Characteristics of all enrolled patients.

PurposeThis study aims to compare the safety and efficiency of modified biweekly CAPOX and conventional triweekly CAPOX in high-risk stage II and stage III post-surgery colorectal (CRC) patients.MethodsFrom July 25, 2018, to May 14, 2021, high-risk stage II and stage III post-surgery CRC patients were randomized in the control triweekly group (intravenous infusion of oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 1000 mg/m2, twice daily from day 1 to day 14) and the experimental biweekly group (intravenous infusion of oxaliplatin 85 mg/m2 on day 1 and oral capecitabine 1000 mg/m2, twice daily from day 1 to day 10). The primary endpoint was the incidence rate of thrombocytopenia. The secondary endpoint was 3-year disease free survival (DFS) rate. The patients follow up was started on July 25, 2018, and finished on October 8, 2024.ResultsA total of 160 patients were 1:1 randomly assigned (80 patients to biweekly group and 80 patients to triweekly group). All grade thrombocytopenia occurred in 33% and 49% patients at biweekly and triweekly group, respectively (P = 0.02). Neutropenia presented in 36% and 51% patients at biweekly and triweekly group, respectively (P = 0.04). The second endpoint 3-year DFS was 85.1% in biweekly group and 80.4% in triweekly CAPOX group (P = 0.51, HR = 0.78, [95%CI, 0.38–1.63]). The total rate of uncomplete therapy patient was 7.5% and 15% in biweekly and triweekly group, respectively (P = 0.13).ConclusionBiweekly CAPOX presented significant less thrombocytopenia and neutropenia than triweekly CAPOX regimen. There was no difference in 3-year DFS between biweekly CAPOX and triweekly CAPOX.Clinical trial registration: ClinicalTials.gov (NCT03564912).

研究目的：本研究旨在对比改良双周CAPOX方案与常规三周CAPOX方案用于高危II期及III期结直肠癌（colorectal cancer, CRC）术后患者的安全性与疗效。研究方法：2018年7月25日至2021年5月14日，将高危II期及III期结直肠癌术后患者随机分为两组：对照组（三周方案组）于第1天静脉输注奥沙利铂130 mg/m²，第1至14天每日两次口服卡培他滨1000 mg/m²；试验组（双周方案组）于第1天静脉输注奥沙利铂85 mg/m²，第1至10天每日两次口服卡培他滨1000 mg/m²。本研究的主要终点为血小板减少症（thrombocytopenia）发生率，次要终点为3年无病生存期（disease free survival, DFS）率。患者随访始于2018年7月25日，截至2024年10月8日。研究结果：共计160例患者按1:1比例随机分组（双周组与三周组各80例）。双周组与三周组各级血小板减少症发生率分别为33%与49%（P=0.02）；中性粒细胞减少症（neutropenia）发生率分别为36%与51%（P=0.04）。次要终点3年DFS率：双周组为85.1%，三周CAPOX组为80.4%（P=0.51，风险比HR=0.78，95%置信区间（confidence interval, CI）：0.38~1.63）。治疗未完成患者总比例：双周组为7.5%，三周组为15%（P=0.13）。研究结论：双周CAPOX方案较三周CAPOX方案的血小板减少症与中性粒细胞减少症发生率显著更低；双周与三周CAPOX方案的3年DFS率无显著差异。临床试验注册：ClinicalTrials.gov（NCT03564912）