Comparison of Patient-and Practitioner-Reported Toxic Effects Associated With Chemoradiotherapy for Head and Neck Cancer
Comparison of Patient-and Practitioner-Reported Toxic Effects Associated With Chemoradiotherapy for Head and Neck Cancer
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DOI：
10.1001/jamaoto.2016.0656
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发表时间：
2016-06-01
影响因子：
7.8
通讯作者：
Chera, Bhishamjit S.
中科院分区：
文献类型：
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作者：
Falchook, Aaron D.;Green, Rebecca;Chera, Bhishamjit S.
重要性头颈部癌放化疗期间患者报告的毒性反应与治疗者报告的毒性反应之间的一致性尚不清楚。目的比较头颈部癌放化疗患者中患者报告的症状严重程度和治疗者报告的毒性反应。和参与者44例患者参加了口咽癌去强化放化疗的2期临床试验，（2012年2月8日至2015年3月2日）。大多数治疗（放疗，60戈伊，同时每周给予顺铂，30 mg/m2）在学术医疗中心进行。纳入的患者既往无头颈部癌症，年龄在18岁或以上，吸烟史为10包-年或更少或超过10包-年但30包-年或更少，过去5年戒烟。癌症状态为未经治疗的人乳头瘤病毒或口咽部或未知头颈部原发部位的p16阳性鳞状细胞癌;癌症分期为T0至T3类、N 0至N2 c类、M0类，东部肿瘤协作组体能状态为0至1。由医生或执业护士使用美国国家癌症研究所不良事件通用术语标准（CTCAE）4.0版评估基线、每周和治疗后的毒性反应。使用CTCAE的患者报告结局版本（PRO-CTCAE）测量患者报告的症状严重程度。使用描述性统计量来表征CTCAE等级和PRO-CTCAE严重程度等级之间的原始一致性。干预使用CTCAE 4.0版和PRO-CTCAE评估基线、每周和治疗后毒性作用。主要结局和指标患者报告的毒性作用之间的原始一致性指数，包括症状频率、严重程度和对日常活动的干扰（评分范围，0 [无]至4 [非常严重]），以及经免疫测定的毒性反应，包括吞咽、口腔疼痛和声音嘶哑（评分范围，1 [轻度]至5 [死亡]）。（39名男性，5名女性;平均[SD]年龄，61 [8.4]岁），有327对CTCAE和PRO-CTCAE症状调查可分析，无毒性作用导致的治疗延迟。当大多数症状不存在时，基线时患者报告的症状严重程度与治疗师报告的症状严重程度一致性较高，但在整个治疗期间随着毒性作用增加而下降。大多数不一致是由于从业者报告的毒性作用严重程度较低（例如，从基线时的45%一致性到疼痛治疗最后一周的27%）。这是特别注意的领域，不容易评估体检，如焦虑和疲劳（例如，疲劳的严重程度从基线的43%下降到12%，在治疗的最后一周）。结论和相关性从业者报告的毒性作用低于患者自我报告在头部和颈部放化疗。纳入患者报告的症状性毒性反应提供了可能增强临床管理并提高临床试验数据质量的信息。
IMPORTANCE Agreement between patient-and practitioner-reported toxic effects during chemoradiotherapy for head and neck cancer is unknown.OBJECTIVE To compare patient-reported symptom severity and practitioner-reported toxic effects among patients receiving chemoradiotherapy for head and neck cancer.DESIGN, SETTING, AND PARTICIPANTS Forty-four patients participating in a phase 2 trial of deintensified chemoradiotherapy for oropharyngeal carcinoma were included in the present study (conducted from February 8, 2012, to March 2, 2015). Most treatment (radiotherapy, 60 Gy, with concurrent weekly administration of cisplatin, 30mg/m(2)) was administered at academic medical centers. Included patients had no prior head and neck cancers, were 18 years or older, and had a smoking history of 10 pack-years or less or more than 10 pack-years but 30 pack-years or less and abstinent for the past 5 years. Cancer status was untreated human papillomavirus or p16-positive squamous cell carcinoma of the oropharynx or unknown head and neck primary site; and cancer staging was category T0 to T3, category N0 to N2c, M0, and Eastern Cooperative Oncology Group performance status 0 to 1. Baseline, weekly, and posttreatment toxic effects were assessed by physicians or nurse practitioners using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Patient-reported symptom severity was measured using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE). Descriptive statistics were used to characterize raw agreement between CTCAE grades and PRO-CTCAE severity ratings.INTERVENTIONS Baseline, weekly, and posttreatment toxic effects assessed using CTCAE, version 4.0, and PRO-CTCAE.MAIN OUTCOMES AND MEASURES Rawagreement indices between patient-reported toxic effects, including symptom frequency, severity, and interference with daily activities (score range, 0 [none] to 4 [very severe]), and practitioner-measured toxic effects, including swallowing, oral pain, and hoarseness (score range, 1 [mild] to 5 [death]).RESULTS Of the 44 patients included in the analysis (39 men, 5 women; mean [SD] age, 61 [8.4] years), there were 327 analyzable pairs of CTCAE and PRO-CTCAE symptom surveys and no treatment delays due to toxic effects. Patient-reported and practitioner-reported symptom severity agreement was high at baseline when most symptoms were absent but declined throughout treatment as toxic effects increased. Most disagreement was due to lower severity of toxic effects reported by practitioners (eg, from 45% agreement at baseline to 27% at the final week of treatment for pain). This was particularly noted for domains that are not easily evaluated by physical examination, such as anxiety and fatigue (eg, severity of fatigue decreased from 43% at baseline to 12% in the final week of treatment).CONCLUSIONS AND RELEVANCE Practitioner-reported toxic effects are lower than patient self-reports during head and neck chemoradiotherapy. The inclusion of patient-reported symptomatic toxic effects provides information that can potentially enhance clinical management and improve data quality in clinical trials.