Reference, Biosimilar Pegfilgrastim Can Be Safely Administered Same Day as Chemotherapy

Investigators concluded that reference or biosimilar pegfilgrastim could be safely administered to patients with lymphoma on the same day they receive chemotherapy, which could reduce scheduling burden and risk of COVID-19 exposure.

Contrary to current utilization guidelines, reference pegfilgrastim or a biosimilar version can be safely administered to patients with lymphoma on the same day they receive chemotherapy, according to a study published in Future Oncology.

The retrospective, single-center, nonrandomized study from the University of Arizona Cancer Center diverts from the notion that pegfilgrastim products should be administered the day after chemotherapy, which is largely considered standard utilization practice, and gives legitimacy to the trend of delivering pegfilgrastim in a more immediate fashion.

“Same-day administration of pegfilgrastim is likely to become the standard administration pattern across many different chemotherapies and tumor types, in order to reduce additional clinic visits and lessen the health care burden. Broader use of lower-cost pegfilgrastim biosimilars is expected to reduce the health care costs further,” wrote the investigators.

Currently, the FDA, the National Comprehensive Cancer Network (NCCN), and Amgen, the manufacturer of originator pegfilgrastim (Neulasta), recommend that pegfilgrastim injection be given to patients no sooner than 24 hours after the last day of each cycle of chemotherapy. The guidelines stem from the concern that patients may experience higher rates of febrile neutropenia (FN) or myelosuppression if pegfilgrastim is given too close to chemotherapy administration.

However, next-day administration of pegfilgrastim can lead to difficulties with scheduling and biosimilar integration. Additionally, the COVID-19 pandemic had created challenges regarding minimizing hospital visits and exposure risk to SARS-CoV-2, the virus that causes COVID-19, 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 second outpatient visit.

The investigators collected data from electronic medical records on patients 18 years or older with a lymphoma diagnosis receiving chemotherapy that contains cyclophosphamide, hydroxydaunorubicin, vincristine (Oncovin), and prednisone with or without rituximab (R-CHOP or 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 the 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% and hospitalization was necessary for 11.1%. In 97.1% (n = 401), pegfilgrastim was administered on the same day as chemotherapy, and in 2.9% (n = 12), pegfilgrastim was administered the following day. FN occurred in 4.2% (n = 17) of cycles in the same-day group and 0 cycles in the next-day group (P = 1.00).

Across all cycles, the pegfilgrastim originator was administered in 88.1% (n = 348) of cycles and a biosimilar was used in 11.9% (n = 47). FN occurred in 4.9% (n = 17) of cycles with the originator and 0 cycles with the biosimilar (P = .24). Hospitalization was needed in 11.2% (n = 39) of cycles of the originator and 2.1% (n = 1) of the biosimilar (P = .07).

The investigators listed the retrospective, noncontrolled, single-center nature of the study as a limitations, indicating that future studies are needed. Additionally, the proportion of patients who received next-day pegfilgrastim was small in the present analysis, suggesting that pragmatic trials across multiple treatment centers could reduce this imbalance.

“Our study findings contribute to the growing body of evidence that aims to define the disease states and chemotherapy regimens in which same-day pegfilgrastim provides safe and reliable prophylaxis of FN. As such, our findings may inform the next update of the NCCN guidelines on hematopoietic growth factors,” said the investigators.

Reference

McBride A, Alrawashdh N, Bartels T, Moore L, Persky D, Abraham I. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. Future Oncol. 2021;17(26):3485-3497. doi:10.2217/fon-2021-0532