Background Changing trends in head and neck cancer (HNC) merit an understanding of late effects of therapy, but few studies examine dysphagia beyond 2 years of treatment. Methods A case series was examined to describe the pathophysiology and outcomes in dysphagic HNC survivors referred for modified barium swallow (MBS) studies ≥5 years after definitive radiotherapy or chemoradiotherapy (01/2001–05/2011). Functional measures included the Penetration-Aspiration Scale (PAS), Performance Status Scale-Head and Neck (PSS-HN), Swallowing Safety Scale (NIH-SSS), and MBSImp. Results Twenty-nine patients previously treated with radiotherapy (38%) or chemoradiotherapy (62%) were included (median years post-treatment: 9, range: 5–19). The majority (86%) had oropharyngeal cancer; 52% were never smokers. Seventy-five percent had T2-T3 disease; 52% were N+. Median age at diagnosis was 55 (range: 38–72). Abnormal late examination findings included: dysarthria/dysphonia (76%), cranial neuropathy (48%), trismus (38%), and radionecrosis (10%). MBS studies confirmed pharyngeal residue and aspiration in all dysphagic cases owing to physiologic impairment (median PAS: 8; median NIH-SSS: 10; median MBSImp: 18) whereas stricture was confirmed endoscopically in 7 (24%). Twenty-five (86%) developed pneumonia, half requiring hospitalization. Swallow postures/strategies helped 69% of cases, but no patient achieved durable improvement across functional measures at last follow-up. Ultimately 19 (66%) were gastrostomy dependent. Conclusions Although functional organ preservation is commonly achieved, severe dysphagia represents a challenging late effect that may develop or progress years after radiation-based therapy for HNC. These data suggest that novel approaches are needed to minimize and better address this complication that is commonly refractory to many standard dysphagia therapies.

Purpose NCI’s Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. We sought to develop a CTCAE-compatible modified barium swallow (MBS) grade for the purpose of grading pharyngeal dysphagia as a toxicity endpoint in cooperative group organ preservation trials for head and neck cancer (HNC). We hypothesized that a 5-point CTCAE-compatible MBS grade (“DIGEST”) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings is feasible and psychometrically sound. Methods A modified Delphi exercise was conducted for content validation, expert consensus, and operationalization of DIGEST criteria. Two blinded raters scored 100 MBS conducted before or after surgical or non-surgical organ preservation. Intra- and inter-rater reliability were tested by weighted Kappa. Criterion validity against OPSE, MBSImP™©, MDADI, and PSS-HN was assessed with one-way ANOVA and post hoc pairwise comparisons between DIGEST grades. Results Intra-rater reliability was excellent (weighted Kappa=0.82–0.84) with substantial to almost perfect agreement between raters (weighted Kappa=0.67–0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r=0.77, p<0.0001), swallow efficiency (OPSE: r=−0.56, p<0.0001), perceived dysphagia (MDADI: r=−0.41, p<0.0001), and oral intake (PSS-HN diet: r=−0.49, p<0.0001). Conclusions With the development of DIGEST, we have adapted MBS rating to the CTCAE nomenclature of ordinal toxicity grading used in oncology trials. DIGEST offers a psychometrically sound measure for HNC clinical trials and investigations of toxicity profiles, dose-response, and predictive modeling.

Purpose To investigate long-term swallowing function in oropharyngeal cancer patients treated with IMRT, and to identify novel dose-limiting criteria predictive for dysphagia. Methods and Materials Thirty-one patients with stage IV oropharyngeal squamous carcinoma enrolled on a phase II trial were prospectively evaluated by modified barium swallow studies at baseline, and 6, 12, and 24 months post-radiation. Candidate dysphagia-associated organs-at-risk (OARs) were retrospectively contoured into original treatment plans. Twenty-one (68%) cases were base of tongue, and 10 (32%) were tonsil. Stage distribution was T1 (12), T2 (10), T3 (4), T4 (2), and TX (3), and N2 (24), N3 (5), and NX (2). Median age was 52.8 years (Range: 42–78). Thirteen (42%) received concurrent chemotherapy during IMRT. Thirteen (42%) were former smokers. Mean dose to glottic larynx for the cohort was limited to 18 Gy (range: 6–39 Gy) by matching IMRT to conventional low neck fields. Results Dose-volume constraints (V30 < 65% and V35 < 35% for anterior oral cavity and V55 < 80% and V65 < 30% for high superior pharyngeal constrictors) predictive for objective swallowing dysfunction were identified by univariate and multivariate analyses. Aspiration and feeding tube dependence were observed in only one patient at 24 months. Conclusions In the context of glottic laryngeal shielding, we describe candidate oral cavity and superior pharyngeal constrictor OARs and dose-volume constraints associated with preserved long-term swallowing function; these constraints are currently undergoing prospective validation. Strict protection of the glottic larynx via beam-split IMRT techniques promises to make chronic aspiration an uncommon outcome.

Almost 40% of patients with oropharyngeal cancer treated with nonsurgical organ preservation modalities may avoid feeding tube placement. Factors that predispose to g-tube placement and prolonged dependence include T3 to T4 tumors, concurrent chemotherapy, current smoking status, and baseline swallowing dysfunction or weight loss. Adherence to an aggressive swallowing regimen may reduce long-term dependence on enteral nutrition and limit the rate of g-tube placement overall.

Objective/Hypothesis To describe clinically relevant between group differences in MD Anderson Dysphagia Inventory (MDADI) scores among head and neck cancer (HNC) patients. Study Design Retrospective cross-sectional study was conducted in 1,136 HNC patients seen for modified barium swallow (MBS) studies. Methods The MDADI was administered by written questionnaire at the MBS appointment. MDADI global, composite, and subscale scores were calculated. Anchor-based methods were employed to determine clinically meaningful between group differences by feeding tube status, aspiration status (per MBS study), and diet level. Results Mean MDADI scores for the 1,136 patients were: emotional 65.8±17.3, functional 68.1±19.6, physical 60.1±18.6, global 59.3±28.3, and composite 64.0±17.1. Three hundred-seventy-eight patients (33%) were feeding tube dependent and 395 (34.8%) were aspirators; 122 (11%) were nothing per oral (PSS-HN diet=0) and 249 (22%) ate unrestricted, regular diets (PSS-HN diet=100). Statistically significant (p<0.0001) between group differences (feeding tube vs. no feeding tube, aspirator vs. non-aspirator, oral vs. non-oral diet, PSS-HN diet levels) were observed for all mean MDADI scores (global, composite, and subscales). A mean difference of 10 points in composite MDADI scores differentiated feeding tube dependent from non-tube dependent patients, aspirators from non-aspirators, and distinct PSS-HN diet levels. Conclusions We identify that a 10 point between-group difference in composite MDADI scores was associated with clinically meaningful between-group differences in swallowing function.