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Intra-operative stimulated Raman histology (SRH) is a novel technology that uses laser spectroscopy and color-matching algorithms to create images similar to the formalin-fixed paraffin-embedded (FFPE) section. We aim to assess the accuracy of SRH in a novel range of sinonasal and skull base tumors.Select patients undergoing sinonasal and skull base surgery using the Invenio Imaging™ Nio™ Laser Imaging SRH system between June 2020 and September 2021 were assessed. The SRH images were reviewed for pathologic features similar to frozen section (FS) and FFPE. Time taken for results and diagnostic concordance was assessed.Sixty-seven SRH images from 7 tumor types in 12 patients were assessed. Pathologies included squamous cell carcinoma, rhabdomyosarcoma, inverted papilloma, adenoid cystic carcinoma, SMARCB1-deficient sinonasal carcinoma, mucosal melanoma, metastatic colonic adenocarcinoma, and meningioma. Tumor was identified in 100% of lesional specimens, with characteristic diagnostic features readily appreciable on SRH. Median time for diagnosis was significantly faster for SRH (4.3 min) versus FS (44.5 min; p = .0001). Where SRH sample site matched precisely to FS (n = 32/67, 47.8%), the same diagnosis was confirmed in 93.8%. Sensitivity, specificity, precision, and overall accuracy of SRH were 93.3%, 94.1%, 93.8%, and 93.3%, respectively. Near-perfect concordance was seen between SRH and FS (Cohen's kappa [κ] = 0.89).Stimulated Raman histology can rapidly produce images similar to FFPE HE in sinonasal and skull base tumors. This technology has the potential to act as an adjunct or alternative to standard FS.4 Laryngoscope, 132:2142-2147, 2022.

Evidence-based enhanced recovery after surgery (ERAS) programs aim to improve patient outcomes and shorten hospital stays. The objective of this study is to describe the development, implementation, and evolution of an ERAS protocol to optimize the perioperative management for patients undergoing endoscopic skull base surgery for pituitary tumors. A systematic review of the literature was performed, best practices were discussed with stakeholders, and institutional guidelines were established and implemented. Key performance indicators (KPI) were measured and patient-reported outcome surveys were collected. The ERAS protocol was introduced successfully at our institution. We describe the process of initiation of the program and the perioperative management of our patients. We demonstrated the feasibility of integration of ERAS protocols for pituitary tumors with multidisciplinary engagement, with a particular emphasis on the use of data informatics and metrics to monitor outcomes. We expect that this approach will translate to improved quality of care for these often-complex patients.

This review explores how human papillomavirus-related oropharyngeal cancer affects health-related quality of life (HR-QoL) and the role patient-reported outcomes (PROs) can play in optimizing treatment. PRO measures (PROMs) are comprehensive, subjective assessments of patients' day-to-day HR-QoL. Developed through a scientifically robust, multistage process, PROMs offer insight into patients' symptoms, function, and satisfaction with care. The use of PROMs can increase symptom awareness, stimulate discussion, and enhance shared decision-making between patients and healthcare providers.

Constitutive MAPK activation silences genes required for iodide uptake and thyroid hormone biosynthesis in thyroid follicular cells. Accordingly, most BRAFV600E papillary thyroid cancers (PTC) are refractory to radioiodide (RAI) therapy. MAPK pathway inhibitors rescue thyroid-differentiated properties and RAI responsiveness in mice and patient subsets with BRAFV600E-mutant PTC. TGFB1 also impairs thyroid differentiation and has been proposed to mediate the effects of mutant BRAF. We generated a mouse model of BRAFV600E-PTC with thyroid-specific knockout of the Tgfbr1 gene to investigate the role of TGFB1 on thyroid-differentiated gene expression and RAI uptake in vivo. Despite appropriate loss of Tgfbr1, pSMAD levels remained high, indicating that ligands other than TGFB1 were engaging in this pathway. The activin ligand subunits Inhba and Inhbb were found to be overexpressed in BRAFV600E-mutant thyroid cancers. Treatment with follistatin, a potent inhibitor of activin, or vactosertib, which inhibits both TGFBR1 and the activin type I receptor ALK4, induced a profound inhibition of pSMAD in BRAFV600E-PTCs. Blocking SMAD signaling alone was insufficient to enhance iodide uptake in the setting of constitutive MAPK activation. However, combination treatment with either follistatin or vactosertib and the MEK inhibitor CKI increased 124I uptake compared to CKI alone. In summary, activin family ligands converge to induce pSMAD in Braf-mutant PTCs. Dedifferentiation of BRAFV600E-PTCs cannot be ascribed primarily to activation of SMAD. However, targeting TGFβ/activin-induced pSMAD augmented MAPK inhibitor effects on iodine incorporation into BRAF tumor cells, indicating that these two pathways exert interdependent effects on the differentiation state of thyroid cancer cells.

High-dose (HD) cisplatin remains the standard of care with chemoradiation for locally advanced oropharyngeal cancer (OPC). Cooperative group trials mandate bolus-HD (100 mg/m2 × 1 day, every 3 weeks) cisplatin administration at the beginning of the week to optimize radiosensitization-a requirement which may be unnecessary. This analysis evaluates the impact of chemotherapy administration day of week (DOW) on outcomes. We also report our institutional experience with an alternate dosing schedule, split-HD (50 mg/m2 × 2 days, every 3 weeks). We retrospectively reviewed 435 definitive chemoradiation OPC patients from 10 December 2001 to 23 December 2014. Those receiving non-HD cisplatin regimens or induction chemotherapy were excluded. Data collected included DOW, dosing schedule (bolus-HD vs split-HD), smoking, total cumulative dose (TCD), stage, Karnofsky Performance Status, human papillomavirus status and creatinine (baseline, peak and posttreatment baseline). Local failure (LF), regional failure (RF), locoregional failure (LRF), distant metastasis (DM), any failure (AF, either LRF or DM) and overall survival (OS) were calculated from radiation therapy start. Median follow-up was 8.0 years (1.8 months-17.0 years). DOW, dosing schedule and TCD were not associated with any outcomes in univariable or multivariable regression models. There was no statistically significant difference in creatinine or association with TCD in split-HD vs bolus-HD. There was no statistically significant association between DOW and outcomes, suggesting that cisplatin could be administered any day. Split-HD had no observed differences in outcomes, renal toxicity or TCD compared to bolus-HD cisplatin. Our data suggest that there is some flexibility of when and how to give HD cisplatin compared to clinical trial mandates.

