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肺癌化疗期间患者报告的健康状况早期变化对临床结局的预测作用超过基线报告的预测:东部肿瘤协作组5592研究结果

Early change in patient-reported health during lung cancer chemotherapy predicts clinical outcomes beyond those predicted by baseline report: results from Eastern Cooperative Oncology Group Study 5592.

作者信息

Eton David T, Fairclough Diane L, Cella David, Yount Susan E, Bonomi Philip, Johnson David H

机构信息

Evanston Northwestern Healthcare and Northwestern University, Evanston, IL 60201, USA.

出版信息

J Clin Oncol. 2003 Apr 15;21(8):1536-43. doi: 10.1200/JCO.2003.07.128.

Abstract

PURPOSE

To determine the ability of longitudinal patient-reported health (PRH) scores to enhance prediction of clinical outcomes beyond baseline scores.

PATIENTS AND METHODS

In 573 advanced non-small-cell lung cancer patients enrolled in a phase III clinical trial, we used baseline and 6-week follow-up PRH scores to predict best response to treatment, disease progression, and survival. Using regression analyses, we tested the predictive ability of the five subscales of the Functional Assessment of Cancer Therapy-Lung (physical, functional, social/family, emotional well-being, and the lung cancer subscale) as well as the trial outcome index (TOI) aggregate score.

RESULTS

After clinical factors were controlled for, baseline physical well-being (PWB) and TOI scores predicted all three clinical outcomes. A higher baseline PWB score was associated with a better response to treatment (odds ratio, 1.09; P <.001) and lower risk of death (risk ratio, 0.95; P <.001). Higher baseline TOI score was associated with a lower risk of disease progression (risk ratio, 0.98; P <.001). These two baseline predictors (PWB and TOI) were then used along with 6-week change scores to classify patients into four groups: low baseline-declined, low baseline-improved, high baseline-declined, and high baseline-improved. Patients with low baseline-declined PWB scores showed the worst responses to treatment and survived the shortest duration. Patients with low baseline-declined TOI scores had the shortest time to progression.

CONCLUSION

The physical aspects of baseline PRH and PRH change during chemotherapy are significant predictors of clinical outcomes in lung cancer. This has implications for patient stratification in clinical trials and may aid decision-making in clinical practice.

摘要

目的

确定纵向患者报告健康(PRH)评分在增强对临床结局预测方面超越基线评分的能力。

患者与方法

在一项III期临床试验纳入的573例晚期非小细胞肺癌患者中,我们使用基线和6周随访PRH评分来预测治疗的最佳反应、疾病进展和生存情况。通过回归分析,我们测试了癌症治疗功能评估-肺癌(身体、功能、社会/家庭、情绪健康和肺癌子量表)的五个子量表以及试验结局指数(TOI)总分的预测能力。

结果

在控制临床因素后,基线身体幸福感(PWB)和TOI评分可预测所有三种临床结局。较高的基线PWB评分与更好的治疗反应相关(优势比,1.09;P<.001)以及较低的死亡风险(风险比,0.95;P<.001)。较高的基线TOI评分与较低的疾病进展风险相关(风险比,0.98;P<.001)。然后将这两个基线预测指标(PWB和TOI)与6周变化评分一起用于将患者分为四组:低基线下降、低基线改善、高基线下降和高基线改善。基线PWB评分低且下降的患者对治疗反应最差,生存时间最短。基线TOI评分低且下降的患者疾病进展时间最短。

结论

基线PRH的身体方面以及化疗期间PRH的变化是肺癌临床结局的重要预测指标。这对临床试验中的患者分层具有启示意义,并可能有助于临床实践中的决策制定。

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