Neoadjuvant Nivolumab Plus Chemotherapy Followed By Response-Adaptive Therapy for HPV+ Oropharyngeal Cancer: OPTIMA II Phase 2 Open-Label Nonrandomized Clinical Trial.

Importance: Immune checkpoint inhibitors improve survival in recurrent and/or metastatic head and neck cancer, yet their role in curative human papillomavirus-positive oropharyngeal cancer (HPV+ OPC) remains undefined. Neoadjuvant nivolumab and chemotherapy followed by response-adaptive treatment in HPV+ OPC may increase efficacy while reducing toxicity. Objective: To determine the deep response rate and tolerability of the addition of neoadjuvant nivolumab to chemotherapy followed by response-adapted locoregional therapy (LRT) in patients with HPV+ OPC. Design, Setting, and Participants: This phase 2 nonrandomized clinical trial conducted at a single academic center enrolled 77 patients with locoregionally advanced HPV+ OPC from 2017 to 2020. Data analyses were performed from February 10, 2021, to January 9, 2023. Interventions: Addition of nivolumab to neoadjuvant nab-paclitaxel and carboplatin (studied in the first OPTIMA trial) followed by response-adapted LRT in patients with HPV+ OPC stages III to IV. Main Outcomes and Measures: Primary outcome was deep response rate to neoadjuvant nivolumab plus chemotherapy, defined as the proportion of tumors with 50% or greater shrinkage per the Response Evaluation Criteria in Solid Tumors 1.1. Secondary outcomes were progression-free survival (PFS) and overall survival (OS). Swallowing function, quality of life, and tissue- and blood-based biomarkers, including programmed death-ligand 1 (PD-L1) expression and circulating tumor HPV-DNA (ctHPV-DNA), were also evaluated. Results: The 73 eligible patients (median [range] age, 61 [37-82] years; 6 [8.2%] female; 67 [91.8%] male) started neoadjuvant nivolumab and chemotherapy. Deep responses were observed in 51 patients (70.8%; 95% CI, 0.59-0.81). Subsequent risk- and response-adaptive therapy was assigned as follows: group A, single-modality radiotherapy alone or transoral robotic surgery (28 patients); group B, intermediate-dose chemoradiotherapy of 45 to 50 Gray (34 patients); and group C, regular-dose chemoradiotherapy of 70 to 75 Gray (10 patients). Two-year PFS and OS were 90.0% (95% CI, 0.80-0.95) and 91.4% (95% CI, 0.82-0.96), respectively. By response-adapted group, 2-year PFS and OS for group A were 96.4% and 96.4%, and group B, 88.0% and 91.0%, respectively. Lower enteral feeding rates and changes in weight, as well as improved swallowing, were observed among patients who received response-adapted LRT. Pathologic complete response rate among patients who underwent transoral robotic surgery was 67.0%. PD-L1 expression was nonsignificantly higher for deeper responses and improved PFS, and ctHPV-DNA clearance was significantly associated with improved PFS. Conclusions and Relevance: This phase 2 nonrandomized clinical trial found that neoadjuvant nivolumab and chemotherapy followed by response-adapted LRT is feasible and has favorable tolerability, excellent OS, and improved functional outcomes in HPV+ OPC, including among patients with high-risk disease. Moreover, addition of nivolumab may benefit high PD-L1 expressors, and sensitive dynamic biomarkers (eg, ctHPV-DNA) are useful for patient selection. Trial Registration: ClinicalTrials.gov Identifier: NCT03107182.

Dose and Volume De-Escalation for Human Papillomavirus-Positive Oropharyngeal Cancer is Associated with Favorable Posttreatment Functional Outcomes.

