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ASCO and ASH Release Updated Guideline on the Use of Chemotherapy-Related Anemia Treatments

WASHINGTON, D.C. – The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have released an updated joint guideline on the use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow to produce more red blood cells, to treat chemotherapy-related anemia.

“One goal of these guidelines is to inform clinicians with the most up-to-date evidence from high-quality studies regarding the risks and benefits of ESAs in patients with cancer,” said J. Douglas Rizzo, MD, MS, co-chair of the guideline panel and Associate Professor of Medicine, Medical College of Wisconsin.

This updated guideline, originally published in 2002, was derived from systematic reviews and analysis of published clinical trials. It outlines the clotting risks of ESAs, makes recommendations on usage, and provides insights on disease progression and patient survival.

Specifically, the guideline:
- Declares epoetin and darbepoetin equally safe and effective.

- Recommends the use of ESAs as a treatment option for cancer patients who become anemic as a result of chemotherapy when their hemoglobin approaches or falls below 10 g/dL, as well as patients with low-risk myelodysplasia.

- Suggests that when using ESAs, hemoglobin can be raised to (or near) a concentration of 12 at which point the dosage should be titrated to maintain that level. Dose reductions are also recommended when hemoglobin rise exceeds 1 g/dL in any two-week period or when the hemoglobin level exceeds 11 g/dL.

- Recommends discontinuing use of ESAs beyond six to eight weeks if a patient has not responded to the drug.

- Recommends monitoring the iron levels of patients being treated with ESAs and providing supplements accordingly.

- Cautions against using ESAs for cancer patients not receiving chemotherapy since recent trials have shown increased thromboembolic risks and decreased survival under these circumstances.

“As new data become available, it is important to update clinical practice guidelines to ensure that physicians make treatment decisions based upon the most up-to-date available evidence,” said Alan E. Lichtin, MD, guideline panel co-chair and Associate Professor of Medicine at the Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio. “However, new evidence can also reinforce previous recommendations, as it did in this guideline.”

ESAs carry an increased risk for blood clots, strokes, and heart attacks in some patients under certain conditions, spurring the FDA to call for new drug warning labels this past March. Following the FDA’s warning, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Decision this summer, outlining the specific conditions under which use of ESAs would be reimbursed for cancer patients.

“We hope that these evidence-based recommendations will influence practice standards and result in better care for patients,” said Samuel Silver, MD, ASH Executive Committee Councillor, Chair, ASH Subcommittee on Reimbursement, and Professor of Internal Medicine at the University of Michigan in Ann Arbor, Michigan.

In developing the guideline update, panel members considered two meta-analyses that reviewed close to 60 randomized clinical trials. Additional evidence was considered when it was considered pertinent to each section of the updated guideline.

The guideline will be published ahead of print on the Web sites of Blood (bloodjournal.org), ASH’s scientific journal, and ASCO’s Journal of Clinical Oncology (jco.org) October 22 at 3:00 p.m. The guideline will be published in print in both journals December 1.

Source: American Society of Clinical Oncology and American Society of Hematology

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