Department of Oncology, National Taiwan University, Taipei, Taiwan.
Oncologist. 2012;17(7):970-7. doi: 10.1634/theoncologist.2011-0411. Epub 2012 Jun 6.
The purpose of this study was to determine the prognostic significance of clinical factors and staging systems for survival of hepatocellular carcinoma (HCC) patients who are candidates for therapeutic clinical trials.
From December 1990 to July 2005, 236 patients with unresectable HCC were enrolled into six published phase II trials assessing various therapeutic regimens. Of these, 156 chemotherapy-naive patients with Child-Pugh class A and Barcelona Clinic Liver Cancer stage C disease were included in this analysis. Twenty-seven relevant clinical characteristics were analyzed to identify prognostic factors of survival. Beyond these prognosticators, the predictive ability of eight staging systems (the tumor-node-metastasis, Okuda, Cancer of the Liver Italian Program [CLIP], Chinese University Prognostic Index, Japanese Integrated Staging, Tokyo, National Taiwan University Risk Estimation, and Advanced Liver Cancer Prognostic System [ALCPS] score) were compared using the Akaike information criteria.
The median overall survival time was 129 days (95% confidence interval, 111-147 days). Significant predictors of a shorter overall survival time were an Eastern Cooperative Oncology Group performance status score ≥2, the presence of symptoms, ascites, an aspartate transaminase level more than two times the upper limit of normal, and regional lymph node involvement. The ALCPS and CLIP scores were superior to the other systems for predicting survival.
The prognosis of patients with advanced HCC who are candidates for therapeutic clinical trials is affected by several factors related to the patient, liver function, and the tumor. The ALCPS and CLIP scores appear to be superior to the other systems for predicting survival.
本研究旨在确定临床因素和分期系统对适合治疗性临床试验的肝细胞癌(HCC)患者生存的预后意义。
1990 年 12 月至 2005 年 7 月,共有 236 例不可切除 HCC 患者入组了评估各种治疗方案的六项已发表的 II 期临床试验。其中,有 156 例初治的 Child-Pugh 分级为 A 级和巴塞罗那临床肝癌分期 C 期的化疗初治患者纳入本分析。分析了 27 个相关的临床特征,以确定生存的预后因素。除了这些预后因素外,还使用赤池信息量准则比较了 8 种分期系统(肿瘤-淋巴结-转移、Okuda、意大利癌症肝脏计划、中国大学预后指数、日本综合分期、东京国立大学风险评估和先进的肝癌预后系统)的预测能力。
中位总生存时间为 129 天(95%置信区间,111-147 天)。总生存时间较短的显著预测因素包括东部肿瘤协作组体能状态评分≥2、存在症状、腹水、天冬氨酸转氨酶水平高于正常值的两倍和区域淋巴结受累。ALCPS 和 CLIP 评分优于其他系统预测生存。
适合治疗性临床试验的晚期 HCC 患者的预后受到与患者、肝功能和肿瘤相关的多个因素的影响。ALCPS 和 CLIP 评分似乎比其他系统更能预测生存。