1865P - DEFENDOR special: Real-world use of pegylated granulocyte-colony stimulating factor in patients with gastrointestinal cancers

Background

Potentially myelosuppressive triplet chemotherapy (CT) combination regimens are considered the most active treatments in gastrointestinal cancer (GIC). Based on key studies, average RDI with FLOT, FOLFIRINOX and FOLFOXIRI is approximately 70-80%, potentially affecting patients (pts) outcomes. Granulocyte colony stimulating factors (G-CSF) have been the standard of care for the prevention of chemotherapy-induced neutropenia (CIN). Here we present the final results of a single-center prospective observational post-registration study of combined CT with empegfilgrastim support to evaluate safety and efficacy in pts with GIC (NCT04905329).

Methods

Pts with resectable gastric carcinoma (GC), locally advanced/ metastatic pancreatic carcinoma (PC) and metastatic colorectal carcinoma (CRC) were treated with perioperative FLOT, FOLFIRINOX and FOLFOXIRI regimens, respectively. All pts had primary prophylaxis of CIN with empegfilgrastim 7,5 mg, subcutaneously once per CT cycle. The primary endpoint was the RDI of CT courses (4-9 cycles per course are allowed). RDI of the regimen was calculated as mean RDI of each agent. Mean expected RDI among patients with GC, PC and CRC was about 70-85% with standard deviation of 15% percentage points(pp), with the sample size of 30 pts in each group the expected precision for mean RDI (half of its 95% confidence interval) was ± 5.6 %pp.

Results

From 2021 to 2024 90 pts (GC, n=30; PC, n=30 and CRC, n=30) were included into the study. The average age of pts GC/PC/CRC was 56.6 (18–73)/61,5(38-79)/54,2(27-68) y.o., resp. RDI for pts with GC/PC/CRC were 92,4±6,6%, 93,7±7,8%, 94,5 ±5,5 % and RDI≥ 85% was achieved in 86,7% pts: 84,2%/90,0%/86,7% for GC/PC/CRC, resp. However, only 75% pts with GC achieved RDI ≥ 85% with postoperative FLOT. Neutropenia grade 3-4 and febrile neutropenia were reported in 4 (4.4%) pts and 2(2,2%) pts, resp.

Conclusions

Primary prolonged G-CSF prophylaxis with empegfilgrastim allows effectively maintaining RDI across pts with GIC in routine clinical practice.

Clinical trial identification

NCT04905329.

Editorial acknowledgement

Legal entity responsible for the study

N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation.

Funding

N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation.

Disclosure

All authors have declared no conflicts of interest.