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A Phase II Exploratory Trial Evaluating CT-based Mid-Treatment Nodal Response to Select for De-escalated chemoradiation therapy in the definitive management of p16+ Oropharyngeal Cancer

Kim, Joseph K; Tam, Moses; Kim, S Gene; Solomon, Eddy; Hill, Colin; Karp, Jerome M; Hung, Christie; Oh, Cheongeun; Concert, Catherine; Rybstein, Marissa; Li, Zujun; Zan, Elcin; Goldberg, Judith D; Hochman, Tsivia; Jacobson, Adam; Duvvuri, Umamaheswar; Persky, Michael; Persky, Mark; Harrison, Louis; Hu, Kenneth
PURPOSE/OBJECTIVE:This prospective, non-randomized phase II single-arm pilot trial aimed to explore favorable mid-treatment nodal response (FMNR) through CT imaging to guide de-escalated chemoradiation therapy (CRT) in patients with favorable risk, node-positive HPV-associated oropharyngeal cancer (OPC). MATERIALS AND METHODS/METHODS:. At week 4, CT imaging evaluated nodal response: ≥40% reduction warranted de-escalation to 60 Gy, while <40% reduction continued standard CRT. Primary endpoint was 2-year PFS from initiation of dose de-escalated CRT. Tissue tumor modified viral (TTMV) HPV DNA samples and DW-MRI were collected at baseline and week 4. MDADI questionnaires were collected at baseline, 1, 3, 6, 12, and 24 months. RESULTS:Of 39 patients, 26 had FMNR and underwent de-escalated treatment. 13 pts had slow mid-treatment nodal shrinkage and received standard dose. At a median follow-up of 47.4 months, the 2-year PFS was 92.1% (95% CI: 0.72-0.98) for the deescalated dose group and 92.3% for the standard dose patients (95% CI: 0.57-0.99), p=0.96. With a median survival follow up of 48.9 months (range: 16.7-77.8 months), there were no deaths or distant failures. FMNR was associated with rapid TTMV HPV DNA clearance, reduced TTMV HPV DNA flare, lower baseline and week 4 MRI diffusivity, and higher baseline and week 4 MRI diffusional kurtosis. No differences in acute or late maximum grade 3-4 toxicity by patient were noted. MDADI composite scores showed minimal clinical important difference (MCID) in the de-escalated group at 1-month post-treatment while the standard group had MCID up to 1-year post-treatment. No patients required feeding tube placement. CONCLUSIONS:De-escalated CRT using CT-based mid-treatment nodal response in favorable risk, node-positive HPV-associated OPC achieved excellent 2-year PFS and OS rates and represents a potential approach in better selecting patients for treatment de-escalation.
PMID: 41101558
ISSN: 1879-355x
CID: 5954192

A Preliminary Validation of an Optimal Cutpoint in Total Number of Patient-Reported Symptoms in Head and Neck Cancer for Effective Alignment of Clinical Resources with Patients' Symptom Burden

Van Cleave, Janet H; Concert, Catherine; Kamberi, Maria; Zahriah, Elise; Most, Allison; Mojica, Jacqueline; Riccobene, Ann; Russo, Nora; Liang, Eva; Hu, Kenneth S; Jacobson, Adam S; Li, Zujun; Moses, Lindsey E; Persky, Michael J; Persky, Mark S; Tran, Theresa; Brody, Abraham A; Kim, Arum; Egleston, Brian L
BACKGROUND/UNASSIGNED:Patients with head and neck cancer (HNC) often experience high symptom burden leading to lower quality of life (QoL). OBJECTIVE/UNASSIGNED:This study aims to conceptually model optimal cutpoint by examining where total number of patient-reported symptoms exceeds patients' coping capacity, leading to a decline in QoL in patients with HNC. METHODS/UNASSIGNED:Secondary data analysis of 105 individuals with HNC enrolled in a clinical usefulness study of the NYU Electronic Patient Visit Assessment (ePVA)©, a digital patient-reported symptom measure. Patients completed ePVA and European Organization for Research and Treatment of Cancer (EORTC©) QLQ-C30 v3.0. The total number of patient-reported symptoms was the sum of symptoms as identified by the ePVA questionnaire. Analysis of variance (ANOVA) was used to define optimal cutpoint. RESULTS/UNASSIGNED:<.0001). CONCLUSIONS/UNASSIGNED:In HNC, defining optimal cutpoints in the total number of patient-reported symptoms is feasible. IMPLICATIONS FOR PRACTICE/UNASSIGNED:Cutpoints in the total number of patient-reported symptoms may identify patients experiencing a high symptom burden from HNC. FOUNDATIONAL/UNASSIGNED:Using optimal cutpoints of the total number of patient-reported symptoms may help effectively align clinical resources with patients' symptom burden.
PMCID:10993689
PMID: 38586274
ISSN: 2691-3623
CID: 5725572