PURPOSE: To report functional outcomes for patients with human papillomavirus-positive oropharyngeal cancer treated on a phase 2 protocol of risk- and induction chemotherapy response-adapted dose and volume de-escalated radiation therapy (RT)/chemoradiation (CRT). METHODS AND MATERIALS: Patients were stratified as low risk (LR) or high risk (HR) according to T/N-stage and smoking history. Induction chemotherapy was followed by radiographic response assessment. LR patients with ≥50% response received 50 Gy RT (RT50), whereas LR patients with 30% to 50% response or HR patients with ≥50% response received 45 Gy CRT (CRT45). All other patients received 75 Gy CRT (CRT75) with RT limited to the first echelon of uninvolved nodes. Pre- and post-RT/CRT modified barium swallow studies were performed. Percutaneous endoscopic gastrostomy (PEG) tube placement, body mass index (BMI), and narcotic use were recorded. Statistical comparisons used linear or logistic regression, the Mann-Whitney U test, the χ2 test, or Fisher's exact test as appropriate. RESULTS: Twenty-eight LR and 34 HR patients were enrolled; 49 completed RT50/CRT45 and 11 completed CRT75. PEG-tube dependency at the end of RT/CRT and 3 months post-RT/CRT significantly differed according to risk and treatment groups (all P < .05). Treatment intensity was independently associated with 3-month PEG status while adjusting for risk group (P = .002). The CRT75 group had a median -8.42% change from baseline BMI at 1 year post-RT/CRT versus -2.54% for the RT50/CRT45 group (P = .01). At the end of RT/CRT, CRT75 patients were less likely to tolerate a normal diet, more likely to have swallowing performance status scale scores ≥4, more likely to have Rosenbek's penetration-aspiration scores ≥7, more likely to have developed trismus, and more likely to require narcotics >2 months (all P < .05). CONCLUSIONS: Induction chemotherapy followed by risk- and response-adapted dose and volume de-escalated RT/CRT is associated with clinically meaningful functional outcomes including (1) improved swallowing function, (2) higher BMI, and (3) shorter narcotic use for patients receiving de-escalation.

Long-term effect of low frequency stimulation of STN on dysphagia, freezing of gait and other motor symptoms in PD.

OBJECTIVE: To evaluate the long-term effect of 60 Hz stimulation of the subthalamic nucleus (STN) on dysphagia, freezing of gait (FOG) and other motor symptoms in patients with Parkinson's disease (PD) who have FOG at the usual 130 Hz stimulation. METHODS: This is a prospective, sequence randomised, crossover, double-blind study. PD patients with medication refractory FOG at 130 Hz stimulation of the STN were randomised to the sequences of 130 Hz, 60 Hz or deep brain stimulation off to assess swallowing function (videofluoroscopic evaluation and swallowing questionnaire), FOG severity (stand-walk-sit test and FOG questionnaire) and motor function (Unified PD Rating Scale, Part III motor examination (UPDRS-III)) at initial visit (V1) and follow-up visit (V2, after being on 60 Hz stimulation for an average of 14.5 months), in their usual medications on state. The frequency of aspiration events, perceived swallowing difficulty and FOG severity at 60 Hz compared with 130 Hz stimulation at V2, and their corresponding changes at V2 compared with V1 at 60 Hz were set as primary outcomes, with similar comparisons in UPDRS-III and its subscores as secondary outcomes. RESULTS: All 11 enrolled participants completed V1 and 10 completed V2. We found the benefits of 60 Hz stimulation compared with 130 Hz in reducing aspiration frequency, perceived swallowing difficulty, FOG severity, bradykinesia and overall axial and motor symptoms at V1 and persistent benefits on all of them except dysphagia at V2, with overall decreasing efficacy when comparing V2 to V1. CONCLUSIONS: The 60 Hz stimulation, when compared with 130 Hz, has long-term benefits on reducing FOG, bradykinesia and overall axial and motor symptoms except dysphagia, although the overall benefits decrease with long-term use. CLINICAL TRIAL REGISTRATION: NCT02549859; Pre-results.

Effect of low versus high frequency stimulation on freezing of gait and other axial symptoms in Parkinson patients with bilateral STN DBS: a mini-review.

Some studies have shown that low frequency stimulation (LFS, most commonly 60 Hz), compared to high frequency stimulation (HFS, most commonly 130 Hz), has beneficial effects, short-term or even long-term, on improving freezing of gait (FOG) and other axial symptoms, including speech and swallowing function, in Parkinson disease (PD) patients with bilateral subthalamic nucleus deep brain stimulation (STN DBS). However, other studies failed to confirm this. It seems not clear what determines the difference in response to LFS. Differences in study design, such as presence or absence of FOG, exact LFS used (60 Hz versus 80 Hz), study size, open label versus randomized double blind assessment, retrospective versus prospective evaluation, medication On or Off state, total electric energy delivered maintained or not with the change in frequency, and the location of active contacts could all potentially affect the results. This mini-review goes over the literature with the aforementioned factors in mind, focusing on the effect of LFS versus HFS on FOG and other axial symptoms in PD with bilateral STN DBS, in an effort to extract the essential data to guide our clinical management of axial symptoms and explore the potential underlying mechanisms as well. Overall, LFS of 60 Hz seems to be consistently effective in patients with FOG at the usual HFS in regards to improving FOG, speech, swallowing function and other axial symptoms, though LFS could reduce tremor control in some patients. Whether LFS simply addresses the axial symptoms in the context of HFS or has other beneficial effects requires further studies, along with the mechanism.

