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Human papillomavirus-related (HPV+) oropharyngeal cancer is a rapidly emerging disease with generally good prognosis. Many prognostic algorithms for oropharyngeal cancer incorporate HPV status as a stratification factor, rather than recognising the uniqueness of HPV+ disease. The International Collaboration on Oropharyngeal cancer Network for Staging (ICON-S) aimed to develop a TNM classification specific to HPV+ oropharyngeal cancer.The ICON-S study included patients with non-metastatic oropharyngeal cancer from seven cancer centres located across Europe and North America; one centre comprised the training cohort and six formed the validation cohorts. We ascertained patients' HPV status with p16 staining or in-situ hybridisation. We compared overall survival at 5 years between training and validation cohorts according to 7th edition TNM classifications and HPV status. We used recursive partitioning analysis (RPA) and adjusted hazard ratio (AHR) modelling methods to derive new staging classifications for HPV+ oropharyngeal cancer. Recent hypotheses concerning the effect of lower neck lymph nodes and number of lymph nodes were also investigated in an exploratory training cohort to assess relevance within the ICON-S classification.Of 1907 patients with HPV+ oropharyngeal cancer, 661 (35%) were recruited at the training centre and 1246 (65%) were enrolled at the validation centres. 5-year overall survival was similar for 7th edition TNM stage I, II, III, and IVA (respectively; 88% [95% CI 74-100]; 82% [71-95]; 84% [79-89]; and 81% [79-83]; global p=0·25) but was lower for stage IVB (60% [53-68]; p0·0001). 5-year overall survival did not differ among N0 (80% [95% CI 73-87]), N1-N2a (87% [83-90]), and N2b (83% [80-86]) subsets, but was significantly lower for those with N3 disease (59% [51-69]; p0·0001). Stage classifications derived by RPA and AHR models were ranked according to survival performance, and AHR-New was ranked first, followed by AHR-Orig, RPA, and 7th edition TNM. AHR-New was selected as the proposed ICON-S stage classification. Because 5-year overall survival was similar for patients classed as T4a and T4b, T4 is no longer subdivided in the re-termed ICON-S T categories. Since 5-year overall survival was similar among N1, N2a, and N2b, we re-termed the 7th edition N categories as follows: ICON-S N0, no lymph nodes; ICON-S N1, ipsilateral lymph nodes; ICON-S N2, bilateral or contralateral lymph nodes; and ICON-S N3, lymph nodes larger than 6 cm. This resembles the N classification of nasopharyngeal carcinoma but without a lower neck lymph node variable. The proposed ICON-S classification is stage I (T1-T2N0-N1), stage II (T1-T2N2 or T3N0-N2), and stage III (T4 or N3). Metastatic disease (M1) is classified as ICON-S stage IV. In an exploratory training cohort (n=702), lower lymph node neck involvement had a significant effect on survival in ICON-S stage III but had no effect in ICON-S stage I and II and was not significant as an independent factor. Overall survival was similar for patients with fewer than five lymph nodes and those with five or more lymph nodes, within all ICON-S stages.Our proposed ICON-S staging system for HPV+ oropharyngeal cancer is suitable for the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer TNM classification. Future work is needed to ascertain whether T and N categories should be further refined and whether non-anatomical factors might augment the full classification.None.

e18513 Background: Distantly metastatic HNSCC carries a poor prognosis with limited palliative systemic treatment options and a paucity of literature examining factors impacting outcomes of such therapy. We sought to evaluate characteristics conferring more favorable responses to frontline palliative systemic therapy after distant failure (DF). Methods: From an IRB-approved database, we identified 332 pts with metastatic HNSCC treated from 1999 to 2019. Pts with locoregional HNSCC who developed DF and subsequently were treated with palliative systemic therapy were included. Pts were categorized by disease factors, and outcomes were analyzed for progression-free survival (PFS) and overall survival (OS) with Kaplan-Meier curves and log-rank p-values. Results: A total of 85 pts were identified with median age 59.5 years (37-89); 82.4% male, 90.6% Caucasian, 52.9% with > 10 pack-years tobacco use history. Oropharynx primary was the most common site (36.5%) followed by oral cavity (23.5%). All 31 oropharynx cancer pts were HPV-related. Sixty-six pts initially received definitive chemoradiotherapy, with 43 receiving concurrent radiosensitizing cisplatin. Median time to DF was 15 months (m). Thirty pts (35.3%) had concurrent locoregional failure with DF. 62.4% had only one metastatic organ site, with lung-only metastasis in 43.5%. Carboplatin/paclitaxel was the most commonly used frontline palliative chemotherapy (50.6%); 22.4% received frontline nivolumab or pembrolizumab, and 9.4% were treated with frontline platinum/5-FU/cetuximab (9.4%). 63.5% of pts achieved a best response of stable disease or better with frontline therapy. At two years after initial DF, 6 pts (7%) were disease-free. Sixteen pts were alive at last follow-up. After DF, median PFS was 6.5 m and median OS was 10.6 m. On univariate analysis, HPV-related disease was associated with increased PFS (9.5 vs 5.1 m, p < 0.0001) and increased OS (21.1 vs 7.7 m, p < 0.0001). Pts with one metastatic organ site had better OS (11.0 vs 6.2 m, p = 0.047). There was a trend of increased OS with lung-only metastasis (14.4 vs 7.7 m, p = 0.0776), and absence of concurrent locoregional failure (10.8 vs 8.3 m, p = 0.1153). Conclusions: Our results demonstrate that HPV-related metastatic HNSCC is associated with a statistically significant increased PFS and OS. Additionally, there was a trend of increased OS with lower locoregional and distant metastatic burden at DF though statistical significance was not achieved.

