Lee Eudocia Q, Muzikansky Alona, Drappatz Jan, Kesari Santosh, Wong Eric T, Fadul Camilo E, Reardon David A, Norden Andrew D, Nayak Lakshmi, Rinne Mikael L, Alexander Brian M, Arvold Nils D, Doherty Lisa, Stefanik Jennifer, LaFrankie Debra, Ruland Sandra F, Pulverenti Julee, Smith Katrina H, Gaffey Sarah C, Hammond Samantha, Wen Patrick Y
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (E.Q.L., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., L.D., J.S., D.L., S.F.R., J.P., K.H.S., S.C.G., S.H., P.Y.W.); Harvard Medical School, Boston, Massachusetts (E.Q.L., E.T.W., D.A.R., A.D.N., L.N., M.L.R., B.M.A., N.D.A., P.Y.W.); Massachusetts General Hospital, Boston, Massachusetts (A.M.); University of Pittsburgh, Pittsburgh, Pennsylvania (J.D.); University of California San Diego, La Jolla, California (S.K.); Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.T.W.); Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (C.E.F.); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire (C.E.F.).
Neuro Oncol. 2016 Jun;18(6):849-54. doi: 10.1093/neuonc/now007. Epub 2016 Feb 21.
Fatigue is common among glioma patients undergoing radiotherapy (RT) and impacts quality of life (QOL). We evaluated whether armodafinil, a wakefulness-promoting medication, improves fatigue in glioma patients undergoing RT.
Eligibility criteria included age ≥18 years, Karnofsky performance status ≥60, and grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy. Patients were randomized 1:1 to armodafinil or placebo for 8 weeks beginning within 10 days of starting RT. Fatigue and QOL were assessed at baseline, day 22, day 43, and day 56 with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy - General (FACT-G), the Brief Fatigue Inventory (BFI), and the Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale between the 2 groups using a 2-sample Wilcoxon statistic.
We enrolled 81 patients total (42 armodafinil and 39 placebo). Armodafinil did not significantly improve fatigue or QOL based on the 42-day change in FACIT-F fatigue subscale, FACT-G, CFS, or BFI. Further analysis suggests no difference between the arms even after accounting for the potential bias of missing data. Treatment was well tolerated with few grade 3 or 4 toxicities.
While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study. Further studies are needed to determine whether pharmacologic treatment improves fatigue in glioma patients undergoing RT.
疲劳在接受放射治疗（RT）的胶质瘤患者中很常见，并且会影响生活质量（QOL）。我们评估了促觉醒药物阿莫达非尼是否能改善接受RT的胶质瘤患者的疲劳症状。
纳入标准包括年龄≥18岁、卡氏功能状态评分≥60，以及正在接受总剂量为50 - 60 Gy放射治疗的2 - 4级胶质瘤患者。患者在开始RT的10天内随机分为1:1的阿莫达非尼组或安慰剂组，为期8周。在基线、第22天、第43天和第56天，使用慢性病治疗功能评估 - 疲劳量表（FACIT - F）、癌症治疗功能评估 - 通用量表（FACT - G）、简明疲劳量表（BFI）和癌症疲劳量表（CFS）对疲劳和生活质量进行评估。主要目的是使用双样本Wilcoxon统计量检测两组之间FACIT - F疲劳子量表42天变化的差异。
我们共纳入81例患者（42例阿莫达非尼组和39例安慰剂组）。根据FACIT - F疲劳子量表、FACT - G、CFS或BFI的42天变化，阿莫达非尼并未显著改善疲劳或生活质量。进一步分析表明，即使考虑到缺失数据的潜在偏差，两组之间也没有差异。治疗耐受性良好，3级或4级毒性反应很少。
虽然治疗耐受性良好，但在这项初步研究中，为期8周的阿莫达非尼疗程并未改善接受RT的胶质瘤患者的疲劳或生活质量。需要进一步研究以确定药物治疗是否能改善接受RT的胶质瘤患者的疲劳症状。
