Zha Sijie, Li Ting, Zheng Qingshan, Li Lujin
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Pharmacol. 2022 Feb 9;13:826785. doi: 10.3389/fphar.2022.826785. eCollection 2022.
This study used model analysis to clarify the benefits and risks of postoperative adjuvant chemotherapy compared with surgery alone in patients with stage II/III colorectal cancer. Clinical trials involving patients with stage II/III colorectal cancer who underwent surgery alone or those who received post-surgical adjuvant chemotherapy were searched in the PubMed and embase databases. By establishing a survival model, the overall survival (OS) and disease-free survival (DFS) of patients who underwent surgery alone or postoperative adjuvant chemotherapy were quantitatively analyzed to compare the differences between the two. In addition, the incidence of grade 3/4 adverse reactions in the adjuvant chemotherapy group was analyzed using the random effects model in the single-arm meta-analysis. A total of 34 studies containing 33,069 patients were included in the analysis. This study found that postoperative adjuvant chemotherapy can effectively improve the OS and DFS of patients with colorectal cancer. The median OS of the adjuvant chemotherapy group and the surgery-only group was 118.8 months (95% CI: 96.6, 146.6) and 74.6 months (95% CI: 57.8, 96.1) respectively; and median DFS was 86.3 months (95% CI: 67.6, 110.6) and 40.8 months (95% CI: 23.7, 69.6) in the adjuvant chemotherapy and surgery-only groups, respectively. Common grade 3/4 adverse reactions in the adjuvant chemotherapy group include diarrhea, stomatitis, leukopenia, and nausea or vomiting, with an incidence of approximately 3%-6%. Patients with mid-stage colorectal cancer can benefit significantly from postoperative adjuvant chemotherapy. This study provides the necessary quantitative information for decision-making regarding the benefits and risks of receiving adjuvant chemotherapy after resection in patients with colorectal cancer.
本研究采用模型分析,以阐明II/III期结直肠癌患者术后辅助化疗与单纯手术相比的获益和风险。在PubMed和Embase数据库中检索了涉及接受单纯手术或术后辅助化疗的II/III期结直肠癌患者的临床试验。通过建立生存模型,对接受单纯手术或术后辅助化疗患者的总生存期(OS)和无病生存期(DFS)进行定量分析,以比较两者之间的差异。此外,在单臂荟萃分析中使用随机效应模型分析辅助化疗组3/4级不良反应的发生率。分析共纳入34项研究,包含33,069例患者。本研究发现,术后辅助化疗可有效改善结直肠癌患者的OS和DFS。辅助化疗组和单纯手术组的中位OS分别为118.8个月(95%CI:96.6, 146.6)和74.6个月(95%CI:57.8, 96.1);辅助化疗组和单纯手术组的中位DFS分别为86.3个月(95%CI:67.6, 110.6)和40.8个月(95%CI:23.7, 69.6)。辅助化疗组常见的3/4级不良反应包括腹泻、口腔炎、白细胞减少以及恶心或呕吐,发生率约为3%-6%。中期结直肠癌患者可从术后辅助化疗中显著获益。本研究为结直肠癌患者切除术后接受辅助化疗的获益和风险决策提供了必要的定量信息。