6533 Background: NCCN guidelines do not recommend routine surveillance imaging for distant failure (DF) after definitive treatment of head & neck squamous cell carcinoma (SCC). We hypothesized that there exists a subset of patients with sufficiently high enough risk for DF to benefit from surveillance imaging. This study attempts to define high risk cohorts of oropharynx (OP) and oral cavity (OC) patients. Methods: A retrospective review was conducted of patients with SCC of the OP or OC at a single tertiary care institution from 1994-2019. Patients were staged according to AJCC 7th edition and included in this study if they completed definitive-intent treatment and received 60 Gray or higher of radiotherapy (RT). Local, regional, and distant failure were estimated with cumulative incidence. Univariable & multivariable risk factors for DF were identified with Fine & Gray competing risk regression. Significant variables were compiled to calculate a risk score. Results: 863 patients were included (676 OP/187 OC). OC patients were 60.4% male, median age 61, with median follow up of 77.5 months. Smoking status was 27.3% current, 44.4% former, 28.3% never, with 30 median pack years. Disease was 57.3% T1-2, 42.7% T3-4, 55.6% N0-2a, 44.4% N2b-3. 94.1% had surgery & 34.3% had concurrent systemic therapy. OP patients were 87.9% male, median age 58, 96.3% HPV+, with median follow up of 60.8 months. Smoking status was 20.9% current, 44.5% former, 34.6% never, with 20 median pack years. Disease was 67.9% T1-2, 32.1% T3-4, 29.9% N0-2a, 70.1% N2b-3. 11.5% had surgery & 87.3% had concurrent systemic therapy. Specifically, 52.2% of OP patients received concurrent cisplatin, 10.6% concurrent cetuximab, and 24.5% other systemic therapies. 11.7% of patients experienced DF, of which 77% failed in the lung. Within the OC cohort, nodal stage 2b or higher was the only predictive factor (HR 3.26, p < 0.001), conferring a 3 year risk of DF of 34% vs 10%. Within the OP cohort, a high risk cohort of 87 patients (12.9%) was identified with a 3 year incidence DF of 22%, compared to 10% or less in lower risk cohorts. This high risk cohort consisted of active smokers treated with definitive RT and either concurrent cisplatin or no concurrent therapy, with at least T3 and N2b disease, as well as any patients treated with definitive RT and concurrent cetuximab. Conclusions: We identified groups of OC & OP patients with greater than 20% risk of developing DF at 3 years, the majority of which occurred in the lung. Surveillance imaging of the chest should be considered for patients meeting these criteria.

BACKGROUND/AIM There are limited data regarding survival, failure patterns, and factors associated with disease recurrence in patients with cutaneous squamous cell cancer of the head and neck (cSCC-HN) with nodal metastases. PATIENTS AND METHODS A retrospective analysis of patients with cSCC-HN metastatic to cervical and/or parotid lymph nodes treated with surgery and post-operative radiation therapy was performed. RESULTS This study included 76 patients (57 immunocompetent and 18 immunosuppressed) with a median follow-up of 18 months. Overall survival, disease-free survival (DFS), and disease recurrence (DR) at 2 years was 60%, 49%, and 40%, respectively. Immunosuppressed patients had significantly lower 2-year DFS (28% vs. 55%; p=0.003) and higher DR (61% vs. 34%; p=0.04) compared to immunocompetent patients. Analysis of immunocompetent patients demonstrated extracapsular extension (ECE) as the only factor associated with DR (p

18Fluorodeoxyglucose positron-emission tomography (FDG-PET) has shown prognostic value in oropharynx cancer but data regarding patients with known human papillomavirus (HPV) status is limited. If prognostic, FDG-PET may play a role in the identification of patients suitable for treatment de-intensification. Patients with stage III-IVB squamous cell carcinoma of the oropharynx treated with definitive chemoradiation with known HPV status were identified. Clinical and PET parameters were compared between HPV-positive and HPV-negative patients and evaluated for prognostic value via Cox proportional hazards univariate and multivariate regression. Seventy patients were identified (58 HPV-positive, 12 HPV-negative) with a median follow-up of 41.5 months. HPV-negative tumors were associated with increased metabolic activity at the primary site but smaller cervical lymph nodes compared to HPV-positive tumors. Univariate and multivariate analysis identified the nodal maximum standard uptake value (SUVmax) as a predictor of disease-free (DFS) and overall survival (OS) among HPV-positive patients independent of other commonly used prognostic factors such as smoking and nodal stage. Pretreatment SUVmax in the nodal volume is a simple parameter that retains prognostic value in the HPV-era. Increased PET activity portends inferior DFS and OS and may be used in conjunction with other known prognostic factors, to identify patients inappropriate for treatment de-intensification strategies in the future.

