Assessing Safety, Costs of Same-Day Prophylactic Pegfilgrastim in GI Cancer Treatment

A study presented at the Hematology/Oncology Pharmacy Association Annual Conference 2024 assessed the safety of same-day administration of prophylactic long-acting granulocyte colony-stimulating factor (GCSF) during chemotherapy treatment of gastrointestinal (GI) cancers.

“Per the [US Food and Drug Administration’s] prescribing and administration instructions, growth factor is supposed to be administered at least 24 hours following completion of chemotherapy due to concerns for paradoxical neutropenia or febrile neutropenia (FN),” wrote the study’s authors. They conducted a retrospective chart review to assess rates of grade 3 or 4 neutropenia and FN between patients receiving GCSF on the same day as chemotherapy completion or the following day. Fifty-seven patients were included in the same-day administration group and 75 were in the next-day administration group. The 2 GCSF administration types were pegfilgrastim-cbqv (utilized in both groups) and pegfilgrastim on-body applicator (utilized in the next-day group only).

The chemotherapy treatments assessed were:

• FLOT: fluorouracil, leucovorin, oxaliplatin, and docetaxel
• FOLFIRI: folinic acid, fluorouracil, and irinotecan
• FOLFOX: folinic acid, fluorouracil, and oxaliplatin
• FOLFIRINOX: folinic acid, fluorouracil, irinotecan, and oxaliplatin
• mFOLFIRINOX: modified FOLFIRINOX

Three cases of FN occurred in the same-day administration group and 2 occurred in the next-day administration group (P=.399). Four cases of grade 3 or 4 neutropenia occurred in the same-day group and 6 occurred in the next-day group (P=1).

“The same-day group received more FOLFIRI and less FOLFIRINOX and mFOLFIRINOX than the next-day group, but the lack of significance in neutropenia and FN reduces concerns of bias,” the authors noted.

One patient in the next-day GCSF administration group died from FN; this patient received a pegfilgrastim on-body applicator. Another patient who received a pegfilgrastim on-body applicator had a device failure that likely resulted in grade 3 neutropenia. Finally, 1 patient in the same-day treatment group who developed FN was found to have a dihydropyrimidine dehydrogenase deficiency, which the authors reported may confound the outcome.

Regarding cost outcomes, the authors noted that 64 patients in the next-day administration group had an additional clinic visit for administration of pegfilgrastim-cbqv, “resulting in various increased costs and time burden.” They added, “Patients receiving same-day pegfilgrastim-cbqv benefitted from decreased cost and increased time savings due to lack of additional clinic visits compared [with] the next-day group.” Pegfilgrastim-cbqv had a lower average wholesale price compared with the on-body applicator.

“Same-day administration of GCSF may be safe in patients receiving fluoropyrimidine GI cancer treatment,” the authors summarized. Additionally, “same-day administration of GCSF may provide patient or institution cost savings compared [with] GCSF on-body applicators; however, costs will vary by institution.” The authors called for additional studies comparing performance data on same- versus next-day administration, as well as further research on device failure of on-body GCSF applicators to assess the risk-benefit profile.

Reference

Zeheralis C, Epstein S, Redecker K, Bahng J, Bailey K. Evaluation of same day vs next day administration of prophylactic pegfilgrastim in fluoropyrimidine based GI cancer treatment. Poster. Presented at the Hematology/Oncology Pharmacy Association Annual Conference 2024; April 3-6, 2024; Tampa, Florida.