Timing to achieve the highest rate of pCR after preoperative radiochemotherapy in rectal cancer: a pooled analysis of 3085 patients from 7 randomized trials
Timing to achieve the highest rate of pCR after preoperative radiochemotherapy in rectal cancer: a pooled analysis of 3085 patients from 7 randomized trials
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DOI：
10.1016/j.radonc.2020.09.026
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发表时间：
2021-01-01
影响因子：
5.7
通讯作者：
Valentini, Vincenzo
中科院分区：
文献类型：
--
作者：
Gambacorta, Maria Antonietta;Masciocchi, Carlotta;Valentini, Vincenzo
目的：局部进展期直肠癌（LARC）新辅助放化疗（Nad-CRT）后的最佳手术时机仍存在争议。本研究的主要目的是确定最佳手术间隔（SI），以达到最高的病理完全缓解率（pCR），其次根据SI评估对生存结局的影响。根据12/0405、EORTC 22921、FFCD 9203、CAO/ARO/AIO-94、CAO-ARO-AIO-04、INTERACT和TROG 01.04。入选标准为：年龄>= 18岁，cT 3 ~ T4和cN 0 -2，确诊时无远处转移临床证据，Nad-CRT后行手术治疗，分类变量采用Pearson卡方检验加Yates连续性校正，连续变量采用Mann-Whitney检验，Mann-Kendall检验，Kaplan-Meier曲线加log-rank检验，单因素和多因素Logistic回归模型进行数据分析。结果：3085例患者符合纳入标准。总体而言，中位SI为6周（范围1-31）时，pCR率为14%。在单因素和多因素logistic回归分析中，SI延长（p< 0.01）、放疗剂量（p <0.01）和Nad-CRT中添加奥沙利铂（p <0.01）对pCR有有利影响。此外，延长SI是不影响局部复发，距离转移，和总survival.Conclusion：这个汇总分析表明，最好的时间来实现pCR在LARC是在10周，考虑到延长SI是无害的生存结局。(C)2020爱思唯尔B. V.保留所有权利。
Purpose: Optimal timing of surgery after neoadjuvant chemoradiotherapy (Nad-CRT) is still controversial in locally advanced rectal cancer (LARC). The primary goal of this study was to determine the best surgical interval (SI) to achieve the highest rate of pathological complete response (pCR) and secondly to evaluate the effect on survival outcomes according to the SI.Patients and methods: Patients data were extracted from the international randomized trials: Accord12/0405, EORTC22921, FFCD9203, CAO/ARO/AIO-94, CAO-ARO-AIO-04, INTERACT and TROG01.04. Inclusion criteria were: age >= 18, cT3-T4 and cN0-2, no clinical evidence of distant metastasis at diagnosis, Nad-CRT followed by surgery.Pearson's Chi-squared test with Yates' continuity correction for categorical variables, the MannWhitney test for continuous variables, Mann-Kendall test, Kaplan-Meier curves with log-rank test, univariate and multivariate logistic regression model was used for data analysis. Results: 3085 patients met the inclusion criteria. Overall, the pCR rate was 14% at a median SI of 6 weeks (range 1-31). The cumulative pCR rate increased significantly when SI lengthened, with 95% of pCR events within 10 weeks from Nad-CRT.At univariate and multivariate logistic regression analysis, lengthening of SI (p< 0.01), radiotherapy dose (p< 0.01), and the addition of oxaliplatin to Nad-CRT (p< 0.01) had a favorable impact on pCR. Furthermore, lengthening of SI was not impact on local recurrences, distance metastases, and overall survival.Conclusion: This pooled analysis suggests that the best time to achieve pCR in LARC is at 10 weeks, considering that the lengthening of SI is not detrimental concerning survival outcomes. (C) 2020 Elsevier B.V. All rights reserved.