Early Stage Pts Research Articles

18568 Background: Cancer patients (pts) often develop chemotherapy-induced anemia (CIA), resulting in increased transfusion incidence and fatigue. Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent that can reduce the incidence of transfusions, increase hemoglobin (Hb) levels to a range of 11 to 13 g/dL (as recommended by evidence-based guidelines), and decrease fatigue in pts with CIA. The 74-hour half-life of DA allows it to be effectively administered weekly (QW), every 2 weeks (Q2W), or every 3 weeks (Q3W). DA treatment can also be synchronized with chemotherapy (Glaspy et al., 2005). Here we examined if the efficacy and safety of DA for treating CIA is affected by the disease stage of the pt. Methods: Eight clinical trials (including single-arm, active-controlled, and placebo-controlled studies) were analyzed that described the administration of DA QW (2 studies), Q2W (3 studies), or Q3W (3 studies) to pts with CIA. Tumor-Nodes-Metastases (TNM) classification was used to define disease stage of I, II, III, or IV. A clinically meaningful endpoint evaluated was the proportion of pts achieving a target Hb of ≥ 11 g/dL. Other endpoints included incidence of transfusions, change in FACT-F score at end of study from baseline, and incidence of adverse events. Results: A high percentage of pts in all disease stages achieved a target Hb of ≥ 11 g/dL in response to DA treatment (see Table ). Early stage pts were seen to benefit at least as much as later stage pts. A similar trend was seen for the other efficacy and safety endpoints (data will be presented). Conclusions: The present analysis suggests that DA administered QW, Q2W, or Q3W can effectively correct anemia when administered to pts in either early or late disease stages. The potential to synchronize DA treatment and chemotherapy regardless of disease stage may increase pt convenience by reducing the number of clinic visits. [Table: see text] [Table: see text]

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