Division of General Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada; Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada; Department of Surgery, St Michael's Hospital, Toronto, ON, Canada.
Division of General Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada.
Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4.
A watch-and-wait approach for patients with clinical complete response to neoadjuvant chemoradiation could avoid the morbidity of conventional surgery for rectal cancer. However, the safety of this approach is unclear. We synthesised the evidence for watch-and-wait as a treatment for rectal cancer.
We systematically searched MEDLINE, Embase, and the grey literature (up to June 28, 2016) for studies of patients with rectal adenocarcinoma managed by watch-and-wait after complete clinical response to neoadjuvant chemoradiation. We determined the proportion of 2-year local regrowth after watch-and-wait. We assessed non-regrowth recurrence, cancer-specific mortality, disease-free survival, and overall survival from studies comparing patients who had watch-and-wait versus those who had radical surgery after detection of clinical complete response or versus patients with pathological complete response.
We identified 23 studies including 867 patients with median follow-up of 12-68 months. Pooled 2-year local regrowth was 15·7% (95% CI 11·8-20·1); 95·4% (95% CI 89·6-99·3) of patients with regrowth had salvage therapies. There was no significant difference between patients managed with watch-and-wait after a clinical complete response and patients with pathological complete response identified at resection with respect to non-regrowth recurrence (risk ratio [RR] 1·46, 95% CI 0·70-3·05) or cancer-specific mortality (RR 0·87, 95% CI 0·38-1·99). Although there was no significant difference in overall survival between groups (hazard ratio [HR] 0·73, 95% CI 0·35-1·51), disease-free survival was better in the surgery group (HR 0·47, 95% CI 0·28-0·78). We found no significant difference between patients managed with watch-and-wait and patients with clinical complete response treated with surgery in terms of non-regrowth recurrence (RR 0·58, 95% CI 0·18-1·90), cancer-specific mortality (RR 0·58, 95% CI 0·06-5·84), disease-free survival (HR 0·56, 95% CI 0·20-1·60), or overall survival (HR 3·91, 95% CI 0·57-26·72).
Most patients treated by watch-and-wait avoid radical surgery and of those who have regrowth almost all have salvage therapy. Although we detected no significant differences in non-regrowth cancer recurrence or overall survival in patients treated with watch-and-wait versus surgery, few patients have been studied and more prospective studies are needed to confirm long-term safety.
None.
对于新辅助放化疗后出现临床完全缓解的患者，观察等待的方法可以避免常规手术治疗直肠癌带来的发病率。但是，这种方法的安全性还不清楚。我们对观察等待作为直肠癌治疗方法的证据进行了综合分析。
我们系统地检索了 MEDLINE、Embase 和灰色文献（截至 2016 年 6 月 28 日），以寻找接受新辅助放化疗后完全临床缓解的直肠腺癌患者接受观察等待治疗的研究。我们确定了观察等待后 2 年局部复发的比例。我们评估了无复发肿瘤的复发、癌症特异性死亡率、无病生存率和总生存率，比较了接受观察等待治疗的患者与检测到临床完全缓解后接受根治性手术治疗的患者或与病理完全缓解的患者。
我们确定了 23 项研究，包括 867 例患者，中位随访时间为 12-68 个月。2 年局部复发的累积率为 15.7%（95%CI 11.8-20.1）；95.4%（95%CI 89.6-99.3）的复发患者接受了挽救治疗。与接受手术治疗的病理完全缓解患者相比，接受观察等待治疗的临床完全缓解患者在无复发肿瘤的复发（风险比[RR]1.46，95%CI 0.70-3.05）或癌症特异性死亡率（RR 0.87，95%CI 0.38-1.99）方面没有显著差异。尽管两组的总生存率没有显著差异（HR 0.73，95%CI 0.35-1.51），但手术组的无病生存率更好（HR 0.47，95%CI 0.28-0.78）。我们发现，与接受手术治疗的临床完全缓解患者相比，接受观察等待治疗的患者在无复发肿瘤的复发（RR 0.58，95%CI 0.18-1.90）、癌症特异性死亡率（RR 0.58，95%CI 0.06-5.84）、无病生存率（HR 0.56，95%CI 0.20-1.60）或总生存率（HR 3.91，95%CI 0.57-26.72）方面均无显著差异。
大多数接受观察等待治疗的患者避免了根治性手术，而那些复发的患者几乎都接受了挽救治疗。尽管我们没有检测到接受观察等待治疗与手术治疗的患者在无复发肿瘤的癌症复发或总生存率方面有显著差异，但研究的患者数量较少，需要更多的前瞻性研究来证实长期安全性。
无。