Low-frequency stimulation of STN-DBS reduces aspiration and freezing of gait in patients with PD.

OBJECTIVES: To study whether 60-Hz stimulation, compared with routine 130 Hz, improves swallowing function and freezing of gait (FOG) in patients with Parkinson disease (PD) who undergo bilateral subthalamic nucleus (STN) deep brain stimulation (DBS). METHODS: We studied 7 patients with PD who experienced FOG that persisted despite routine 130-Hz stimulation and dopaminergic medication. Each patient received 3 modified barium swallow (MBS) studies in a single day under 3 DBS conditions in the medication-on state: 130 Hz, 60 Hz, or DBS off, in a randomized double-blind manner. The laryngeal penetration and aspiration events were cautiously assessed, and a swallowing questionnaire was completed. The Unified Parkinson's Disease Rating Scale, Part III motor score, axial subscore, tremor subscore, and FOG by a questionnaire and stand-walk-sit test were also assessed. The best DBS condition (60 Hz here) producing the least FOG was maintained for 3 to 8 weeks, and patients were assessed again. Changes in measurements between the 60 Hz and 130 Hz were analyzed using paired t test, with swallowing function as primary and the remainder as secondary outcomes. Changes between other DBS conditions were further explored with Bonferroni correction. RESULTS: Compared with the routine 130 Hz, 60-Hz stimulation significantly reduced aspiration frequency by 57% on MBS study and perceived swallowing difficulty by 80% on questionnaire. It also significantly reduced FOG, and axial and parkinsonian symptoms. The benefits at 60-Hz stimulation persisted over the average 6-week assessment. CONCLUSIONS: Compared with the routine 130 Hz, the 60-Hz stimulation significantly improved swallowing function, FOG, and axial and parkinsonian symptoms in patients with PD treated with bilateral STN-DBS, which persisted over the 6-week study period. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with PD who experience FOG, STN-DBS at 60 Hz decreases aspiration events observed during MBS compared with DBS at 130 Hz.

Chemoradiation for patients with large-volume laryngeal cancers.

BACKGROUND: Patients with T4 laryngeal cancers, including those with large-volume (cartilage or tongue-base invasion) lesions, are often excluded from organ-preservation trials due to expectations of inferior outcome in terms of survival and function. We hypothesize that such patients indeed have acceptable survival and function when treated with organ-preservation strategies. METHODS: Retrospective analysis of prospectively collected data of a cohort of patients with T4 laryngeal cancer was carried out. Follow-up ranged from 0.18 to 15.6 years. All T4 laryngeal cancer patients who were enrolled in the University of Chicago concomitant chemoradiotherapy protocols from 1994 to the present were reviewed. This study was composed of 80 newly diagnosed T4 laryngeal cancer patients. Efficacy of treatment was determined through evaluations of survival and function. Survival was evaluated via Kaplan-Meier methods. Swallowing function was evaluated by an oropharyngeal motility (OPM) study and swallowing scores were assigned. Higher scores reflected increasing swallowing dysfunction. RESULTS: Fifty-five of 80 patients (~69%) had documented large-volume tumor. Two- and 5-year overall survivals were 60.0% and 48.7%, respectively. Disease-specific 2- and 5-year survivals for the group were 80.1% and 71.3%, and 79.4 and 74.3%, respectively, for the 55 patients with large volume status. Progression-free survival rates were 52.6% and 47.6%. Forty-four of 65 patients (~68%) with OPM data had a Swallowing Performance Status Scale (SPSS) score of ≤5, indicating various degrees of swallowing abnormalities not requiring a gastrostomy tube. This is a functional-preservation rate of 67.7%. CONCLUSIONS: Chemoradiation for patients with T4 laryngeal cancer appears to be an effective and reasonable option, particularly in light of the satisfactory survival and function-preservation rates.

Characteristics associated with swallowing changes after concurrent chemotherapy and radiotherapy in patients with head and neck cancer.