Repeat re-irradiation with interstitial HDR-brachytherapy for an in-field isolated nodal recurrence in a patient with HPV-positive squamous cell carcinoma of the head and neck [Case Report]

Kim, Joseph K; Hardy-Abeloos, Camille; Purswani, Juhi M; Kamen, Emily; Concert, Catherine M; Duckworth, Tamara; Tam, Moses; Haas, Jonathan; Rybstein, Marissa; Vaezi, Alec; Jacobson, Adam; Hu, Kenneth S
PURPOSE/OBJECTIVE:Locoregionally recurrent head and neck cancer is a complex clinical scenario that often requires multimodality treatment. These patients have often previously received definitive treatment with a combination of surgery, radiation therapy, and systemic therapy, which can make further management difficult. A second isolated locoregional failure is rare and clinicians are faced with a challenge to optimize disease control while minimizing treatment-related toxicity. METHODS AND MATERIALS/METHODS:In this report, we present the diagnosis, management, and outcomes of a patient with an isolated locoregional recurrence who was previously treated with two courses of radiation. The patient was treated with a second course of reirradiation using interstitial brachytherapy as well as a discussion regarding patient selection and optimal management for recurrent head and neck cancer. RESULTS:Repeat reirradiation using interstitial HDR-brachytherapy with the use of an alloderm spacer was successfully delivered to the patient for an in-field right neck nodal recurrence. He received a total EQD2/BED dose of 127.70/153.24 Gy. At 1-year followup, the patient was without evidence of recurrent disease or new significant side effects. CONCLUSION/CONCLUSIONS:Recurrent head and neck cancer should be managed with a multidisciplinary approach given the complex clinical scenario. Reirradiation is a commonly used salvage measure for recurrent head and neck cancer that requires careful planning and patient selection due to prior treatment-related effects and dose constraints. We reported a case of a second course of reirradiation using interstitial HDR-brachytherapy for locoregionally recurrent head and neck cancer and showed no recurrence of disease or worsening long term side effects at 1 year.
PMID: 36593130
ISSN: 1873-1449
CID: 5409832

A Phase II Trial Evaluating Rapid Mid-Treatment Nodal Shrinkage to Select for Adaptive Deescalation in p16+Oropharyngeal Cancer Patients Undergoing Definitive Chemoradiation [Meeting Abstract]

Kim, J. K.; Tam, M.; Karp, J. M.; Oh, C.; Kim, G.; Solomon, E.; Concert, C. M.; Vaezi, A. E.; Li, Z.; Tran, T.; Zan, E.; Corby, P.; Feron-Rigodon, M.; Fitz, C. Del Vecchio; Goldberg, J. D.; Hochman, T.; Givi, B.; Jacobson, A.; Persky, M.; Hu, K. S.
ISI:001079706803134
ISSN: 0360-3016
CID: 5591182

Pain Prevalence in Head and Neck Cancer [Meeting Abstract]

Van Cleave, Janet; Brooks, Christopher; Zahriah, Elise; Riccobene, Ann; Most, Allison; Liang, Eva; Concert, Catherine
ISI:000792497000113
ISSN: 1526-5900
CID: 5246592

THE USEFULNESS OF THE NYU ELECTRONIC PATIENT VISIT ASSESSMENT (EPVA)(c) FOR HEAD AND NECK CANCER IN ESTABLISHING SYMPTOM BURDEN CUTPOINTS [Meeting Abstract]

Van Cleave, Janet H.; Concert, Catherine; Hu, Kenneth S.; Liang, Eva; Egleston, Brian L.
ISI:000790312800467
ISSN: 0190-535x
CID: 5246522

