Sidney Kimmel Comprehensive Cancer Center, Women's Malignancies Disease Group, Johns Hopkins University School of Medicine, Baltimore, MD.
AstraZeneca, Gaithersburg, MD.
JCO Oncol Pract. 2023 Nov;19(11):981-989. doi: 10.1200/OP.23.00038. Epub 2023 Sep 21.
Treatment-associated symptoms drive early discontinuation of adjuvant endocrine therapy (ET) for breast cancer. We hypothesized that symptom monitoring with electronic patient-reported outcomes (ePROs) during adjuvant ET will enhance symptom detection, symptom management, and persistence.
Eligible patients were initiating ET for stage 0-III breast cancer. Participants completed ePRO surveys via smartphone at baseline and 1, 3, 6, and 12 months. Measures included Patient-Reported Outcomes Measurement Information System Anxiety, Depression, Fatigue, and Vaginal Discomfort; plus Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items assessing joint pain, hot flashes, vaginal dryness, concentration problems, and memory problems. Scores surpassing prespecified thresholds triggered alerts, and recommended symptom management pathways were provided to clinicians. The primary objective was to evaluate feasibility, assessed by survey completion rates, with targets of >65% for the baseline survey and ≥1 follow-up survey during the first 6 months. Secondary objectives included 12-month ET discontinuation rate (target: ≤15%), describing symptoms and evaluating pathway implementation.
Among 250 participants, 73.2% completed the baseline survey and 69.6% completed ≥1 follow-up survey during the first 6 months. Thirty-one percent of participants had ≥1 symptom alert at baseline and 74% had ≥1 symptom alert during follow-up. The proportions of participants for whom pathway-concordant symptom management was documented at each time point ranged from 12.8% to 36.6%. Twenty-eight participants (11.2%) discontinued ET by 12 months.
Symptom monitoring with ePROs during adjuvant ET is feasible. Despite infrequent documentation of pathway-concordant symptom management after symptom alerts, ePROs were associated with favorable short-term ET persistence.
与治疗相关的症状会导致乳腺癌患者提前停止辅助内分泌治疗（ET）。我们假设在辅助 ET 期间使用电子患者报告结局（ePRO）进行症状监测将增强症状检测、症状管理和持续性。
符合条件的患者正在开始接受 0-III 期乳腺癌的 ET。参与者通过智能手机在基线和 1、3、6 和 12 个月时完成 ePRO 调查。评估指标包括患者报告的测量信息系统焦虑、抑郁、疲劳和阴道不适；以及患者报告的常见不良事件术语版本评估关节疼痛、热潮红、阴道干燥、注意力问题和记忆问题。超过预定阈值的评分会触发警报，并向临床医生提供推荐的症状管理途径。主要目标是评估完成率，基线调查完成率>65%，前 6 个月至少有 1 次后续调查。次要目标包括 12 个月的 ET 停药率（目标：≤15%），描述症状并评估途径的实施情况。
在 250 名参与者中，73.2%完成了基线调查，69.6%在头 6 个月内完成了≥1 次后续调查。31%的参与者在基线时有≥1 个症状警报，74%的参与者在随访中有≥1 个症状警报。在每个时间点，符合途径的症状管理被记录的参与者比例在 12.8%到 36.6%之间。28 名参与者（11.2%）在 12 个月内停止 ET。
在辅助 ET 期间使用 ePRO 进行症状监测是可行的。尽管在出现症状警报后，符合途径的症状管理很少有记录，但 ePRO 与短期 ET 持续时间的改善有关。