OBJECTIVE. To address the lack of validated patient-reported outcome (PRO) instruments that define and quantify patient expectations in thyroid cancer surgery, we developed and initially validated ThyroidEx, a novel disease-specific PRO instrument. STUDY DESIGN. Survey study. SETTING. Single-institution tertiary care cancer center. METHODS. An expert panel drafted an initial set of thyroid cancer–specific concepts, which was used in semistructured concept elicitation interviews with patients with thyroid cancer 4 weeks before and 8 weeks after surgery. Candidate items were generated per patient responses and refined via cognitive interviewing and additional review by the expert panel. The draft ThyroidEx was then preoperatively administered to a separate cohort undergoing thyroid cancer surgery to establish a final item set and initial psychometric evidence. RESULTS. Prospective concept elicitation interviews generated 358 patient-elicited concepts (n = 15 patients). These were then placed into 70 unique subcategories from which 41 items were generated for cognitive interviews with 20 patients preoperatively and 28 postoperatively. After expert panel review, ThyroidEx included 18 items across 2 scales (Expectations and Concerns), with an additional item about beliefs. In the preoperative cohort in phase 2 (n = 67), internal consistency Cronbach’s α values ranged from 0.81 to 0.89. Descriptive analysis showed significant differences between patients’ concerns and expectations and clinicians’ perceptions. CONCLUSION. Defining expectations represents an important modifier in the measurement of PROs. Preliminary validation of ThyroidEx revealed incongruent expectations between expert opinion and patients. Future development and implementation of ThyroidEx may affect preoperative consultation and the consent process.

Patient-reported outcome measures (PROM) are used to assess value-based care. Little is known as to whether PROM response in breast cancer reflects the diverse patient population. The BREAST-Q, a validated measure of satisfaction and quality of life, and Recovery Tracker, a postoperative assessment tool, are PROM routinely delivered to all patients undergoing breast surgery at our institution. Here we determine whether response to PROM differs by age, race, language, or disease stage.All patients who had a breast operation between January 2020 and July 2021 were requested to complete the BREAST-Q and Recovery Tracker. Non-responders did not complete the PROM at any timepoint; responders completed 1 or more. Primary outcomes included rates of non-response versus response overall.Of 6374 patients identified, 5653 (88.7%) responded to either PROM [4366/4751 (91.9%) BREAST-Q; 2746/3384 (81.1%) Recovery Tracker]. On univariate analysis, non-responders were older (60 years versus 55 years, p0.001) and more often non-English speaking (p0.001), Hispanic ethnicity (p = 0.031), and Black race (p0.001), versus responders. On multivariate analysis, non-responders were significantly more often Black race and non-English speaking (p0.001). Non-English speakers were significantly less responsive among all ethnicities and races except Black race. Although breast cancer stage did not reach significance for response, patients with malignant disease and those receiving neoadjuvant chemotherapy responded more often.Our findings demonstrate high patient engagement using 2 different PROM following breast surgery, but suggest that PROM results may not reflect the experience of the entire breast cancer population. Care process changes based solely on PROM should consider these findings to ensure that the views of the entire spectrum of patients with breast cancer are represented.

Oral cancer treatment involving the maxilla and/or mandible often results in esthetic and functional deficits that can diminish the patient's quality of life. As a result, expeditious reconstruction of the defect and dental rehabilitation is desirable. Dental rehabilitation shortly after reconstruction with an osteocutaneous free flap and resection prosthesis is a persistent challenge for patients with oncologic defects where immediate dental rehabilitation is not a possibility. Additionally, conventional prosthesis fabrication techniques are impractical or impossible due to postoperative anatomical changes and limitations in clinical armamentarium. To address these limitations, a technique and a novel implant-supported prosthetic workflow for the oncologic patient were developed to provide interim dental rehabilitation for such clinical situations. This article describes the prosthesis fabrication technique, reports short-term outcomes, and evaluates patient-reported quality-of-life outcomes using the FACE-Q Head and Neck Cancer Module.

Background and objectives Total laryngectomy in thyroid cancer is controversial. Functional and oncologic outcomes are needed to inform surgical indications in this population. Methods A retrospective cohort study was performed at a tertiary referral center from 1997 to 2018 to identify patients with a diagnosis of thyroid carcinoma who underwent total laryngectomy. Complications, survival outcomes, and functional outcomes were analyzed. Results Thirty patients met the inclusion criteria. The mean age was 62 years (range, 30-88 years) and the male-to-female ratio was 1:2.75. The most common diagnosis was well-differentiated thyroid cancer (53.3%), followed by poorly differentiated (30%) and anaplastic (16.7%). Total laryngectomy was performed with a 10% rate of Clavien-Dindo Grade III-V complications. The median overall survival was 40 months (range, 1-237). Five-year overall survival was 39.5% and disease-specific survival was 51.1%. Locoregional control was achieved in 80.0% of patients. Twelve months postoperatively, 100% of surviving patients were taking oral intake and 86.4% had a self-reported functional voice. Conclusion Total laryngectomy for locally advanced thyroid cancer is safe and provides acceptable rates of locoregional control. While the risk of distant metastases remains high, advances in systemic therapy may justify aggressive local control strategies to improve the quality of life.

BACKGROUND: Sinonasal mucosal melanoma (SNMM) is an aggressive cancer with high mortality. Identifying patients at risk of distant metastasis assists with management and prognostication. We aimed to define the relationship between volume, survival, and risk of distant metastases. METHODS: A retrospective review of all patients with SNMM treated at a single institution over a 21-year period was conducted. Tumor volume was calculated using cross-sectional imaging and survival analysis was performed. RESULTS: Sixty-one patients were included. Tumor volume was predictive of local progression free survival (LPFS) (p=0.032), distant metastases free survival (DMFS) (p=0.002), and overall survival (OS) (p=0.022). It was a better predictor than AJCC stage and T-classification. Tumor volume equal to or greater than 5cm(3) was associated with a significantly worse DMFS and OS (p=0.022 and 0.009, respectively). CONCLUSION: Calculation of tumor volume assists in quantifying the risk of distant metastases and death in SNMM.

Because of the national emergency triggered by the coronavirus disease 2019 (COVID‐19) pandemic, government‐mandated public health directives have drastically changed not only social norms but also the practice of oncologic medicine. Timely head and neck cancer (HNC) treatment must be prioritized, even during emergencies. Because severe acute respiratory syndrome coronavirus 2 predominantly resides in the sinonasal/oral/oropharyngeal tracts, nonessential mucosal procedures are restricted, and HNCs are being triaged toward nonsurgical treatments when cures are comparable. Consequently, radiation utilization will likely increase during this pandemic. Even in radiation oncology, standard in‐person and endoscopic evaluations are being restrained to limit exposure risks and preserve personal protective equipment for other frontline workers. The authors have implemented telemedicine and multidisciplinary conferences to continue to offer standard‐of‐care HNC treatments during this uniquely challenging time. Because of the lack of feasibility data on telemedicine for HNC, they report their early experience at a high‐volume cancer center at the domestic epicenter of the COVID‐19 crisis., Cancer care is undeniably affected by the coronavirus disease 2019 (COVID‐19) public health emergency, but quality cancer care must persist. A high‐volume cancer center from the domestic epicenter of the COVID‐19 crisis shares its multidisciplinary approach to integrating current public health restrictions and adopting telemedicine to optimize the care of patients with head and neck cancer; it is hoped that this center's experience will provide helpful insights to oncology colleagues.

