Cancer pts with CIA may experience decreased quality of life (QOL) and may require red blood cell transfusions (TFNs). DA increases hemoglobin (Hb) to levels recommended by practice guidelines (11 to 13g/dL), thereby reducing TFN requirements and improving QOL. With chemotherapy (CTX) regimens involving various dosing intervals, being able to synchronize DA dose with CTX could be beneficial. This ongoing phase 2, 25-wk, randomized, open-label, multicenter trial compares the efficacy of DA extended dosing schedule (EDS) administration (every 2 wks [Q2W] or every 3 wks [Q3W]) with DA administered weekly (QW) in pts with CIA. Eligible pts were ≥18 years, had nonmyeloid malignancies, were anemic (Hb<11.0g/dL), and were scheduled to receive ≥8 additional wks of CTX administered QW, Q2W (including every 4 wks [Q4W] with visits Q2W), or Q3W. Pts were randomized in a 1:1 ratio to EDS or QW stratified by length of CTX cycle, screening Hb (<10 vs ≥10g/dL), and tumor type (lung/gynecological vs other nonmyeloid malignancies). Pts in the QW arm received DA 150mcg QW regardless of CTX schedule. Pts in the EDS arm received DA either 300mcg Q2W (with QW or Q2W CTX) or 500mcg Q3W. The primary endpoint was change in Hb from baseline (BL) to wk 13; other endpoints included percentage of pts with ≥1 TFN from BL to wk 13, change in pt-reported outcomes (including Functional Assessment of Cancer Therapy-Fatigue [FACT-F]), and safety. This planned interim analysis presents wk 13 data for pts (n=487 of 750 planned) who were randomized on or before January 23, 2006 and could complete ≥13 wks on study. Patient characteristics and efficacy were similar between the 2 groups (Table). To date, the incidence and types of adverse events reported by pts were generally similar between the 2 groups. Only 1 pt (EDS) had a serious thromboembolic event considered related to DA. 16 QW and 12 EDS pts had died as of the interim analysis. Causes of death included disease progression (6 QW, 3 EDS), cardio-respiratory arrest (2 QW), and acute renal failure (2 QW). These interim results suggest that once per CTX cycle dosing with DA may be well-tolerated and effective in these pts.

Table

QWEDS
n=245n=242
*Least squares mean; **Last value carried forward; KM: Kaplan-Meier. 
Mean (SD) Age, yrs 61.9 (12.8) 62.6 (13.2) 
Most common tumor type (%) Breast (27) Breast (31) 
% Pts with stage IV cancer 51 52 
Mean (SD) BL Hb (g/dL) 10.1 (0.9) 10.2 (0.8) 
Mean* (99.9%CL) change in Hb (BL-wk 13) [n] (LVCF**) (g/dL) 1.0 (0.7,1.3) [244] 0.9 (0.5,1.2) [241] 
KM% (99.9%CL) pts who achieved target Hb (≥11g/dL) [n] 78 (68,89) [210] 76 (65,87) [215] 
Crude% (99.9%CL) pts who achieved target Hb (≥11g/dL) [n] 70 (59,80) [210] 64 (54,75) [215] 
Mean (SD) Hb after achieving target (g/dL) [n] 11.6 (0.8) [182] 11.7 (0.7) [166] 
KM% (99.9%CL) pts who had TFNs [n] 21 (12,29) [245] 22 (13,31) [242] 
Mean* (SE) change in FACT-F [n] 1.6 (0.85) [161] 2.7 (0.84) [168] 
QWEDS
n=245n=242
*Least squares mean; **Last value carried forward; KM: Kaplan-Meier. 
Mean (SD) Age, yrs 61.9 (12.8) 62.6 (13.2) 
Most common tumor type (%) Breast (27) Breast (31) 
% Pts with stage IV cancer 51 52 
Mean (SD) BL Hb (g/dL) 10.1 (0.9) 10.2 (0.8) 
Mean* (99.9%CL) change in Hb (BL-wk 13) [n] (LVCF**) (g/dL) 1.0 (0.7,1.3) [244] 0.9 (0.5,1.2) [241] 
KM% (99.9%CL) pts who achieved target Hb (≥11g/dL) [n] 78 (68,89) [210] 76 (65,87) [215] 
Crude% (99.9%CL) pts who achieved target Hb (≥11g/dL) [n] 70 (59,80) [210] 64 (54,75) [215] 
Mean (SD) Hb after achieving target (g/dL) [n] 11.6 (0.8) [182] 11.7 (0.7) [166] 
KM% (99.9%CL) pts who had TFNs [n] 21 (12,29) [245] 22 (13,31) [242] 
Mean* (SE) change in FACT-F [n] 1.6 (0.85) [161] 2.7 (0.84) [168] 

Disclosures: Data on Q2W dosing of Aranesp and unlicensed doses of Aranesp are included in the abstract.; H. Lam and T. Lillie are employees of Amgen, Inc.; L. Schwartzberg consulted for Amgen. R. Burkes consulted for Amgen, Roche, Novartis, and Astra Zeneca. V. Charu consulted for Amgen, Genentech, and Celgene.; H. Lam has ownership interest (Amgen stock options). T. Lillie has ownership interest (Amgen stock and stock options). B. Mirtsching has ownership interest (Amgen stock). V. Charu has ownership interest in Amgen, Genentech, J&J, OSI, BRL, and Boston Scientific.; B. Mirtsching has received research funding from Amgen for Denosumab and Panitumumab clinical trials. L. Yee has received clinical trial grants. R. Burkes received funding from Amgen. V. Charu has research funding from Amgen, Genentech, and Bristol Myers. T. Rearden received funding from Amgen.; B. Mirtsching received honararia from Amgen. R. Burkes received honoraria from Amgen, Roche, Novartis, and Astra Zeneca. V. Charu has received honoraria for consultancy on advisory board of Amgen.; L. Schwartzberg is on the speakers bureau at Amgen. R. Burkes is on the advisory committee and speakers bureau for Amgen, Roche, Novartis, and Astra Zeneca. T. Rearden is on the advisory board and speakers bureau for Amgen. P. Silberstein is on the speakers bureau for Genentech, Lily, Pfizer, Sanofi-Aventis Pharmaceuticals.

Author notes

*

Corresponding author

Sign in via your Institution