Is adjuvant chemotherapy necessary for patients with ypT0–2N0 rectal cancer treated with neoadjuvant chemoradiotherapy and curative surgery?

对于新辅助放化疗加根治性手术的ypT0–2N0直肠癌患者,辅助化疗是必要的吗?

Background and objective:The benefit from adjuvant chemotherapy for patients treated with neoadjuvant chemoradiotherapy(NCRT)and curative surgery remains controversial,particularly among those responding well to NCRT.This retrospective study aimed to clarify the benefits of adjuvant chemotherapy in terms of the oncological outcomes of patients with ypT0–2N0 rectal cancer after NCRT and curative surgery.Methods:All patients with ypT0–2N0 rectal cancer after NCRT and curative resection between 2005 and 2014 were examined.The oncological outcomes between patients treated with adjuvant chemotherapy and those without any chemotherapy were compared.Results:The clinicopathological characteristics of 110 patients were reviewed in this study;one patient was excluded due to lack of follow-up.Of the 109 patients included,58(53.2%)underwent adjuvant chemotherapy(chemo group),whereas the remaining 51(46.8%)did not receive any chemotherapy(non-chemo group).After a median follow-up of 50 months,there were no significant differences in the 5-year overall survival(OS)or recurrence-free survival(RFS)rates between the groups(OS:92.1 vs 86.3%,P=0.375;RFS:80.9 vs 74.7%,P=0.534).Subgroup analysis also demonstrated no significant differences in 5-year OS and RFS rates between patients with ypT0N0 rectal cancer(P=0.712 and P=0.599,respectively)and those with ypT1–2N0 disease(P=0.255 and P=0.278,respectively).Conclusions:These results indicate that patients with ypT0–2N0 rectal cancer after NCRT followed by curative surgery may not derive significant benefit from adjuvant chemotherapy.However,further prospective randomized trials,with larger sample sizes,are warranted to confirm this conclusion.

背景与目的:辅助化疗能否令新辅助放化疗加根治性手术的直肠癌患者受益仍存在争议,尤其是对于那些新辅助放化疗反应良好者。本回顾性研究旨在明确辅助化疗能否给新辅助放化疗加根治性手术的ypT0-2N0直肠癌患者带来肿瘤学获益。方法:回顾性收集2005-2014年间中国医学科学院肿瘤医院接受新辅助放化疗加根治性手术处理的ypT0-2N0直肠癌患者。将术后接受与不接受辅助化疗的两组患者进行预后比较。结果:收集到110例患者的临床病理资料,其中1例患者因缺乏随访资料而删去。最终纳入研究的109例患者中,58例(53.2%)接受了辅助化疗(化疗组),51例(46.8%)未辅助化疗(未化疗组)。中位随访时间为50个月。两组患者的5年总生存率(OS)和5年无复发生存率(RFS)的差异均无统计学意义(5年OS:92.1%vs.86.3%,P=0.375;5年RFS:80.9%vs.74.7%,P=0.534)。分层分析结果显示,无论是ypT0N0还是ypT1-2N0患者,化疗组与非化疗组之间的5年OS和5年RFS的差异均无统计学意义(均P>0.05)。结论:对于接受新辅助放化疗和根治性手术治疗的ypT0–2N0直肠癌患者,辅助化疗并不能显著改善其预后。但该结论还有待于更大样本量的前瞻性临床随机对照试验来进行验证。