Background Severe late dysphagia is common after chemoradiotherapy for cancers of the larynx and oropharynx. Options for reduction of severe late dysphagia are limited for human papillomavirus (HPV)-negative patients. In this study, the role of feeding tube choice in severe late dysphagia is investigated. Methods Patients disease-free after chemoradiotherapy for HPV-negative cancers of the laryngopharynx who received a feeding tube on-treatment were identified. The incidence of severe late dysphagia after reactive nasogastric (R-NG), proactive or reactive percutaneous gastrostomy (P-PEG or R-PEG) was assessed using log-rank and Cox analyses. Results Seventy-eight patients received a feeding tube on-treatment and remained disease-free. Median follow-up was 64 months. The 5-year incidence of severe late dysphagia was 30.8% in the R-NG cohort (n = 36), 56.4% in the R-PEG (n = 17; p = .193), and 60.9% in the P-PEG (n = 25; p = .016) cohorts. On multivariate analysis, percutaneous gastrostomy (PEG) feeding was independently associated with an increased rate of severe late dysphagia. Conclusion R-NG use during chemoradiotherapy is associated with less severe late dysphagia and is preferred over PEG. © 2015 Wiley Periodicals, Inc. Head Neck, 2015

An often overlooked, yet useful, technique in the treatment of palmar hand burns is the use of glabrous skin grafting, particularly in dark-skinned individuals. Pediatric palmar burns are a particularly unique subset of burns. The typical split-thickness or full-thickness skin grafts leave a notably different skin texture and pigmentation. It is also known that the psychological aspects of a pediatric burn can be quite burdensome for a child as he or she progresses through childhood and adolescence. For a dark-skinned patient the placement a standard full-thickness skin graft in a nonpigmented palm provides for a constant reminder of a traumatic event. We report a case series of pediatric patients who were managed with glabrous skin grafting from the plantar aspect of the foot.A retrospective review of palmar skin burns requiring grafting at a single pediatric burn center experience over a 2 and a half year time period was performed. Seventeen patients were identified. Our treatment algorithm for deep partial thickness burns first relies on a combination of operative and nonoperative measures to expedite the demarcation of the burn injury. If the burn is full thickness in nature or if a lack of progression of healing is identified within the first 14 days of injury, then skin grafting is recommended. Our technique for performing the graft is described.The average age at time of surgery was 2.05 years (6 months to 6.8 years). Fourteen of the 17 patients had darker skin types (Fitzpatrick Type III-VI) and identified themselves as either Hispanic or African American. The average size of the area requiring skin graft after debridement was 0.94% total body surface area (0.5%-2.0%). Of the patients that were not lost to follow-up, 1 patient required additional grafting after developing a finger contracture for splint noncompliance. Aesthetically, the wounds went on to heal with an excellent pigment match and an inconspicuous donor site.In the management of deep-partial or full-thickness palmar skin burns in the pediatric population that require grafting, the use of plantar glabrous skin grafts offers a reliable option for coverage. The aesthetic and functional results are improved over standard techniques.

Summary Objectives Long term swallowing dysfunction in patients with oropharynx squamous cell carcinoma (OPSCC) treated with concurrent chemoradiation (CRT) is declining. While the use of intensity modulated radiotherapy (IMRT) is commonly believed to be a potential cause, we hypothesize that the increasing incidence of human papillomavirus (HPV) related disease may also favorably impact this outcome. Materials and methods We reviewed 130 HPV+ and 17 HPV− patients with stage III–IV OPSCC treated exclusively with conventional 3-field radiotherapy with chemotherapy between 2002 and 2010. The rates of normal diet, limited diet (significant restrictions in the types of foods eaten, and/or requiring nutritional supplementation for weight maintenance) and feeding tube dependence (FTD) were compared between HPV+ and HPV− patients. Cox proportional hazards modeling were used to perform univariate analysis (UVA) to examine predictors of a combined endpoint of dietary limitation, which included limited diet and/or FTD. These outcomes were also compared to our previously reported cohort of OPSCC patients treated between 1989 and 2002 to assess changes in toxicity over time given the changing disease epidemiology, in the setting of identical treatment regimens. Results With a median follow-up of 55 months, HPV+ patients more frequently had resumed a normal diet (87% vs. 65%) at last follow up and had lower rates of limited diet (9% vs. 18%) and FTD (4% vs. 18%) compared to HPV− patients (p = 0.02). HPV status was the only significant predictor of reduced swallowing dysfunction on UVA (HR 0.19; p = 0.008). When compared to our 1989–2002 cohort, patients treated between 2002 and 2010 had less FTD (7.5% vs. 34%, p Conclusions HPV+ patients with OPSCC have reduced late swallowing dysfunction after chemoradiation compared to HPV− patients. The changing epidemiology of OPSCC may play a role in toxicity reduction in these patients, independent of the increasing use of IMRT.

