Febrile neutropenia (FN) is a serious side effect of many cancer treatments and can lead to severe infection and sepsis with potentially fatal consequences. Granulocyte colony-stimulating factors are frequently used prophylactically to reduce the risk, severity, and duration of FN, and as an adjunct to support the delivery of myelosuppressive regimens.
Pegfilgrastim (Neulasta) is a pegylated, long-acting granulocyte colony-stimulating factor approved for the treatment of neutropenia. It works by stimulating the bone marrow and boosting neutrophil counts, which helps to protect patients against severe neutropenia and infection. Currently, there are 4 pegfilgrastim biosimilars approved in the United States: pegfilgrastim-jmdb (Fulphila), pegfilgrastim-cbqv (Udenyca), pegfilgrastim-bmez (Ziextenzo), and pegfilgrastim-apgf (Nyvepria). These agents offer additional treatment options at potentially lower costs, which could create savings for patients and the healthcare system as a whole.
Currently, the FDA and the National Comprehensive Cancer Network recommend that pegfilgrastim injection be given to patients no sooner than 24 hours after the last day of each cycle of chemotherapy. These guidelines were established out of an abundance of caution to reduce the risk for FN or myelosuppression, which can develop if the agent is given too soon after chemotherapy administration.
However, next-day administration of pegfilgrastim can lead to difficulties in scheduling and biosimilar integration. In addition, the COVID-19 pandemic had created challenges regarding in-person clinic visits, leading many patients to self-administer pegfilgrastim using prefilled syringes or an on-body injector (Neulasta Onpro) that has failure rates ranging from 1.7% to 6.9%. Administering pegfilgrastim on the same day as chemotherapy could eliminate the need for a subsequent outpatient visit.
“One of the key considerations for decision-making is the possibility of avoiding a second clinic visit 24 hours after chemotherapy to administer prophylactic pegfilgrastim, which would alleviate the burden on patients and healthcare providers, while also minimizing the risk of COVID-19,” wrote Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, Clinical Assistant Professor, The University of Arizona College of Pharmacy, Tucson, and colleagues in a recent article published in Future Oncology. In this article, the authors discussed results of a recent retrospective, real-world, clinical trial evaluating same-day versus next-day administration of pegfilgrastim or a pegfilgrastim biosimilar in patients with lymphoma who were treated with chemotherapy.
Study Details
Dr McBride and colleagues collected data from electronic medical records on patients aged ≥18 years with lymphoma who were receiving chemotherapy that contained cyclophosphamide, hydroxydaunorubicin, vincristine (Oncovin), and prednisone (CHOP) with or without rituximab (Rituxan; R-CHOP). All of the patients had to have received FN prophylaxis with same-day or next-day pegfilgrastim at the University of Arizona Cancer Center between October 1, 2013, and December 30, 2020. The patients were followed for up to 6 cycles of chemotherapy.
Overall, 93 patients with lymphoma, who received a combined total of 460 cycles of CHOP-like chemotherapy, were included in the analysis. The median age of patients was 66 years and 62.4% were male. The most common lymphoma types were diffuse large B-cell lymphoma (58.1%) and follicular lymphoma (19.4%). R-CHOP was used for 72.0% of patients.
Among the 460 cycles of pegfilgrastim prophylaxis, FN occurred in 5.0% of patients and hospitalization was necessary for 11.1% of patients. In 97.1% of the cycles, pegfilgrastim was administered on the same day as chemotherapy, and in 2.9%, pegfilgrastim was administered the following day. FN occurred in 4.2% of cycles in the same-day group and 0 cycles in the next-day group.
Across all cycles, reference pegfilgrastim was administered in 88.1% of cycles and a pegfilgrastim biosimilar was administered in 11.9%. FN occurred in 4.9% of cycles with the reference drug and 0 cycles with the biosimilar. Hospitalization was required in 11.2% of cycles of the originator and 2.1% of the biosimilar.
Of the 460 chemotherapy cycles administered, dose reductions or delays occurred in 12.8% of cycles. Dose reductions or delays occurred in 13.2% of cycles with same-day pegfilgrastim, 8.3% of cycles with next-day pegfilgrastim, and in 10.6% of cycles without prophylactic pegfilgrastim. The majority of dose reductions or delays with same-day pegfilgrastim were associated with chemotherapy (eg, neuropathy, cardiac issues). In cycles with prophylactic pegfilgrastim, dose reductions or delays occurred in 13.8% of cycles with reference pegfilgrastim and 10.6% of cycles with the pegfilgrastim biosimilar.
The investigators concluded that there was no significant difference in the incidence of FN, grade 3/4 chemotherapy-induced neutropenia, chemotherapy delays due to myelosuppression, or hospitalizations in patients receiving prophylactic pegfilgrastim on the same day as chemotherapy. They also noted that the incidence of FN with same-day pegfilgrastim was notably lower than in previous reports in patients with very similar characteristics.
“Overall, these findings suggest that same-day pegfilgrastim could be safely administered in patients with lymphoma in the real-world setting. In addition to lessening the healthcare burden, same-day pegfilgrastim administration could reduce the risk of in-hospital COVID-19 infection in this vulnerable patient population,” Dr McBride and colleagues wrote.
Source: McBride A, Alrawshdh N, Bartels T, et al. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. Future Oncol. 2021;17:3485-3497.
