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).
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.