Basu A, Philip E J, Dewitt B, Hanmer J, Chattopadhyay A, Yau C, Melisko M E, Esserman L J
Department of Surgery, University of California San Francisco, San Francisco, CA 94115 USA.
School of Medicine, University of California San Francisco, San Francisco, CA 94115 USA.
NPJ Breast Cancer. 2020 Oct 14;6:52. doi: 10.1038/s41523-020-00193-6. eCollection 2020.
The majority of women diagnosed with breast cancer will experience some form of drug-related toxicity and subsequent impairments in Health-related Quality of Life (HRQoL). Despite this, HRQoL is assessed inconsistently and there is no validated method to integrate HRQoL data into the assessment of therapeutic agents. This proof of concept study utilizes data from the neoadjuvant I-SPY 2 clinical trial to describe the development of the Quality of Life Index (QoLI) measure. The QoLI represents a single composite score that incorporates validated longitudinal measures of clinical efficacy and QoL and one that permits a more comprehensive, direct comparison of individual therapeutic agents. Preliminary data suggest the QoLI is able to distinguish between agents based on their efficacy and toxicity; with further validation, the QoLI has the potential to provide more patient-centered evaluations in clinical trials and help guide treatment decision making in breast cancer and other oncologic diseases.
大多数被诊断为乳腺癌的女性会经历某种形式的药物相关毒性以及随后与健康相关的生活质量（HRQoL）受损。尽管如此，HRQoL的评估并不一致，并且没有经过验证的方法将HRQoL数据纳入治疗药物的评估中。这项概念验证研究利用新辅助I-SPY 2临床试验的数据来描述生活质量指数（QoLI）测量方法的开发。QoLI代表一个单一的综合评分，它纳入了经过验证的临床疗效和QoL纵向测量指标，并且能够对各个治疗药物进行更全面、直接的比较。初步数据表明QoLI能够根据药物的疗效和毒性进行区分；经过进一步验证后，QoLI有可能在临床试验中提供更多以患者为中心的评估，并有助于指导乳腺癌和其他肿瘤疾病的治疗决策。
