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结肠癌辅助治疗治愈的证据:基于18项随机试验中20898例患者个体数据的观察结果

Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials.

作者信息

Sargent Daniel, Sobrero Alberto, Grothey Axel, O'Connell Michael J, Buyse Marc, Andre Thierry, Zheng Yan, Green Erin, Labianca Roberto, O'Callaghan Chris, Seitz Jean Francois, Francini Guido, Haller Daniel, Yothers Greg, Goldberg Richard, de Gramont Aimery

机构信息

Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA.

出版信息

J Clin Oncol. 2009 Feb 20;27(6):872-7. doi: 10.1200/JCO.2008.19.5362. Epub 2009 Jan 5.

Abstract

PURPOSE

Limited data are available on the time course of treatment failures (recurrence and/or death), the nature and duration of adjuvant treatment benefit, and long-term recurrence rates in patients with resected stage II and III colon cancer.

METHODS

The data set assembled by the Adjuvant Colon Cancer Endpoints Group, a collection of individual patient data from 18 trials and more than 20,800 patients testing fluorouracil-based adjuvant therapy in patients with stage II or III colon cancer, was analyzed.

RESULTS

A significant overall survival (OS) benefit of adjuvant therapy was consistent over the 8-year follow-up period. The risk of recurrence in patients treated with adjuvant chemotherapy never exceeds that of control patients, signifying that adjuvant therapy cures some patients, as opposed to delaying recurrence. After 5 years, recurrence rates were less than 1.5% per year, and after 8 years, they were less than 0.5% per year. Significant disease-free survival (DFS) benefit from adjuvant chemotherapy was observed in the first 2 years. After 2 years, DFS rates in treated and control patients were not significantly different, and after 4 years, no trend toward benefit was demonstrated. This benefit was primarily driven by patients with stage III disease.

CONCLUSION

Adjuvant chemotherapy provides significant DFS benefit, primarily by reducing the recurrence rate, within the first 2 years of adjuvant therapy with some benefit in years 3 to 4, translating into long-term OS benefit. This reflects the curative role of chemotherapy in the adjuvant setting. After 5 years, recurrence rates in patients treated on clinical trials are low, and after 8 years, they are minimal; thus, long-term follow-up for recurrence is of little value.

摘要

目的

关于II期和III期结肠癌切除术后患者治疗失败(复发和/或死亡)的时间进程、辅助治疗获益的性质和持续时间以及长期复发率的数据有限。

方法

分析了由辅助性结肠癌终点研究组收集的数据集,该数据集来自18项试验的个体患者数据,超过20800例II期或III期结肠癌患者接受了基于氟尿嘧啶的辅助治疗。

结果

在8年的随访期内,辅助治疗具有显著的总生存(OS)获益。接受辅助化疗的患者的复发风险从未超过对照组患者,这表明辅助治疗治愈了一些患者,而不是延迟复发。5年后,复发率每年低于1.5%,8年后,每年低于0.5%。在最初2年观察到辅助化疗有显著的无病生存(DFS)获益。2年后,治疗组和对照组患者的DFS率无显著差异,4年后,未显示出获益趋势。这种获益主要由III期疾病患者驱动。

结论

辅助化疗在辅助治疗的前2年提供显著的DFS获益,主要是通过降低复发率,在第3至4年也有一定获益,转化为长期OS获益。这反映了化疗在辅助治疗中的治愈作用。5年后,临床试验中接受治疗的患者复发率较低,8年后,复发率极低;因此,对复发进行长期随访价值不大。

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