S430 SWALLOWING AFTER OROPHARYNGEAL CANCER (OPC); A LONG TERM FOLLOW UP STUDY

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1 S430 SWALLOWING AFTER OROPHARYNGEAL CANCER (OPC); A LONG TERM FOLLOW UP STUDY Jo M Patterson, PhD, MSc, BScHons, E McColl, PhD, C Kelly, FRCR, J A Wilson, MD; Sunderland Royal Hospital, Newcastle University, Northen Centre for Cancer Care UK Background Little is known about the long-term swallowing outcomes for OPC patients treated with (chemo)radiotherapy, with few studies reporting data beyond 2 years. OPC patients are younger and have better survival than other head and neck cancer groups. Retrospective OPC survivorship data point to long term dietary restriction, chronic aspiration and pneumonia. We aimed to investigate the incidence of late dysphagia in a prospective, longitudinal OPC cohort. Methods 82 out of 93 eligible OPC patients from NE England were prospectively recruited and assessed pretreatment, three, six, twelve and 60 months post-treatment. Outcome measures included a swallowing specific questionnaire, a Flexible Endoscopic Evaluation of Swallowing, a water swallow test and a diet texture score. Results Forty-seven patients (57%) were alive beyond 5 years post-(chemo)radiotherapy; 21 patients died within the first year. A marked deterioration on all swallowing measures occurred between pre- and three months post-treatment (p<=0.01). A significant improvement between three and twelve months was found on two clinical swallowing measures, but not the patient self report. At one year, 33% had a gastrostomy and 5% were nil by mouth. At five years, just 7% had retained their gastrostomy but 9 patients had a laryngectomy; five for a dysfunctional larynx and one patient had a permanent tracheostomy. Follow up swallowing outcomes are currently being analysed and will be presented. Conclusions Long-term dysphagia is a difficult and challenging problem following (chemo)radiotherapy. This late effect may develop several years beyond treatment, with a small number requiring major surgery for dysfunction. These consequences need to be better understood, so that patients are fully informed of potential late toxicities and to compare outcomes as OPC treatments evolve.

2 S431 DYSPHAGIA QUALITY OF LIFE SCORES AND TREATMENT OUTCOMES IN OROPHARYNGEAL CANCER PATIENTS: IS IT TIME TO RECONSIDER THE PROPHYLACTIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY? Paul B Romesser, MD, Eric Sherman, MD, Jeremy Setton, MD, Karen Shupak, MD, Daphna Gelblum, MD, Shyam Rao, MD, PhD, Nancy Lee, MD; Memorial Sloan-Kettering Cancer Center Purpose/Objectives: The optimal use of prophylactic percutaneous gastrostomy (ppeg) in the management of head and neck cancer is controversial. Therefore, we compared dysphagia quality-of-life (QOL) scores and treatment outcomes between ppeg and non-ppeg patients during chemoradiation (CRT) for a cohort of oropharyngeal cancer (OPC) patients Materials/Methods: From 1998 to 2012, 601 OPC patients were treated with definitive CRT to a median dose of 70 Gy. Prior to 2008, ppeg was routinely recommended for all patients (n=392). Based on institutional consensus, the policy was changed and patients were expectantly monitored throughout treatment (n=209). Patients with poor treatment tolerance and concerns for malnutrition were referred for reactive PEG (rpeg) placement. Patient-reported dysphagia QOL outcomes were prospectively collected by the validated M.D. Anderson dysphagia inventory (MDADI) in 201 patients. The median follow-up was 35 months (range, months). Kaplan-Meier method with a log-rank comparison and Cox proportional hazards models were performed for survival outcomes. Results: Global dysphagia QOL scores were significantly worse for ppeg than expectantly managed patients (p=0.02). Seventy (33.5%) of the 209 expectantly managed patients required rpeg at a median of 30 days after the start of CRT (range, days). The median percent weight loss between ppeg and expectantly managed patients at end-crt was 8.2% vs. 9.8% (p<0.001), 1-month post-crt was 9.0% vs. 10.5% (p<0.001), and 3-months post-crt was 12.3% vs. 13.6% (p=0.001), respectively. There was no significant difference in locoregional control (p=0.43), freedom from distant metastases (p=0.35), or overall survival (p=0.06) between the cohorts. On multivariate analysis, lower Karnofsky performance score (p=0.004), higher tumor stage (p<0.001), concurrent C225 (p<0.001), higher BMI (p=0.034), and history of tobacco use (p=0.018) were associated with a greater hazard for all-cause mortality. Treatment-related weight loss and ppeg were not independently predictive of overall survival. Conclusions: Expectantly managed patients had significantly improved outcomes on a prospectively collected and previously validated QOL dysphagia inventory when compared to ppeg patients. Despite a significantly greater weight loss in expectantly managed patients than those with ppeg, this relative 1.5% difference did not affect outcomes. Thus these data, in the largest reported series evaluating the clinical benefit of ppeg to date, does not support the routine use of ppeg.

