氟尿嘧啶和亚叶酸联合术中化疗对结直肠癌根治术后患者生存的影响：一项回顾性队列研究。
Effect of intra-operative chemotherapy with 5-fluorouracil and leucovorin on the survival of patients with colorectal cancer after radical surgery: a retrospective cohort study.
机构信息
The Second Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050001, China.
Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
出版信息
Chin Med J (Engl). 2023 Apr 5;136(7):830-839. doi: 10.1097/CM9.0000000000002598.
BACKGROUND
The effect of intra-operative chemotherapy (IOC) on the long-term survival of patients with colorectal cancer (CRC) remains unclear. In this study, we evaluated the independent effect of intra-operative infusion of 5-fluorouracil in combination with calcium folinate on the survival of CRC patients following radical resection.
METHODS
1820 patients were recruited, and 1263 received IOC and 557 did not. Clinical and demographic data were collected, including overall survival (OS), clinicopathological features, and treatment strategies. Risk factors for IOC-related deaths were identified using multivariate Cox proportional hazards models. A regression model was developed to analyze the independent effects of IOC.
RESULTS
Proportional hazard regression analysis showed that IOC (hazard ratio [HR]=0.53, 95% confidence intervals [CI] [0.43, 0.65], P < 0.001) was a protective factor for the survival of patients. The mean overall survival time in IOC group was 82.50 (95% CI [80.52, 84.49]) months, and 71.21 (95% CI [67.92, 74.50]) months in non-IOC group. The OS in IOC-treated patients were significantly higher than non-IOC-treated patients ( P < 0.001, log-rank test). Further analysis revealed that IOC decreased the risk of death in patients with CRC in a non-adjusted model (HR=0.53, 95% CI [0.43, 0.65], P < 0.001), model 2 (adjusted for age and gender, HR=0.52, 95% CI [0.43, 0.64], P < 0.001), and model 3 (adjusted for all factors, 95% CI 0.71 [0.55, 0.90], P = 0.006). The subgroup analysis showed that the HR for the effect of IOC on survival was lower in patients with stage II (HR = 0.46, 95% CI [0.31, 0.67]) or III disease (HR=0.59, 95% CI [0.45, 0.76]), regardless of pre-operative radiotherapy (HR=0.55, 95% CI [0.45, 0.68]) or pre-operative chemotherapy (HR=0.54, 95% CI [0.44, 0.66]).
CONCLUSIONS
IOC is an independent factor that influences the survival of CRC patients. It improved the OS of patients with stages II and III CRC after radical surgery.
TRIAL REGISTRATION
chictr.org.cn, ChiCTR 2100043775.
背景
术中化疗（IOC）对结直肠癌（CRC）患者的长期生存的影响仍不清楚。本研究评估了在根治性切除术后，5-氟尿嘧啶联合亚叶酸钙术中输注对 CRC 患者生存的独立影响。
方法
共纳入 1820 例患者，其中 1263 例接受 IOC，557 例未接受 IOC。收集了临床和人口统计学数据，包括总生存（OS）、临床病理特征和治疗策略。使用多变量 Cox 比例风险模型确定与 IOC 相关死亡的风险因素。建立回归模型分析 IOC 的独立影响。
结果
比例风险回归分析显示，IOC（风险比[HR]=0.53，95%置信区间[0.43，0.65]，P<0.001）是患者生存的保护因素。IOC 组的平均总生存时间为 82.50（95%CI[80.52，84.49]）个月，非 IOC 组为 71.21（95%CI[67.92，74.50]）个月。IOC 治疗患者的 OS 明显高于非 IOC 治疗患者（P<0.001，对数秩检验）。进一步分析显示，在未调整模型（HR=0.53，95%CI[0.43，0.65]，P<0.001）、模型 2（调整年龄和性别，HR=0.52，95%CI[0.43，0.64]，P<0.001）和模型 3（调整所有因素，95%CI 0.71[0.55，0.90]，P=0.006）中，IOC 降低了 CRC 患者的死亡风险。亚组分析显示，在 II 期（HR=0.46，95%CI[0.31，0.67]）或 III 期疾病（HR=0.59，95%CI[0.45，0.76]）患者中，IOC 对生存的影响 HR 较低，无论术前放疗（HR=0.55，95%CI[0.45，0.68]）或术前化疗（HR=0.54，95%CI[0.44，0.66]）如何。
结论
IOC 是影响 CRC 患者生存的独立因素。它提高了根治性手术后 II 期和 III 期 CRC 患者的 OS。
试验注册
chictr.org.cn，ChiCTR2100043775。
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