Safety and efficacy of PEG-rhG-CSF as primary prophylaxis for neutropenia in gastrointestinal cancer patients receiving combination chemotherapy including oral agents: a prospective, exploratory, non-randomized controlled study.

2026-04-14
Frontiers in oncology 16
- Hui Wang
- Xiaoling Zhang
- Yunyi Du
- Min Liu
- Ning Ma
- Yangjun Gao
- Mei Wang
- Linlin Cai
- Tingting Feng
- Suxia Yang
- Wenqing Hu
- Gehong Zhang
- Jun Zhao

PubMed: 42057816
DOI: 10.3389/fonc.2026.1764358

Study Design

Type: Clinical Trial
Sample size: n = 49
Population: GI cancer patients receiving combination chemotherapy regimens that include oral chemotherapy agents
Methods: Prospective, single-center, open-label, exploratory, non-randomized controlled study; treatment group received subcutaneous injection of PEG-rhG-CSF (6mg) 24 hours after oxaliplatin, control group received no primary prophylaxis
Blinding: Open-label
Duration: 3-week cycle, patients completed at least two treatment cycles
Funding: Unclear

Purpose

The safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for prevention of chemotherapy-induced neutropenia (CIN) in patients undergoing oral chemotherapy remain unclear. This study aimed to investigate the safety and efficacy of PEG-rhG-CSF as primary prophylaxis for CIN in gastrointestinal (GI) cancer patients receiving combination chemotherapy regimens that include oral chemotherapy agents.

Methods

This is a prospective, single-center, open-label, exploratory, non-randomized controlled study. GI cancer patients was treated with intravenous oxaliplatin (130mg/m² on day 1) combined with either oral capecitabine (1000mg/m²) or S-1 (an oral fluoropyrimidine combination of tegafur, gimeracil, and oteracil potassium; 40-60 mg) administered twice daily on days 1-14 of a 3-week cycle. The treatment group received subcutaneous injection of PEG-rhG-CSF (6mg) 24 hours after oxaliplatin, while the control group received no primary prophylaxis. The primary endpoint was safety, and secondary endpoints included the incidence of CIN.

Results

Between March 2022 and January 2023, 49 patients were screened, and 43 patients who completed at least two treatment cycles were included in the final analysis (26 in treatment group and 17 in control group). The overall adverse events (AEs) did not differ statistically (93.8% vs 100.0%, p = 0.542). For grade ≥ 3 AEs, the incidence of neutropenia was significantly lower in the treatment group compared to the control group (3.1% vs 35.3%, p = 0.005). No significant differences were observed in the rates of grade ≥ 3 thrombocytopenia (6.3% vs 17.6%, p = 0.326) and leukopenia (3.1% vs 0.0%, p = 1.000). Grade≥2 CIN was significantly lower in the treatment group (25.0% vs. 76.5%, p < 0.001).

Conclusion

In GI cancer patients on oral agents, primary PEG-rhG-CSF prophylaxis was well-tolerated and reduced grade ≥2 CIN, though randomized studies are needed.

Clinical trial registration

https://www.chictr.org.cn, identifier ChiCTR2100054854.