PMID- 32073955 OWN - NLM STAT- MEDLINE DCOM- 20210129 LR - 20210521 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 38 IP - 15 DP - 2020 May 20 TI - Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. PG - 1685-1692 LID - 10.1200/JCO.19.02381 [doi] AB - 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. FAU - Yeung, Anamaria R AU - Yeung AR AD - University of Florida, Gainesville, FL. FAU - Pugh, Stephanie L AU - Pugh SL AD - NRG Oncology Statistics and Data Management Center, Philadelphia, PA. FAU - Klopp, Ann H AU - Klopp AH AD - MD Anderson Cancer Center, Houston, TX. FAU - Gil, Karen M AU - Gil KM AD - Summa Health System, Akron, OH. FAU - Wenzel, Lari AU - Wenzel L AD - University of California Irvine, Irvine, CA. FAU - Westin, Shannon N AU - Westin SN AD - MD Anderson Cancer Center, Houston, TX. FAU - Gaffney, David K AU - Gaffney DK AD - Huntsman Cancer Institute, University of Utah, Salt Lake City, UT. FAU - Small, William Jr AU - Small W Jr AD - Loyola University Chicago, Chicago, IL. FAU - Thompson, Spencer AU - Thompson S AD - University of Oklahoma Health Sciences Center, Oklahoma City, OK. FAU - Doncals, Desiree E AU - Doncals DE AD - Cooper Cancer Center, Summa Akron City Hospital, Akron, OH. FAU - Cantuaria, Guilherme H C AU - Cantuaria GHC AD - Northside Hospital, Atlanta, GA. FAU - Yaremko, Brian P AU - Yaremko BP AD - London Regional Cancer Program, London, United Kingdom. FAU - Chang, Amy AU - Chang A AD - Pamela Youde Nethersole Eastern Hospital, Hong Kong, Special Administrative Region, People's Republic of China. FAU - Kundapur, Vijayananda AU - Kundapur V AD - Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada. FAU - Mohan, Dasarahally S AU - Mohan DS AD - Kaiser Permanente Cancer Treatment Center, South San Francisco, CA. FAU - Haas, Michael L AU - Haas ML AD - Reading Hospital, Reading, PA. FAU - Kim, Yong Bae AU - Kim YB AD - Severance Hospital, Yonsei University Health System, Seoul, South Korea. FAU - Ferguson, Catherine L AU - Ferguson CL AD - Georgia Regents University, Augusta, GA. FAU - Deshmukh, Snehal AU - Deshmukh S AD - NRG Oncology Statistics and Data Management Center, Philadelphia, PA. FAU - Bruner, Deborah W AU - Bruner DW AD - Emory University, Atlanta, GA. FAU - Kachnic, Lisa A AU - Kachnic LA AD - Vanderbilt University School of Medicine, Nashville, TN. LA - eng GR - U10 CA180868/CA/NCI NIH HHS/United States GR - UG1 CA189867/CA/NCI NIH HHS/United States GR - U24 CA081647/CA/NCI NIH HHS/United States GR - U10 CA037422/CA/NCI NIH HHS/United States GR - U10 CA021661/CA/NCI NIH HHS/United States GR - U24 CA180803/CA/NCI NIH HHS/United States GR - U10 CA180822/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20200219 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 SB - IM CIN - Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):839-845. PMID: 33069345 MH - Female MH - Humans MH - Male MH - *Patient Reported Outcome Measures MH - Radiotherapy, Intensity-Modulated/*methods PMC - PMC7238486 EDAT- 2020/02/20 06:00 MHDA- 2021/01/30 06:00 PMCR- 2021/05/20 CRDT- 2020/02/20 06:00 PHST- 2020/02/20 06:00 [pubmed] PHST- 2021/01/30 06:00 [medline] PHST- 2020/02/20 06:00 [entrez] PHST- 2021/05/20 00:00 [pmc-release] AID - 1902381 [pii] AID - 10.1200/JCO.19.02381 [doi] PST - ppublish SO - J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19.