KEY TAKEAWAYS
- The PATHOS phase 3 trial aimed to evaluate clinician-graded swallowing function via MBS before and after TOS in oropharyngeal cancer patients.
- DIGEST grading may offer enhanced sensitivity in detecting functional changes, highlighting the need for pre-adjuvant rehabilitation.
The ongoing PATHOS trial focuses on de-escalated adjuvant therapy after transoral surgery for HPV-associated oropharyngeal cancer, aiming to preserve function. Following transoral surgery (TOS), acute dysphagia is anticipated, with a 13% post-TOS aspiration rate in E3311 trial patients, highlighting the need for tailored interventions in head and neck cancer care.
Joanne Patterson and the team conducted a study that aimed to evaluate clinician-graded swallowing function via modified barium swallow (MBS) before and after TOS in the PATHOS trial, prior to adjuvant therapy randomization.
This interim analysis of the PATHOS trial involved conducting standardized MBS assessments. These assessments were graded using the Penetration-Aspiration Scale (PAS) and Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), with the graders blinded to the timepoint.
Aspiration rates (defined as PAS ≥6), any grade dysphagia (defined as DIGEST grade >0), and high-grade dysphagia (defined as DIGEST grade >1) were compared between baseline and 4 weeks post-TOS using McNemar’s test.
About 60 patients who underwent TOS between November 2015 and April 2021 across 15 UK centers were included. Both pre- and post-TOS MBS assessments were graded at the time of analysis. No aspiration was observed at baseline; however, post-TOS, aspiration increased to 6/60 (10%) MBS (P= 0.014).
Using the DIGEST grading system, which considers penetration/aspiration and residue as markers of swallowing efficiency, swallowing impairment was more prevalent. According to DIGEST, any grade dysphagia (DIGEST grade >0) was prevalent in 16/60 (27%) of baseline MBS, increasing to 37/60 (62%) after TOS (P< 0.001). High-grade dysphagia (DIGEST grade >1) was present in 1/60 (2%) of baseline MBS, rising to 10/60 (17%) after TOS (P= 0.007).
The analysis revealed that baseline aspiration rates were low but significantly increased to 10% after TOS, aligning with findings from E3311. Initial observations indicated that DIGEST grading may offer heightened sensitivity in detecting MBS changes, reflecting broader functional alterations beyond aspiration.
Notably, image-graded dysphagia was prevalent in over half of the patients before adjuvant therapy, suggesting a window for post-surgical rehabilitation to enhance function before initiating adjuvant therapy.
The trial is sponsored by the Lisette Nixon, from the Velindre NHS Trust.
Source: https://astro.confex.com/astro/hncs2024/meetingapp.cgi/Paper/59766
Clinical Trial: https://clinicaltrials.gov/study/NCT02215265
Patterson J, Hurt C, Barbon CEA, et al. (2024) “Aspiration rates and clinician-graded dysphagia after transoral surgery (TOS): an interim analysis of modified barium swallow (MBS) studies (videofluoroscopy) from the PATHOS trial.” Presented at MHNCS 2024 (171).