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Anne K. Hubben, Nathan Pennell, Marc Shapiro, Craig Savage and James P. Stevenson

Purpose: National guidelines do not include routine pGCSF as primary prophylaxis (PP) for patients receiving chemotherapy associated with a low risk for febrile neutropenia (FN). Inappropriate pGCSF can increase patient morbidity, financial burden, and overall health care costs. In 2013, an interdisciplinary group at TCI implemented a QI project to reduce inappropriate PP pGCSF in patients with lung cancer; this included prescriber education and modification of chemotherapy orders by risk of FN in the electronic medical record (EMR). Inappropriate pGCSF was reduced from 28% to 4%. In this 5-year follow up study we analyzed pGCSF use in lung cancer patients. Methods: We conducted a review of lung cancer patients who received pGCSF with chemotherapy initiated between January 2016 and August 2018. PP pGCSF use was appropriate if prescribed with chemotherapy regimens with a high risk (>20%) for FN, or intermediate risk (10%–20%) if other accepted FN risk factors were present. PP use with FN low-risk (<10%) chemotherapy was considered inappropriate. Treating physicians were anonymously surveyed about their practices. Results: 294 patients with lung cancer received 1,353 doses of pGCSF during the study period. 58 (20%) were treated at TCI by subspecialty thoracic oncologists and 236 (80%) were treated at regional network sites. 100/294 (34%) patients received low-risk regimens. 62/100 (62%) patients treated with low-risk regimens received 311 doses of PP pGCSF (inappropriate use). 5/62 (8%) of inappropriate use occurred at TCI; 57/62 (92%) at network sites. Of 130 patients who received an intermediate risk regimen, 99 (76%) received PP pGCSF. At least one risk factor for FN was identified in 80/99 (80%) of these patients; age >65 and prior chemotherapy or radiation were the top-cited factors. 33/294 (11%) patients were hospitalized for FN during the study period; 7/100 (7%) received low-risk regimens, 15/130 (11.5%) intermediate-risk, and 11/46 (24%) high-risk regimens. All physicians responding to the survey indicated awareness of guidelines and EMR risk identification. Conclusion: After initial success at our center, we found that guideline-based alignment of pGCSF prescribing in lung cancer patients was not sustained. Despite reported familiarity with guidelines for PP pGCSF use, this analysis suggests an opportunity for re-education and further EMR modification. Based on July 2018 CMS average sales price, reduction in inappropriate use presents a potential cost savings of $1.5 million during the study.

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David C. Dale

Neutrophils are the body's critical phagocytic cells for defense against bacterial and fungal infections; bone marrow must produce approximately 10 x 109 neutrophils/kg/d to maintain normal blood neutrophil counts. Production of neutrophils depends on myeloid growth factors, particularly granulocyte colony-stimulating factor (G-CSF). After the original phase of development, researchers modified these growth factors to increase their size and delay renal clearance, increase their biologic potency, and create unique molecules for business purposes. Pegylated G-CSF is a successful product of these efforts. Researchers have also tried to identify small molecules to serve as oral agents that mimic the parent molecules, but these programs have been less successful. In 2006, the European Medicines Agency established guidelines for the introduction of new biologic medicinal products claimed to be similar to reference products that had previously been granted marketing authorization in the European community, called bio-similars. Globally, new and copied versions of G-CSF and other myeloid growth factors are now appearing. Some properties of the myeloid growth factors are similar to other agents, offering opportunities for the development of alternative drugs and treatments. For example, recent research shows that hematopoietic progenitor cells can be mobilized with a chemokine receptor antagonist, chemotherapy, G-CSF, and granulocyte macrophage colony-stimulating factor. Advances in neutrophil biology coupled with better understanding and development of myeloid growth factors offer great promise for improving the care of patients with cancer and many other disorders.

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Pegylated Granulocyte Colony-Stimulating Factor (pGCSF) Use for Lung Cancer Patients: Five-Year Follow Up of a Quality Improvement (QI) Initiative at the Cleveland Clinic Taussig Cancer Institute (TCI) Hubben Anne K. MD Pennell Nathan MD, PhD Shapiro Marc MD