患者因素对结肠癌患者复发风险及奥沙利铂获益时间依赖性的影响：来自辅助结肠癌终点（ACCENT）数据库现代辅助研究的分析
Impact of Patient Factors on Recurrence Risk and Time Dependency of Oxaliplatin Benefit in Patients With Colon Cancer: Analysis From Modern-Era Adjuvant Studies in the Adjuvant Colon Cancer End Points (ACCENT) Database.
作者信息
Shah Manish A, Renfro Lindsay A, Allegra Carmen J, André Thierry, de Gramont Aimery, Schmoll Hans-Joachim, Haller Daniel G, Alberts Steven R, Yothers Greg, Sargent Daniel J
机构信息
Manish A. Shah, Weill Cornell Medical College, New York/Presbyterian Hospital, New York, NY; Lindsay A. Renfro, Steven R. Alberts, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Carmen J. Allegra, University of Florida, Gainesville, FL; Thierry André, Hôpital Saint Antoine, Paris; Aimery de Gramont, Franco-British Institute, Levallois-Perret, France; Hans-Joachim Schmoll, University Clinic Halle (Saale), Halle, Germany; Daniel G. Haller, University of Pennsylvania, Philadelphia; and Greg Yothers, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA.
出版信息
J Clin Oncol. 2016 Mar 10;34(8):843-53. doi: 10.1200/JCO.2015.63.0558. Epub 2016 Jan 25.
PURPOSE
Fluorouracil plus leucovorin (FU + LV) adjuvant chemotherapy reduced the risk of recurrence and death across all time points in a pooled analysis of 20,898 patients with colon cancer from 18 randomized studies. The impact of oxaliplatin added to FU + LV on the time course of recurrence and survival remains unknown.
PATIENTS AND METHODS
A total of 12,233 patients enrolled to the randomized trials C-07, C-08, N0147, MOSAIC (Adjuvant Treatment of Colon Cancer), and XELOXA (Adjuvant XELOX) were pooled to examine the impact of oxaliplatin and tumor-specific factors on the time course of recurrence and death. For each end point, continuous-time risk was modeled over 6 years post treatment in all oxaliplatin-treated patients and patients concurrently randomized to FU + LV with or without oxaliplatin; the latter analyses supported time-dependent treatment comparisons.
RESULTS
Addition of oxaliplatin significantly reduced the risk of recurrence within the first 14 months post treatment for patients with stage II disease and within the first 4 years for patients with stage III disease. Oxaliplatin also significantly reduced risk of death from 2 to 6 years post treatment for patients with stage III disease, with no differences in timing of outcomes between treatment groups (ie, oxaliplatin did not simply postpone recurrence or death compared with FU + LV alone). Patients with stage II disease receiving oxaliplatin did not exhibit a significant reduction in risk of death in the first 6 years post treatment. Recurrence risk peaked near 14 months for both treatments, and risk of recurrence and death increased with increased tumor and nodal burden.
CONCLUSIONS
These analyses support the addition of oxaliplatin to fluoropyrimidine-based adjuvant therapy in patients with stage III disease and underscore the need for adequate surveillance of patients with colon cancer during the first 3 years after adjuvant therapy.
目的
在一项对来自18项随机研究的20898例结肠癌患者的汇总分析中，氟尿嘧啶加亚叶酸钙（FU + LV）辅助化疗在所有时间点均降低了复发和死亡风险。在FU + LV基础上加用奥沙利铂对复发和生存时间进程的影响尚不清楚。
患者与方法
汇总了随机试验C-07、C-08、N0147、MOSAIC（结肠癌辅助治疗）和XELOXA（辅助性XELOX）中的12233例患者，以研究奥沙利铂和肿瘤特异性因素对复发和死亡时间进程的影响。对于每个终点，在所有接受奥沙利铂治疗的患者以及同时随机接受FU + LV联合或不联合奥沙利铂治疗的患者中，对治疗后6年内的连续时间风险进行建模；后者的分析支持了时间依赖性治疗比较。
结果
对于II期疾病患者，加用奥沙利铂可显著降低治疗后前14个月内的复发风险；对于III期疾病患者，可显著降低治疗后前4年内的复发风险。奥沙利铂还显著降低了III期疾病患者治疗后2至6年的死亡风险，各治疗组之间的结局时间无差异（即，与单独使用FU + LV相比，奥沙利铂并非只是推迟复发或死亡）。接受奥沙利铂治疗的II期疾病患者在治疗后前6年内的死亡风险未显著降低。两种治疗的复发风险均在14个月左右达到峰值，且复发和死亡风险随肿瘤和淋巴结负担的增加而增加。
结论
这些分析支持在III期疾病患者中于基于氟嘧啶的辅助治疗中加用奥沙利铂，并强调在辅助治疗后的前3年内对结肠癌患者进行充分监测的必要性。
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