In an analysis from the NRG Oncology RTOG 1203 study reported in the Journal of Clinical Oncology, Yeung et al found improved patient-reported gastrointestinal toxicity with intensity-modulated radiotherapy vs standard radiotherapy among patients with cervical or endometrial cancer requiring postoperative radiotherapy. The analysis also showed that clinicians underreported gastrointestinal adverse events compared with patients.
A prior report from the trial showed no difference between radiotherapy groups using clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) scores to assess symptomatic adverse events.
In the trial, patients were randomly assigned to postoperative pelvic intensity-modulated radiotherapy or standard four-field radiotherapy. Patients completed the six-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for gastrointestinal toxicity assessing abdominal pain, diarrhea, and fecal incontinence, with symptoms reported on a five-point scale. PRO-CTCAE scores ≥ 3 (high-grade scores) correspond to adverse event frequency rating of frequently or almost constantly, severity rating of severe or very severe, or interference with usual or daily activities rating of quite a bit or very much.
“Patient-reported [adverse events] showed a reduction in symptoms with intensity-modulated radiotherapy compared with standard radiotherapy, whereas clinician-reported [adverse events] revealed no difference. Clinicians also underreported symptomatic gastrointestinal [adverse events] compared with patients. This suggests that patient-reported symptomatic [adverse events] are important to assess in this disease setting.”— Yeung et al
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Among 278 eligible patients, 234 consented and completed the PRO-CTCAE.
Compared with clinician reporting of grade ≥ 3 toxicity, patients more frequently reported high-grade abdominal pain (21.6% vs 2.5%, P < .0001), high-grade diarrhea (43.2% vs 4.7%, P < .0001), and high-grade fecal incontinence (6.8% vs 0%).
Similar differences were observed in comparisons between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity: clinician-reported any grade vs patient reported rates were 35.6% for abdominal pain vs 80.1% of patients reporting at least mild abdominal pain (P < .0001), 75% for diarrhea vs 86.9% of patients reporting diarrhea occurring at least rarely (P = .0002), and 3.0% for fecal incontinence vs 52.5% of patients reporting fecal incontinence occurring at least rarely (P < .0001).
Comparison between radiotherapy groups in patient-reported rates of high-grade adverse events at 5 weeks of radiotherapy showed significantly lower frequency of diarrhea (33.7% vs 51.9%, P = .01), frequency of fecal incontinence (1.1% vs 9.3%, P = .01), and interference of fecal incontinence (4.4% vs 12.9%, P = .04) in the intensity-modulated radiotherapy vs standard radiotherapy groups.
The investigators concluded, “Patient-reported [adverse events] showed a reduction in symptoms with intensity-modulated radiotherapy compared with standard radiotherapy, whereas clinician-reported [adverse events] revealed no difference. Clinicians also underreported symptomatic gastrointestinal [adverse events] compared with patients. This suggests that patient-reported symptomatic [adverse events] are important to assess in this disease setting.”
Anamaria R. Yeung, MD, of the University of Florida, Gainesville, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.