3 S432 A COMPARATIVE STUDY OF SWALLOW AND QUALITY OF LIFE OUTCOMES IN TWO MATCHED PATIENT COHORTS WITH SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX Conor McKenna, BSc, Jonathan Bernstein, MD, FRCS, Jarrod Homer, MD, FRCS; University of Manchester, Manchester Royal Infirmary Introduction: The treatment of oropharyngeal squamous cell carcinoma (OPSCC) can have a significant impact on swallow and quality of life (QOL). There may be clinical equipoise between surgical and nonsurgical management of OPSCC and data comparing swallow and QOL outcomes are insufficient. Functional outcomes data could help inform the choice of treatment modalities. The aim of this study was to compare swallow and QOL outcomes in matched surgical (transoral laser microsurgery) and nonsurgical ([chemo]radiotherapy) treatment groups. Methods:Matching criteria were; subsite, age +/- 5 years, T stage (T1/2 or T3/4) and presence/absence of cervical lymph node metastasis. Fifteen patient pairs (n=30) met the matching criteria. The MD Anderson Dysphagia Inventory (MDADI) and University of Washington QOL (UW-QOL) scores, feeding requirements, and clinicopathologic data were collated. Data were analysed using the Wilcoxon signedrank test and Spearman correlation. Summary of patient characteristics: Characteristic n % Median age (IQR) 59.5 ( ) Gender Male Female Soft palate Subsite Tonsil Base of tongue T Stage T1/ T3/ N Status N +ve N -ve Transoral laser microsurgery Yes No Neck dissection Yes No Radiotherapy Yes No 3 10 Chemotherapy Yes No Median follow up in months (IQR) 13.4 ( )

4 Results: There was strong correlation between MDADI total score and UW-QOL health related QOL score (r=0.52, P=0.004) and mood score (r=0.70, P<0.0001). Comparison of MDADI and UW-QOL scores and clinical data in the two matched treatment groups revealed no significant differences. Analysis of outcomes for patients treated with transoral laser microsurgery revealed higher gastrostomy rates and higher UW-QOL Anxiety scores in patients with base of tongue primaries compared with patients with tonsil primaries (P<0.05). Conclusion: Swallow outcomes following treatment for OPSCC have a significant impact on QOL scores and therefore should be given consideration in treatment selection. The use of transoral laser microsurge

