Anemia often occurs in cancer patients receiving chemotherapy. QoL can be affected by symptoms of anemia, fatigue being the most common. Evaluation of QoL with validated tools (eg EORTC QLQ C30) is time-consuming. Correlation between fatigue assessed with a VAS and QoL is unclear. Aim: To determine the correlation between fatigue assessed by a VAS and QoL in cancer patients treated with biosimilar epoetin alfa (Sandoz) for CIA.
CIROCO is a non-interventional, prospective, multicenter study of adult patients (Full Analysis Set [FAS] population, n = 538) with ≥2 cycles of chemotherapy planned after study inclusion, with CIA and receiving biosimilar epoetin alfa. Data were collected on day of inclusion (T0), and after 2–3 (follow-up; T1) and 4–6 chemotherapy cycles (end of follow-up; T2). Patients and physicians separately assessed fatigue using a VAS (range 0–10); patients assessed QoL with the EORTC QLQ C30 questionnaire.
Data are reported for a subgroup of patients with solid tumors (FAS population, n = 434). Mean (SD) hemoglobin (Hb) at baseline was 9.7 (±0.8) g/dL. Mean (SD) increase in Hb was 1.2 (±1.4) g/dL between T0 and T1 and 0.4 (±1.5) g/dL between T1 and T2. In the safety population (n = 464), 151 (32.5%) had adverse events (AEs; n = 320), 64 patients (13.8%) had serious AEs (n = 144) and 14 patients (3%) experienced AEs considered related to study treatment (n = 25). In the FAS population, between T0 and T2, mean (SD) change in fatigue VAS score (patient-reported) was +5.2 (±92.6) % and mean (SD) change in QoL was 29.9 (±98.0) %. The Pearson correlation coefficient for fatigue VAS score and QoL was –0.4993 (p < 0.0001) at T0, –0.5726 (p < 0.0001) at T1, and –0.5681 (p < 0.0001) at T2. Using fatigue VAS, physician assessment of fatigue was consistent with patient perceptions at T0 (5.0±2.1 vs 5.3±2.2), T1 (4.3±2.2 vs 4.8±2.3) and T2 (4.2±2.3 vs 4.7±2.3).
Biosimilar epoetin alfa was effective in this study, with improvements observed in Hb and QoL. A correlation was observed between reduced fatigue assessed with a VAS and improved QoL.
Clinical trial identification
Legal entity responsible for the study
Tony Reardon, Spirit Medical Communications Ltd.
N. Baize: Steering Committee member: CIROCO study. All other authors have declared no conflicts of interest.