Objective: Despite extensive research into the treatment of partial-thickness burns, to date there has not been the emergence of a preeminent modality. This pilot study, the first such study to be performed in a burn unit in the US, was designed to evaluate the efficacy and outcomes of the application of copolymer dressing (Suprathel; PolyMedics Innovations Corporation, Stuttgart, Germany) for both superficial and deeper partial-thickness burns. Method: The copolymer dressing was used as a primary wound dressing to treat superficial and deep partial-thickness burns (average 5% total body surface area) in paediatric patients. Burns were debrided within 24 hours, at bedside, in the burn unit or in the operating room. The copolymer dressing was then applied directly to the wound and covered with a non-adherent second layer and an absorptive outer dressing. After discharge, patients were seen every 5–7 days until healed. Parameters evaluated included average hospital length of stay, average number of intravenous doses of narcotics administered, pain score at first follow-up visit, average time to complete re epithelialisation, incidence of burn wound infection, and patient/parent satisfaction on a 4-point scale. We also evaluated our experience with the dressing. Data were evaluated retrospectively under an Investigational Review Board approved protocol. Results: Of the 17 patients assessed the average hospital length of stay was 1.4 days during which the average number of intravenous narcotic doses administered before copolymer dressing application was 1.5 and after was 0.1 doses. At the first follow-up visit, average pain score was 1.2 on a 10-point scale and the average time to re epithelialisation was 9.5 days. There was no incidence of burn wound infection. Patient/parent satisfaction was average of 3.66 on a 4-point scale. The staff had found that the self-adherence and elasticity of the dressing made it easy to apply and stay adherent, especially in areas of difficult contour. There were no readmissions for further debridement or skin grafting. Conclusion: Our experience shows that patients may be discharged shortly after the application of the copolymer dressing, with manageable pain scores and ease of use as determined by the caretakers high satisfaction. This new, fully synthetic copolymer dressing is easy to apply, does not require any additional antimicrobial coverage and may be used to successfully manage deeper partial-thickness burns, donor sites or burns in areas of contour, where many other dressings might not be considered or be appropriate. Declaration of interest: None declared

Time to treatment initiation (TTI) is increasing and is associated with worsening survival. In the current study, the authors sought to identify a mechanism for this relationship by assessing the effect of TTI on clinical-to-pathologic upstaging in patients with head and neck squamous cell carcinoma (HNSCC).Using the National Cancer Data Base, the authors analyzed patients receiving definitive surgery for SCC of the oral cavity, oropharynx, larynx, and hypopharynx from 2005 through 2014. The primary outcome was T, N, or stage group upstaging, defined as higher pathologic stage than clinical stage. TTI was defined as the time between diagnosis and surgery. Multivariable logistic and Cox proportional hazards regression modeled upstaging and survival, respectively.Cohorts of 60,194 patients, 51,380 patients, and 52,980 patients, respectively, with complete T, N, and stage group data were included. N upstaging was most common (18.6%), followed by stage group (17.4%) and T (12.1%) upstaging; all types were predicted by TTI. Compared with a TTI of 1 to 6 days, TTIs as short as 7 to 13 days (odds ratio, 1.20; P = .038) or ≥ 70 days (odds ratio, 2.04; P .001) were found to predict T upstaging, a finding that is consistent for N and stage group upstaging. Using restricted cubic splines, relative odds of T and stage group upstaging escalated to 2.25 and 1.93, respectively, at a TTI of 365 days. In survival analyses, T (hazard ratio [HR], 1.53), N (HR, 1.88), and stage group (HR, 1.69) upstaging all predicted mortality (P .001), whereas TTI only predicted mortality after 70 days (HR, 1.11; P = .023).Tumor progression, measured by clinical-to-pathologic upstaging, increases mortality for patients with HNSCC experiencing treatment delays. Cancer 2018;124:1400-14. © 2018 American Cancer Society.

Objective: Traditional burn dressings demonstrate unfavourable tendencies of shrinking when wet and failing to maintain their integrity when manipulated. To overcome these obstacles, gel-forming fibre dressings have emerged as an alternative. Our objective was to observe the clinical properties and healing ability in the setting of burn wounds in a paediatric centre of a chitosan-based dressing containing silver. Methods: A sample of 12 partial-thickness burns in 10 children were identified for treatment with the chitosan-based silver dressing. The dressings were moistened before application, and monitored for any shrinkage on application. Patients were monitored for healing at outpatient follow-up visits and the dressings were allowed to separate as healing occurred. Results: We treated 12 burns in 10 children with an average age of 5.2 years. The burns had an average proportion of total body surface area (TBSA) of 3.6 % and involved the trunk and all extremities. Wounds healed mostly or completely in an average of 8.3 days. Dressings retained their size when wet and integrity when removed. No burns were found to be infected at any point in the study. Conclusions: The chitosan-based dressing offered an optimal environment for moist wound management, and did not demonstrate the shrinkage or disintegration that diminishes the clinical usability of widely used hydrofibre dressings. The burns healed within an expected period of time, and did not undergo any infectious processes. Based on the results of this pilot study, the chitosan-based silver dressing is deserving of further study as an alternative to traditional burn dressings.

Background While the role of the gut microbiome in inflammation and colorectal cancers has received much recent attention, there are few data to support an association between the oral microbiome and head and neck squamous cell carcinomas. Prior investigations have been limited to comparisons of microbiota obtained from surface swabs of the oral cavity. This study aims to identify microbiomic differences in paired tumor and non-tumor tissue samples in a large group of 121 patients with head and neck squamous cell carcinomas and correlate these differences with clinical-pathologic features. Methods Total DNA was extracted from paired normal and tumor resection specimens from 169 patients; 242 samples from 121 patients were included in the final analysis. Microbiomic content of each sample was determined using 16S rDNA amplicon sequencing. Bioinformatic analysis was performed using QIIME algorithms. F-testing on cluster strength, Wilcoxon signed-rank testing on differential relative abundances of paired tumor-normal samples, and Wilcoxon rank-sum testing on the association of T-stage with relative abundances were conducted in R. Results We observed no significant difference in measures of alpha diversity between tumor and normal tissue (Shannon index: p = 0.13, phylogenetic diversity: p = 0.42). Similarly, although we observed statistically significantly differences in both weighted (p = 0.01) and unweighted (p = 0.04) Unifrac distances between tissue types, the tumor/normal grouping explained only a small proportion of the overall variation in the samples (weighted R2 = 0.01, unweighted R2

