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

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: ) 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: < 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.