Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Br J Surg. 2013 Jun;100(7):933-9. doi: 10.1002/bjs.9112. Epub 2013 Mar 27.
Neoadjuvant chemoradiotherapy (CRT) has been proven to increase local control in rectal cancer, but the optimal interval between CRT and surgery is still unclear. The purpose of this study was to analyse the influence of variations in clinical practice regarding timing of surgery on pathological response at a population level.
All evaluable patients who underwent preoperative CRT for rectal cancer between 2009 and 2011 were selected from the Dutch Surgical Colorectal Audit. The interval between radiotherapy and surgery was calculated from the start of radiotherapy. The primary endpoint was pathological complete response (pCR; pathological status after chemoradiotherapy (yp) T0 N0).
A total of 1593 patients were included. The median interval between radiotherapy and surgery was 14 (range 6-85, interquartile range 12-16) weeks. Outcome measures were calculated for intervals of less than 13 weeks (312 patients), 13-14 weeks (511 patients), 15-16 weeks (406 patients) and more than 16 weeks (364 patients). Age, tumour location and R0 resection rate were distributed equally between the four groups; significant differences were found for clinical tumour category (cT4: 17·3, 18·4, 24·5 and 26·6 per cent respectively; P = 0·010) and clinical metastasis category (cM1: 4·4, 4·8, 8·9 and 14·9 per cent respectively; P < 0·001). Resection 15-16 weeks after the start of CRT resulted in the highest pCR rate (18·0 per cent; P = 0·013), with an independent association (hazard ratio 1·63, 95 per cent confidence interval 1·20 to 2·23). Results for secondary endpoints in the group with an interval of 15-16 weeks were: tumour downstaging, 55·2 per cent (P = 0·165); nodal downstaging, 58·6 per cent (P = 0·036); and (near)-complete response, 23·2 per cent (P = 0·124).
Delaying surgery until the 15th or 16th week after the start of CRT (10-11 weeks from the end of CRT) seemed to result in the highest chance of a pCR.
新辅助放化疗（CRT）已被证明可提高直肠癌的局部控制率，但 CRT 与手术之间的最佳间隔时间仍不清楚。本研究旨在分析人群水平上手术时机的临床实践变化对病理反应的影响。
从荷兰外科结直肠审计中选择了 2009 年至 2011 年间接受术前 CRT 治疗的所有可评估直肠癌患者。从放疗开始计算放疗与手术之间的间隔。主要终点是病理完全缓解（pCR；放化疗后（yp）T0N0 的病理状态）。
共纳入 1593 例患者。放疗与手术的中位间隔时间为 14 周（范围 6-85 周，四分位间距 12-16 周）。计算了间隔时间小于 13 周（312 例）、13-14 周（511 例）、15-16 周（406 例）和大于 16 周（364 例）的结局指标。年龄、肿瘤位置和 R0 切除率在四组之间分布均匀；临床肿瘤分期（cT4：分别为 17.3%、18.4%、24.5%和 26.6%；P=0.010）和临床转移分期（cM1：分别为 4.4%、4.8%、8.9%和 14.9%；P<0.001）有显著差异。CRT 开始后 15-16 周行切除术可获得最高的 pCR 率（18.0%；P=0.013），且具有独立相关性（风险比 1.63，95%置信区间 1.20-2.23）。在间隔时间为 15-16 周的组中，次要终点的结果为：肿瘤降期 55.2%（P=0.165）；淋巴结降期 58.6%（P=0.036）；（近）完全缓解 23.2%（P=0.124）。
将手术推迟至 CRT 开始后第 15 或 16 周（距 CRT 结束后 10-11 周）似乎可获得最高的 pCR 机会。