Background Chemoradiotherapy results in excellent outcomes in locally advanced head and neck squamous cell carcinoma (HNSCC). This trial compared 2 chemoradiotherapy regimens. Methods Patients with locally advanced HNSCC were treated with radiation (70–74.4 Gy), and randomized to arm A: cisplatin 100 mg/m2 on radiotherapy (RT) days 1, 22, and 43, or arm B: cisplatin (20 mg/m2/day) and 5-fluorouracil (5-FU; 1000 mg/m2/day) continuous 96-hour infusions on RT weeks 1 and 4. The primary endpoint was relapse-free survival (RFS). Results Between February 2008 and October 2011, 69 patients were enrolled in this study. The study prematurely closed when a scheduled interim analysis showed superior outcomes in both arms and futility of continuation. Eighty-three percent of patients had oropharyngeal cancer, of these, 86% were human papillomavirus (HPV)/p16+. The 3-year Kaplan–Meier outcome estimates (median follow-up, 41 months) for arms A and B were: RFS 87% versus 80% (p = .24), overall survival 97% versus 85% (p = .013), locoregional control 96% versus 94% (p = .52), and distant metastatic control 91% versus 87% (p = .9). Conclusion Multiagent was not superior to single-agent chemoradiotherapy. Overrepresentation of HPV/p16+ patients resulted in better than expected outcomes. © 2014 Wiley Periodicals, Inc. Head Neck 37: 1583–1589, 2015

e17570 Background: IMRT for HNSCC limits exposure to critical nearby structures thereby reducing toxicities. Real world data on toxicities after long term follow-up post IMRT for HNSCC are lacking. This study assessed the incidence of late toxicities in patients with HNSCC within 5 years post-treatment with definitive IMRT (d-IMRT). Methods: This is a retrospective, IRB approved, single-institution review of patients (pts) with stage I-IVB HNSCC treated with d-IMRT +/- chemotherapy between 2009 and 2013. The primary outcomes were incidence of severe late toxicities (dysphagia requiring esophageal stricture dilation, physician-reported grade 2 or worse neck fibrosis and xerostomia) occurring 3 months or more after completion of IMRT; feeding tube (FT) dependence within 1st year of IMRT completion, and FT dependence beyond 1st year post IMRT. Toxicities were deemed acute if they occurred during IMRT and up to 90 days post IMRT. Results: 274 pts, median age 59 years (38 – 82.9), were identified. 67.6% were HPV positive, 10.5% HPV negative and HPV status was unknown in 21.9%. Site of disease was oropharynx in 70%, larynx in 25% and hypopharynx in 4%. 206 pts (75.2%) received d-IMRT alone, 37 (13.5%) had definitive concurrent chemoradiation – mostly with cisplatin (58%), and 31 (11.3%) received adjuvant IMRT. Of the 243 pts treated with d-IMRT +/- chemotherapy, 80 (32.9%) required FT during RT due to grade 2 or worse acute dysphagia. Excluding 11 pts with disease recurrence or new HNSCC diagnosis, FT dependence at any time from 3 months to one year post IMRT occurred in 22 of 232 pts (9.48%), while FT dependence beyond 1st year post IMRT occurred in 8 pts (3.4%). 11 pts (4.7%) required stricture dilation for late dysphagia. Late grade 2 or worse fibrosis and xerostomia occurred in 7 (3.0%) and 89 (38.4%) pts, respectively. Conclusions: Our study suggests that except for xerostomia, severe late toxicities after definitive IMRT for HNSCC is likely uncommon. Prospective studies with late IMRT toxicities and their impact on quality of life (QoL) as endpoints are warranted.

6080 Background: Adjuvant CRT with high-dose cisplatin remains standard treatment for OCSCC with high risk pathologic features of positive surgical margins (SM+) and/or extranodal extension (ENE). High-dose cisplatin is associated with significant toxicities, and alternative dosing schedules or treatments are used. We evaluated outcomes associated with different systemic therapies concurrent with RT and the effect of cumulative dosing of cisplatin. Methods: An IRB-approved collaborative database of patients (pts) with primary OCSCC (Stage I-IVB AJCC 7th edition) treated with primary surgical resection between 1/1/2005 and 1/1/2015 with or without adjuvant therapy was established from 6 academic institutions. Pts were categorized by systemic therapy received, and resultant groups compared for demographic data, pathologic features, and outcomes by t-test and Chi-squared tests. Kaplan-Meier curves, log-rank p-values, and multivariate analysis (MVA) for disease free survival (DFS) and freedom from metastatic disease (DM). Results: From a total sample size of 1282 pts, 196 pts were identified with high risk features (SM+, ENE) who were treated with adjuvant CRT. Median age was 56 years, 63.3% of pts were men, 81.1% were Caucasian, 70.9% had significant tobacco history. 35.7% of pts had SM+, 82.7% ENE, 65.3% with perineural invasion (PNI), 49% had lymphovascular space invasion (LVSI). There was a trend associating higher cisplatin dose delivered with improved locoregional control, DM, and overall survival (OS) (p-values 0.131, 0.084, and 0.187, respectively). DFS was significantly better with higher cisplatin dose (HR = 0.95 per 100 mg/m2 increase in cisplatin). Administration schedule of cisplatin (weekly versus high-dose) was not significantly associated with DFS. On MVA, PNI and higher cisplatin dose remained statistically significant for DFS (p < 0.001 and 0.007). Median OS by cisplatin dose was 10.5 ( < 200 mg/m2) vs. 20.8 months ( > / = 200 mg/m2). Conclusions: This multi-institutional analysis demonstrated cumulative cisplatin dose > / = 200 mg/m2 was associated with improved DFS in high risk resected OCSCC pts. It remains unclear by this analysis if cisplatin administration schedule has any prognostic implication. Further study is warranted to elucidate the optimal cisplatin schedule for this population.

