163 - Real World Validation of a Head and Neck Specific Patient-Reported Outcome CTCAE Measure in a Radiation Oncology Clinic

Purpose/Objective(s): Head and neck (HN) radiotherapy (RT) is associated with a substantial acute and late toxicity burden. Patient-reported outcomes (PROs) are critical in understanding the patient’s perception of RT toxicity and may provide valuable data points in both clinical trials and the clinic. We sought to evaluate the concordance between clinician rated CTCAE and PRO-CTCAE in HN cancer patients treated with RT.

Materials/Methods: From 10/2020 to 03/2024 all new and returning patients to our HN RT clinic received a focused, HN-specific PRO-CTCAE toxicity assessment. The 11-question form contained 10 modified PRO-CTCAE items—HN pain (severity, frequency and interference), dry mouth, taste changes, difficulty swallowing, voice quality changes, hoarseness, fatigue (severity and interference)—and a self-report swallowing assessment using the Functional Oral Intake Scale (FOIS). Corresponding CTCAE measures were also scored and recorded as part of routine clinic visits. Encounters containing CTCAE and PRO-CTCAE data were eligible for analysis. The strength of association between CTCAE and PRO-CTCAE ratings were examined using Spearman’s (r) correlation. Statistical significance was defined as P<0.05.

Results: A total of 806 encounters for 364 consecutive patients were available for analysis. Among the included patients, the most frequent primary site was oropharynx (36%) and the majority had locally advanced disease (63%), were treated with curative intent (84%), or received concurrent chemotherapy (56%). Associations between clinician and patient rated toxicities were strongest for FOIS (r=0.758) and weakest for voice changes (r=0.397). Pain (r=0.617), dry mouth (r=0.526), problems with taste (r=0.647), and difficulty swallowing (r=0.517) also exhibited a strong association between clinician and patient toxicities ratings. For all symptoms, correlation between CTCAE and PRO-CTCAE were statistically significant (P<0.001). When temporal trends were examined, clinician and patient ratings for dry mouth and taste demonstrated higher concordance at later time points (=12 months after RT), while voice changes and pain demonstrated higher concordance at earlier time points (=3 months after RT).

Conclusion: In the setting of RT for HN cancer, we demonstrate significant associations between clinician and patient rating of symptoms using the CTCAE and PRO-CTCAE scales, respectively. Concordance of clinician and patient ratings improved over time and were most strongly in agreement for FOIS, suggesting it should be routinely incorporated into clinical assessment.