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  • Title: Patient-Reported Outcomes and Early Discontinuation in Aromatase Inhibitor-Treated Postmenopausal Women With Early Stage Breast Cancer.
    Author: Kadakia KC, Snyder CF, Kidwell KM, Seewald NJ, Flockhart DA, Skaar TC, Desta Z, Rae JM, Otte JL, Carpenter JS, Storniolo AM, Hayes DF, Stearns V, Henry NL.
    Journal: Oncologist; 2016 May; 21(5):539-46. PubMed ID: 27009936.
    Abstract:
    BACKGROUND: Early discontinuation of aromatase inhibitors (AIs) is common and leads to poor outcomes but is challenging to predict. In the Exemestane and Letrozole Pharmacogenetics trial, a high rate of early discontinuation due to intolerance was observed. We hypothesized that early changes in patient-reported outcomes (PROs) predict AI discontinuation and that biochemical factors are associated with changes in PROs. PATIENTS AND METHODS: Postmenopausal women with early-stage breast cancer enrolled in a prospective randomized trial of exemestane versus letrozole completed questionnaires at baseline and serially over 24 months to assess overall quality of life (EuroQOL Visual Analog Scale [VAS]); mood; and multiple symptoms, including a musculoskeletal symptom cluster. A joint mixed-effects/survival model was used to estimate the effect of the change in PROs on AI discontinuation. Associations between biochemical factors and change in PROs were examined. RESULTS: A total of 490 patients were analyzed. Worsening of EuroQOL VAS and the musculoskeletal cluster were associated with the highest risk for early discontinuation (hazard ratio [HR], 2.77 [95% confidence interval (CI), 2.72-2.81; p = .015]; HR, 4.39 [95% CI, 2.40-8.02; p < .0001], respectively). Pharmacokinetics and estrogen metabolism were not consistently associated with change in PRO measures. No clinically significant differences in any PRO between AIs were observed. CONCLUSION: Changes in PROs early during AI therapy were associated with treatment discontinuation. Identification of these changes could be used to target interventions in patients at high risk for early discontinuation. IMPLICATIONS FOR PRACTICE: Early changes in patient-reported outcomes (PROs) can predict nonpersistence to aromatase inhibitor therapy. If used in clinical practice, PROs might identify women at highest risk for early discontinuation and allow for interventions to improve tolerance before significant toxicities develop. Further research is needed to improve capturing PROs in routine clinical practice. 摘要 背景. 芳香化酶抑制剂 (AI) 早期停药很常见, 可导致转归不良, 但又难以预测。在依西美坦和来曲唑的药物遗传学研究中, 观察到很高比例的早期停药是由不耐受引起。我们假设患者报告转归 (PRO) 的早期改变可预测 AI 停药, 而且生化因素与 PRO 的改变有关。 患者与方法. 一项比较依西美坦与来曲唑的前瞻性随机临床试验纳入了绝经后早期乳腺癌女性患者, 其中患者在基线以及 24 个月期间连续完成问卷以评估总体生活质量[EuroQOL视觉模拟量表 (VAS) ]、心境, 以及包括肌肉骨骼症状簇在内的多种症状。使用联合混合效应/生存模型估算 PRO 改变对 AI 停药的影响。对生化因素与 PRO 改变之间的相关性进行检验。 结果. 共对 490 例患者进行了分析。 EuroQOL VAS 分数变差及肌肉骨骼症状簇与最高等级的早期停药风险相关, 风险比 (HR) 分别为 2.77 [95%置信区间 (CI): 2.72∼2.81) P=0.015]和 4.39 (95%CI: 2.40∼8.02, P<0.0001)。药代动力学及雌激素代谢与 PRO 测值变化之间不存在一贯的相关性。未观察到不同 AI 的各种 PRO 之间存在具有临床意义的差异。 结论. AI治疗期间的PRO早期改变与停药相关。鉴别出这些改变有助于对早期停药高危患者采取有针对性的干预措施。The Oncologist 2016;21:539–546 对临床实践的提示: 患者报告转归 (PRO) 的早期改变可预测患者对芳香化酶抑制剂治疗的不依从。如将 PRO 用于临床实践, 也许能鉴别出早期停药的最高危患者, 使得医生能够在出现明显的毒性之前对其进行干预以改善耐受性。有必要开展进一步的研究以改进 PRO 在日常临床工作中的采集。
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