e17521 Background: Human papillomavirus-mediated (HPV+) oropharyngeal cancer is now defined as a clinically distinct entity from HPV-unrelated (HPV-) disease in the 8th edition AJCC staging system, which more accurately informs prognosis for HPV+ patients. Treatment decisions are currently made according to the AJCC 7th ed staging. HPV+ patients are associated with favorable outcome. This study aims to analyze the national pattern of practice for HPV+ disease. Methods: Patients with oropharyngeal squamous cell carcinoma (OPSCC) diagnosed from 2010-2012 were identified from the National Cancer Database (NCDB). Patients were staged using the AJCC 7th system. Chemotherapy, radiotherapy and surgery were counted as treatment modalities. Fisher’s exact test and chi-squared test were used to assess treatment patterns over time. Overall survival (OS) was compared with Cox proportional hazards model. Results: 5,928 HPV+ OPSCC patients were identified. Single modality (surgery or radiation) was the most common treatment choice, used in 53.6% of stage I and 48.8% of stage II patients. For stage I, the use of dual modality therapy (70.8% received surgery with radiation) decreased from 36% in 2010 to 19% in 2012 (p = 0.05), though no significant difference in OS was seen between dual modality and single modality. Dual modality with chemoradiation was the main approach for stage III (58.6%) and stage IVA (67.5%) disease. Use of trimodality decreased from 2010 to 2012 in both stage III (p = 0.03) and stage IVA (p < 0.01). Conclusions: Using a national cohort of HPV+ patients from the NCDB, we showed that single modality was the most common for stages I/II and dual modality was the mainstay for stages III/IVA. Usage of aggressive approaches (dual modality for stages I/II and trimodality for stages III/IVA) decreased over time. Prospective studies would be needed to determine the optimized therapeutic choice for HPV+ patients given favorable outcome.

e17567 Background: Patients (pts) with adverse pathologic factors in resected OCSCC excluding positive surgical margins or extranodal extension represent a group of INT risk disease. Though not standard of care, adjuvant CRT is often used in INT pts. We conducted a multi-institutional study to evaluate factors associated with improved outcomes in INT pts treated with or without chemotherapy. Methods: An IRB-approved collaborative database of patients with primary OCSCC (Stage I-IVB AJCC 7th edition) treated with primary surgical resection between 1/1/2005 and 1/1/2015 with or without adjuvant therapy was established from 6 academic institutions. Pts were categorized by pathologic features and adjuvant therapy. Kaplan Meier curves, log-rank p-values and multivariate analysis (MVA) were used to describe outcomes by treatment including locoregional control (LRC) and disease free survival (DFS). Results: From a total sample size of 1270 patients, 455 INT risk pts were treated with primary surgical resection and adjuvant therapy; 95 received CRT, 274 received RT alone, and 86 received RT without recorded chemotherapy. 49% of pts had perineural invasion (PNI), 24.8% lymphovascular space invasion, 21.5% poorly differentiated histology, 47.3% with pT3/4 disease, and 27.9% with > 2 lymph node positive (LN+). 55.8% of CRT pts were treated with cisplatin. > 2 LN+ was the only significant predictor of LRC (HR 1.49, p= 0.049). PNI and > 2 LN+ were significant predictors of DFS (HR 1.52, p= 0.003 and HR 1.76, p< 0.001). On MVA, after adjusting for > 2 LN+, treatment with cisplatin-RT was borderline significant for LRC (HR 0.52, p= 0.08). 3 year LRC in pts with > 2 LN+ was 84.4% in pts treated with cisplatin-RT compared with 64.9% for RT alone. Conclusions: The addition of cisplatin-based CRT to INT risk pts is controversial but among pts with > 2 LN+ there was a trend toward benefit. This study is limited by small numbers of pts treated with CRT, though these results highlight the need for further investigation in this population to identify INT pts who would benefit from adjuvant therapy intensification.

