Yeo W, Mo F K F, Koh J, Chan A T C, Leung T, Hui P, Chan L, Tang A, Lee J J, Mok T S K, Lai P B S, Johnson P J, Zee B
Department of Clinical Oncology and Surgery, Centre for Clinical Trials, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, China.
Ann Oncol. 2006 Jul;17(7):1083-9. doi: 10.1093/annonc/mdl065. Epub 2006 Apr 6.
Patients with unresectable hepatocellular carcinoma (HCC) have a dismal prognosis. The objective of this study was to evaluate whether patient-reported baseline quality of life (QoL) measured by the EORTC QLQ-C30 instrument is predictive of survival for these patients.
Two hundred and thirty-three patients with unresectable HCC (mainly hepatitis B-associated) who were recruited into two separate randomized phase III clinical studies, based on palliative chemotherapy and palliative hormonal therapy, respectively, gave consent and received pretreatment QoL assessment. EORTC QLQ-C30 scores and clinical variables at the time of study entry were analyzed to identify factors that influenced survival by applying multivariate analysis. Independent prognostic factors for survival were studied by Cox regression analysis.
Median survival of the 233 patients was 5.5 months (95% CI 4.2-6.5 months). Significant independent predictors of shorter survival were advanced Okuda staging (P = 0.0030; HR = 2.058), high baseline total bilirubin (P = 0.0008; HR = 1.013) and worse QoL score in the appetite score domain (P = 0.0028; HR for 10 point increase = 1.070). Patients who were entered into the chemotherapy trial (P = 0.0002; HR = 0.503), those who scored better in the physical functioning domain (P = 0.0034; HR for 10 point decrease = 0.911) and the role functioning domain (P = 0.0383; HR for 10 point decrease = 0.944) of the QoL questionnaire, were associated with longer survival.
In the studied HCC population, patient-reported baseline QoL provides additional prognostic information that supplements traditional clinical factors, and is a new prognostic marker for survival for patients with unresectable HCC.
无法切除的肝细胞癌(HCC)患者预后不佳。本研究的目的是评估通过欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30)测量的患者报告的基线生活质量(QoL)是否可预测这些患者的生存情况。
233例无法切除的HCC患者(主要与乙型肝炎相关)分别基于姑息化疗和姑息激素治疗被纳入两项独立的随机III期临床研究,他们均签署了知情同意书并接受了治疗前的QoL评估。通过多变量分析对研究入组时的EORTC QLQ-C30评分和临床变量进行分析,以确定影响生存的因素。通过Cox回归分析研究生存的独立预后因素。
233例患者的中位生存期为5.5个月(95%可信区间4.2 - 6.5个月)。生存时间较短的显著独立预测因素为奥田分期晚期(P = 0.0030;风险比[HR] = 2.058)、基线总胆红素水平高(P = 0.0008;HR = 1.013)以及食欲评分领域的QoL评分较差(P = 0.0028;评分每增加10分的HR = 1.070)。进入化疗试验的患者(P = 0.0002;HR = 0.503)、在QoL问卷的身体功能领域(P = 0.0034;评分每降低10分的HR = 0.911)和角色功能领域(P = 0.0383;评分每降低10分的HR = 0.944)得分较高的患者,生存期较长。
在所研究的HCC人群中,患者报告的基线QoL提供了补充传统临床因素的额外预后信息,并且是无法切除的HCC患者生存的新预后标志物。