A Prospective, Observational Study of the Effectiveness and Safety of a Weekly Fixed Dose of Darbepoetin alfa with Current Practice Iron Management for the Treatment of Chemotherapy-Induced Anemia (CIA): A Subanalysis in Patients (pts) with Lymphoproliferative Malignancies (LPM).
Bibliographic record
Abstract
Abstract Background: Darbepoetin alfa (Aranesp®) is a unique erythropoiesis-stimulating protein effective for the treatment of CIA when administered weekly (QW), every 2 weeks (wks) or every 3 wks. Fixed dosing of darbepoetin alfa is routinely used in clinical practice, but little data are available on its patterns of use and the impact of iron status on its effectiveness. Methods: This was a subanalysis of LPM pts included in a prospective, single-arm, multicenter study conducted in Spain. Pts were ≥ 18 yrs old, anemic (hemoglobin [Hb] ≤11 g/dL), scheduled to receive ≥ 12 wks of chemotherapy, and without iron, vitamin B12, or folate deficiencies. Pts were treated with darbepoetin alfa 150 mcg QW; the dose was to be doubled to 300 mcg QW if Hb increased <1 g/dL after 4 wks. Oral iron (200 mg QD) was recommended if transferrin saturation was ≤ 30%, transferrin was ≥ 400 mcg/dL, and/or ferritin was ≤ 300 mcg/L at any time during the study. The primary endpoint was hematopoietic response (Hb increase ≥ 2 g/dL or Hb ≥ 12g/dL in the absence of transfusions in the previous 28 days). Secondary endpoints included the percentage of pts with functional or absolute iron deficiency and its correlation with response rates, change in FACT-Fatigue score from baseline to end of treatment (EOT), and safety. Results: Of a total of 293 patients enrolled, 129 had LPM and were included in this analysis. Of the LPM patients, 55% were women, median age was 67.3 yrs (range: 20.6–88.4), median weight was 67 kg (range: 40.5–115.0). Eleven percent had Hodgkin’s disease, 33.9% had non-Hodgkin’s lymphoma. 5.5% had chronic lymphocytic leukemia, and 49.6% had multiple myeloma. Most pts (80.5%) had baseline Hb between 9–11 g/dL; 19.5 % had Hb < 9 g/dL. Darbepoetin alfa was administered for a median of 16 wks (range:1–16). At wk 5, 25.6 % of pts had their dose doubled to 300 mcg QW. The observed hematopoietic response was 70.73% (95%CI: 62.69, 78.77). The proportion of pts transfused from wk 5 to EOT was 12.7%. During the study, 31.5% pts received oral iron, 10.3% developed absolute iron deficiency, and 8% had iron blockade. Mean (95% CI) FACT-Fatigue score increased from 34.1 (32.2, 35.9) to 40.0 (38.2, 41.8) (p<0.0001). Darbepoetin alfa was well tolerated with 2.4% of pts experiencing adverse events considered related to the study drug. Conclusions: darbepoetin alfa, given as a fixed dose, is an effective and well-tolerated treatment for CIA in pts with LPM. Darbepoetin alfa significantly improved health-related quality of life in this routine clinical practice setting.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".