Abstract
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/m(2) on day 1) combined with either oral capecitabine (1000mg/m(2)) 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.