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Original Investigation |

Comparison of Patient- and Practitioner-Reported Toxic Effects Associated With Chemoradiotherapy for Head and Neck Cancer

Aaron D. Falchook, MD1; Rebecca Green, MS1; Mary E. Knowles, ANP1; Robert J. Amdur, MD2,3; William Mendenhall, MD2,3; David N. Hayes, MD, MPH4,5; Juneko E. Grilley-Olson, MD4,5; Jared Weiss, MD4,5; Bryce B. Reeve, PhD6; Sandra A. Mitchell, PhD7; Ethan M. Basch, MD4,5; Bhishamjit S. Chera, MD1,4
[+] Author Affiliations
1Department of Radiation Oncology, University of North Carolina, Chapel Hill
2Department of Radiation Oncology, University of Florida Hospitals, Gainesville
3Shands Cancer Center, University of Florida Hospitals, Gainesville
4Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill
5Division of Hematology/Oncology, Department of Medicine, University of North Carolina, Chapel Hill
6Gillings School of Global Public Health, University of North Carolina, Chapel Hill
7Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland
JAMA Otolaryngol Head Neck Surg. 2016;142(6):517-523. doi:10.1001/jamaoto.2016.0656.
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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, 30 mg/m2) 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  Raw agreement 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.

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Common Terminology Criteria for Adverse Events (CTAE) and the Patient-Reported Outcomes Version of the CTCAE (PRO-CTCAE) Symptom Survey Pairs for Pain, Dysphagia, Nausea, and Vomiting

Differences noted in reports on pain (A), dysphagia (B), nausea (C), and vomiting (D) are plotted against the mean of the PRO-CTCAE score (score range, 0 [none] to 4 [very severe]) and the CTCAE grade (score range, 1 [mild] to 5 [death]) from 327 survey pairs. The large bubble point (position 0, 0) for all symptoms indicates a high level of agreement between patients and practitioners when toxic effects are absent. As the toxic effects increase (x-axis), the number of agreements between patients and practitioners diminishes, as demonstrated by the decreasing size of the bubbles and their greater distance from the x-axis. Bubble points lying directly on the x-axis indicate that patient-reported severity tended to be greater than the corresponding toxic effect grade provided by the practitioner.

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