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.
Study Details
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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Key Findings
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.