5 S433 THE EFFICACY OF PROPHYLACTIC SWALLOW INTERVENTIONS IN THE HEAD AND NECK CANCER PATIENT UNDERGOING ORGAN PRESERVATION CANCER TREATMENT Barbara P Messing, MA, CCCSLP, BCSS, Joseph A Califano, MD, FACS, Patrick K Ha, MD, FACS, Ray Blanco, MD, FACS, John Saunders, MD, FACS, Carole Fakhry, MD, FACS, Melissa Kim, MS, CCCSLP, Bethany Hieber, MS, CCCSLP, Lisa Valasek, MS, CCCSLP, Dorothy Gold, MSW, LCSWC, OSWC, Karen Harrer, MSW, LCSWC, Karen Ulmer, BSN, RN, CORLN, Samantha Gebhart, Clinical, Research, Coordinator; Greater Baltimore Medical Center, The Milton J Dance Jr. Head & Neck Center, Johns Hopkins Head & Neck Surgery located at GBMC Background: Primary treatment for head and neck cancer historically has involved extensive surgical procedures. Over the past years, organ-preservation protocols were developed to offer patients alternatives to extensive surgical interventions. These protocols aimed to improve survival, cosmesis, speech and swallow function, and maximize quality of life (QOL). Organ-preservation protocols typically involve a combination of radiation therapy and chemotherapy with or without neck dissection. Objectives: The objectives of this study were to determine whether patients who perform prophylactic swallow exercises during and post-cancer treatment are able to: (1) maintain a higher diet level, (2) have less swallowing impairment, and (3) have a better health related QOL. Methods: A prospective, randomized, IRB approved clinical trial was conducted on 60 patients- > 21 years of age with stage 3-4, biopsy-proven squamous cell carcinoma of the head and neck. All patients were provided with a TheraBite Jaw Motion Rehabilitation System. The control group was given standard care as needed. The exercise group was instructed in swallow exercises by a speech-language pathologist. Measurements in both groups of patients were taken pre-treatment, and 3, 6, 12, and 24- months post-treatment. The measurements included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC-QOL), a cranial nerve assessment using the Rating of Oral Motor Skills (ROMS) and Modified Barium Swallow Study (MBS) measures. Results: Results were analyzed across patients with measurements at all five time points. QOL improved over time with only slight differences between the two groups. Generally both groups of patients showed similar levels of oromotor function over time. The largest difference occurred at 6 months where the exercise group had 27% more patients maintaining close to normal oromotor function skills (60%) as compared to the control group (33%) on the ROMS. Also at the 6-month time point, there were 20% more control patients (50%) with trismus than exercise patients (30%). Baseline scores were 17% and 0% for the control vs. exercise group, respectively. However, none of these differences were statistically different because of the small sample size. It should be noted that both groups received a therabite at the start of treatment. When comparing baseline and 3 months post treatment, MBS studies showed patients had the following mean (sd) for the FOSAD pharyngeal phase, respectively: 1) control group, 2.3 (2.6) and 3.0 (2.2); and 2) exercise group, 1.3 (1.9) and 1.4 (1.9). Similarly for the OPSE score, baseline and 3 months post treatment showed the following mean (sd), respectively: 1) control group, 68.0 (26.5) and 61.7 (24.0); and 2) exercise group, 86.9 (29.0) and 71.9 (21.1).

6 Conclusions: A swallow exercise program improves swallow function for patients undergoing chemoradiation when comparing exercise and control groups from baseline to 6 months post treatment. QOL improved over time for both groups to greater than baseline by 24 months post treatment. A large percentage of patients retained normal incisal opening using the therabite device during and post treatment. Further review of the data may elicit additional functional outcomes.

