Ha Gi Won, Lee Min Ro
Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Korea.
Ann Surg Treat Res. 2020 Aug;99(2):97-109. doi: 10.4174/astr.2020.99.2.97. Epub 2020 Jul 31.
The role of adjuvant chemotherapy for patients with ypT0-2N0 rectal cancer following neoadjuvant chemoradiotherapy (nCRT) and curative surgery is uncertain. We performed a meta-analysis using selected studies to compare adjuvant chemotherapy with observation for this cohort of patients.
PubMed, Embase, and the Cochrane Library were searched. Data were pooled, and overall effect size was calculated using random effect models. Outcome measures were 5-year overall survival (OS), disease-free survival (DFS), local, and distant recurrence.
We included 17 nonrandomized studies for qualitative analysis and 16 nonrandomized studies that examined 4,747 patients for the meta-analysis. In analysis of patients with ypT0N0 rectal cancer, adjuvant chemotherapy had no significant effect on OS (odds ratio [OR], 1.53; 95% confidence interval [CI], 0.86-2.72; I = 27%), DFS (OR, 1.22; 95% CI, 0.61-2.42; I = 5%), local recurrence (OR, 0.78; 95% CI, 0.08-7.37; I = 0%), and distant recurrence (OR, 1.04; 95% CI, 0.41-2.62; I = 0%). In analysis of patients with ypT1-2N0 rectal cancer, adjuvant chemotherapy also had no significant effect on OS (OR, 2.15; 95% CI, 0.59-7.80; I = 26%), DFS (OR, 1.66; 95% CI, 0.35-7.85; I = 44%), local recurrence (OR, 2.56; 95% CI, 0.72-9.13; I = 0%), and distant recurrence (OR, 1.15; 95% CI, 0.23-5.87; I = 0%).
Adjuvant chemotherapy may have no oncologic benefits in patients with ypT0-2N0 rectal cancer after nCRT and radical surgery. Routine use of adjuvant chemotherapy for those patients may be avoided.
新辅助放化疗（nCRT）及根治性手术后，辅助化疗在ypT0-2N0期直肠癌患者中的作用尚不确定。我们通过纳入选定研究进行荟萃分析，比较该队列患者辅助化疗与观察等待的疗效。
检索了PubMed、Embase和Cochrane图书馆。汇总数据，并使用随机效应模型计算总体效应量。观察指标为5年总生存率（OS）、无病生存率（DFS）、局部和远处复发率。
我们纳入了17项非随机研究进行定性分析，16项非随机研究纳入荟萃分析，共涉及4747例患者。在对ypT0N0期直肠癌患者的分析中，辅助化疗对OS（比值比[OR]，1.53；95%置信区间[CI]，0.86-2.72；I² = 27%）、DFS（OR，1.22；95% CI，0.61-2.42；I² = 5%）、局部复发（OR，0.78；95% CI，0.08-7.37；I² = 0%）和远处复发（OR，1.04；95% CI，0.41-2.62；I² = 0%）均无显著影响。在对ypT1-2N0期直肠癌患者的分析中，辅助化疗对OS（OR，2.15；95% CI，0.59-7.80；I² = 26%）、DFS（OR，1.66；95% CI，0.35-7.85；I² = 44%）、局部复发（OR，2.56；95% CI，0.72-9.13；I² = 0%）和远处复发（OR，1.15；95% CI，0.23-5.87；I² = 0%）也无显著影响。
nCRT及根治性手术后，辅助化疗对ypT0-2N0期直肠癌患者可能无肿瘤学获益。可避免对这些患者常规使用辅助化疗。
