September 21 2022
PHILADELPHIA, PA – An analysis of the NRG Oncology clinical trial NRG-RTOG 1203 indicates that patients reported fewer adverse events following intensity-modulated radiotherapy (IMRT) treatment when compared to patients who received the standard 4-field pelvic radiotherapy. Although patient-reported data exhibited a difference between the two treatments, clinician-reported data showed no difference in symptoms for patients in the two treatment arms. These findings suggest that patient-reported symptoms were more sensitive and perhaps more accurate, whereas clinician data may have under-reported the symptoms that were experienced. The results of this analysis were recently published in the Journal of Clinical Oncology.
In the NRG-RTOG 1203 trial, women with cervical or endometrial cancer were randomly assigned to receive either the standard of care 4-field pelvic radiotherapy treatment or the experimental IMRT treatment. Before treatment, after 5 weeks of treatment, at 4-6 weeks following radiotherapy, and at 1-3 years following radiotherapy, patients completed a 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) tracking gastrointestinal toxicities including abdominal pain, diarrhea, and fecal incontinence. Clinicians reported the same toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) tool.
“This analysis of NRG-RTOG 1203 is the first large-scale, multi-institutional, phase 3 trial that used both patient-reported PRO-CTCAE and clinician-reported CTCAE to assess the difference in symptomatic adverse events between two treatments,” stated Anamaria R. Yeung, MD, of the University of Florida and the lead author on this manuscript. “These results highlight the importance of utilizing patient-reported outcomes alongside clinician-reported symptoms as patients are the most aware of how treatments affect them. Additionally, patient-reported symptoms allow clinicians to give other patients a better perspective of how a treatment may affect them based on the experiences of their peers in addition to the advice of the treating physician.”
As compared to clinicians, women participating in NRG-RTOG 1203 reported significantly higher-grade abdominal pain 19.1% (P < .0001), diarrhea 38.5% (P < .0001), and fecal incontinence 6.8%. After five weeks of radiotherapy treatment, women who received IMRT reported experiencing fewer high-grade gastrointestinal adverse events than the women who received 4-field pelvic RT with regard to the 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). Clinician-reported adverse events revealed no difference between the treatment arms for the same toxicities.
In future trials where the primary endpoint is symptomatic adverse events, researchers should strongly consider using patient-reported outcomes as the primary toxicity outcome measure. While clinician-reported AEs should still be reported, clinicians maybe under-reporting symptoms which could lead to the incorrect conclusion that there is no difference in toxicity between the studied treatments.
NRG-RTOG 1203 was supported by grants U10CA21661, U10CA37422, CA81647, U24CA180803, U10CA180868, U10CA180822, UG1CA189867 from the National Cancer Institute (NCI).
Citation
Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. 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 Feb 19:JCO1902381. doi: 10.1200/JCO.19.02381. [Epub ahead of print] PubMed PMID: 32073955.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.
www.nrgoncology.org