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Circulating Tumor HPV-DNA Kinetics in p16+ Oropharyngeal Cancer Patients Undergoing Adaptive Radiation De-Escalation Based on Mid-Treatment Nodal Response [Meeting Abstract]

Kim, J K; Tam, M; Oh, C; Feron-Rigodon, M; Joseph, B; Vaezi, A E; Li, Z; Tran, T; Kim, G; Zan, E; Corby, P; Vecchio, Fitz C D; Goldberg, J D; Hochman, T; Givi, B; Jacobson, A; Persky, M; Hu, K S
Purpose/Objective(s): Human-papilloma virus-positive (HPV+) OPSCC is known to have an excellent prognosis with a favorable response to CRT. Several studies have shown that de-intensified treatment in select patients (pts) can achieve similar survival outcomes to standard treatment while reducing acute and long-term toxicity. Additionally, rapid clearance of circulating tumor HPV DNA may be useful in predicting the likelihood of disease control. Materials/Methods: We evaluated pts enrolled on a phase II institutional clinical trial. Pts with HPV+ OPSCC were included and were treated with definitive CRT with cisplatin. All pts were initially planned to receive standard radiation dose (S-RT) to 70 Gy; those who achieved a favorable mid-treatment response (FMTR) of >40% lymph node shrinkage at week 4 of radiation (RT) received a de-escalated dose (D-RT) to 60 Gy. Blood samples were taken at screening, week 4 of RT, and at follow-up visit after RT and circulating tumor tissue modified viral HPV NDA (TTMV) was qualtified. We define a "substantial TTMV clearance" as either >95% reduction in TTMV from screening to week 4 (screening level >200 copies/ml) or undetectable ctHPVDNA at week 4 (any detectable screening level). Fisher tests were used to evaluate the association of TTMV and treatment group.
Result(s): At the time of this analysis, 35 pts were enrolled in the clinical trial with a median age of 60 years at diagnosis (range 38 to 76). 25 pts achieved a FMTR and received D-RT while 10 pts received S-RT. 29 pts (7 S-RT, 18 D-RT) had detectable screening TTMV and week 4 TTMV samples available for analysis. D-RT pts had a significantly higher rate of substantial TTMV clearance at week 4 compared to S-RT: 14.3% (1/7) pts in the S-RT vs. 61.1% (11/18) pts in the D-RT (OR 0.090 [0.002 - 0.105], p=0.036). 6 of 25 pts (24%) had a flare in their TTMV from screening to week 4 including 57.1% (4/7) of the S-RT and 11.1% (2/18) of the D-RT; there was a significantly higher likelihood of TTMV flare in the S-RT group (OR 9.34 [0.898 - 150.960], p=0.032). 24 pts (6 S-RT, 18 D-RT) with initial detectable screening TTMV also had a follow-up TTMV sample available. The median time from screening to follow-up was 81.0 days for all pts (76.5 days for D-RT, 84.0 days for S-RT). 95.7% of pts (83.3% of S-RT, 100%% of D-RT) had complete TTMV clearance at follow-up.
Conclusion(s): We report a statistically significant correlation between substantial TTMV clearance and a FMTR of >40% nodal shrinkage. 61.1% of D-RT pts achieved a substantial TTMV clearance compared to 14.3% in the S-RT group. Additionally, we observed that pts who did not achieve a FMTR had a higher likelihood of TTMV flare at week 4. Nearly all pts achieved a complete TTMV clearance by follow-up. Mid-treatment TTMV clearance may help identify pts who may benefit from further de-escalation as well as those who should continue with standard therapy. This study has the identifier NCT03215719.
ISSN: 1879-355x
CID: 5366202

Including Surgical Resection in the Multimodal Management of Very Locally Advanced Sinonasal Cancer