ImportanceUse of proton therapy reirradiation (PT-ReRT) for head and neck cancer is increasing; however, reports are heterogenous and outcomes can be difficult to interpret.ObjectiveTo evaluate outcomes and toxic effects following PT-ReRT in a uniform and consecutive cohort of patients with head and neck squamous cell carcinoma.Design, Setting, and ParticipantsThis retrospective cohort study included patients with recurrent primary head and neck squamous cell carcinoma who were treated with PT-ReRT from January 1, 2013, to December 31, 2020, at a single institution. Patient, clinical, and treatment characteristics were obtained, and multidisciplinary review was performed to record and grade early and late toxic effects.ExposuresProton therapy reirradiation.Main Outcomes and MeasuresFollow-up was defined from the start of PT-ReRT. The Kaplan-Meier method was used for outcomes of interest, including local control (LC), locoregional control, distant metastatic control, progression-free survival, and overall survival (OS). Cox proportional hazards regression modeling was used to assess associations of covariates with OS.ResultsA total of 242 patients (median [range] age, 63 [21-96] years; 183 [75.6%] male) were included. Of these patients, 231 (95.9%) had a Karnofsky performance status score of 70 or higher, and 145 (59.9%) had at least a 10–pack-year smoking history. Median (range) follow-up was 12.0 (5.8-26.0) months for all patients and 24.5 (13.8-37.8) months for living patients. A total of 206 patients (85.1%) had recurrent disease vs second primary or residual disease. The median (range) interval between radiation courses was 22 (1-669) months. Median PT-ReRT dose was 70 cobalt gray equivalents (CGE) for the fractionated cohort and 44.4 CGE for the quad shot cohort. For the fractionated cohort, the 1-year LC was 71.8% (95% CI, 62.8%-79.0%) and the 1-year OS was 66.6% (95% CI, 58.1%-73.8%). For the quad shot cohort, the 1-year LC was 61.6% (95% CI, 46.4%-73.6%) and the 1-year OS was 28.5% (95% CI, 19.4%-38.3%). Higher Karnofsky performance status scores (hazard ratio [HR], 0.50; 95% CI, 0.25-0.99; P = .046) and receipt of salvage surgery prior to PT-ReRT (HR, 0.57; 95% CI, 0.39-0.84; P = .005) were associated with improved OS, whereas receipt of quad shot (HR, 1.97; 95% CI, 1.36-2.86; P Conclusions and RelevanceThe findings of this cohort study suggest that, compared with previous reports with photon-based reirradiation, patients are living longer with aggressive PT-ReRT; however, surviving patients remain at risk of early and late complications.

Pharyngocutaneous fistula (PCF) is a major morbidity of salvage total laryngectomy (TL). Understanding the factors predicting PCF is fundamental to managing laryngeal cancer. We aim to assess factors associated with PCF following salvage TL in a multicenter, international retrospective cohort study of academic centers in the US and Canada.In total, 550 patients post-salvage TL were identified (mean [SD; range] age, 64 [10.4; 32-90] years; 465 [85 %] male and 84 [15 %] female) between 2000 and 2014. Rate of PCF was 23 % (n = 127) with median time to PCF of 2.9 weeks. Surgical management of PCF was required in 43 % (n = 54) while 57 % (n = 73) required wound care alone. Rates of PCF differed by primary treatment modality [radiation, 20 % (n = 76); chemoradiation, 27 % (n = 40); not available (n = 6)] and use of vascularized tissue in pharyngeal closure [free/regional flap, 18 % (n = 25); no vascularized tissue/primary closure, 24 % (n = 98); not available (n = 4)]. There was no statistically significant association between PCF and treatment with chemoradiation (HR, 1.32; 95 % CI, 0.91-1.93, p = 0.14) or lack of vascularized tissue reconstruction (HR, 1.41, 95 % CI 0.91-2.18, p = 0.12). Significant association between PCF and advanced stage (T3 or T4), positive margin, close margin (lt;5mm), lymphovascular invasion and pre-operative tracheostomy were identified on univariable analysis. Positive surgical margin (HR, 1.91; 95 % CI, 1.11 to 3.29) was the only significant association on multivariable analysis.We highlight positive surgical margin as the only variable significantly associated with increased risk of PCF following salvage TL on multivariable analysis in a large cohort across several major head and neck oncology centers.

PURPOSE Telomerase reverse transcriptase ( TERT) promoter mutations are prognostic in many cancers and have been observed in human papillomavirus (HPV)–negative head and neck squamous cell carcinomas (HNSCCs). However, the role of TERT promoter mutations in HPV-negative HNSCCs remains poorly understood in these cancers, which have increased risk for locoregional failure (LRF). PATIENTS AND METHODS We retrospectively identified patients who were diagnosed with HNSCC between July 1, 2004, and October 12, 2017, at Memorial Sloan Kettering Cancer Center and whose tumors underwent next-generation sequencing using the MSK-IMPACT panel. Patients with HPV-positive oropharyngeal squamous cell carcinoma (SCC) were excluded. Cumulative incidence of LRF, patterns of failure, and overall survival were measured. RESULTS We identified 117 patients with SCC of the oral cavity (OSCC), larynx, hypopharynx, or HPV-negative oropharynx whose tumors underwent next-generation sequencing. Sequencing was performed on 95 tumors that were obtained after recurrence and 22 that were obtained before recurrence. TERT promoter mutations were enriched in OSCC compared with laryngopharyngeal cancers (81.1% v 7.0%; P < .001), which was the largest genetic difference between these anatomic disease subsites. TERT promoter mutations were associated with LRF in OSCCs (Gray's test, P < .001) and in the overall cohort (Gray's test, P < .001). On multivariate analysis, TERT promoter mutations were associated with an increased risk for LRF (subdistribution hazard ratio, 2.82; 95% CI, 1.47 to 5.42; P = .0019), independent of oral cavity primary site and TP53 mutation status. CONCLUSION TERT promoter status is associated with the cumulative incidence of LRF and patterns of failure. TERT promoter mutations may define a subset of OSCCs with unique pathogenesis that is associated with an increased risk of LRF. Validation in prospective cohorts is warranted.

Objectives Sinonasal and skull base tumors are rare, making it difficult to identify trends in surgical outcome. This study examines complications in a large cohort of patients undergoing surgery for sinonasal malignancy. Methods Following IRB approval, an institutional database was reviewed to identify patients who underwent surgery for sinonasal or skull base malignancies from 1973 to 2016 at our institution. Charlson comorbidity index score and Clavien-Dindo grade were calculated. The main study endpoint was subgroup analysis of Clavien-Dindo Grade 0, Grades 1-2, and Grades 3-5 complications. An ordinal logistic regression model was constructed to assess the association between comorbidities, demographics, tumor characteristics, and surgical complications. Results In total, 448 patients met inclusion criteria. Perioperative mortality rate at 30 days was 1.6% (n = 7). The rate of severe complications (Clavien-Dindo 3 or higher) was 13.6% (n = 61). Multivariate analysis using an ordinal logistic regression model showed no association between Charlson comorbidity index score and Clavien-Dindo grade of postoperative complication. Advanced T-stage was significantly associated with complications (p = 0.0014; odds ratio: 3.442 [95% confidence interval: 1.615, 7.338]). Conclusion Surgery for sinonasal and skull base tumors is safe with a low mortality rate. Advanced T-stage is associated with postoperative complications. These findings have implications for preoperative risk stratification. Key Points Surgery for sinonasal malignancy is safe with a 30 mortality of 1.6% and rate of severe complications of 12.8%. There is no association between patient comorbidity and post operative complication. On multivariate analysis, only advanced T stage was associated with increased rate of surgical complication.

