Yennurajalingam Sriram, Basen-Engquist Karen, Reuben James M, Fellman Bryan M, Shete Sanjay, Maddi Rama, Williams Janet L, Dev Rony, Hui David, Bruera Eduardo
Department of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, USA.
Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Support Care Cancer. 2022 Jan;30(1):497-509. doi: 10.1007/s00520-021-06463-8. Epub 2021 Jul 31.
Cancer-related fatigue (CRF) is the most frequent and debilitating symptom in patients with advanced cancer. There are limited effective treatments for CRF. The objective of this prospective longitudinal study was to evaluate the change in CRF at Day 43 after treatment with combination therapy of oral Anamorelin 100 mg daily with physical activity and nutrition counseling.
In this study, patients with CRF [≤ 34 Functional Assessment of Chronic Illness Therapy-Fatigue subscales(FACIT-F)] received Anamorelin 100 mg orally daily with standardized physical activity and nutrition counseling for 43 days. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Anorexia Cachexia(FAACT-ACS), Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), Patient-Reported Outcomes Measurement Information System(PROMIS-Fatigue), body composition, and physical performance tests were assessed at baseline, Day 15, 29, and 43. Frequency and type of side effects were determined by NCI CTAE 4.0.(NCT03035409).
28/45 (62%) of patients dosed were evaluable at Day 43. The mean, SD for FACIT-F subscale improvement from baseline was 4.89 (± 13.07), P = .058, MFSI-SF (G) - 3.46 (± 6.86), P = 0.013, PROMIS-fatigue - 4.14 (± 7.88), P = 0.010, FAACT ACS 3.48 (± 8.13), P = 0.035. Godin Liesure-Time physical activity questionnaire 7.41 (± 16.50), P = 0.038. Weight (kg) 1.81 (± 2.63), P = 0.005, and Lean Body Mass 1.54 (± 1.85), P = 0.001, IGF-1 36.50 (± 48.76), P = 0.015. There was no significant improvement in physical performance outcomes. No adverse events > grade 3 related to the study drug were reported.
The use of the combination therapy was associated with improvement of CRF (FACIT-F fatigue, PROMIS-fatigue, MFSI-SF-general), activity (Godin-leisure time), anorexia (FAACT), body composition, and IGF-1 levels. Further studies using combination therapy for CRF are justified.
癌症相关疲劳（CRF）是晚期癌症患者最常见且使人衰弱的症状。针对CRF的有效治疗方法有限。这项前瞻性纵向研究的目的是评估口服阿那莫林100毫克每日联合体育活动及营养咨询治疗43天后CRF的变化。
在本研究中，CRF患者[慢性病治疗功能评估-疲劳子量表（FACIT-F）≤34]每日口服100毫克阿那莫林，并接受标准化体育活动及营养咨询，为期43天。在基线、第15天、第29天和第43天评估慢性病治疗功能评估-疲劳（FACIT-F）、厌食恶病质（FAACT-ACS）、多维疲劳症状量表简表（MFSI-SF）、患者报告结局测量信息系统（PROMIS-疲劳）、身体成分和身体性能测试。通过美国国立癌症研究所不良事件通用术语标准4.0确定副作用的频率和类型。（NCT03035409）
45名给药患者中有28名（62%）在第43天可进行评估。FACIT-F子量表相对于基线的平均改善值及标准差为4.89（±13.07），P = 0.058；MFSI-SF（G）为-3.46（±6.86），P = 0.013；PROMIS-疲劳为-4.14（±7.88），P = 0.010；FAACT ACS为3.48（±8.13），P = 0.035。戈丁休闲时间体育活动问卷评分为7.41（±16.50），P = 0.038。体重（千克）为1.81（±2.63），P = 0.005；去脂体重为1.54（±1.85），P = 0.001；胰岛素样生长因子-1为36.50（±48.76），P = 0.015。身体性能指标未出现显著改善。未报告与研究药物相关的3级以上不良事件。
联合治疗的使用与CRF（FACIT-F疲劳、PROMIS-疲劳、MFSI-SF-总体）、活动（戈丁休闲时间）、厌食（FAACT）、身体成分和胰岛素样生长因子-1水平的改善相关。进一步开展针对CRF的联合治疗研究是合理的。
