Introduction/Background: Patients with locally advanced rectal cancer (LARC) with pathological complete response (pCR) after neoadjuvant chemo-radiotherapy (NCRT) are a privileged group because of the favorable progression of their disease. However, their follow-up patterns after surgery are similar to those of other groups with worse prognosis, with the consequent psychological and economic impact.Methods: This is a retrospective observational multicenter study with data obtained from the Spanish Rectal Cancer Project. Patients with LARC who underwent surgery with curative intent after NCRT and achieved pCR were selected. The last follow-up update was conducted in December 2021. A conditional survival model was used to analyze oncological outcomes during follow-up. Recurrence-free survival (RFS) was analyzed for the entire cohort of patients and for those who survived at one, two, and three years.Results: A total of 815 patients from 32 hospitals were included. Their mean age was 65.1 years, and 36.1% of them were women. Of the 815 patients, 35 died or experienced recurrence (local or systemic) in the first postoperative year, and 780 were included in the conditional survival analysis one year after surgery. The probability of RFS at 5 years was 86.5% in the whole cohort and 89.4%, 92.9%, and 95.2% for survivors at one, two, and three years, respectively. The probability of recurrence in these same groups was 6.5%, 4.3%, 1.8%, and 0.6%.Conclusions: Follow-up of patients with LARC and pCR after NCRT followed by surgery could be adapted based on conditional survival data showing that the probability of RFS increases as patients remain recurrence-free, and recurrences more than 3 years after treatment are exceptional.
引言/背景：局部进展期直肠癌患者在新辅助放化疗后达到病理完全缓解，因其疾病进展良好而属于预后优势群体。然而，术后随访模式却与其他预后较差群体相似，由此带来相应的心理和经济负担。 方法：本研究为回顾性观察性多中心研究，数据来源于西班牙直肠癌项目数据库。筛选标准为接受新辅助放化疗后行根治性手术并获得病理完全缓解的局部进展期直肠癌患者。末次随访更新时间为2021年12月。采用条件生存模型分析随访期间的肿瘤学结局，对全队列患者及术后1年、2年、3年无复发生存者分别进行无复发生存分析。 结果：共纳入来自32家医院的815例患者，平均年龄65.1岁，女性占比36.1%。术后第一年内共有35例患者死亡或出现局部/全身复发，术后满1年时780例患者纳入条件生存分析。全队列5年无复发生存率为86.5%，而术后1年、2年、3年无复发生存者的5年无复发生存率分别为89.4%、92.9%和95.2%。对应各组的累计复发率分别为6.5%、4.3%、1.8%和0.6%。 结论：基于条件生存数据显示，随着患者无复发生存时间延长，其无复发生存概率持续增加，且治疗3年后复发极为罕见。因此，对新辅助放化疗后手术获得病理完全缓解的局部进展期直肠癌患者，可依据该动态风险特征制定个体化随访策略。
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