Importance Increasingly complex surgical procedures are being performed in the outpatient setting, increasing the burden on patients and caregivers to manage their postoperative symptoms. Electronic patient-reported symptom tracking may reduce this burden and help patients distinguish between expected symptoms and those requiring intervention. Objective To determine whether electronic symptom reporting with clinical alerts for 10 days after ambulatory cancer surgery is associated with a reduction in potentially avoidable urgent care visits, defined as a visit not leading to admission. Design, Setting, and Participants This retrospective cohort study was conducted at the Josie Robertson Surgery Center (JRSC), Memorial Sloan Kettering Cancer Center’s ambulatory surgery center with overnight stay capacity from September 20, 2016, to December 31, 2018. Patients undergoing prostatectomy, nephrectomy, mastectomy with or without immediate reconstruction, hysterectomy, or thyroidectomy at the surgery center before (n = 4195) and after (n = 2970) implementation of the Recovery Tracker (RT) electronic postoperative symptom survey were included. Data analyses were conducted from February 1 to November 24, 2020. Exposures A short electronic survey assessing symptoms daily for 10 days after surgery, administered via the patient portal, with alerts to the clinical team and follow-up for concerning responses. Main Outcomes and Measures The main outcome was Memorial Sloan Kettering urgent care center visits with and without readmission and any readmission within 30 days after surgery. Nursing workload was measured by patient phone calls, emails, and secure messages as documented in the electronic medical record. Results A total of 7165 patients were analyzed, including 4195 (median age, 53 [interquartile range (IQR), 44-63] years; 3490 women [83%]) from the pre-RT implementation period and 2970 (median age, 56 [IQR, 46-65] years; 2221 women [75%]) from after full implementation. On multivariable, intent-to-treat analysis by study period, having surgery in the post-RT period was associated with a 22% decrease in the odds of an urgent care center visit without readmission (OR, 0.78; 95% CI, 0.60-1.00;P = .047). Having responded to at least 1 survey was associated with a 42% reduction in the odds of an urgent care center visit without readmission (OR, 0.58; 95% CI, 0.39-0.87;P = .007). There was no change in the risk of admission. Nursing calls increased by a mean of 0.86 (95% CI, 0.75-0.98) calls per patient after RT implementation (P Conclusions and Relevance In this cohort study, electronic symptom reporting with nursing follow-up for clinical alerts was associated with a reduction in potentially avoidable urgent care visits. The low risk and high benefit of this intervention suggest that these systems should be more broadly implemented.

Background and objectives Remifentanil infusion is used as an intraoperative anesthetic for thyroidectomy, but has been associated with acute opioid tolerance and hyperalgesia. A national shortage of remifentanil provided an opportunity to study postoperative pain in patients undergoing thyroidectomy. Methods Retrospective review of prospectively collected data from an outpatient surgery center. Primary analysis compared patients treated before and after remifentanil shortage. Results Median postoperative opioid consumption was 20 morphine milligram equivalents (MMEs) among those treated in the high-dose period and 15 MMEs in the low-dose period. Remifentanil/weight received was a significant predictor of requiring a postoperative narcotic (P = .006). Total non-remifentanil narcotics administered were equivalent but patients in the low dose period received higher amounts of intraoperative long-acting narcotics. Conclusions Remifentanil infusion for thyroid surgery is associated with higher postoperative pain and postoperative narcotics requirement. While a hyperalgesia state is possible, shifting of longer-acting narcotics from intraoperative to postoperatively is also supported.

BACKGROUND AND OBJECTIVES: The reported risk of nodal metastasis in hard palate and upper gingival squamous cell carcinoma (SCC) has been inconsistent with inadequate consensus regarding the utility of neck dissection in the clinically negative (cN0) neck. MATERIALS AND METHODS: Using the National Cancer Database (NCDB), cN0 patients diagnosed with SCC of the head and neck with the subsites of the hard palate and upper gingiva were identified from 2004–2014. RESULTS: A total of 1,830 patients were identified, and END was performed on 422 patients with cN0 tumors. Pathologically positive nodes occurred in 14% (59/422) of patients in this cohort. Higher tumor stage, academic hospital type, and large hospital volume (>28 cancer-specific cases/year) were associated with a higher likelihood of END both in univariate and multivariate analyses (P < 0.05). Patients >80 years of age were less likely to receive END on multivariate analysis (OR 0.52, 0.32–0.84). No variables, including advanced T stage, predicted occult metastases. Cox proportional hazards regression analysis showed that patients who underwent END demonstrated improved OS over an 11-year period (hazard ratio 0.75, P = 0.002). On subgroup analysis this improvement was significant in patients with both stage T1 and T4 tumors. CONCLUSIONS: Tumor stage, hospital type, and hospital volume were associated with higher rates of END for patients with cN0 hard palate SCC and after controlling for clinical factors, END was associated with improved overall survival.

TPS6109 Background: Definitive treatment of locally advanced HNSCC can require radical surgery and reconstruction often resulting in unacceptable functional consequences. Radiotherapy, often with concurrent chemotherapy, is administered postoperatively to achieve the best chance for cure. Induction chemotherapy has previously been shown to reduce the extent of surgical resection and need for adjuvant radiation (RT). The purpose of this trial is to evaluate if an induction regimen combining cytotoxic chemotherapy, EGFR targeting, and immune checkpoint blockade can pathologically downstage resectable HNSCC sufficiently to decrease surgical morbidity and justify omission of adjuvant RT-based therapy. Compared to standard docetaxel, cisplatin, and 5-FU (TPF), docetaxel, cisplatin, and cetuximab (TPC) has been shown to be a therapeutic alternative with a more favorable toxicity profile. Targeting PD-1 alone can induce significant pathologic responses in resectable HNSCC patients. Combining PD-1 inhibitors with cetuximab has shown promising activity in incurable HNSCC; cetuximab may optimize the tumor immune microenvionment for PD-1 therapy by stimulating IFN-gamma secretion to increase dendritic cell maturation and CD8 T cell expression of PD1. Based on this rationale, we are evaluating the novel induction regimen of platinum, docetaxel, cetuximab plus cemiplimab (anti-PD1 antibody). Methods: This is a 10-patient pilot study for locally advanced, resectable HNSCC patients for whom standard management requires adjuvant RT +/- chemotherapy. Patients will receive neoadjuvant treatment with a loading dose of cetuximab and cemiplimab followed by 3 cycles of cisplatin or carboplatin, docetaxel, cetuximab and cemiplimab followed by definitive surgical resection of the primary site +/- neck dissection(s). Post-operative RT +/- radiosensitizing agent(s) will be administered per standard of care (SOC) based on pathologic staging (rather than clinical staging at presentation). If the pathologic stage following induction and surgery is ypT0-2N0 without adverse features, adjuvant RT will not be administered and 6 months of adjuvant cemiplimab will be given. Otherwise, patients will receive SOC adjuvant RT-based treatment. The primary endpoint is safety and tolerability. Secondary endpoints include feasibility assessed by the number of patients whose definitive surgery was delayed due to toxicity and quantifying the number in whom clinical to pathologic downstaging is achieved and the planned surgery and/or need for adjuvant-RT based therapy is modified. Exploratory endpoints include evaluating the association between biomarkers in the tumor microenvironment and peripheral blood with pathologic response. 8 of 10 patients have been enrolled. Clinical trial information: NCT04722523.

