0.4 (±1.5) g/dL after 4 to 6 cycles of chemotherapy.

In the safety population of 464 patients, 32.5% had adverse events (AEs) and 13.8% had serious AEs. However, only 3% of patients had AEs that were considered related to the study treatment.

In the full-analysis set population, between the 2- to 3-month follow-up measurement and the 4- to 6-cycle of chemotherapy measurement, the mean change in fatigue VAS score as reported by the patients was 5.2% (±92.6). The mean change in EORTC QLQ C30 score was 29.9 % (±98.0). Using the fatigue VAS, the physician assessment of fatigue was consistent with patient perceptions at all measurement timepoints.

The researchers concluded that biosimilar epoetin alfa was effective in treating these patients’ anemia, with improvements demonstrated in both hemoglobin levels and quality of life measurements.

Reference

Desrame J, et al. Correlation between fatigue evaluated with a visual analog scale (VAS) and quality of life (QoL) in cancer patients treated with biosimilar epoetin alfa for chemotherapy-induced anemia (CIA): the CIROCO study. Presented at the European Society for Medical Oncology (ESMO) 2018 Congress, October 19-23, 2018; Munich, Germany. Abstract 1790P. https://cslide.ctimeetingtech.com/esmo2018/attendee/confcal/show/session/258.