e21056 Background: High risk cutaneous squamous cell cancer of the head and neck (cSCC-HN) have suboptimal outcomes with surgery and postoperative radiation. We report preliminary safety outcomes of a phase II study (NCT03057613) exploring the safety and efficacy of the addition of Pembrolizumab to postoperative IMRT. Methods: Patients with cSCC-HN were eligible for this IRB approved study if they had resection of all gross disease and demonstrated (a) invasion of the skeleton or skull base; (b) node positive disease; (c) or a tumor > 2cm with ≥1 of the following risk factors: recurrent disease, perineural invasion, lymphovascular space invasion, poorly differentiated, positive margins, satellitosis or in-transit metastases. Immune competent pts and those with CLL were eligible. This study aimed to accrue 34 evaluable patients to assess a primary safety endpoint of dose limiting toxicity (DLT) defined as any grade ≥3 toxicity at least possibly related to the immunotherapy. Assuming toxicity of < 20% is acceptable and > 40% is unacceptable, if ≥11 of 34 (32%) patients experienced a DLT, the regimen would be considered unsafe. Results: Of 15 pts already enrolled on this study, 11 have completed the protocol treatment. There were no DLTs observed to date. Grade 2 immune related toxicity was seen in two patients, one with bullous pemphigoid and another with lymphopenia and peripheral neuropathy and weakness in his hands in the setting of a prior cervical spine injury. Both responded to steroids and recovered completely. Based on this initial cohort, the 95% confidence intervals (CI) on DLTs for the entire cohort is 0-28%. Using the most conservative CI of 28%, the likelihood of 11 of the remaining 23 patients experiencing a DLT is 3.4%. Assuming a CI of 20%, the risk is 0.3%. None of the 11 pts who have completed protocol therapy have experienced a recurrence. Conclusions: The addition of Pembrolizumab to postoperative IMRT in high risk cSCC-HN is safe and will be studied in a randomized phase III adjuvant study (Keynote 630). This phase II study will continue to enroll CLL patients to assess safety and efficacy signals in this unique higher risk population. Clinical trial information: NCT03057613.

Mammary analogue secretory carcinoma (MASC) is a recently identified salivary tumor that shares morphological features of secretory carcinoma of the breast, salivary acinic cell carcinoma, low grade cystadenocarcinoma and mucoepidermoid carcinoma. To date, a majority of cases have been reported in the major salivary glands with very few seen in the palate. We present 2 single institution cases of MASC of the soft palate to help further characterize this novel tumor.

To determine the patterns of adjuvant chemoradiotherapy use in elderly patients treated with definitive surgical resection for squamous cell carcinoma of the head and neck with extracapsular extension (ECE) or positive margins and determine whether an association with overall survival (OS) exists with adjuvant concurrent chemoradiotherapy (CRT).The National Cancer Database was queried to identify patients with SCC of the oral cavity, oropharynx, larynx, and hypopharynx who were treated with primary definitive surgery and adjuvant radiation therapy between 2004 and 2012. For elderly patients (aged70 years) with pathology revealing ECE or positive margin, the benefit of concurrent chemotherapy was explored using multivariable Cox proportional hazards modeling.A total of 7349 patients were identified meeting study criteria, of whom 1187 were elderly (aged70 years) with a median follow-up of 30.6 months. Of these elderly patients, 445 had ECE or positive margin and represent the study population, of whom 187 (42%) received CRT. Delivery of CRT in this cohort increased over the study period, and intensity modulated radiation therapy was associated with increased use of CRT (odds ratio 2.07; P=.004). Increasing age was associated with reduced use of CRT (odds ratio 0.88; P.001). Chemoradiotherapy was associated with a significant improvement in OS on multivariable analysis (hazard ratio 0.74; P=.04) and a trend toward significance on inverse propensity score analysis (hazard ratio 0.78; P=.051). Three-year OS was 53.8% in the CRT group, compared with 44.6% in the adjuvant radiation therapy-alone patients.The use of adjuvant CRT is increasing among elderly patients with resected squamous cell carcinoma of the head and neck exhibiting ECE or positive margins. Chemoradiotherapy was associated with an improvement in OS on multivariable analysis but not propensity-weighted analysis. Among fit elderly patients with ECE or positive margins after definitive surgical resection, concurrent chemotherapy can be carefully considered.

Objective Cigarette lighters are frequent vectors in intentional contact burns. Time and temperature needed to cause thermal injury are considered to differentiate accidental from inflicted burns. This study examines the minimum time needed to heat a cigarette lighter’s top to temperatures capable of inflicting any clinically visible skin burn. This information could be useful in child abuse and other forensic cases. Methods A literature search was performed to establish the time and temperature at which partial/full thickness skin burns are acquired, regardless of vector. Using a thermocouple, the temperature of the top of two common lighters was measured at ten second intervals while sustaining maximal flame held both upright and sideways and during cooling once the flame was extinguished. Results In the literature, the lowest temperatures documented to cause burns in one second were 69 °C–70 °C for transepidermal or partial thickness burns. From an ambient temperature prior to flame ignition, it took over 50 s for the lighter tops to reach 60 °C when held upright. After 180 s, the lighters were shut off. It then took less than 60 s for the lighters to cool to less than 60 °C. The BIC lighter held to the side heated to 60 °C in about 15 s and needed over 100 s to cool to under 60 °C. Conclusions Cigarette lighter burns are often blamed on non-intentional occurrences. At least 50 s of sustained flame is needed to heat typical cigarette lighter tops to temperatures capable of inflicting clinically visible skin burns. This time is longer than the time required to light a cigarette. Therefore, for a cigarette lighter to inflict a contact burn injury, there needs to be intent and preparation, making accidental cigarette lighter burns unlikely.