e13650 Background: Studies suggest that oncology patients are satisfied and sometimes prefer telehealth over an in-person visit; however, data are scarce on when patients find telehealth helpful. Such information would be key in understanding how telehealth can be optimally integrated into cancer care delivery. This study aims to identify factors that influence patient experience of telehealth among a multidisciplinary head and neck oncology population. Methods: From Mar 2020 to Dec 2020, we surveyed head and neck oncology patients at a comprehensive cancer center and 6 satellite sites in New York and New Jersey. We assessed patient experience of telehealth versus in-person visit (primary outcome) and their satisfaction with telehealth (secondary outcome). We conducted multivariate regression to analyze covariates that may influence their experience and satisfaction. Covariates included patient factors (age, gender, race, marital status, primary language, home state, home distance from center, current location at home or clinic), clinical factors (diagnosis, performance status, receiving chemotherapy or radiation), physician factors (profession, current location at main or regional campus), visit factors (type, length, billing level, month, first telehealth visit or not), and a technological factor (device type). Results: Among 1,071 completed surveys (response rate 24.0%), 551 first-unique surveys were analyzed. Surveyed patients were predominantly 60 years or older (64.1%), white (88.3%), married (73.8%), and lived within 50 miles from our cancer center (76.1%). Majority had diagnoses of head and neck cancers (65.7%), followed by thyroid cancers (23.8%), and skin cancers (10.5%). While most patients would recommend telehealth (82.4%), only half reported telehealth the same or better compared to in-person visits (55.7%), whereas the other half reported not as good or unsure (44.3%). In multivariate analyses, patients who found telehealth the same or better than in-person visits were more likely to have thyroid cancers (adjusted odds ratios [aOR]: 2.18, CI 95% 1.44 - 3.36) and have visits from July to December (aOR 1.61, CI 95% 1.14 - 2.27). Satisfaction with telehealth was higher among patients with thyroid cancers (aOR: 2.58, CI 95% 1.20 - 6.41), on visits when patients were at home (aOR 3.48, CI 95% 1.37 - 8.42) and when physicians were on campus (aOR 1.73, CI 95% 1.00 - 2.99). Conclusions: Patient experience with telehealth is diverse among the head and neck oncology population; while one-half found telehealth the same or better compared to in-person visits, the other half found it not as good or unsure. More favorable telehealth experience among patient subgroups highlights the multidisciplinary nature of head and neck oncology and improved acceptance of telehealth over time. Future research to optimize patient experience is needed to ensure successful integration of telehealth in head and neck oncology practices.

1517 Background: Strategies to improve transitions from the hospital to home for patients with cancer are considered an important component of quality, patient-centered care in oncology. CMS evaluates cancer hospital performance based on the 30-day unplanned hospital readmission rate, and this measure has been endorsed by the National Quality Forum. Nationally, the 30-day readmission rate for oncology patients ranges from 19%-27%. These readmissions come at high psychosocial, physical, and financial costs for patients and caregivers. A remote monitoring intervention that includes frequent contacts with the patient is likely to be effective in improving this transition. Methods: We evaluated the feasibility, acceptability, and perceived value of a mobile health intervention to monitor and manage symptoms of adult medical and surgical oncology patients discharged from an NCI-designated cancer center to home. Patients were monitored for 10 days, which is the median time to readmission for an oncology patient. The technology supporting the program included: 1) a patient portal enabling daily electronic patient-reported outcomes assessments; 2) a pulse oximeter to provide data on blood oxygen level and heart rate; 3) alerts for concerning symptoms; 4) an application to allow staff to review and trend symptom data; 5) a secure platform to support communications and televisits between staff and patients; 6) an advanced feedback report to provide just-in-time patient symptom education. Feasibility and acceptability were evaluated through engagement (goal: > 50% response rate) and symptom alerts and perceived value was measured through a patient engagement survey that included a net promoter score (how likely the patient is to recommend the program to similar patients; goal > 0.7). Results: Between September 27, 2020 to December 31, 2021, the program enrolled 1,091 medical oncology (median age: 63 years, 55% female) and 4,222 surgical oncology patients (median age: 63 years,55% female). Of those enrolled, 65% of medical and 74% of surgical oncology patients participated in home remote monitoring by self-reporting symptom data. This resulted in 2,869 completed symptom assessment from medical and 16,009 completed assessments from surgical patients. Sixty-three percent of medical oncology assessments resulted in a yellow (moderate) or red (severe) symptom alert compared with 26% for surgical oncology patients. Pain was the predominant symptom generating red alerts for medical oncology patients (17%). Fifty-two percent of patients completed the engagement survey, and the net promoter score was 0.82. Conclusions: A remote monitoring program after discharge was feasible, acceptable, and perceived to be of value by oncology patients discharged from a cancer center. Surgical and medical patients have similar response rates but differ in symptom burden. Future work will evaluate the value of a remote symptom monitoring platform in decreasing readmissions.

Aims In the era of precision medicine, accurate pathologic diagnoses are crucial for appropriate management. Methods We herein described the histologic features and clinical impacts of 66 salivary gland epithelial neoplasms in which the diagnosis was altered after expert review. Results The most common revised diagnosis was that of salivary duct carcinoma (SDC, n = 12), adenoid cystic carcinoma (n = 12), and myoepithelial carcinoma (n = 10). The most common initial diagnosis was mucoepidermoid carcinoma (n = 19) with SDC being the most common revised diagnosis (7/19). Thirteen salivary gland carcinomas were initially diagnosed as benign entities, whereas five benign tumors were initially interpreted as carcinoma. The change in diagnosis was considered to be clinically significant in 65 (97%) cases. Conclusions Given their rarity, salivary gland neoplasms are prone to diagnostic inaccuracy and discrepancy. A constellation of histologic features and ancillary studies are useful in reaching the correct diagnosis, which can have significant clinical impacts.

