Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study

Abstract

Purpose: In oncology trials, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is the standard tool for reporting adverse events (AEs), but it may underreport symptoms experienced by patients. This analysis of the NRG Oncology RTOG 1203 compared symptom reporting by patients and clinicians during radiotherapy (RT).

Patients and methods: Patients with cervical or endometrial cancer requiring postoperative RT were randomly assigned to standard 4-field RT or intensity-modulated RT (IMRT). Patients completed the 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence at various time points. Patients reported symptoms on a 5-point scale. Clinicians recorded these AEs as CTCAE grades 1 to 5. Clinician- and patient-reported AEs were compared using McNemar's test for rates > 0%.

Results: Of 278 eligible patients, 234 consented and completed the PRO-CTCAE. Patients reported high-grade abdominal pain 19.1% (P < .0001), high-grade diarrhea 38.5% (P < .0001), and fecal incontinence 6.8% more frequently than clinicians. Similar effects were seen between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity. Between-arm comparison of patient-reported high-grade AEs revealed that at 5 weeks of RT, patients who received IMRT experienced fewer GI AEs than patients who received 4-field pelvic RT with regard to frequency of diarrhea (18.2% difference; P = .01), frequency of fecal incontinence (8.2% difference; P = .01), and interference of fecal incontinence (8.5% difference; P = .04).

Conclusion: Patient-reported AEs showed a reduction in symptoms with IMRT compared with standard RT, whereas clinician-reported AEs revealed no difference. Clinicians also underreported symptomatic GI AEs compared with patients. This suggests that patient-reported symptomatic AEs are important to assess in this disease setting.

FIG 1.

CONSORT diagram. PRO-CTCAE, patient-reported outcomes version of Common Terminology Criteria for Adverse Events; IMRT, intensity-modulated radiotherapy; RT, radiotherapy.

FIG 2.

(A) Comparison of any-grade clinician-reported (by Common Terminology Criteria for Adverse Events [CTCAE]) and patient-reported (by patient-reported outcomes version of CTCAE [PRO-CTCAE]) symptomatic adverse events (AEs). Includes AEs of any CTCAE grade or PRO-CTCAE score ≥ 1. All comparisons between PRO-CTCAE and CTCAE were P < .05. (B) Comparison of high-grade clinician-reported (CTCAE) and patient-reported (PRO-CTCAE) symptomatic AEs. Includes AEs of CTCAE grade or PRO-CTCAE score ≥ 3. PRO-CTCAE score of 3 or 4 represents AE frequency of frequently or almost constantly, AE severity of severe or very severe, or AE interference with usual or daily activities of quite a bit or very much. All comparisons between PRO-CTCAE and CTCAE were P < .05, except for fecal incontinence.

FIG 3.

(A) Percentage of patients with high-grade (score ≥ 3) abdominal pain severity and interference by arm. (B) Percentage of patients with high-grade diarrhea frequency by arm. (C) Percentage of patients with high-grade fecal incontinence frequency and interference by arm. IMRT, intensity-modulated radiotherapy; RT, radiotherapy. (*) P < .05.