OBJECTIVE: To define factors that acutely influenced swallowing function prior to and during concurrent chemotherapy and radiotherapy. DESIGN: A summary score from 1 to 7 (the swallowing performance status scale [SPS]) of oral and pharyngeal impairment, aspiration, and diet, was assigned to each patient study by a single senior speech and swallow pathologist, with higher scores indicating worse swallowing. Generalized linear regression models were formulated to asses the effects of patient factors (performance status, smoking intensity, amount of alcohol ingestion, and age), tumor factors (primary site, T stage, and N stage), and treatment-related factors (radiation dose, use of intensity-modulated radiation therapy, response to induction chemotherapy, postchemoradiotherapy neck dissection, and preprotocol surgery) on the differences between SPS score before and after treatment. SETTING: University hospital tertiary care referral center. PATIENTS: The study included 95 patients treated under a multiple institution, phase 2 protocol who underwent a videofluorographic oropharyngeal motility (OPM) study to assess swallowing function prior to and within 1 to 2 months after the completion of concurrent chemotherapy and radiotherapy. MAIN OUTCOME MEASURES: Factors associated with swallowing changes after chemoradiotherapy. RESULTS: The mean pretreatment and posttreatment OPM scores were 3.09 and 3.77, respectively. Patients with T3 or T4 tumors (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.15-0.95; P = .04) and a performance status of 1 or 2 (OR, 0.37; 95% CI, 0.15-0.91; P = .03) were less likely to have worsening of swallowing after chemoradiotherapy. There was a trend for worse swallowing with increasing age (OR, 1.04; 95% CI, 0.99-1.09; P = .08). Only T stage (T3 or T4) was associated with improved swallowing after treatment (OR, 8.96; 95% CI, 1.9-41.5; P < .001). CONCLUSION: In patients undergoing concurrent chemotherapy and radiotherapy, improved swallowing function over baseline is associated with advanced T stage.

Prolonged cricopharyngeal muscle spasm after resection of the cervical vagus nerve in a 15-year-old.

Cervical vagal schwannomas are rare pediatric head and neck neoplasms that present a surgical challenge if the nerve is intimately involved with the mass. In some instances, resection of the vagus nerve with the mass is required. This will usually result in vocal cord paralysis and uncommonly dysphagia due to unilateral cricopharyngeal spasm. We present a case in which these two complications resulted in significant dysphagia and aspiration, which improved with expectant management.

Swallowing disorders in the first year after radiation and chemoradiation.

BACKGROUND: Radiation alone or concurrent chemoradiation can result in severe swallowing disorders. This manuscript defines the swallowing disorders occurring at pretreatment and 3 and 12 months after completion of radiation or chemoradiation. METHODS: Forty-eight patients (10 women and 38 men) participated in this study involving videofluorographic evaluation of oropharyngeal swallow at the 3 time points. RESULTS: At baseline, patients had some swallow disorders, probably related to presence of their tumor. At 3 months posttreatment, frequency of reduced tongue base retraction, slow or delayed laryngeal vestibule closure, and reduced laryngeal elevation increased from baseline. Some disorders continued at 12 months posttreatment. Functional swallow decreased over time in patients treated with chemoradiation, but not those treated with radiation alone. DISCUSSION: Chemoradiation results in fewer functional swallowers than radiation alone at 12 months posttreatment completion.

Aspiration in chemoradiated patients with head and neck cancer.

OBJECTIVE: To review the incidence of aspiration after chemoradiation therapy in patients with head and neck cancer (HNC). DESIGN: Retrospective review. SETTING: Academic institution. PATIENTS: One hundred thirty patients with advanced HNC underwent chemoradiation therapy at our institution between 1998 and 2002 as part of a larger, multi-institutional, prospective study of induction chemotherapy followed by chemoradiation therapy; the 118 patients (91%) for whom oropharyngeal motility (OPM) study data were available are discussed in this article. MAIN OUTCOME MEASURES: Incidence of trace ( 5%) aspiration (deep laryngeal or tracheal penetration) as determined by pretreatment and posttreatment OPM studies and correlation of the findings with the patients' reported symptoms. RESULTS: Eighty-one patients (69%) underwent at least 1 OPM study demonstrating aspiration within the first year after chemoradiation therapy, with 30 (25%) demonstrating frank aspiration. Of the patients who aspirated, 61 (75%) reported no symptoms of coughing or choking (80% of trace and 67% of frank aspirators). The patients with cancer of the larynx and hypopharynx were more likely to be aspirators (P = .007 and P = .004, respectively). Of the 62 patients with available pretreatment OPM data, 33 (53%) demonstrated aspiration at baseline. CONCLUSIONS: Aspiration is highly prevalent among patients with advanced HNC at baseline and is worse in the posttreatment period after chemoradiation therapy. The majority of these patients report no symptoms. All patients with advanced HNC should undergo instrumental swallow assessment, even in the absence of symptoms, to detect subclinical aspiration and to institute therapeutic maneuvers and swallow precautions as well as to determine the safety of oral feeding.