Purpose/Objective(s) Stage T4 larynx and hypopharynx cancers were poorly represented in the original organ preservation trials, so concerns over reduced outcomes with nonoperative management have led to a preference for surgery. For patients who refuse surgery or are not surgical candidates, there is little data to guide decision making and counseling. Therefore, we conducted a retrospective analysis of nonoperatively managed T4 larynx and hypopharynx cancer to report long-term therapeutic and functional outcomes. Materials/Methods Patients with primary larynx (n = 44) and hypopharynx (n = 53) cancer treated non-surgically with definitive radiation therapy (RT) or chemoradiation therapy (CRT) between 1/1/1997 and 12/31/2015 were included. Data collected included age, sex, KPS, smoking status, cancer site, T stage, N stage, CRT versus RT alone, IMRT versus non-IMRT, RT dose, resectability (as noted by surgeon), percutaneous endoscopic gastrostomy (PEG) and tracheostomy status, locoregional failure (LRF), distant metastases (DM), disease-free survival (DFS), and overall survival (OS). The Kaplan-Meier method was used to estimate time-to-event outcomes on univariate analysis (UVA). Results Median follow-up of surviving patients was 59 (range 15-154) and 45 (range 14-190) months for larynx and hypopharynx patients, respectively. The 2-/5-year OS rates were 73%/38% for larynx patients and 52%/29% for hypopharynx patients. LRF occurred in 25% (n = 11) and 19% (n = 10) of larynx and hypopharynx patients, respectively. Median disease-free interval to recurrence was 12 and 7 months in larynx and hypopharynx patients, respectively. On UVA of the larynx subset, N3 nodal status and non-IMRT treatment (n = 20, 45%) were significantly associated with detriment to OS (P = 0.046 and 0.037); treatment with RT alone impacted DFS (P = 0.028); age > 70 was significantly associated with LRF (P = 0.038, Gray's test). On UVA of the hypopharynx subset, only T4b status significantly impacted OS (P = 0.009) with no other predictive factors on outcomes analysis. In the larynx group, 75% required a tracheostomy and/or PEG, 55% of whom had neither device at most recent follow-up. Likewise, of the 86% of hypopharynx patients requiring tracheostomy and/or PEG, 27% had neither at last follow-up. Conclusion We report very encouraging disease control and survival for patients with stage T4 larynx and hypopharynx cancer who are not surgical candidates or refuse surgery. Overall, outcomes are better for larynx cancers than hypopharynx. With adequate supportive care and rehabilitation, patients are able to reach functional preservation, especially in the larynx subset. Given our analysis, we predict that both functional and therapeutic outcomes are further improved in the current IMRT era.

Objective To characterize a subset of patients with metastatic head and neck cutaneous squamous cell carcinoma in a tertiary North American center and describe oncologic outcomes following definitive treatment. Study Design Retrospective chart review. Setting National Cancer Institute–designated Comprehensive Cancer Center. Methods We conducted a retrospective chart review of patients with cutaneous squamous cell carcinoma with metastases to intraparotid lymph nodes who underwent parotidectomy between 1993 and 2020. Baseline patient and tumor characteristics were assessed. Regional control, disease-specific survival, and overall survival were estimated using Kaplan-Meier method. Multivariate analysis was used to determine the relationship between adverse pathological features and survival. Results A total of 122 patients were included. The median age was 76, 84.4% of patients were male, and 17.2% were immunosuppressed. Regional control, disease-specific survival, and overall survival were 68.5%, 70.7%, and 59.4% at 5 years, respectively. Perineural and lymphovascular invasion were predictive of worse disease-specific survival. Extracapsular spread was observed in 90.2% of patients and was not a significant predictor of outcome. Conclusions We found the demographics and oncologic outcomes of our cohort in the Northeast United States to be comparable with those previously reported in Australia and the Sun Belt of the United States. We noted a high rate of extracapsular spread but did not find it to be a significant predictor of recurrence or survival. Future efforts should address the impact of extracapsular spread on prognosis and adjuvant treatment decisions.

Background Patient-reported outcomes (PROs) allow for the direct measurement of functional and psychosocial effects related to treatment. However, technological barriers, survey fatigue, and clinician adoption have hindered the meaningful integration of PROs into clinical care. The objective of the authors was to develop an electronic PROs (ePROs) program that meets a range of clinical needs across a head and neck multidisciplinary disease management team. Methods The authors developed the ePROs module using literature review and stakeholder input in collaboration with health informatics. They designed an ePROs platform that was integrated as the standard of care for personalized survey delivery by diagnosis across the disease management team. Tableau software was used to create dashboards for data visualization and monitoring at the clinical enterprise, disease subsite, and patient levels. All patients who were treated for head and neck cancer were eligible for ePROs assessment as part of the standard of care. A descriptive analysis of ePROs program implementation is presented herein. Results The Head and Neck Service at Memorial Sloan Kettering Cancer Center has integrated ePROs into clinical care. Surveys are delivered via the patient portal at the time of diagnosis and longitudinally through care. From August 1, 2018, to February 1, 2020, a total of 4154 patients completed ePROs surveys. The average patient participation rate was 69%, with a median time for completion of 5 minutes. Conclusions Integration of the head and neck ePROs program as part of clinical care is feasible and could be used to assess value and counsel patients in the future. Continued qualitative assessments of stakeholders and workflow will refine content and enhance the health informatics platform. Lay summary Patients with head and neck cancer experience significant changes in their quality of life after treatment. Measuring and integrating patient-reported outcomes as a part of clinical care have been challenging given the multimodal treatment options, vast subsites, and unique domains affected. The authors present a case study of the successful integration of electronic patient-reported outcomes into a high-volume head and neck cancer practice.

Objectives Determining surgical trends and outcomes for sinonasal tumors is challenging given their low incidence and heterogeneous pathology. This study utilized the National Cancer Database (NCDB) to identify trends and outcomes associated with surgical management of sinonasal tumors. Design Retrospective database analysis. Setting National Cancer Database. Participants Patients with sinonasal malignancies identified from the NCDB between 2010 and 2015. Main Outcome Measures The primary outcome was the choice of surgical therapy used for sinonasal tumor resection: endoscopic versus open approach. Each was cohort analyzed with respect to various demographic and clinicopathologic factors. A treatment effect model was used to identify potential differences between surgical approaches. Survival was evaluated using Kaplan–Meier analysis. Results A total of 10,193 patients with sinonasal malignancies were identified in the NCDB database; of these, 2,292 had a documented subsite, histology, and definitive surgical treatment with documented surgical approach and were included in the analysis. About 71.9% of patients had an open approach and 28.1% a purely endoscopic procedures. Tumor histology, treatment facility type, margin status, and length of stay were all variables that were associated with significant differences between the open and endoscopic cohort. Five-year survival rates for the open and endoscopic cohorts were not significantly different (59.6 and 60.8%, respectively). Conclusions Assessment of the NCDB revealed that 28% patients with sinonasal malignancy were selected for endoscopic surgery. These patients had comparable oncologic outcomes to open resection.

