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新辅助放化疗后临床完全缓解的直肠癌患者采用观察等待策略与手术切除的比较。

The watch-and-wait strategy versus surgical resection for rectal cancer patients with a clinical complete response after neoadjuvant chemoradiotherapy.

机构信息

Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China.

Department of Endoscopy, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.

出版信息

Radiat Oncol. 2021 Jan 19;16(1):16. doi: 10.1186/s13014-021-01746-0.

Abstract

BACKGROUND

The watch-and-wait strategy offers a non-invasive therapeutic alternative for rectal cancer patients who have achieved a clinical complete response (cCR) after chemoradiotherapy. This study aimed to investigate the long-term clinical outcomes of this strategy in comparation to surgical resection.

METHODS

Stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy and achieved a cCR were selected from the databases of three centers. cCR was evaluated by findings from digital rectal examination, colonoscopy, and radiographic images. Patients in whom the watch-and-wait strategy was adopted were matched with patients who underwent radical resection through 1:1 propensity score matching analyses. Survival was calculated and compared in the two groups using the Kaplan-Meier method with the log rank test.

RESULTS

A total of 117 patients in whom the watch-and-wait strategy was adopted were matched with 354 patients who underwent radical resection. After matching, there were 94 patients in each group, and no significant differences in term of age, sex, T stage, N stage or tumor location were observed between the two groups. The median follow-up time was 38.2 months. Patients in whom the watch-and-wait strategy was adopted exhibited a higher rate of local recurrences (14.9% vs. 1.1%), but most (85.7%) were salvageable. Three-year non-regrowth local recurrence-free survival was comparable between the two groups (98% vs. 98%, P = 0.506), but the watch-and-wait group presented an obvious advantage in terms of sphincter preservation, especially in patients with a tumor located within 3 cm of the anal verge (89.7% vs. 41.2%, P < 0.001). Three-year distant metastasis-free survival (88% in the watch-and-wait group vs. 89% in the surgical group, P = 0.874), 3-year disease-specific survival (99% vs. 96%, P = 0.643) and overall survival (99% vs. 96%, P = 0.905) were also comparable between the two groups, although a higher rate (35.7%) of distant metastases was observed in patients who exhibited local regrowth in the watch-and-wait group.

CONCLUSION

The watch-and-wait strategy was safe, with similar survival outcomes but a superior sphincter preservation rate as compared to surgery in rectal cancer patients achieving a cCR after neoadjuvant chemoradiotherapy, and could be offered as a promising conservative alternative to invasive radical surgery.

摘要

背景

对于接受新辅助放化疗后达到临床完全缓解(cCR)的直肠癌患者,观察等待策略提供了一种非侵入性的治疗选择。本研究旨在比较该策略与手术切除的长期临床结果。

方法

从三个中心的数据库中选择接受新辅助放化疗且达到 cCR 的 II/III 期直肠腺癌患者。cCR 通过直肠指检、结肠镜检查和影像学检查结果进行评估。对采用观察等待策略的患者通过 1:1 倾向评分匹配分析与接受根治性切除术的患者进行匹配。使用 Kaplan-Meier 方法和对数秩检验计算并比较两组的生存情况。

结果

共有 117 例采用观察等待策略的患者与 354 例接受根治性切除术的患者相匹配。匹配后,每组有 94 例患者,两组在年龄、性别、T 分期、N 分期或肿瘤位置方面无显著差异。中位随访时间为 38.2 个月。采用观察等待策略的患者局部复发率较高(14.9%比 1.1%),但多数(85.7%)可挽救。两组 3 年无复发生存率相近(98%比 98%,P=0.506),但观察等待组在保肛方面具有明显优势,尤其是肿瘤位于肛缘 3cm 以内的患者(89.7%比 41.2%,P<0.001)。3 年无远处转移生存率(观察等待组 88%比手术组 89%,P=0.874)、3 年疾病特异性生存率(99%比 96%,P=0.643)和总生存率(99%比 96%,P=0.905)在两组之间也相似,尽管观察等待组中局部复发的患者远处转移率较高(35.7%)。

结论

对于接受新辅助放化疗后达到 cCR 的直肠癌患者,观察等待策略是安全的,与手术相比,其生存结果相似,但保肛率更高,可作为一种有前途的非侵入性根治性手术替代方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ffb/7816381/408268592e39/13014_2021_1746_Fig1_HTML.jpg

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