TY - JOUR
T1 - Improvement in Patient-Reported Outcomes with Intensity-Modulated Radiotherapy (RT) Compared with Standard RT
T2 - A Report from the NRG Oncology RTOG 1203 Study
AU - Yeung, Anamaria R.
AU - Pugh, Stephanie L.
AU - Klopp, Ann H.
AU - Gil, Karen M.
AU - Wenzel, Lari
AU - Westin, Shannon N.
AU - Gaffney, David K.
AU - David, William Small
AU - Thompson, Spencer
AU - Doncals, Desiree E.
AU - Cantuaria, Guilherme H.C.
AU - Yaremko, Brian P.
AU - Chang, Amy
AU - Kundapur, Vijayananda
AU - Mohan, Dasarahally S.
AU - Haas, Michael L.
AU - Kim, Yong Bae
AU - Ferguson, Catherine L.
AU - Deshmukh, Snehal
AU - Bruner, Deborah W.
AU - Kachnic, Lisa A.
N1 - Publisher Copyright:
© 2020 by American Society of Clinical Oncology
PY - 2020/2/19
Y1 - 2020/2/19
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85084919913&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85084919913&partnerID=8YFLogxK
U2 - 10.1200/JCO.19.02381
DO - 10.1200/JCO.19.02381
M3 - Article
C2 - 32073955
AN - SCOPUS:85084919913
SN - 0732-183X
VL - 38
SP - 1685
EP - 1692
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 15
ER -