Although perineural invasion (PNI) is recognized as an adverse prognostic factor in oral tongue squamous cell carcinoma (SCC), the patterns of failure are poorly defined.Patients with oral tongue SCC who received primary surgical treatment were identified. Specimens were reviewed by head and neck pathologists. Disease-specific survival (DSS) and locoregional recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and distant recurrence-free survival (DRFS) were calculated. The PNI and PNI characteristics were analyzed as predictors of outcome. The utility of grading the extent of PNI was assessed by quantifying the number of PNI foci per slide reviewed, nerve caliber, and percent circumference involved.Patients with PNI had a decreased DSS; however, PNI was not predictive of LRFS or RRFS. Patients with PNI were more likely to develop a distant recurrence and 19.40 (confidence interval [CI] 6.70-56.14; P .001) times more likely to develop a distant recurrence if PNI foci density was1.The presence of PNI in oral tongue SCC predicts worse DSS, with distant recurrence as the most common pattern of failure. High PNI foci density is associated with worse DRFS.

Importance Pharyngocutaneous fistula (PCF) results in an inflammatory reaction, but its association with the rate of locoregional and distant control, disease-free survival, and overall survival in laryngeal cancer remains uncertain. Objective To determine if pharyngocutaneous fistula after salvage laryngectomy is associated with locoregional and distant control, disease-free survival, and/or overall survival. Design, Setting, and Participants A multicenter collaborative retrospective cohort study conducted at 5 centers in Canada and the US of 550 patients who underwent salvage laryngectomy for recurrent laryngeal cancer from January 1, 2000, to December 31, 2014. The median follow-up time was 5.7 years (range, 0-18 years). Main Outcomes and Measures Outcomes examined included locoregional and distant control, disease-free survival, and overall survival. Fine and Gray competing risk regression and Cox-proportional hazard regression models were used for outcomes. Competing risks and the Kaplan-Meier methods were used to estimate outcomes at 3 years and 5 years. Results In all, 550 patients (mean [SD] age, 64 [10.4] years; men, 465 [85%]) met inclusion criteria. Pharyngocutaneous fistula occurred in 127 patients (23%). The difference in locoregional control between the group of patients with PCF (75%) and the non–PCF (72%) group was 3% (95% CI, −6% to 12%). The difference in overall survival between the group with PCF (44%) and the non–PCF group (52%) was 8% (95% CI, −2% to 20%). The difference in disease-free survival between PCF and non–PCF groups was 6% (95% CI, −4% to 16%). In the multivariable model, patients with PCF were at a 2-fold higher rate of distant metastases (hazard ratio, 2.00; 95% CI, 1.22 to 3.27). Distant control was reduced in those with PCF, a 13% (95% CI, 3% to 21%) difference in 5-year distant control. Conclusions and Relevance This multicenter retrospective cohort study found that development of PCF after salvage laryngectomy is associated with an increased risk for the development of distant metastases.

Background and Objectives Primary surgical treatment of patients with early T-classification (T1-T2) oropharyngeal squamous cell carcinoma (OPSCC) has increased. We sought to determine how often these patients receive postoperative chemoradiation (CRT). Methods Patients with T1-T2 OPSCC in the National Cancer Database who underwent primary surgery were evaluated for receipt of postoperative CRT. Postoperative CRT use was examined among patients with high risk factors (positive margins and/or extracapsular spread [ECS]), intermediate risk factors (negative margins, no ECS, and either pT3-4 and/or N2-N3), and no apparent risk factors. Results Of 4833 patients with T1-T2 OPSCC who underwent primary surgery, 43% had high risk pathologic factors, of whom only 63% received postoperative CRT. Another 31% had no apparent risk factors, of whom 16% nonetheless received postoperative CRT. On multivariable analysis, in addition to tumor and demographic factors, patients treated at community hospitals were more likely to receive postoperative CRT (O.R. 1.41 C.I. 1.18-1.87, P = 0.001). Conclusions Variation in postoperative CRT use indicates a lack of consensus and/or knowledge about its benefits and indications. Usage of postoperative CRT regardless of pathologic risk factors suggests an area where future efforts at implementation of best practices may be targeted.

Aims: The BRAFV600E oncogene, reported in 40%–60% of papillary thyroid cancer (PTC), has an important role in the pathogenesis of PTC. It is associated with the loss of thyroid iodide-metabolizing genes, such as sodium/iodide symporter (NIS), and therefore with radioiodine refractoriness. Inhibition of mitogen-activated protein kinase (MAPK) pathway, constitutively activated by BRAFV600E, is not always efficient in resistant tumors suggesting that other compensatory mechanisms contribute to a BRAFV600E adaptive resistance. Recent studies pointed to a key role of transforming growth factor β (TGF-β) in BRAFV600E-induced effects. The reactive oxygen species (ROS)-generating NADPH oxidase NOX4, which is increased in PTC, has been identified as a new key effector of TGF-β in cancer, suggestive of a potential role in BRAFV600E-induced thyroid tumors. Results: Here, using two human BRAFV600E-mutated thyroid cell lines and a rat thyroid cell line expressing BRAFV600E in a conditional manner, we show tha...

BACKGROUND Improved understanding and management of health-related quality of life represents one of the greatest unmet needs for patients with head and neck malignancies. The purpose of this study was to prospectively measure health-related quality of life associated with different anatomical (head and neck) surgical resections. METHODS A prospective analysis of health-related quality of life was performed in patients undergoing surgical resection with flap reconstruction for stage II or III head and neck malignancies. Patients completed the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire-30 and the European Organization for Research and Treatment of Cancer Head and Neck Cancer Module-35 preoperatively, and at set postoperative time points. Scores were compared with a paired t test. RESULTS Seventy-five patients were analyzed. The proportion of the cohort not alive at 2 years was 53 percent. Physical, role, and social functioning scores at 3 months were significantly lower than preoperative values (p < 0.05). At 12 months postoperatively, none of the function or global quality-of-life scores differed from preoperative levels, whereas five of the symptom scales remained below baseline. At 1 year postoperatively, maxillectomy, partial glossectomy, and oral lining defects had better function and fewer symptoms than mandibulectomy, laryngectomy, and total glossectomy. From 6 to 12 months postoperatively, partial glossectomy and oral lining defects had greater global quality of life than laryngectomies (p < 0.05). CONCLUSIONS Postoperative health-related quality of life is associated with the anatomical location of the head and neck surgical resection. Preoperative teaching should be targeted for common ablative defects, with postoperative expectations adjusted appropriately. Because surgery negatively impacts health-related quality of life in the immediate postoperative period, the limited survivorship should be reviewed with patients. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, IV.

BACKGROUND: Despite advances in treatment, the recurrence rates for laryngeal cancer range from 16% to 40%. METHODS: Patients with recurrent laryngeal cancer treated at Memorial Sloan Kettering (MSK) from 1999 to 2016 were reviewed. Survival outcomes were analyzed. RESULTS: Of 241 patients, 88% were male; the median age was 67 years; 71% had primary glottic tumors. At initial treatment, 72% of patients were seen with early stage disease; primary treatment was radiation (68%), chemoradiation (29%), and surgery (3%). The most common salvage surgery was total laryngectomy (74%). Forty-seven percentage were upstaged at salvage surgery. The 2- and 5-year disease-specific survival (DSS) was 74% and 57%, respectively. Patients with cT4 disease treated with nonsurgical primary management had a 0% 5-year DSS. Independent predictors of DSS were tumor location, perineural invasion, margin, and stage. CONCLUSIONS: Salvage surgery results in acceptable oncologic outcomes. Stage, disease site, perineural invasion, and margins are associated with inferior DSS.