7 S434 DOES ADJUVANT NECK DISSECTION INCREASE RISK OF CHRONIC DYSPHAGIA AFTER OROPHARYNGEAL IMRT WITH SYSTEMIC THERAPY? Katherine A Hutcheson, PhD, Amal Abualsahm, BDS, Alejandro Sosa, DMD, Randal S Weber, MD, Beth M Beadle, MD, PhD, Erich M Sturgis, MD, Jan S Lewin, PhD; The University of Texas MD Anderson Cancer Center Objective: Conflicting results are reported with regard to the impact of adjuvant neck dissection on radiation-associated dysphagia after nonsurgical therapy for head and neck cancer. The purpose of this analysis was to assess the impact of adjuvant neck dissection on chronic dysphagia after intensity modulated radiotherapy (IMRT) with systemic therapy for oropharyngeal cancer Methods: This retrospective cohort study included 349 patients with a minimum of 1 year disease-free follow-up after IMRT and systemic therapy for oropharyngeal squamous cell carcinoma ( ). A composite dysphagia endpoint was the primary outcome defined by aspiration, stricture, or pneumonia >12 months post treatment. Adjuvant neck dissection after nonsurgical therapy was the primary independent variable. Patient, tumor, and nonsurgical treatment factors were also examined using logistic regression analysis. Results: Adjuvant neck dissection (ND) was performed in 75 (21%) patients a median of 2.5 months after IMRT and systemic therapy. Bilateral (n=4), radical (n=1), and levels I or V (n=4) ND were rare. Most ND specimen (69/75, 92%) were negative for residual tumor. Overall, 41 (12%) of the total 349 patients developed chronic dysphagia. Adjuvant neck dissection did not increase the prevalence of chronic dysphagia (9% ND vs. 12% no ND, p=0.464) or the duration of gastrostomy dependence (median: 4.6 mos. ND vs. 5.3 mos. no ND, p=0.482). Likewise, laterality (p=0.464) and levels of ND (p=0.293) did not significantly impact the prevalence of chronic dysphagia. Other predictors of chronic dysphagia were examined. Prevalence of chronic dysphagia was significantly associated with age (p=0.0017), T- classification (p=0.0002), baseline dietary restrictions (p=0.002), systemic agent (p=0.005), total IMRT dose (p=0.0001), and total fractions (p=0.0018). Conclusion: In the setting of selective neck dissection for residual adenopathy after nonsurgical therapy, adjuvant neck dissection after IMRT and systemic therapy for oropharyngeal SCCA did not significantly elevate risk of chronic dysphagia or duration of gastrostomy dependence. Baseline factors including pretreatment function, age, and T-classification and the intensity of nonsurgical therapy better predict chronic dysphagia.

8 S435 SEQUENTIAL EVALUATION CLARIFIES THE TIME-DEPENDENT DAMAGES ON VOCAL AND SWALLOWING FUNCTIONS INDUCED BY (CHEMO-)RADIOTHERAPY AGAINST HEAD AND NECK CANCER Yoshie Iino, MSc, Koichiro Saito, MD, PhD, Tetsuya Tsuji, MD, PhD, Yorihisa Imanishi, MD, PhD, Kaoru Ogawa, MD, PhD, Meigen Liu, MD, PhD; Keio University School of Medicine; National Cancer Center Hospital East Background and purpose: (Chemo-)radiotherapy ((C)RTx) is one of the established therapeutic options for head and neck cancer (HNC). While improving the curative effect of this organ-preserving treatment modality, well-refined management of unavoidable adverse reactions is indispensable to provide better medical care. The purpose of this study was to assess the time-dependent damages observed on vocal and swallowing functions of the patients with HNC receiving (C)RTx, for the future improvement of intra- and posttherapeutic patient care. Materials and methods: From January through December 2013, fourteen male patients with laryngeal cancer (LC, n=8) or oropharyngeal cancer (OPC, n=6) were treated in our institution using (C)RTx, and these patients were incorporated in this study. The median total radiation dose was 64.7 Gy, and CRTx was performed on 2 LC patients and on all OPC patients. GRBAS scale and acoustic/aerodynamic analyses were used as objective vocal parameters. Endoscopic swallowing evaluation was carried out to objectively evaluate the swallowing function. Subjective vocal and swallowing assessments were performed using VHI and Swallowing Ability Scale respectively. Furthermore, UWQOL (ver. 4) was used to assess health-related QOL of the patients. Sequential measurements were performed pre-, intra- (3, 5, and 7 weeks), and post-(c)rtx (2, 4, and 12 weeks). Results: 1) Vocal function (Figure 1) While vocal deterioration was not observed before 50 Gy irradiation in objective measurement, gradual worsening was observed immediately from the beginning of (C)RTx in LC. Both objective and subjective vocal deteriorations were observed after 50 Gy irradiation in OPC. Worst vocal function was observed at the end of treatment in both cancers. In LC, vocal recovery reached pre-therapeutic level 1 month after treatment. Furthermore, rather better function was obtained 3 months after treatment compared with pre-therapeutic voice in LC. On the other hand, relatively quick vocal recovery was observed in OPC to require 2 weeks to reach pre-therapeutic level. 2) Swallowing function (Figure 2) Although abnormal laryngeal sensory thresholds were observed after 30 Gy irradiation in both cancers, swallowing status stayed relatively in good condition in LC. Gradual deterioration of swallowing function was observed in OPC from the beginning of (C)RTx to reach the worst level at the end of treatment. Objective assessment showed the gradual recovery of swallowing function to reach pre-therapeutic

