Department of Oncology, Unit of Medical Oncology, Azienda USL2 Lucca Via dell'Ospedale 1, 55100 Lucca, Italy.
Department of Medical Oncology, San Raffaele Scientific Institute, 20133 Milano, Italy.
Br J Cancer. 2014 Apr 29;110(9):2165-9. doi: 10.1038/bjc.2014.190. Epub 2014 Apr 8.
The role of second-line chemotherapy (CT) is not established in advanced biliary tract cancer (aBTC). We investigated the outcome of aBTC patients treated with second-line CT and devised a prognostic model.
Baseline clinical and laboratory data of 300 consecutive aBTC patients were collected and association with overall survival (OS) was investigated by multivariable Cox models.
The following parameters resulted independently associated with longer OS: Eastern Cooperative Oncology Group performance status of 0 (P<0.001; hazard ratio (HR), 0.348; 95% confidence interval (CI) 0.215-0.562), CA19.9 lower than median (P=0.013; HR, 0.574; 95% CI 0.370-0.891), progression-free survival after first-line CT ≥ 6 months (P=0.027; HR, 0.633; 95% CI 0.422-0.949) and previous surgery on primary tumour (P=0.027; HR, 0.609; 95% CI 0.392-0.945). We grouped the 249 patients with complete data available into three categories according to the number of fulfilled risk factors: median OS times for good-risk (zero to one factors), intermediate-risk (two factors) and poor-risk (three to four factors) groups were 13.1, 6.6 and 3.7 months, respectively (P<0.001).
Easily available clinical and laboratory factors predict prognosis of aBTC patients undergoing second-line CT. This model allows individual patient-risk stratification and may help in treatment decision and trial design.
二线化疗（CT）在晚期胆道癌（aBTC）中的作用尚未确定。我们研究了接受二线 CT 治疗的 aBTC 患者的结果，并设计了一个预后模型。
收集了 300 例连续 aBTC 患者的基线临床和实验室数据，并通过多变量 Cox 模型研究其与总生存期（OS）的关系。
以下参数与更长的 OS 独立相关：东部肿瘤协作组表现状态为 0（P<0.001；风险比（HR），0.348；95%置信区间（CI），0.215-0.562），CA19.9 低于中位数（P=0.013；HR，0.574；95%CI，0.370-0.891），一线 CT 后无进展生存期≥6 个月（P=0.027；HR，0.633；95%CI，0.422-0.949）和原发性肿瘤的先前手术（P=0.027；HR，0.609；95%CI，0.392-0.945）。我们根据满足风险因素的数量将 249 例具有完整数据的患者分为三组：良好风险（零至一个因素）、中危（两个因素）和差危（三个至四个因素）组的中位 OS 时间分别为 13.1、6.6 和 3.7 个月，差异有统计学意义（P<0.001）。
易于获得的临床和实验室因素可预测接受二线 CT 治疗的 aBTC 患者的预后。该模型可对患者进行个体风险分层，并有助于治疗决策和试验设计。
