Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.
Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.
Despite the fact that pegfilgrastim in its on-body injector presentation has the potential to be deployed improperly if it is not placed correctly on the skin, researchers found that there was no difference in rates of FN among patients who used the on-body device versus patients who had in-clinic injections of pegfilgrastim.1
The researchers in the study reviewed the records of all patients prescribed pegfilgrastim at the University of Vermont Cancer Center from January 2016 to November 2017 and identified 326 patients, 91 of whom received the on-body injection. In total, 24 (7.4%) patients developed FN (7.7% of the on-body injector group and 7.2% of the in-clinic group; P =.86). There were no differences in the incidence of FN by patient characteristics, tumor type, stage, or type of chemotherapy used.
According to the authors, despite the potential for error in placement and delivery inherent in the on-body device, in a real-world setting, in-clinic and on-body injection are equivalent.
Another study examining the on-body administration of pegfilgrastim reported that, in a study of 706 patients undertaken from January 2015 to June 2017, use of the on-body injector significantly reduced the need for return clinic visits for FN prophylaxis in the community oncology practice setting. After the device became available to patients in July 2016, say the researchers, the prevalence of attended next-day visits decreased by 86.4%, and the prevalence of scheduled next-day visits decreased by 81.1%.2
Despite the feasibility and benefits of on-body pegfilgrastim delivery, other research shows that many eligible patients are not receiving any FN prophylaxis.
A retrospective analysis, derived from data from 2009 to 2013, revealed that across 4 US health systems (Geisinger Health System, Henry Ford Health System, Kaiser Permanente Northwest, and Reliant Medical Group), only 32% of patients receiving myelosuppressive chemotherapy for breast cancer, colorectal cancer, lung cancer, or non-Hodgkin lymphoma received FN prophylaxis with G-CSF agents in their first treatment cycle.3 Only 44% received prophylaxis with G-CSF agents at any time during their course of treatment.
A greater percentage of patients with breast cancer received G-CSF prophylaxis in both cycle 1 (53.3%) and any cycle (65.9%) than patients with any other cancer type studied. The cancer type with the lowest percentage of patients treated with G-CSF in cycle 1 (2.7%) or any cycle (13.0%) was colorectal cancer.
The incidence of FN was 4% in cycle 1, and 9% in all cycles overall, and was 40% lower in cycle 1 with G-CSF prophylaxis (P = .018). Most episodes of FN (76%) required hospitalization.
The authors write that clinicians should give careful consideration to identifying patients who have an elevated risk of FN in order to ensure the appropriate use of supportive care.
References
1. Ng H, Douce D, Byingon A, et al. Man vs machine: Are febrile neutropenia rates different using an in-clinic vs on-body injection? J Clin Oncol. 2018;36(suppl; Abstract e18756).
2. Lin J, Yucel A, Walker MS, et al. Effect of pegfilgrastim on-body injector (OBI) on cancer care: A real-world health system and interrupted time series analysis. J Clin Oncol. 2018;36(suppl; Abstract e18859).
3. Weycker D, Silvia A, Shyta E, et al. Use of supportive care and risk of febrile neutropenia (FN) among patients receiving myelosuppressive chemotherapy for solid tumors or non-Hodgkin's lymphoma (NHL) at four US health systems. J Clin Oncol. 2018;36(suppl; Abstract e18756).
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.