Anamaria R Yeung1, Stephanie L Pugh2, Ann H Klopp3, Karen M Gil4, Lari Wenzel5, Shannon N Westin3, David K Gaffney6, William Small7, Spencer Thompson8, Desiree E Doncals9, Guilherme H C Cantuaria10, Brian P Yaremko11, Amy Chang12, Vijayananda Kundapur13, Dasarahally S Mohan14, Michael L Haas15, Yong Bae Kim16, Catherine L Ferguson17, Snehal Deshmukh2, Deborah W Bruner18, Lisa A Kachnic19. 1. University of Florida, Gainesville, FL. 2. NRG Oncology Statistics and Data Management Center, Philadelphia, PA. 3. MD Anderson Cancer Center, Houston, TX. 4. Summa Health System, Akron, OH. 5. University of California Irvine, Irvine, CA. 6. Huntsman Cancer Institute, University of Utah, Salt Lake City, UT. 7. Loyola University Chicago, Chicago, IL. 8. University of Oklahoma Health Sciences Center, Oklahoma City, OK. 9. Cooper Cancer Center, Summa Akron City Hospital, Akron, OH. 10. Northside Hospital, Atlanta, GA. 11. London Regional Cancer Program, London, United Kingdom. 12. Pamela Youde Nethersole Eastern Hospital, Hong Kong, Special Administrative Region, People's Republic of China. 13. Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada. 14. Kaiser Permanente Cancer Treatment Center, South San Francisco, CA. 15. Reading Hospital, Reading, PA. 16. Severance Hospital, Yonsei University Health System, Seoul, South Korea. 17. Georgia Regents University, Augusta, GA. 18. Emory University, Atlanta, GA. 19. Vanderbilt University School of Medicine, Nashville, TN.
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-fieldRT 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.
RCT Entities:
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 CTCAEtoxicity 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.
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