Aims

Although there is emerging evidence to suggest equivalent oncological outcomes using a watch and wait approach compared with primary total mesorectal excision surgery, there is a paucity of evidence about the safety and efficacy of this approach in routine clinical practice. Here we report the long-term outcomes and quality of life from patients managed with watch and wait following a clinical complete response (cCR) to neoadjuvant therapy.

Materials and methods

Patients with adenocarcinoma of the rectum with cCR following neoadjuvant therapy managed using watch and wait were retrospectively identified. Demographic data, performance status, pretreatment staging information, oncological and surgical outcomes were obtained from routinely collected clinical data. Quality of life was measured by trained clinicians during telephone interviews.

Results

Over a 7-year period, 506 patients were treated for rectal cancer, 276 had neoadjuvant therapy and 72 had a cCR (26.1%). Sixty-three were managed with watch and wait. Thirteen patients had mucosal regrowth. There was no significant difference in the incidence of metastatic disease between the surgical and watch and wait cohorts (P = 0.38). The 13 patients with mucosal regrowth underwent salvage surgery. Eleven of the patients who underwent surgical resection had R0 resections. There was also a statistically and clinically significant improvement in the Functional Assessment of Cancer Therapy – Colorectal (FACT-C) trial outcome index (P = 0.022).

Conclusion

This study shows that watch and wait is safe and effective outside of tertiary referral centres. It suggests that an opportunistic cCR is durable and when mucosal regrowth occurs it can be salvaged. Finally, we have shown that quality of life is probably improved if a watch and wait approach is adopted.

中文翻译：

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在公共资助的综合医院中，使用观察和等待方法管理直肠癌是否可行、安全和有效？

目标

尽管有新的证据表明使用观察和等待方法与初次全直肠系膜切除手术相比具有相同的肿瘤学结果，但缺乏关于这种方法在常规临床实践中的安全性和有效性的证据。在这里，我们报告了在对新辅助治疗产生临床完全反应 (cCR) 后接受观察和等待管理的患者的长期结果和生活质量。

材料和方法

回顾性确定了使用观察和等待管理的新辅助治疗后具有 cCR 的直肠腺癌患者。从常规收集的临床数据中获得人口统计学数据、体能状态、治疗前分期信息、肿瘤学和手术结果。生活质量由训练有素的临床医生在电话采访中测量。

结果

在 7 年期间，506 名患者接受了直肠癌治疗，276 人接受了新辅助治疗，72 人获得了 cCR（26.1%）。63 人通过观察和等待进行管理。13 名患者出现黏膜再生。手术组和观察等待组的转移性疾病发生率无显着差异（P = 0.38）。13例黏膜再生患者接受了抢救手术。接受手术切除的患者中有 11 例进行了 R0 切除。癌症治疗功能评估 - 结直肠（FACT-C）试验结果指数也有统计学和临床​​显着改善（P = 0.022）。

结论

这项研究表明，在三级转诊中心之外，观察和等待是安全有效的。这表明机会性 cCR 是持久的，当发生粘膜再生时，它可以被挽救。最后，我们已经证明，如果采用观察和等待的方法，生活质量可能会得到改善。