Evaluation of clinical use and effectiveness of darbepoetin alfa in cancer patients with chemotherapy-induced anemia.

PURPOSE

To investigate the patterns of use of darbepoetin alfa in Spanish centers, and to evaluate its effectiveness in the treatment of chemotherapy-induced anemia under clinical practice conditions.

METHODS

This was an observational, retrospective, multicenter study in adult patients with non-myeloid malignancies who initiated chemotherapy and darbepoetin alfa. Data was collected for up to 16 weeks or until treatment discontinuation.

RESULTS

A total of 685 patients (72.7% with solid tumors and 27.3% with hematologic malignancies) were included in the study. Median age was 64.7 years (range 18.5-88.9 years), 50.7% were women, 82.4% had ECOG status 0-1 and 80.5% had stage III/IV cancer. At darbepoetin initiation, mean hemoglobin (Hb) was 100 g/L (SD 10), with 11.0% and 23.1% of patients below 90 g/L in solid and hematologic malignancies, respectively. A decrease in transfusion requirements was observed between weeks 5-16 with respect to weeks 0-16 (13.3% [95% CI: 10.7 to 15.9] versus 19.0% [95% CI: 16.0 to 22.0]). Hb levels were significantly increased during the treatment (mean change of 10.4 g/L for solid tumors [p < 0.001], and 16.6 g/L for hematologic malignancies [p < 0.001]). The percentage of patients with baseline Hb level <110 g/L who achieved an Hb level ≥110 g/L during the study was 66.5% (95% CI: 62.5% to 70.5%). Six serious adverse reactions were considered related to darbepoetin alfa (thromboembolic events, 1.0%).

CONCLUSIONS

With the limitation of a retrospective design, our results suggest that darbepoetin alfa is a well tolerated treatment that increases hemoglobin levels and reduces the need for transfusion in cancer patients receiving chemotherapy in clinical practice.