A phase 2 study to evaluate the efficacy of darbepoetin-alfa administered using an extended dose schedule versus weekly dosing in cancer patients with chemotherapy-induced anemia
| Autor: | Tom Lillie, L. Yee, Ronald Burkes, Peter T. Silberstein, Timothy Rearden, Lee S. Schwartzberg, B. Mirtsching, Veena Charu, H. Lam |
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| Rok vydání: | 2007 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 25:19501-19501 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 19501 Background: Chemotherapy-induced anemia (CIA) can be effectively treated with darbepoetin alfa (DA) using different dosing schedules. Since chemotherapy (CTX) regimens involve various dosing schedules, the ability to synchronize DA dose with CTX could be beneficial. Methods: This phase 2, 25-week (wk), randomized, open-label study compares the efficacy and safety of DA administered using an extended dose schedule (EDS) (every 2 wks [Q2W] or every 3 wks [Q3W]) vs weekly (QW) dosing in patients (pts) with CIA. Pts were randomly assigned to receive DA EDS (either 300 mcg Q2W [with CTX QW, Q2W, or Q4W] or 500 mcg Q3W [with CTX Q3W]) vs 150 mcg DA QW (with CTX QW, Q2W, Q3W, or Q4W). Randomization was stratified by length of CTX cycle, screening hemoglobin (Hb) (< 10 vs = 10 g/dL), and type of cancer (lung/gynecological vs other cancers). The primary endpoint was the change in Hb from baseline (BL) to wk 13; other endpoints included the change in Hb from BL to end of study (EOS), percentage of pts with = 1 transfusion (TFN) from BL to wk 13 and EOS, and safety. Results: Final data for the total 25-wk study period will be presented. Results from a planned interim analysis for all pts who were enrolled in the study and received = 1 dose of DA (n = 752) are shown for wk 13 endpoints (Table). The groups had similar mean change in Hb from BL to wk 13, with a difference (QW minus EDS) (95% CL) of 0.2 (-0.1, 0.4) g/dL. The % pts who achieved target Hb were also similar (difference [95% CL] = 0 [-7, 6]). At the time of the interim analysis, the incidence and types of adverse events were similar between the groups. Ten (3%) EDS and 15 (4%) QW pts had thromboembolic events, 5 (1%) EDS and 2 (1%) QW pts had cerebrovascular accidents, and 19 (5%) EDS and 22 (6%) QW pts had died. Conclusions: This is the first trial synchronizing DA dosing (Q2W and Q3W) with CTX schedules. The interim results suggest that DA administered once per CTX cycle is well-tolerated and efficacious in these patients. [Table: see text] No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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