Effects of radiotherapy with or without chemotherapy on tongue strength and swallowing in patients with oral cancer.

BACKGROUND: Oral tongue strength and swallowing ability are reduced in patients treated with chemoradiotherapy for oral and oropharyngeal cancer. METHODS: Patients with oral or oropharyngeal cancer treated with high-dose chemoradiotherapy underwent tongue strength, swallowing, and dietary assessments at pretreatment and 1, 3, 6, and 12 months posttreatment. Tongue strength was assessed using the Iowa Oral Performance Instrument (IOPI). Oral and pharyngeal residue was evaluated utilizing videofluoroscopy. RESULTS: Mean maximum tongue strength dropped a nonsignificant amount immediately after treatment, and then increased significantly at 6- and 12-months posttreatment completion. Analyses were adjusted for patient dropout. Tongue strength was not significantly correlated with swallow observations of percentage oral and pharyngeal residue. Ability to eat various diet consistencies was reduced after treatment but improved over time at a rate similar to changes in oral intake and type of diet. CONCLUSIONS: Parallel but not significant changes in oral intake, diet, and tongue strength in the first year post chemoradiation therapy need further study in a larger population.

Relationship between swallow motility disorders on videofluorography and oral intake in patients treated for head and neck cancer with radiotherapy with or without chemotherapy.

BACKGROUND: Current research demonstrates that swallow function is impaired after treatment with organ-sparing chemoradiotherapy. Few studies, however, have related observed swallowing disorders with the patient's oral intake and diet in a large cohort of patients. METHODS: Swallowing function was examined using the modified barium swallow (MBS) procedure in 170 patients treated with radiotherapy with or without chemotherapy for cancer of the head and neck at 5 evaluation points: pretreatment and at 1, 3, 6, and 12 months posttreatment. Fisher's exact test was used to examine the relationship between swallow motility disorders and oral intake or diet consistencies. RESULTS: Limitations in oral intake and diet during the first year after cancer treatment were significantly related to reduced laryngeal elevation, reduced cricopharyngeal opening, and rating of nonfunctional swallow on at least 1 swallow of any bolus type. CONCLUSIONS: Swallow motility disorders had a significant impact on the eating ability of patients after treatment for head and neck cancer with radiotherapy with or without chemotherapy.

Intensity-modulated radiation therapy in advanced head and neck patients treated with intensive chemoradiotherapy: preliminary experience and future directions.

We review our recent experience with intensity-modulated radiation therapy (IMRT) and conventional three-dimensional radiation therapy (C3DRT) in advanced head and neck cancer. Sixty-nine patients with Stage IV head and neck cancer (and stage III base of tongue and hypopharynx) enrolled in a Phase II study of definitive chemoradiation; 20 received all or part of their radiation with IMRT. Image-guided set-up, using video subtraction techniques, was used in all patients. Six weekly doses of induction carboplatin (AUC=2) and paclitaxel (135 mg/m2) were followed by alternating weekly chemoradiation to 75 Gy with 1.5 Gy BID fractions, concurrent with paclitaxel (100 mg/m2/week), 5-fluorouracil (600 mg/m2/d) and hydroxyurea (500 mg PO BID). Two consecutive cohorts enrolled, differing in radiation scheme: 75 Gy to gross disease in both, 60 or 54 Gy to first echelon lymphatics and 45 or 39 Gy to second echelon lymphatics. With a median follow-up of 47 months, 3-year overall survival is 68.5% and 3-year locoregional control is 94.0%, with no significant differences between those treated with C3DRT versus IMRT, nor between the two radiation dosing schemes. Actuarial overall survival without tracheostomy or laryngectomy, or without a gastrostomy tube was also similar. Acute mucositis, dermatitis and pain were similar with C3DRT and IMRT. Preliminary data suggests IMRT is well tolerated, and does not compromise locoregional control, indicating that IMRT adequately covers the clinical volume at risk. Building on the present clinical experience, future directions include more directed efforts at reducing toxicity, with better planning software and planning techniques.

