E2399: Correlation of objective and self report measures of swallowing function after concurrent chemoradiation (CCR) for head and neck cancer (HNC)

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6022 Background: We conducted a correlative study for E2399, a function preservation trial, to assess the acute and long-term effects of CCR on swallowing and the relationship of “gold standard” objective measures to self-report measures. Methods: Swallow evaluations were done at baseline, 3, 12 and 24 months post treatment. Self report measures consisted of the PSS- HN and FACT-G/HN. Objective measures include the modified barium swallow (MBS) scored using a physiologic measure, the Dysphagia Outcome Severity Scale (DOSS) and a functional measure, the Functional Communication Measure (FCM), which is the accepted Medicare standard for assessment of swallow function. Results: Statistically significant correlations were found between the DOSS or FCM and the swallow items for the HN subscale and the PSS-HN. Associations for the FCM were stronger than for the DOSS. At 3-months post-treatment the average correlation of the FCM with the FACT-HN and PSS swallow items was 0.585 (Maximum r =0.746, p < 0.001, Minimum r =0.297, p = 0.074), while the respective average correlation for the DOSS was 0.379 (Maximum r =0.556, p < 0.001, Minimum r =0.078, p = 0.644).There were poor correlations between the DOSS or FCM with the FACT-G at all time points. DOSS scores were lower than FCM scores at all time points (p < 0.05) and the discrepancy between the DOSS and the FCM scores increased post-treatment from an average of 0.43 at 3-months to ∼1.13 at the 24-month assessment. Both the DOSS and the FCM scores at baseline (p < 0.03) and at 3-months (p < 0.01) were associated with overall survival. Conclusions: The DOSS reflects physiologic abnormalities that may not be indicative of clinical dysfunction and therefore demonstrated lower associations with self-report measures of swallowing function than the FCM. The FCM correlated well with the FACT-HN and the PSS-HN swallow items. These findings suggest that PROs have practical utility in assessing swallowing function outcome and may be used in clinical trials as a surrogate for objective measures of swallow function. No significant financial relationships to disclose.