Efficace Fabio, Therasse Patrick, Piccart Martine J, Coens Corneel, van Steen Kristel, Welnicka-Jaskiewicz Marzena, Cufer Tanja, Dyczka Jaroslaw, Lichinitser Michail, Shepherd Lois, de Haes Hanneke, Sprangers Mirjam A, Bottomley Andrew
European Organisation for Research and Treatment of Cancer, EORTC Data Center, Quality of Life Unit, Ave E Mounier 83, 1200 Brussels, Belgium.
J Clin Oncol. 2004 Aug 15;22(16):3381-8. doi: 10.1200/JCO.2004.02.060.
The purpose of this research was to evaluate whether baseline health-related quality of life (HRQOL) parameters are prognostic factors for survival in locally advanced breast cancer patients. Although the literature highlights the important role of HRQOL parameters in predicting survival in advanced metastatic disease, little evidence exists for earlier stages.
The overall sample consisted of 448 patients randomly assigned to receive cyclophosphamide, epirubicin, and fluorouracil versus epirubicin, cyclophosphamide, and granulocyte colony-stimulating factor. Patients were enrolled in 12 countries. HRQOL baseline scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap resampling technique was used to assess the stability of the outcomes. Bootstrap results were then applied for model averaging purposes as a means to account for the observed model selection uncertainty.
The final multivariate model retained inflammatory breast cancer (T4d) as the only factor predicting overall survival (OS) with a hazard ratio of 1.375 (95% CI, 1.027 to 1.840; P =.03). The presence of inflammatory breast cancer lowers the median survival time from 6.6 to 4.2 years (36% reduction). None of the preselected HRQOL variables were prognostic for OS or disease-free survival, in either the univariate or multivariate analysis.
Our findings suggest that baseline HRQOL parameters have no prognostic value in a nonmetastatic breast cancer population.
本研究旨在评估基线健康相关生活质量（HRQOL）参数是否为局部晚期乳腺癌患者生存的预后因素。尽管文献强调了HRQOL参数在预测晚期转移性疾病生存中的重要作用，但早期阶段的证据较少。
总体样本包括448例患者，随机分配接受环磷酰胺、表柔比星和氟尿嘧啶与表柔比星、环磷酰胺和粒细胞集落刺激因子治疗。患者来自12个国家。使用欧洲癌症研究与治疗组织生活质量问卷C30评估HRQOL基线评分。采用Cox比例风险回归模型进行生存的单变量和多变量分析。此外，使用自助重采样技术评估结果的稳定性。然后将自助结果应用于模型平均，以考虑观察到的模型选择不确定性。
最终的多变量模型保留炎性乳腺癌（T4d）作为预测总生存期（OS）的唯一因素，风险比为1.375（95%CI，1.027至1.840；P=0.03）。炎性乳腺癌的存在使中位生存时间从6.6年降至4.2年（降低36%）。在单变量或多变量分析中，预先选择的HRQOL变量均对OS或无病生存期无预后价值。
我们的研究结果表明，基线HRQOL参数在非转移性乳腺癌人群中无预后价值。