Site of disease and treatment protocol as correlates of swallowing function in patients with head and neck cancer treated with chemoradiation.

BACKGROUND: The relationship between type of chemoradiation treatment, site of disease, and swallowing function has not been sufficiently examined in patients with head and neck cancer treated primarily with chemoradiation. METHODS: Fifty-three patients with advanced-stage head and neck cancer were evaluated before and 3 months after chemoradiation treatment to define their swallowing disorders and characterize their swallowing physiology by site of lesion and chemoradiation protocol. One hundred forty normal subjects were also studied. RESULTS: The most common disorders at baseline and 3 months after treatment were reduced tongue base retraction, reduced tongue strength, and slowed or delayed laryngeal vestibule closure. Frequency of functional swallow did not differ significantly across disease sites after treatment, although frequency of disorders was different at various sites of lesion. The effects of the chemotherapy protocols were small. CONCLUSIONS: The site of the lesion affects the frequency of occurrence of specific swallow disorders, whereas chemoradiation protocols have minimal effect on oropharyngeal swallow function.

Eating ability in head and neck cancer patients after treatment with chemoradiation: a 12-month follow-up study accounting for dropout.

BACKGROUND: Head and neck cancer patients treated with chemoradiation have difficulty eating a normal diet. This study was designed to characterize eating ability over 12 months after chemoradiation treatment. Analyses take patient dropout into account. METHODS: Two hundred fifty-five patients with head and neck cancer treated with chemoradiation were followed for 12 months. Eating ability was analyzed using generalized linear model methods that accounted for non-ignorable dropout. RESULTS: Eating ability was compromised immediately after treatment and improved over 12 months to near pretreatment levels. Ability to eat at most 50% of the diet orally did not return to baseline levels (p <.05). However, the percent of patients eating a normal diet did return to baseline levels. Accounting for dropout modified the results, but the pattern of significance was similar. CONCLUSIONS: Treatment of head and neck cancer with chemoradiation has a significant effect on eating ability, which improves after 12 months after treatment.

Xerostomia: 12-month changes in saliva production and its relationship to perception and performance of swallow function, oral intake, and diet after chemoradiation.

BACKGROUND: Previous investigators have found permanent changes in saliva production after chemoradiation but have not examined these in relation to swallowing measures, diet changes, and patient comfort over time. METHODS: Thirty patients with advanced stage cancer of the oropharynx treated with chemoradiation were followed with videofluoroscopic swallow studies, a measure of stimulated total saliva production, a questionnaire of their perception of dry mouth, and a questionnaire on the nature of their oral intake at pretreatment until 12 months after treatment. RESULTS: Saliva declined significantly from pretreatment to 12 months. Swallowing-related complaints increased significantly over the 12 months, especially in patients with lower saliva weights. Diet choices increased over time after treatment, except crunchy foods. Swallow measures did not relate to saliva weight. CONCLUSIONS: Reduced saliva weight does not correlate with slowed or inefficient swallow. Instead, reduced saliva weight seems to change patients' perceptions of their swallowing ability and, on that basis, their diet choices.

Swallow function and perception of dysphagia in patients with head and neck cancer.

BACKGROUND: The relationship between subjective complaints of dysphagia and objective measures of swallow function in patients with cancers of the oral cavity, pharynx, or larynx, treated with radiotherapy +/- chemotherapy has not been well documented in the literature. METHODS: Swallowing function in 132 patients with various lesions was evaluated using videofluoroscopy and analyzed by patient complaint of dysphagia grouping. RESULTS: Patients with complaints of dysphagia demonstrated significantly worse swallow function as indicated by lower oropharyngeal swallow efficiency (OPSE), longer transit times, larger residues, and more swallows with aspiration. Patients with complaints of dysphagia also tended to take less of their nutrition by mouth and less variety of food consistencies in their diet compared with those without complaint. CONCLUSIONS: Patients were able to perceive decrements in their swallowing function as dysphagia and may have limited their oral intake in response to that perception. The ability to accurately perceive swallowing function may be useful for self-monitoring changes in dysphagia status during a course of swallow therapy.