How women with cervical or endometrial cancer requiring postoperative radiotherapy (RT) view their treatment-related adverse events (AEs) may be significantly different than how their physicians view their AEs. Researchers compared symptoms reported by patients and by clinicians during RT and found clinicians tended to underreport symptomatic gastrointestinal AEs. The findings from the study, which were published in the Journal of Clinical Oncology, also found that patients reported fewer symptoms with intensity-modulated RT (IMRT) compared with standard RT. Clinician-reported AEs revealed no differences between IMRT and standard RT.
The trial included women with cervical or endometrial cancer requiring postoperative RT and patients were randomly assigned to standard 4-ﬁeld RT or IMRT (ClinicalTrials.gov Identifier: NCT00331760). Each individual was treated with 45 or 50.4 Gy based on physician preference and all the participants completed the 6-item patient reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for gastrointestinal toxicity. This tool assesses abdominal pain, diarrhea, and fecal incontinence at various time points. The researchers compared patients’ reported symptoms to what clinicians recorded as CTCAE.
A total of 234 patients consented and completed the PRO-CTCAE. Researchers found that patients reported high-grade abdominal pain 19.1% more often than their clinicians. The findings were similar with high-grade diarrhea and fecal incontinence, which were both more frequently reported by patients compared to their clinicians. For grade 1 or higher CTCAE toxicity and any-grade patient-reported toxicity, clinicians tended to underreport compared with patients.
The any-grade CTCAE abdominal pain rate reported by clinicians was 35.6%. However, 80.1% of patients reported at least mild abdominal pain, with 69.5% reporting abdominal pain that interfered with usual activities. The grade 3 or higher CTCAE toxicity rate was 2.5% among clinicians, however that was substantially less than the 21.6% of women who reported severe or very severe abdominal pain.
When the researchers looked at patient-reported high-grade AEs after 5 weeks of RT, they found individuals who received IMRT reported fewer gastrointestinal AEs than those who received 4-ﬁeld pelvic RT with regard to diarrhea (33.7% vs 51.9%), frequency of fecal incontinence (1.1% vs 9.3%), and interference of fecal incontinence (4.4% vs 12.9%).
- Yeung AR, Pugh SL, Klopp AH, et al. Improvement in patient-reported outcomes with intensity-modulated radiotherapy (RT) compared with standard RT: a report from the NRG Oncology RTOG 1203 study. J Clin Oncol. 2020;38:1685-1692. doi: 10.1200/JCO.19.02381