Aspiration rates and clinician-graded dysphagia after transoral surgery (TOS): an interim analysis of modified barium swallow (MBS) studies (videofluoroscopy) from the PATHOS trial

Abstract

Purpose/objective(s): PATHOS is an ongoing Phase II/III randomized trial examining risk-stratified de-escalated adjuvant therapy after transoral surgery (TOS) for human papillomavirus associated oropharyngeal cancer. While the goal of TOS is functional preservation, acute postsurgical dysphagia is expected with post-TOS aspiration prevalence (prior to adjuvant treatment) recently reported in 13% of patients from the E3311 trial. Our objective was to assess clinician-graded swallowing function per modified barium swallow (MBS, videofluoroscopy) in the PATHOS trial before and after TOS, prior to randomization for adjuvant therapy.

Materials/methods: this is an interim analysis of the PATHOS trial. Standardized MBS were conducted and blind (to timepoint) graded using the Penetration-Aspiration Scale (PAS) and Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). Aspiration rates (per maximum PAS ≥6), any grade dysphagia (per DIGEST grade >0) and high-grade dysphagia (per DIGEST grade >1) were compared baseline to 4 weeks post-TOS in all patients using McNemar's test.

Results: 60 patients were included who underwent TOS between November 2015 and April 2021 in 15 UK centers and had both pre- and post-TOS MBS graded at the time of analysis. There was no aspiration at baseline; aspiration increased to 6/60 (10%) MBS after TOS (p = 0.014). Swallowing impairment was more prevalent using the DIGEST grade that accounts for both penetration/aspiration as well as residue as a marker of swallowing efficiency. Per DIGEST, any grade baseline dysphagia (DIGEST grade >0) was prevalent in 16/60 (27%) of baseline MBS increasing to 37/60 (62%) after TOS (p < 0.001), and high grade dysphagia (DIGEST grade >1) was prevalent in 1/60 (2%) of MBS at baseline increasing to 10/60 (17%) after TOS (p =0.007).

Conclusion: aspiration rates were low overall, significantly increasing to 10% of MBS after TOS (before adjuvant therapy) in similar magnitude to rates observed in E3311. Preliminary results suggest that DIGEST grading may be more sensitive to detect changes on MBS that reflect potentially important functional changes beyond aspiration. By this measure, image-graded dysphagia was prevalent in more than half of patients prior to adjuvant therapy supporting an opportunity for post-surgical rehabilitation to optimize function in the interval prior to adjuvant therapy.

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Identifiers

ORCID for C. Hurt: orcid.org/0000-0003-1206-8355

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