Integrating Late- Breaking Growth Factor Evidence, Guidelines, and Policy Into Clinical Practice
Supportive care for patients with cancer is designed to minimize or prevent chemotherapy-induced adverse effects and disease-related symptoms and complications. Two of the most profound adverse effects patients undergoing chemotherapy experience are anemia and neutropenia. The success in managing chemotherapy-induced anemia (CIA) and chemotherapy-induced neutropenia (CIN) has been dramatically advanced with the advent of erythropoieticstimulating agents (ESAs) and colony stimulating factors (CSFs), respectively.
Over time, ESAs have been investigated, off-label, in other populations of patients with cancer, including patients with anemia receiving radiotherapy or not actively receiving either chemotherapy or radiotherapy, as well as in approved CIA populations using target hemoglobin levels inconsistent with approved labeling. Several of these studies suggest decreased survival times, tumor progression, and/or increased thrombotic events in the ESA-treatment arms. This information initiated revisions to national consensus guidelines and product labeling, as well as the implementation of a new National Coverage Determination for ESAs from the Centers for Medicare and Medicaid Services.
The rapid changes affecting the use of ESAs (National and Local Coverage Determinations, commercial payer policies, or evidence-based and consensus guidelines) have led to confusion among health care professionals, especially because some of the information sources appear to be confl icting. Regardless of how institutions decide to interpret and apply the available evidence and information, it is clear that the recent changes will have a signifi cant effect on clinical practice. Pharmacists can play a key role in the clinical and economic management of ESAs as well as CSFs. As part of a multidisciplinary growth factor management program, the pharmacist can positively affect appropriate medication use, improve patient safety and patient outcomes, and positively affect the financial performance of the organization.