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer

Van Cleave, Janet H; Fu, Mei R; Bennett, Antonia V; Concert, Catherine; Riccobene, Ann; Tran, Anh; Most, Allison; Kamberi, Maria; Mojica, Jacqueline; Savitski, Justin; Kusche, Elise; Persky, Mark S; Li, Zujun; Jacobson, Adam S; Hu, Kenneth S; Persky, Michael J; Liang, Eva; Corby, Patricia M; Egleston, Brian L
Background/UNASSIGNED:Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. Methods/UNASSIGNED:Between January 2018 and August 2019, 75 participants were enrolled in a clinical usefulness study of the ePVA. Upon signing informed consent, participants completed the ePVA and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) general (C30) questionnaire v3.0 (scores range from 0 to 100 with 100 representing best HRQoL). Clinical usefulness of the ePVA was defined as demonstration of reliability, convergent validity with HRQoL, and acceptability of the ePVA (i.e., >70% of eligible participants complete the ePVA at two or more visits and >70% of ePVA reports are read by providers). Formal focus group discussions with the interdisciplinary team that cared for patients with HNC guided the development of the ePVA as a clinical support tool. Qualitative and quantitative methods were used throughout the study. Descriptive statistics consisting of means and frequencies, Pearson correlation coefficient, and Student's t-tests were calculated using SAS 9.4 and STATA. Results/UNASSIGNED:The participants were primarily male (71%), White (76%), diagnosed with oropharyngeal or oral cavity cancers (53%), and undergoing treatment for HNC (69%). Data analyses supported the reliability (alpha =0.85), convergent validity with HRQoL scores, and acceptability of the ePVA. Participants with the highest number of symptoms and functional limitations reported significantly worse HRQoL (sum of symptoms: r=-0.50, P<0.0001; sum of function limitations: r=-0.56, P<0.0001). Ninety-two percent of participants (59 of 64) who had follow-up visits within the 6-month study period completed the ePVA at two or more visits and providers read 89% (169 of 189) of automated ePVA reports. The use of the ePVA as a clinical support tool for real-time interventions for symptoms and functional limitations reported by patients is described in a clinical exemplar. Conclusions/UNASSIGNED:This research indicates that the ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. The study findings support future translational research to enhance the usefulness of the ePVA in real world settings for early interventions that decrease symptom burden and improve the QoL of patients with HNC.
PMCID:7882269
PMID: 33634190
ISSN: 2306-9740
CID: 4795022

Improving thyroid function monitoring in head and neck cancer patients: A quality improvement study

Bhatt, Nupur; Taufique, Zahrah; Kamen, Emily; Wang, Binhuan; Concert, Catherine; Li, Zujun; Hu, Kenneth; Givi, Babak
OBJECTIVE:To investigate and improve compliance of thyroid function monitoring in head and neck cancer patients who received radiotherapy to the cervical region before and after instituting quality improvement interventions. METHODS:Using the Plan, Do, Study, Act (PDSA) methodology, patients with head and neck malignancies who received radiotherapy to the cervical region from 2013-2015 were identified at a tertiary medical center. The status of the patients' thyroid monitoring and related characteristics were recorded. A quality improvement project was subsequently implemented by data sharing and providing feedback to practitioners involved in head and neck cancer care and creating a tracking database for all patients who received radiotherapy to the neck. After implementation of these interventions, data was collected on patients meeting the inclusion criteria from 2015-2017. RESULTS:One hundred fifty-six patients met criteria pre-intervention and ninety-eight patients met criteria post-intervention. Compliance of thyroid monitoring went up from 34% to 80% after interventions (P < .0001). There was a significant increase in thyroid testing performed by radiation oncologists after interventions from 2% to 21%, while medical oncologists and otolaryngologists remained consistent in their compliance rates. CONCLUSION/CONCLUSIONS:It is possible to improve compliance with evidence-based recommendations and improve the quality-of-care for head and neck cancer survivors through simple, cost effective interventions. LEVEL OF EVIDENCE/METHODS:2 Laryngoscope, 2019.
PMID: 31778220
ISSN: 1531-4995
CID: 4216182

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.
ISI:000580656800061
ISSN: 0360-3016
CID: 4688592

Chemoradiotherapy in Oral Cavity Cancer

Chapter by: Shah, Bhartesh A; Yan, Sherry X; Concert, Catherine; Hu, Kenneth
in: Textbook of oral cancer : prevention, diagnosis and management by Warnakulasuriya, S; Greenspan, John S [Eds]
Cham, Switzerland : Springer, [2020]
pp. 291-301
ISBN: 9783030323158
CID: 5422992