Erythropoietin Stimulating Agents (ESAs): Reassessment of Use in Cancer and Chronic Kidney Disease (CKD) Settings in the United States, Canada, and Europe.
Bibliographic record
Abstract
Abstract Abstract 4538 Introduction International reassessments of erythropoiesis stimulating agents (ESAs) for anemia have recently occurred. While ESAs prevent blood transfusions and, improve select quality of life domains among chronic kidney disease (CKD) patients, 8 trials individually identified increased mortality and/or tumor progression among cancer patients treated with ESAs. For CKD, one study of non-dialysis CKD patients targeted to higher versus lower hemoglobin (Hb) levels identified 34% increased relative risk (17.5% vs. 13.5%) for death, acute myocardial infarction, congestive heart failure hospitalization, or stroke with a higher Hb target. Methods Guidelines, notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and CKD settings within the U.S., Europe, and Canada were reviewed. Results: Cancer Setting In 2008, the Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to Hb levels < 10 g/dL. In the U.S., ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) reports that ESA benefits do not outweigh risks. In Europe, ESA reimbursement is included in global provider payments. Between 2001 and 2006, ESA use increased 51%; since 2006, use has decreased 10%. Canadian manufacturers recommend ESA usage based on patient preference. In Canada, reimbursement for myelosuppressive chemotherapy with ESAs is restricted to Hb levels of 10-11 g/dL in Alberta and 11-12.5 g/dL in British Columbia. Usage increased 20% between 2004 and 2007. CKD Setting The FDA recommends Hb levels < 12 g/dL and Medicare reimbursement is restricted to Hb levels ≥ 13 g/dL. Between 2001 and 2006, usage increased 480% (non-dialysis) and 40% (dialysis) in the U.S. Since 2007, ESA use has decreased 30% (non-dialysis) and 17% (dialysis). The EMEA recommends target Hb levels of 10-12 g/dL. In Europe, ESA usage has increased 10% since 2001. The 2009 Canadian label recommends Hb levels < 12 g/dL. Within Canada, ESA usage increased 30% since 2004. Conclusions While reassessments of ESA safety have occurred internationally, safety concerns in the U.S. have resulted in marked decrements in ESA use among cancer and CKD patients, whereas in Europe and Canada ESA use has increased over time. Disclosures: No relevant conflicts of interest to declare.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.005 | 0.013 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.006 | 0.013 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".