Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study

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-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.

Comparison of Hematologic Toxicity and Bone Marrow Compensatory Response in Head and Neck vs. Cervical Cancer Patients Undergoing Chemoradiotherapy

“…Previous studies have found that hematologic toxicity varies as a function of bone marrow radiation dose, volume, and location ( 5 , 10 , 13 , 17 – 23 ). These studies have led to the development of bone marrow radiation dose constraints that have been incorporated into clinical trials and routine practice for cervical cancer patients ( 5 , 6 ). It is not known whether additional reduction in marrow radiation, on par with levels in head/neck cancer treatment, would further reduce toxicity or whether benefits would outweigh risks associated with potentially increased dose to other organs.…”

“…Evolution in radiation technology has allowed substantially greater ability to reduce dose to critical normal tissues, such as bone marrow, offering the possibility to preserve hematopoietic function and permit better treatment tolerance in patients undergoing chemoradiotherapy. Bone marrow dose constraints have been integrated into clinical trials and routine practice for cervical cancer patients ( 5 , 6 ). However, it is unclear whether greater reductions in bone marrow doses, such as can be achieved with proton therapy ( 7 ), would further limit hematopoietic toxicity.…”

Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial

“…Further, this trial primarily investigates impact on quality of life endpoints associated with hypofractionated WPRT through a non-inferiority study design and by using a validated patient-reported outcome questionnaire. These questionnaires are known to better represent symptomatic adverse reactions experienced by patients receiving WPRT when compared to physician-reported endpoints [ 19 ].…”

Registering Study Analysis Plans (SAPs) Before Dissecting Your Data—Updating and Standardizing Outcome Modeling

“…To obtain reliable information about toxicities that influence patient's quality of life, normal tissue toxicities are likely best represented by patient-reported outcomes (PROs) ( 7 ). Using clinical decision-support tools ( 8 , 9 ) and keeping the number of items/questions as few as possible ( 10 ) are necessary for actionability to patient-reported complaints.…”