9 level 1 month after treatment. However, delay in the recovery of subjective evaluation was observed to require cautions on food intake even 3 months after treatment. 3) QOL Three domains of pain, taste, and saliva were measured by UWQOL. These domains were not clearly disturbed in LC. Four OPC patients required opioid for their pain management. All 3 domains showed the worst score at the end of treatment in OPC. Taste and saliva domains remained at the lower scores compared with pre-therapeutic scores 3 months after treatment. Conclusions: Our study clarified the time-dependent damages on vocal and swallowing functions induced by (C)RTx against LC and OPC. Timing and degree of each adverse reaction should be precisely assessed objectively and subjectively to serve a well-refined patient care to improve their QOL.

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11 S436 LONG-TERM (> 5-YEARS) RESULTS OF CONCURRENT CHEMO-RADIOTHERAPY ON SWALLOWING FUNCTION, SPEECH, VOICE, AND QUALITY OF LIFE IN ADVANCED HEAD AND NECK CANCER PATIENTS TREATED WITH PREVENTIVE SWALLOWING EXERCISES Sophie A Kraaijenga, MD, Lisette van der Molen, SLP, PhD, Irene Jacobi, PhD, Michiel W van den Brekel, MD, PhD, Frans J Hilgers, MD, PhD; The Netherlands Cancer Institute, Department of Head and Neck Oncology and Surgery, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands Introduction: Concurrent chemo-radiotherapy (CCRT) for advanced head-and-neck cancer (HNC) is associated with substantial early and late toxicities, most notably with regard to swallowing function, but also with substantial impact on speech and voice quality. Many HNC centers have introduced strategies to reduce these sequels following CCRT, such as reduction of the radiation dose to swallowing structures and by introducing preventive swallowing exercises. However, despite the increased awareness of acute dysphagia and other sequels in HNC survivors,few studies investigated treatmentinduced effects (and its devastating impact on quality of life) on the long-term, i.e. beyond five years of treatment. Objectives: Assessment of long-term (>5 years) results of CCRT on speech and swallowing function in patients with advanced HNC, who participated in a randomized controlled trial (RCT) on preventive swallowing rehabilitation 1. Patients and Methods: The original RCT started with 55 patients (December March 2008), who were assigned to either standard swallowing exercises (n=28) or exercises based on the TheraBite Jaw Motion Rehabilitation system (n=29). Beyond five years of treatment, 26 patients were still alive of which 19 were able to participate (see consort flowchart). Assessment of functional (speech and swallowing) sequels was performed with multidimensional outcome-measures, i.e. videofluoroscopy, mouth opening measurements, Functional Oral Intake Scale (FOIS), speech and voice quality, and studyspecific questionnaires. All outcome-measures were assessed at fixed points in time: pre-treatment (baseline), and at 10-weeks, 1-year, 2-years, and >5-years post-treatment. Results: Overall, beyond five years of treatment (mean 6.1 years) many initial tumor-, and treatmentrelated problems remained similarly low as reported for the 2-years results 2, except xerostomia (68%; p=0.003). All patients were able to consume a normal oral diet (FOIS score 7). Mean weight (77.8 kg) did not differ significantly from baseline values (p=0.414). However, 4 out of 17 patients (24%), who had a videofluoroscopy, showed penetration (n=3) and/or aspiration (n=1), and 77% had more than normal residue above and below the hyoid bone. Mean maximum inter-incisor mouth opening increased to 53 mm (range mm), with only 1 patient (5%) showing trismus at this later assessment point. Patients' perceived trismus was higher, though, and reported as problematic by 32% of the patients. Pain was absent in 64%, and mild in 36% of patients. Voice quality was perceptually deteriorated (less voiced, decreased pitch) for the tumors located at the hypopharynx (received the highest radiotherapy doses to the larynx), while the nasopharyngeal cancer patients, who earlier showed improvements, showed increased nasality again. The majority of patients (56%) still perceived their voice as different from baseline. Conclusion: This is one ofthe first studies thatinvestigated CCRT-induced effects on speech and swallowing function in HNC patients beyond five years of treatment. Overall, functional problems >5- years post-treatment are limited in this patient cohort, possibly due to the preventive and continued

