Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Cancer. 2018 Mar 1;124(5):991-997. doi: 10.1002/cncr.31133. Epub 2017 Nov 13.
The improving efficacy of cancer treatment has resulted in an increasing array of treatment-related symptoms and associated burdens imposed on individuals undergoing aggressive treatment of their disease. Often, clinical trials compare therapies that have different types, and severities, of adverse effects. Whether rated by clinicians or patients themselves, it can be difficult to know which side effect profile is more disruptive or bothersome to patients. A simple summary index of bother can help to adjudicate the variability in adverse effects across treatments being compared with each other.
Across 4 studies, a total of 5765 patients enrolled in cooperative group studies and industry-sponsored clinical trials were the subjects of the current study. Patients were diagnosed with a range of primary cancer sites, including bladder, brain, breast, colon/rectum, head/neck, hepatobiliary, kidney, lung, ovary, pancreas, and prostate as well as leukemia and lymphoma. All patients were administered the Functional Assessment of Cancer Therapy-General version (FACT-G). The single item "I am bothered by side effects of treatment" (GP5), rated on a 5-point Likert scale, is part of the FACT-G. To determine its validity as a useful summary measure from the patient perspective, it was correlated with individual and aggregated clinician-rated adverse events and patient reports of their general ability to enjoy life.
Analyses of pharmaceutical trials demonstrated that mean GP5 scores ("I am bothered by side effects of treatment") significantly differed by maximum adverse event grade (P<.001) in all trials, with a clear trend toward increasing GP5 scores with level of increasing adverse event grade. Effect sizes ranged from 0.13 to 0.46. Analyses of cooperative group trials demonstrated a significant correlation between GP5 and item GF3 ("I am able to enjoy life") in the predicted direction.
The single FACT-G item "I am bothered by side effects of treatment" is significantly associated with clinician-reported adverse events and with patients' ability to enjoy their lives. It has promise as an overall summary measure of the burden of a given set of treatment toxicities compared with another. Future research can identify the contribution of individual side effects compared with one another in terms of how each may contribute to overall bother. Cancer 2018;124:991-7. © 2017 American Cancer Society.
癌症治疗效果的提高导致了越来越多的与治疗相关的症状，并给正在接受疾病积极治疗的个体带来了相关负担。通常，临床试验比较的是具有不同类型和严重程度不良反应的治疗方法。无论是由临床医生还是患者自己进行评估，都很难知道哪种副作用对患者的干扰或困扰更大。一个简单的困扰综合指数可以帮助判断相互比较的治疗方法中不良反应的可变性。
在 4 项研究中，共有 5765 名患者参加了合作组研究和行业赞助的临床试验，成为本研究的对象。患者被诊断患有一系列原发性癌症部位，包括膀胱癌、脑癌、乳腺癌、结肠癌/直肠癌、头颈部癌、肝胆癌、肾癌、肺癌、卵巢癌、胰腺癌和前列腺癌以及白血病和淋巴瘤。所有患者均接受了癌症治疗功能评估一般量表（FACT-G）的评估。“我被治疗副作用困扰”这一单项（GP5），采用 5 级 Likert 量表进行评估，是 FACT-G 的一部分。为了确定其作为患者视角的有用综合衡量指标的有效性，将其与个体和综合临床医生评估的不良事件以及患者对其享受生活的总体能力的报告进行了相关性分析。
药物试验的分析表明，在所有试验中，最大不良事件等级的平均 GP5 评分（“我被治疗副作用困扰”）显著不同（P<.001），随着不良事件等级的升高，GP5 评分呈明显上升趋势。效应大小范围从 0.13 到 0.46。合作组试验的分析表明，GP5 与项目 GF3（“我能够享受生活”）呈预期的显著正相关。
FACT-G 的单一项目“我被治疗副作用困扰”与临床医生报告的不良事件以及患者享受生活的能力显著相关。它有望成为比较特定治疗毒性负担的综合总体衡量指标。未来的研究可以确定个体副作用之间的相互贡献，以及每个副作用如何对整体困扰产生影响。癌症 2018；124：991-7。©2017 美国癌症协会。
