Objectives:Additional adjuvant treatment in patients with rectal cancer with limited response to neoadjuvant treatment to mitigate their higher risk of treatment failure remains controversial.Methods:This is a post hoc analysis of a cohort study of 3 randomized phase 2 or 3 trials (CAO/ARO/AIO-94, -04, and -12 trial) that included 1948 patients with locally advanced rectal adenocarcinoma. After excluding patients with missing information, 1788 patients (1254 men and 524 women; median age: 62.6 years, age range: 19–84 years) were eligible. We analyzed the extent of tumor response and its association with the incidence of treatment failure after different neoadjuvant treatment approaches.Results:Tumor response was significantly enhanced with more intensive neoadjuvant treatment. After a median follow-up of 55 months for the entire cohort (IQR: 37 months–62 months), the incidence of treatment failure (TF) stratified by tumor response or post-neoadjuvant pathological outcome was not significantly affected by the intensity of neoadjuvant treatment, whereas the ypTNM stage was significantly associated with the risk of treatment failure.Conclusions:In this cohort study, we provide evidence that limited or no response to intensified neoadjuvant treatment protocols is not likely to be more strongly associated with an extensive risk of TF after 5-FU CRT+/− adjuvant chemotherapy.
目的:对于新辅助治疗反应有限的直肠癌患者,是否应增加辅助治疗以降低其较高的治疗失败风险,目前仍存在争议。方法:本研究为一项队列研究的事后分析,该队列研究纳入了3项随机II期或III期试验(CAO/ARO/AIO-94、-04和-12试验),共包括1948例局部晚期直肠腺癌患者。排除信息缺失的患者后,共有1788例患者(1254例男性和524例女性;中位年龄:62.6岁,年龄范围:19–84岁)符合条件。我们分析了不同新辅助治疗方案下肿瘤反应的程度及其与治疗失败发生率的关系。结果:更强化新辅助治疗显著增强了肿瘤反应。在整个队列中位随访55个月(四分位距:37个月–62个月)后,按肿瘤反应或新辅助治疗后病理结果分层的治疗失败(TF)发生率并未受到新辅助治疗强度的显著影响,而ypTNM分期与治疗失败风险显著相关。结论:在这项队列研究中,我们提供的证据表明,对于强化新辅助治疗方案反应有限或无反应的患者,其与5-FU放化疗±辅助化疗后广泛治疗失败风险的关联性可能并未更强。