12 post-treatment rehabilitation programs which were applied. Patients' perceived functional changes correlated only weakly with objective outcome measures. 1. van der Molen e.a. Dysphagia. 2011;26: van der Molen e.a. Eur Arch Otorhinolaryngol.online Jul 28, 2013.

13 S437 A PILOT STUDY OF LONG TERM WEIGHT CHANGE IN PATIENTS WITH TRANS- ORAL ROBOTIC SURGERY Zi Zhang, MD, MSCE, Bert W O'Malley, Jr., MD, FACS, Kaitlyn R Rubnitz, BS, Jonathan Newman, BS, Kathryn H Schmitz, PhD, MPH, Gregory S Weinstein, MD, FACS; University of Pennsylvania Objective: Historically, weight loss has been common after head and neck cancer. With the increased use of trans-oral robotic surgery (TORS), little is known about its impact on patients' post-treatment weight change. Our goal was to determine the effect of primary TORS on the long-term post-treatment weight. Methods: We conducted a pilot retrospective cohort study. Adult oropharyngeal squamous cell carcinoma patients with known p16 testing as a surrogate marker for high-risk human papilloma virus (HPV) who received their initial treatment at the University of Pennsylvania during 2010 were included. Patient's demographics, height, weight, smoking status, cancer stage, and treatment types were collected from the electronic medical records. The outcomes measures were patient weights collected at 0-6, 6-12, and month post-treatment. Results: Of the 158 patients with primary therapy at Penn in 2010 and enrolled in our Penn Tumor Registry, we identified 42 patients who were tested for p16, and for whom follow-up weights were available for at least 1 year post treatment. The mean age at diagnosis was 61 ± 11, 79% were male (n=33), 93% were white (n=39), and 79% were p16 positive (n=33). Among this cohort, 45% of patients (n=19) received primary TORS with or without postoperative radiation or chemotherapy. Patients with primary TORS were more likely to be p16 positive (95% versus 65%), but there were no significant differences in other characteristics between patients with and without TORS. Patients with primary TORS displayed steady weight gain from 6- to 24-month follow-up after the initial treatment associated weight loss, and primary TORS patients recovered their weight to pre-treatment levels at 24-month follow-up. However, patients without TORS had continuous weight loss from pretreatment to 12-month follow up, and were only able to maintain their weight from 12- to 24-month follow-up. Conclusion: Patients with primary TORS appears to recover their post-treatment weight sooner than patients without TORS and return to their pre-treatment weight within 2 years. Our data suggests that TORS may help to preserve function and facilitate postoperative recovery in oropharyngeal squamous cell carcinoma.

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