BACKGROUND Timely postoperative radiation therapy (RT) within 50 days of surgery for head and neck cancers provides a survival advantage. METHODS Using the National Cancer Database, we performed a propensity score-matched analysis comparing patients undergoing open or endoscopic surgery for squamous cell carcinoma (SCC) of the nasal cavity and paranasal sinuses from 2010 to 2015. RESULTS Among 168 pairs, patients undergoing endoscopic surgery had shorter time to surgery (24.2 vs 36.7 days, P

6019 Background: Our previously published proof-of-concept trial using functional imaging to select patient with human papillomavirus (HPV) oropharyngeal carcinoma (OPC) for radiation de-escalation showed promising results. Here we report the outcome of a larger validation trial using the same paradigm where select HPV+ OPC patients received a definitive dose of 30Gy concurrently with chemotherapy and were subsequently observed. Methods: The trial enrolled patients who had p16+, T0-2, N1-N2c, M0 OPC by AJCC 7th TNM. Patients were required to have resection of the primary site (negative margin not required) or core biopsy of lymph node if unknown primary. In addition to standard positron emission tomography (PET), a pre-radiation dynamic 18F-FMISO (fluoromisonidazole) PET was performed to identify hypoxia in gross nodal disease. Patients with evidence of hypoxia ( > 1.2 tumor to muscle standard uptake value on 18F-FMISO) underwent repeat18F-FMISO PET around 2 weeks into radiation. Patients without pre-radiation hypoxia or with resolution of hypoxia on 18F-FMISO PET received 30Gy with 2 cycles of concurrent chemotherapy (cisplatin 100mg/m2 or carboplatin AUC 1.25 x 4 with 5-fluorouracil 2400 mg/m2). Results: From 11/2/17-1/4/21, 158 HPV+ OPC patients consented and were enrolled on trial. Patient characteristics were as follows: male (90%); ages 36-80 years; T-stage T0(26), T1(77), T2(55); N stage N1(19), N2a(15), N2b(95), N2c(29). Of the 114 patients with pre-treatment hypoxia, 24 had persistent hypoxia and received 70Gy. 128 patients were de-escalated to 30Gy and chemotherapy (86% cisplatin). 6 patients withdrew from trial [3 decided to receive standard of care; 3 refused 18F-FMISO PET]. Acute mucositis rates were 11% grade 0, 59% grade 1, and 30% grade 2, respectively. Acute xerostomia rates were 92% grade 1 and 8% grade 2, respectively. Weight loss was infrequent and only 19% complained of grade 1 and 5% complained of grade 2 weight loss. Six patients experienced grade 3 adverse events (diarrhea (2), syncope (2), vasovagal (1), dysphagia (1)). No patients required PEG tubes. With a median follow-up is 12 months (range: 2 months to 40 months), the 1-year locoregional control, distant metastasis-free overall survival rates were 94%, 100%, and 100%, respectively. Among the 30Gy de-escalated patients, none failed in the primary site. 8 patients had recurrent nodal disease underwent successful salvage surgery of which no additional therapy was given to 4 patients. Conclusions: Major de-escalation to 30Gy using patient specific treatment response based on hypoxia resolution resulted in excellent locoregional control with significant toxicity reduction. Updated results along with detailed correlative analysis will be presented. Clinical trial information: NCT03323463.

6060 Background: Patients with ER after surgery and prior to postoperative radiation (RT) for SCC of the OC have aggressive biology and poor prognosis. After the introduction of a PET/CT simulator in our department, we incorporated post-operative PET/CT as part of RT planning. We hypothesized PET/CT would improve detection of macroscopic disease before postoperative RT. Methods: We reviewed the medical records of patients treated with postoperative radiotherapy between 2005 and 2019 for OC SCC. Clinicopathologic risk factors were recorded. Intermediate risk factors (IRFs) included pT3-4 disease, nodal disease, perineural invasion (PNI), lymphovascular invasion (LVI), and close ( < 5mm) surgical margins (SM); extranodal extension (ENE) and positive SM were considered high-risk factors (HRF). Patients were stratified into risk groups based upon the number and type of risk factors: 0-1 IRFs, 2 IRFs, ≥3 IRFs, and any HRF. Patients were considered to have ER if they had biopsy confirmed recurrence, or if the imaging or exam was sufficiently suspicious, after discussion with the head and neck team, to warrant treatment to definitive doses of RT (70 Gy). Results: Our cohort included 391 patients with SCC of the OCC who were treated with postoperative radiotherapy. 61% of patients were male, 35% had pT3-4 disease, 36% had pN2a-3 disease, 53% had PNI, 20% had LVI, 30% had ENE, and 14% had positive SM. The most common sites were oral tongue (46%), alveolar ridge (18%), and buccal mucosa (13%). 237 (61%) patients underwent postoperative PET/CT planning, and 165 patients (41%) were planned with CT only. Patients screened with post-operative PET/CT were more likely to be diagnosed with ER (46/237, 19.4%) than those simulated with CT only (6/154, 3.9%, p < 0.0001). Among patients simulated with PET/CT, 7%, 9%, 14%, and 35% of patients were diagnosed with ER for patients with 0-1 IRFs, 2 IRFs, ≥3 IRFs, and any HRF, respectively. Median follow-up was 4.1 years (95% CI 3.6 – 4.5). Among 52 patients with ER, 24 (49.0%) had local, 41 (83.7%) had regional, and 5 (10.2%) had distant recurrence. 17 (33%) of ER were biopsy proven. For patients with ER, 3-year freedom from locoregional recurrence, distant-metastasis free survival, and overall survival were 45.2% (95% CI 32% - 64%), 55% (95% CI 42% – 72%), and 43% (95% CI 30% - 61%), respectively. For patients without ER, use of postoperative PET/CT was associated with improved disease-free survival (HR 0.68, 95% CI 0.46 – 0.98, p = 0.041) and overall survival (HR 0.59, 95% CI 0.38 – 0.91, p = 0.019). Conclusions: Postoperative PET/CT may increase detection ER compared to CT simulation alone and improve risk stratification. Patients with ER are at high risk of locoregional failure, distant metastases, and mortality, despite salvage therapy. A prospective trial is underway at our institution to systemically study the role of PET/CT for detection of ER.

Background and Objectives Transoral robotic surgery (TORS) has increased for treatment of oropharyngeal squamous cell carcinoma (OPSCC). To define the adoption of TORS, we analyzed patterns of surgical treatment for OPSCC in the US. Methods Cases of T1-T3 OPSCC treated with surgery between 2010 and 2013 from the National Cancer Database were queried. Results Of 3,071 patients who underwent primary surgical management for T1-T3 OPSCC, 846 (28%) underwent TORS. On multivariable analysis, low tumor stage (T2 vs. T1: OR 0.75, CI 0.37–0.51, P