Results of a Real-world Study of Enzalutamide and Abiraterone Acetate With Prednisone Tolerability (REAAcT)
Results of a Real-world Study of Enzalutamide and Abiraterone Acetate With Prednisone Tolerability (REAAcT)
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DOI：
10.1016/j.clgc.2019.07.017
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发表时间：
2019-12-01
影响因子：
3.2
通讯作者：
McGowan, Tracy
中科院分区：
文献类型：
--
作者：
Shore, Neal D.;Saltzstein, Daniel;McGowan, Tracy
REAAcT是一项前瞻性的、现实世界证据为基础的、对恩杂鲁胺或醋酸阿比特龙加强的松治疗转移性去势抵抗性前列腺癌患者耐受性的正面研究。两组的基线值相似，包括约20%的认知障碍。治疗2个月后，与醋酸阿比特龙加强的松相比，恩杂鲁胺组的疲劳和神经认知差异更大。未观察到其他显著差异。背景：本研究的目的是评估恩杂鲁胺（ENZA）或醋酸阿比特龙加强的松（AA+P）治疗转移性去势抵抗性前列腺癌患者的耐受性差异。患者和方法：这是一项IV期、前瞻性、开放标签、多中心、真实世界的研究。在治疗医师的判断下，患者被开了ENZA或AA+P。在基线和2个月时对4个认知领域（Cogstate）、患者报告的结果（欧洲癌症研究和治疗组织生活质量问卷- core 30 [EORTC QLQ-30]、慢性疾病治疗功能评估-疲劳[facit -疲劳]、癌症治疗功能评估-认知功能[FACT-Cog]）和患者/护理者调查进行计算机化测试。收集了安全数据。结果：在100例治疗患者中，92例可评估（46例/组）。基线特征相似，20%的患者观察到轻度认知障碍。与AAthornP的-0.01（95%可信区间，-2.40 - 2.38）相比，ENZA的facit -疲劳指数从基线值-4.00（95%可信区间，-6.61 - -1.39）显著恶化。总体而言，与AAthornP相比，ENZA报告了更多的不良事件（ae）和更多的疲劳ae（分别为52%对36%和26%对8%）。3/4级ae相似（4%对6%）。ENZA报告的独特神经精神ae包括健忘症、认知障碍、记忆障碍和混乱状态；AAthornP包括脑血管意外、晕厥前、脊髓压迫。有临床意义的认知能力下降在4例使用ENZA的患者和1例使用AAthornP的患者中出现。然而，Cogstate测试、EORTC QLQ-C30和FACT-Cog评估的总体平均变化与基线相似，没有显示出有意义的变化。与患者的反应相比，护理人员的调查反应表明，患ENZA的人更容易疲劳，患AAthornP的人更容易情绪低落。结论：尽管基线值相似，但与AAthornP相比，ENZA观察到更多的疲劳和神经认知差异。(C) 2019 Elsevier Inc.版权所有。
REAAcT was a prospective, real-world evidence-based, head-to-head study of tolerability of enzalutamide or abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer. Baseline values in the 2 arms were similar, including approximately 20% cognitive impairment. After 2 months of therapy, more fatigue and neurocognitive differences were observed with enzalutamide compared with abiraterone acetate plus prednisone. No other significant differences were observed.Background: The objective of this study was to evaluate differences in tolerability in patients with metastatic castration-resistant prostate cancer treated with enzalutamide (ENZA) or abiraterone acetate plus prednisone (AA+P). Patients and Methods: This was a phase IV, prospective, open-label, multicenter, real-world study. Patients were prescribed ENZA or AA+P at the treating physician's discretion. Computerized tests of 4 cognitive domains (Cogstate), patient-reported outcomes (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-30], Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], Functional Assessment of Cancer Therapy-Cognitive Function [FACT-Cog]), and patient/caregiver surveys were assessed at baseline and 2 months. Safety data were collected. Results: Of 100 treated patients, 92 were evaluable (46/arm). Baseline characteristics were similar, with mild cognitive impairment observed in similar to 20% of patients. The FACIT-Fatigue demonstrated a statistically significant worsening from baseline of -4.00 (95% confidence interval, -6.61 to -1.39) for ENZA compared with AAthornP, -0.01 (95% confidence interval, -2.40 to 2.38). Overall, more adverse events (AEs) and more AEs of fatigue were reported with ENZA versus AAthornP (52% vs. 36% and 26% vs. 8%, respectively). Grade 3/4 AEs were similar (4% vs. 6%). Unique neuropsychiatric AEs reported with ENZA included amnesia, cognitive disorders, memory impairment, and confusional state; those for AAthornP included cerebrovascular accident, presyncope, and spinal cord compression. Clinically meaningful cognitive decline was seen in 4 patients on ENZA versus 1 patient on AAthornP. However, the overall mean changes from baseline for the Cogstate tests, the EORTC QLQ-C30, and the FACT-Cog assessment were similar and showed no meaningful change. Caregiver survey responses noted more fatigue with ENZA and more moodiness with AAthornP compared with patient responses. Conclusions: Although baseline values were similar, more fatigue and neurocognitive differences were observed with ENZA compared with AAthornP. (C) 2019 Elsevier Inc. All rights reserved.