Karp, Jerome M; Hu, Kenneth S; Persky, Michael; Persky, Mark; Jacobson, Adam; Tran, Theresa; Li, Zujun; Givi, Babak; Tam, Moses M
OBJECTIVE:Sinonasal cancer often presents as locoregionally advanced disease. National guidelines recommend management of stage T4b tumors with systemic therapy and radiotherapy, but recent studies suggest that including surgical resection in the multimodal treatment of these tumors may improve local control and survival. We queried the National Cancer Database to examine patterns of care and outcomes in T4b sinonasal squamous cell carcinoma (SCC). STUDY DESIGN/METHODS:Prospectively gathered data. SETTING/METHODS:National Cancer Database. METHODS:Patients with T4b N0-3 M0 sinonasal squamous cell carcinoma diagnosed in 2004 to 2016 were stratified between those who received chemoradiotherapy and those who underwent surgical resection with neoadjuvant or adjuvant treatment. The overall survival of each cohort was assessed via Kaplan-Meier analysis and Cox proportional hazard models, with repeat analysis after reweighting of data via inverse probability of treatment weighting. RESULTS:= .004]). CONCLUSION/CONCLUSIONS:Surgical treatment with neoadjuvant or adjuvant treatment for stage T4b sinonasal SCC was associated with promising survival outcomes, suggesting a role for incorporating surgery in treatment of select T4b SCC, particularly when removal of all macroscopic disease is feasible.
PMID: 34962843
ISSN: 1097-6817
CID: 5108122

Improving Quality and Safety of Thyroidectomy [Meeting Abstract]

Papazian, M; Roland, J T; Shao, Q; Vaezi, A; DeLacure, M; Tran, T; Persky, M J; Persky, M S; Jacobson, A; Givi, B
Introduction: Thyroidectomy is commonly performed in otolaryngology. Complications such as recurrent laryngeal nerve (RLN) injury and severe hypocalcemia have reported incidences in national studies as high as 3% and 8%, respectively. Narcotic pain medications are commonly used for postoperative pain management. Here, we present the long-term results of a thyroidectomy quality and safety improvement program, with an emphasis on reducing narcotic use.
Method(s): All surgeons who perform thyroidectomy established standards for antibiotic administration, postoperative calcium management, and narcotics use. The program was established in 2018 and data on adverse events, length of stay, antibiotic and narcotic use were recorded prospectively from June 2018 to January 2021. Data trends were analyzed throughout the course of the study.
Result(s): During the study period, 542 thyroidectomies were performed by 14 surgeons. The average length of stay was less than 24 hours. Five (0.9%) adverse events were recorded: 1 (0.2%) temporary RLN dysfunction, 3 (0.6%) hematomas, 1 (0.2%) surgical site infection, and 1 (0.2%) temporary hypocalcemia. The average number of narcotics prescribed declined from 18 doses (95%CI: 16.8-18.5) in 2019 to 9 in 2020 (95%CI: 8.5-9.6) (p<0.0001), without an increase in need for refills. No instances of permanent hypocalcemia or permanent RLN injury were identified.
Conclusion(s): By implementing a thyroidectomy quality improvement program, we achieved extremely low rates of adverse events and significantly reduced the use of narcotics without adverse effects. These data can inform practitioners and the public about expected outcomes of thyroid surgery, and establish benchmarks for quality and safety.
ISSN: 1879-1190
CID: 5024602

Trimodality Treatment of Very Locally Advanced Sinonasal Cancer: A National Cancer Database Analysis [Meeting Abstract]

Karp, J. M.; Hu, K. S.; Persky, M.; Jacobson, A.; Tran, T.; Li, Z.; Givi, B.; Tam, M.
ISSN: 0360-3016
CID: 4686342

De-escalation with Definitive Unilateral Neck Radiation for T3 or N2b/N3 p16+Tonsil Squamous Cell Carcinoma Using Prospectively Defined Criteria [Meeting Abstract]

Yan, S. X.; Mojica, J.; Barbee, D.; Harrison, L. B.; Gamez, M. E.; Tam, M.; Concert, C. M.; Li, Z.; Culliney, B.; Jacobson, A.; Persky, M.; DeLacure, M.; Persky, M.; Tran, T.; Givi, B.; Hu, K. S.
ISSN: 0360-3016
CID: 4688592

Resection Margin Distance in Extra-Hepatic Cholangiocarcinoma: How Much Is Enough? [Meeting Abstract]

