Joye Ines, Debucquoy Annelies, Fieuws Steffen, Wolthuis Albert, Sagaert Xavier, D'Hoore André, Haustermans Karin
a Department of Oncology , KU Leuven, University of Leuven , Leuven , Belgium ;
b Department of Radiation Oncology , University Hospitals Leuven , Leuven , Belgium ;
Acta Oncol. 2016 Aug;55(8):1047-52. doi: 10.3109/0284186X.2016.1167954. Epub 2016 May 4.
Rectal cancer patients who achieve a good response to chemoradiotherapy (CRT), may be offered less invasive surgery or even no surgery at all. Implementation of such a policy, however, requires precise patient selection. This study identifies pretreatment clinical factors that are associated with pathological complete response (pCR) and ypT0-1N0 and evaluates their performance as a selection tool for organ-preserving strategies.
Patients with rectal cancer treated with CRT and total mesorectal excision between January 2000 and December 2014 were retrospectively included. Following clinical characteristics were extracted from the medical files: age, gender, body mass index, ASA score, cT-stage, cN-stage, distance from the anal verge, pretreatment carcinoembryonic antigen (CEA), pretreatment hemoglobin and distance from the mesorectal fascia. Univariable and multivariable binary logistic regression models were used to predict pCR and ypT0-1N0. The discriminative ability of the prediction models was evaluated by receiver operating characteristic analysis.
A total of 620 patients were included of whom 120 experienced a pCR (19%) and 170 patients achieved ypT0-1N0 response (27%). A low pretreatment CEA, a high pretreatment hemoglobin and a high cN-stage were associated with pCR in multivariable analysis. A low pretreatment CEA, a low cT-stage and a high cN-stage were associated with ypT0-1N0. After cross validation, the area under the curve for the pCR and ypT0-1N0 prediction model equaled 0.609 and 0.632, respectively.
Despite their statistical significance, the value of pretreatment clinical variables in the prediction of pCR and ypT0-1N0 is very limited. To safely select patients for organ preservation, other strategies need to be explored.
对放化疗(CRT)反应良好的直肠癌患者,可能会接受侵入性较小的手术,甚至完全不进行手术。然而,实施这样的政策需要精确的患者选择。本研究确定与病理完全缓解(pCR)和ypT0-1N0相关的治疗前临床因素,并评估它们作为保留器官策略选择工具的性能。
回顾性纳入2000年1月至2014年12月期间接受CRT和全直肠系膜切除术治疗的直肠癌患者。从病历中提取以下临床特征:年龄、性别、体重指数、美国麻醉医师协会(ASA)评分、cT分期、cN分期、距肛缘距离、治疗前癌胚抗原(CEA)、治疗前血红蛋白以及距直肠系膜筋膜的距离。使用单变量和多变量二元逻辑回归模型预测pCR和ypT0-1N0。通过受试者工作特征分析评估预测模型的判别能力。
共纳入620例患者,其中120例实现pCR(19%),170例患者达到ypT0-1N0反应(27%)。多变量分析显示,治疗前CEA水平低、治疗前血红蛋白水平高和cN分期高与pCR相关。治疗前CEA水平低、cT分期低和cN分期高与ypT0-1N0相关。交叉验证后,pCR和ypT0-1N0预测模型的曲线下面积分别为0.609和0.632。
尽管具有统计学意义,但治疗前临床变量在预测pCR和ypT0-1N0方面的价值非常有限。为了安全地选择适合保留器官的患者,需要探索其他策略。