T2 glottic cancer with impaired vocal cord mobility (T2b) is known to have higher local failure rates when compared with T2 cancers without impaired cord mobility (T2a) treated with radiotherapy (RT) alone.In this retrospective review, we identified and compared the local control rates of 3 groups: T2aN0 treated with RT; T2bN0 treated with RT; and T2b-3N0-2 treated with chemoradiotherapy (CRT).The 3-year local control rate was 95.1% for T2aN0, 73.2% for T2bN0 treated with RT, and 91.5% for the CRT group (p = .01). On univariate analysis, T2bN0 disease versus T2aN0 treated with RT alone (p = .03) was significantly associated with inferior local control.Patients with glottic cancer with impaired vocal cord mobility (T2b) have a high rate of local failure with RT alone. The addition of concurrent chemotherapy should be considered for patients highly motivated toward larynx preservation and willing to accept the potential toxicity. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1832-1836, 2016.

Achieving locoregional control in high-risk patients with head and neck cancer who are poor candidates for standard continuous-course (chemo) radiotherapy due to advanced age, comorbidities, or very advanced disease is challenging. At our Institution, we have significant experience with a regimen of split-course, accelerated, hypofractionated radiotherapy (SCAHRT) for these patients.The SCAHRT regimen consisted of 60-72 Gy in 20-24 fractions separated by several weeks mid-course to allow for toxicity recovery and disease reassessment. It was used for patients with advanced age, significant co-morbidities, anticipated intolerance to definitive (chemo)radiation, and those with oligometastatic disease. Disease-free and overall survival rates were calculated using Kaplan-Meier analysis.Fifty-eight out of 65 patients (89%) completed both courses of treatment. Patients without metastatic or recurrent disease were evaluated for treatment response and survival (n=39). Among this group, total tumor response was 91%, and median locoregional failure-free survival and overall survival were 25.7 and 8.9 months, respectively.In high-risk patients unable to tolerate continuous-course definitive (chemo)radiation, SCAHRT is a safe, well-tolerated and effective method of achieving durable locoregional disease control. In properly selected patients, this regimen is preferable to purely palliative approaches.

Objective Porcine xenograft (PX) has become a valuable part of the armamentarium of treatment options in a US paediatric burn centre. The use in adult patients has been well described in the burn literature, but there is minimal literature describing its use in children. The objective of this article is to describe a three-years' experience with PX use in paediatric burns. Method A retrospective medical record review of patients with superficial partial-thickness burns treated with PX admitted to a paediatric burn centre between February 2009 and November 2012. Results A total of 164 patients met the inclusion criteria. Burn total body surface area (TBSA) ranged from 0.5% to 28%. After the placement of PX, significant decreases were seen in the need for narcotic analgesics and burn dressing changes. Only four of 164 patients (2.4%) developed infections, although only one of these infections was at the site of the xenograft. Conclusion PX appears to reduce pain and eliminate the need for procedural intravenous sedation in many patients. This can make burn wound care more child-friendly and shorten hospital length of stay. The complication rate is low and manageable. The authors believe that PX is an effective and safe treatment for superficial partial-thickness burns in children. Declaration of interest: P. M.Glat, is a paid consultant and speaker for Mölnlycke Health Care, the manufacturer of EZ Derm.

Human papillomavirus (HPV)-positive oropharyngeal cancer is associated with favorable outcomes, prompting investigations into treatment deintensification. The purpose of this study was for us to present the predictors of distant metastases in patients with HPV-positive oropharyngeal cancer treated with cisplatin-based chemoradiotherapy (CRT) or cetuximab-based bioradiotherapy (bio-RT).In patients with stage III to IVb HPV-positive oropharyngeal cancer, the Kaplan-Meier analysis was used to calculate distant metastases rates. Univariate analysis (UVA) and multivariate analysis (MVA) were used to identify factors associated with distant metastases.Increased distant metastases rates were noted in active smokers versus never/former smokers (22% vs 5%), T4 vs T1 to T3 (15% vs 6%), and cetuximab-based bio-RT versus CRT (23% vs 5%). All remained significant on MVA.T4 tumors and active smokers have substantial rates of distant metastases, and trials investigating intensified systemic therapies may be considered. Higher rates of distant metastases observed with concurrent cetuximab are hypothesis generating, but further data are needed. © 2017 Wiley Periodicals, Inc. Head Neck 39: 940-946, 2017.

The purpose of the present study was to identify variables associated with high risk of failure in patients with locally advanced squamous cell carcinoma of the oral cavity (SCC-OC).This retrospective study included 191 patients with stage III-IVb SCC-OC treated with post-operative radiotherapy (RT) or chemoradiotherapy (CRT) between 1995 and 2013. Disease-free (DFS) and overall survival (OS) were analyzed; variables associated with inferior DFS were identified.Seventy-five patients (39%) recurred. DFS and five-year OS were 52% and 54%, respectively. Poorly differentiated tumors (p=0.03), recurrent tumors (p=0.02) and high nodal ratio (p=0.02) were associated with an increased risk of recurrence. CRT was associated with improved DFS in patients with positive margins and/or extracapsular extension (p=0.021).Tumors that are recurrent, high grade, or have high nodal ratio are at risk of recurrence. Presence of these disease features should be taken into consideration for better risk stratification.