Empegfilgrastim for primary febrile neutropenia prophylaxis during induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in head and neck squamous cell carcinoma.

Abstract

e18030 Background: Induction chemotherapy (CT) with docetaxel, cisplatin, and 5fluorouracil (DCF) before chemoradiotherapy can improve disease control in advanced head and neck squamous cell carcinoma (HNSCC) but is associated with a high risk of severe hematologic toxicity, including febrile neutropenia (FN). Empegfilgrastim is a long-acting granulocyte colony stimulating factor (GCSF) designed to reduce chemotherapy-induced neutropenia and FN. This single-center retrospective study evaluated the incidence of neutropenic complications in HNSCC patients (pts) receiving DCF induction CT with primary FN prophylaxis using empegfilgrastim. Methods: This was a retrospective, single-center cohort of pts with unresectable stage III/IVA hypopharyngeal, laryngeal, or oropharyngeal squamous cell carcinoma treated with 3 cycles of DCF induction CT (docetaxel 75 mg/m² day 1, cisplatin 75 mg/m² day 1, 5fluorouracil 1000 mg/m²/day as a continuous infusion on days 1–4, every 3 weeks), followed by empegfilgrastim 7.5 mg subcutaneously on days 4–8 of each cycle. The primary endpoint was the incidence of grade 3–4 neutropenia (CTCAE v5.0). Secondary endpoints included incidence of FN, nonhematologic adverse events (AEs) grade ≥3, and tumor response after induction CT. Results: A total of 55 pts with unresectable stage III/IVA HNSCC were included: hypopharynx (n=33), larynx (n=8), and oropharynx (n=14). The median age was 60 years (range 39–77); 83% had ECOG performance status 0–1 and 85% were male. Most pts (48/55, 89%) completed all 3 planned DCF cycles. Objective response was assessable in 32 pts, of whom 70% achieved an objective response, including 13 complete responses; the median change in target lesion size was −60% (range −84% to −28%). Grade 3–4 neutropenia occurred in 6 pts (11%), and FN in 4 pts (7.3%). The incidence of any nonhematologic AE grade ≥3 was 3/55 (5%). Conclusions: Primary prophylaxis with empegfilgrastim during DCF induction CT was associated with a relatively low incidence of grade 3–4 neutropenia and FN in pts with advanced HNSCC, while allowing the majority to complete planned treatment. Further analyses are planned to compare the efficacy and safety of empegfilgrastim administration on day 2 versus day 3 of the DCF regimen.