Wagner Lynne I, Zhao Fengmin, Hong Fangxin, Williams Michael E, Gascoyne Randy D, Krauss John C, Advani Ranjana H, Go Ronald S, Habermann Thomas M, Leach Joseph W, O'Connor Brian, Schuster Stephen J, Cella David, Horning Sandra J, Kahl Brad S
Lynne I. Wagner and David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL; Fengmin Zhao, Fangxin Hong, Dana-Farber Cancer Institute, Boston, MA; Michael E. Williams, University of Virginia, Charlottesville, VA; John C. Krauss, University of Michigan, Ann Arbor, MI; Ranjana H. Advani, Stanford University, Stanford; Sandra J. Horning, Genentech, South San Francisco, CA; Ronald S. Go, Gunderson Health System, La Crosse; Brad S. Kahl, University of Wisconsin, Madison, WI; Thomas M. Habermann, Mayo Clinic, Rochester; Joseph W. Leach, Metro Minnesota Community Clinical Oncology Program, Minneapolis, MN; Brian O'Connor, Frederick Memorial Health System, Frederick, MD; Stephen J. Schuster, University of Pennsylvania, Philadelphia, PA; and Randy D. Gascoyne, British Columbia Cancer Agency, Vancouver, BC, Canada.
J Clin Oncol. 2015 Mar 1;33(7):740-8. doi: 10.1200/JCO.2014.57.6801. Epub 2015 Jan 20.
The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial (RESORT) randomly assigned to maintenance rituximab (MR) versus rituximab re-treatment (RR). A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style.
Patients (N = 253) completed patient-reported outcome (PRO) measures at random assignment to MR or RR (baseline); at 3, 6, 12, 24, 36, and 48 months after random assignment; and at rituximab failure. PRO measures assessed illness-related anxiety and coping style, and secondary end points including general anxiety, worry and interference with emotional well-being, depression, and health-related quality of life (HRQoL). Patients were classified as using an active or avoidant illness-related coping style. Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style.
Illness-related anxiety was comparable between treatment arms at all time points (P > .05), regardless of coping style (active or avoidant). Illness-related anxiety and general anxiety significantly decreased over time on both arms. HRQoL scores were relatively stable and did not change significantly from baseline for both arms. An avoidant coping style was associated with significantly higher anxiety (18% and 13% exceeded clinical cutoff points at baseline and 6 months, respectively) and poorer HRQoL compared with an active coping style (P < .001), regardless of treatment arm assignment.
Surveillance until RR at progression was not associated with increased anxiety compared with MR, regardless of coping style. Avoidant coping was associated with higher anxiety and poorer HRQoL.
本研究旨在比较利妥昔单抗延长疗程或再治疗试验(RESORT)中随机分配接受利妥昔单抗维持治疗(MR)与利妥昔单抗再治疗(RR)的参与者之间与疾病相关的焦虑情况。次要目的是检验MR与RR在焦虑方面的优势是否取决于与疾病相关的应对方式。
患者(N = 253)在随机分配至MR或RR时(基线)、随机分配后3、6、12、24、36和48个月以及利妥昔单抗治疗失败时完成患者报告结局(PRO)测量。PRO测量评估了与疾病相关的焦虑和应对方式,以及次要终点,包括一般性焦虑、担忧和对情绪幸福感的干扰、抑郁以及健康相关生活质量(HRQoL)。患者被分类为采用积极或回避的与疾病相关的应对方式。使用独立样本t检验和线性混合效应模型来确定治疗组在PRO终点上的差异以及基于应对方式的差异。
在所有时间点,无论应对方式(积极或回避)如何,各治疗组之间与疾病相关的焦虑情况相当(P > 0.05)。两组中与疾病相关的焦虑和一般性焦虑均随时间显著降低。两组的HRQoL评分相对稳定,与基线相比无显著变化。与积极应对方式相比,回避应对方式与显著更高的焦虑(基线和6个月时分别有18%和13%超过临床临界值)以及更差的HRQoL相关(P < 0.001),无论治疗组分配如何。
与MR相比,进展时监测至RR与焦虑增加无关,无论应对方式如何。回避应对与更高的焦虑和更差的HRQoL相关。