A phase II randomized trial of three loading doses of epoetin alfa followed by every three-week (q3w) dosing in cancer patients receiving chemotherapy
Bibliographic record
Abstract
8219 Early rise in hemoglobin (Hb) correlates with improvement in quality of life (QOL) in a phase II randomized trial of 3 loading doses of epoetin alfa followed by every three-week (q3w) dosing in cancer patients receiving chemotherapy. Background Weekly dosing of 40,000 IU epoetin alfa is an effective dose in increasing Hb, reducing transfusion and improving QOL. A loading dose to allow hb to reach 12 g/dL followed by q3w dosing was proven to be effective. Method & Results This study evaluates the effectiveness of three loading doses (30,000 IU 2X/wk, 40,000 IU 2X/wk and, 60,000 QW) given for 4 weeks followed by two different Q3W doses (80,000 IU or 120,000 IU) in maintaining Hb levels and improving QOL (Fact-F). At trial entry (week 0) patients were randomized to one of the three loading doses. An interim analysis after 18 patients enrolled showed ≥ 1 g/dL increase in Hb for all 3 groups (p=0.002) after 4 weeks of dosing and a trend towards significant improvement in QOL (p = 0.052). Patients also maintained their Hb levels after being switched to both q3w regimens for 12 weeks. QOL Data The FACT-F results at baseline (n=17), week 4 (n=16), and week 11 (n=6) were 27.4, 32.6, and 33.3 respectively. The FACT-F baseline to week 4 (n=16) and, baseline to week 11 analysis were 5.1 (p=0.051), and 3.5 respectively. Conclusion This preliminary look indicated that patients on epoetin alfa can be maintained with q3w dosing and significant increase in Hb and improvement in QOL was obtained at week 4 after treatment. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho-Biotech, Ortho-Biotech Canada Ortho-Biotech Ortho-Biotech Canada
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".