Rahnemai-Azar, A.; Ronnekleiv-Kelly, S. M.; Abbott, D.; Ethun, C.; Poultsides, G.; Tran, T.; Fields, R.; Krasnick, B. A.; Martin, R.; Scoggins, C. R.; Idrees, K.; Isom, C. A.; Hatzaras, I.; Shenoy, R.; Shen, P.; Perkins, J. D.; Pawlik, T.; Maithel, S.; Weber, S.
ISSN: 1068-9265
CID: 3705512

Resection margin distance in extrahepatic cholangiocarcinoma: How much is enough? [Meeting Abstract]

Rahnemai-Azar, A A; Ronnekleiv-Kelly, S; Abbott, D; Ethun, C G; Poultsides, G A; Tran, T; Fields, R; Krasnick, B A; Martin, R C G; Scoggins, C R; Idrees, K; Isom, C A; Hatzaras, I; Shenoy, R; Shen, P; Perkins, J D; Pawlik, T M; Maithel, S K; Weber, S M
Background: Surgical resection is required for curative treatment of patients with extra-hepatic cholangiocarcinoma (EH-CCA). The objective of this study was to determine if the distance of surgical margin was associated with outcome.
Method(s): Patients who underwent curative-intent resection for EH-CCA between 2000 and 2015 at 10 hepatobiliary centers across the U.S. were evaluated using prospectively collected data. Cox proportional hazard model was utilized to evaluate the influence of the extent of the margin on outcome.
Result(s): 538 patients with EH-CCA who underwent curative-intent resection were included: 383 (71%) undergoing R0 resection, 153 (28%) undergoing R1 resection, and 2 with R2 resection. A negative surgical margin (R0) was associated with improved recurrence-free (RFS) and overall survival (OS) (RFS: 10.5% vs. 3.6% (R1) and OS: 25.8% vs. 9.3% (R1). Subsequently, further analysis on 161 patients with complete data on distance of resection margin, all undergoing R0 resection, was performed to assess the impact of extent of margin on outcome. On multi-variable analysis, the resection margin distance, analyzed as a continuous variable, was not associated with either improved RFS (RR 1.00, 95% CI 0.96-1.05; p 0.71) or OS (RR 0.99, 95% CI 0.96-1.01; p 0.49). Increasing age, increased tumor size, and LN metastasis were identified as independent predictors of OS; while RFS were mainly dependent on tumor size and LN metastasis (Table).
Conclusion(s): Achieving R0 resection is acceptable for EH-CCA tumors, and obtaining additional margin does not confer a benefit on overall survival. Increasing age, tumor size, and LN metastasis are independent predictors of RFS and OS, but increased margin width is not associated with improvement in either. Multivariable analysis of factors affecting OS of patients with extra-hepatic CCA who underwent surgical resection, with significant factors noted in bold
ISSN: 1527-7755
CID: 3811602

De-escalation in HPV Era: Definitive Unilateral Neck Radiation for T3 or N2b/N3 p16+Tonsil Squamous Cell Carcinoma Using Prospectively Defined Criteria [Meeting Abstract]

Yan, S. X.; Mojica, J.; Barbee, D.; Harrison, L. B.; Gamez, M. E.; Tam, M.; Concert, C. M.; Li, Z.; Culliney, B.; Jacobson, A.; Persky, M.; DeLacure, M.; Persky, M.; Tran, T.; Givi, B.; Hu, K. S.
ISSN: 0360-3016
CID: 4111372

Functional Swallowing Outcomes Using FEES Evaluation After Swallowing-Sparing IMRT in Unilateral Versus Bilateral Neck Radiation [Meeting Abstract]

Tam, M.; Mojica, J.; Kim, N. S.; No, D.; Li, Z.; Tran, T.; DeLacure, M.; Givi, B.; Jacobson, A.; Persky, M.; Hu, K. S.
ISSN: 0360-3016
CID: 3035552

Utilization of Immunotherapy in Head and Neck Cancers Pre-Food and Drug Administration Approval of Immune Checkpoint Inhibitors [Meeting Abstract]

Wu, S. P. P.; Tam, M.; Gerber, N. K.; Li, Z.; Schmidt, B.; Persky, M.; Sanfilippo, N. J.; Tran, T.; Jacobson, A.; DeLacure, M.; Hu, K. S.; Persky, M.; Schreiber, D. P.; Givi, B.
ISSN: 0360-3016
CID: 3035562