Shannon S Wu, A Dimitrios Colevas, Luis Martinez Ramirez, Uchechukwu C Megwalu, Michelle M Chen, Aronpreet Atwell, Vasu Divi
{"title":"Cost of Neoadjuvant Immunotherapy vs Up-Front Surgery in Cutaneous Squamous Cell Carcinoma: A Post Hoc Analysis of a Nonrandomized Clinical Trial.","authors":"Shannon S Wu, A Dimitrios Colevas, Luis Martinez Ramirez, Uchechukwu C Megwalu, Michelle M Chen, Aronpreet Atwell, Vasu Divi","doi":"10.1001/jamaoto.2025.0001","DOIUrl":"10.1001/jamaoto.2025.0001","url":null,"abstract":"<p><strong>Importance: </strong>There is increasing interest in use of neoadjuvant immunotherapy (NAT) in advanced cutaneous squamous cell carcinoma (cSCC) to reduce surgical morbidity and forego adjuvant therapy, while potentially improving survival outcomes.</p><p><strong>Objective: </strong>To assess the cost to Medicare of NAT compared with up-front surgery.</p><p><strong>Design, setting, and participants: </strong>This cohort study was a post hoc analysis of a phase 2 clinical trial evaluating the feasibility of neoadjuvant atezolizumab. The study was conducted from June 2021 to December 2023 at a tertiary-level academic institution among 20 patients with advanced stage II-IV cSCC.</p><p><strong>Interventions: </strong>Up to 3 doses of neoadjuvant atezolizumab, followed by surgical resection with or without adjuvant radiation therapy.</p><p><strong>Main outcomes and measures: </strong>Direct medical costs in US dollars of care received on trial were compared with baseline treatment plans of up-front surgery developed a priori from a Medicare payer perspective.</p><p><strong>Results: </strong>Of 20 patients with advanced cSCC enrolled (median [range] age, 71.5 [53-88] years; 17 male [85.0%]), most individuals had stage III (12 patients [60.0%]) or IV (5 patients [25.0%]) disease. The median (range) follow-up was 14.2 (3.5-28.7) months. Compared with $26 602.67 for up-front surgery, NAT was associated with mean overall costs of $51 561.02, or a 93.8% increase, equivalent to $24 958.36 (95% CI, $22 057.95 to $24 692.43) per patient, which was primarily associated with the drug acquisition costs of atezolizumab ($30 603.96). NAT was associated with mean cost reductions from $12 707.07 to $10 543.71 (17.0%) in surgery and $11 711.97 to $7157.32 (38.9%) in radiation across all patients compared with up-front surgery. Adjuvant radiation therapy was obviated in 5 of 17 patients not previously irradiated (29.4%), reducing costs of radiation. Mean (SD) surgical complexity was reduced from 63.81 (30.55) to 44.71 (32.49) work relative value units (wRVUs; difference, 19.10 wRVU; 95% CI, 5.00 to 33.20 wRVU). NAT was associated with 5 fewer free flaps, 4 fewer neck dissections, 5 more organ-preserving resections, and 3 conversions from inpatient to outpatient surgery.</p><p><strong>Conclusions and relevance: </strong>This study found that treatment with 3 doses of NAT was associated with an overall cost increase compared with up-front surgery, driven by drug acquisition costs, and cost reductions from less extensive surgical resections and obviated adjuvant radiation. Predictive markers for response to NAT could optimize patient selection and improve cost-effectiveness.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04710498.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Junzhe Wang, Floor Couvreur, Joshua D Farrell, Reshma Ghedia, Nael Shoman, David P Morris, Robert B A Adamson
{"title":"Fusion of Middle Ear Optical Coherence Tomography and Computed Tomography.","authors":"Junzhe Wang, Floor Couvreur, Joshua D Farrell, Reshma Ghedia, Nael Shoman, David P Morris, Robert B A Adamson","doi":"10.1001/jamaoto.2025.0043","DOIUrl":"10.1001/jamaoto.2025.0043","url":null,"abstract":"<p><strong>Importance: </strong>Middle ear optical coherence tomography (OCT) imaging in patients has not previously been directly compared with a standard of care clinical 3-dimensional imaging technology, such as computed tomography (CT).</p><p><strong>Objective: </strong>To qualitatively compare the capabilities of middle ear OCT with CT in normal and pathological ears on representative slices in coregistered OCT and CT datasets.</p><p><strong>Design, setting, and participants: </strong>This case series included 3 patients and 3 ears: 1 normal middle ear, 1 ear affected by traumatic injury, and 1 ear with cholesteatoma. The ears were imaged with both OCT and high-resolution clinical temporal bone CT. Participants were drawn from the patient population of a tertiary otology clinic. CT and OCT images were aligned using rigid coregistration with manual landmark selection. Data were collected from January 2022 to April 2023, and data were analyzed from February 2022 to December 2023.</p><p><strong>Main outcomes and measures: </strong>Images were analyzed qualitatively for field of view (FOV), resolution, shadowing, artifacts, soft tissue and bony tissue contrast, and presentation of diagnostically important features.</p><p><strong>Results: </strong>In the 3 imaged ears, OCT was capable of visualizing many of the important features indicative of middle ear pathology. Compared with CT, OCT exhibited a limited FOV largely confined to the mesotympanum and subject to shadowing from bony structures. However, OCT could resolve soft tissue features that were not readily apparent in the CT images to have a higher resolution than CT and to provide excellent anatomical fidelity with CT, which allowed OCT images to be accurately coregistered with CT images.</p><p><strong>Conclusions and relevance: </strong>In this case series, while OCT was not capable of replacing CT due to its limited FOV and inability to image through thick bony tissues, it visualized signs of pathology, including some soft tissue features, that are difficult to visualize with CT. Given OCT's ability to image in real time, its compatibility with in-office imaging, and its lack of ionizing radiation, it may, despite its limitations compared with CT, be an appealing imaging modality for many applications in middle ear diagnostics.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Linda X Yin, Christine M Lohse, Kathleen J Yost, Amy M Tuchscherer, Eliot J Martin, Heidi Semann, Gabriela A Calcano, Daniel L Price, Kendall K Tasche, Kathryn M Van Abel, Eric J Moore
{"title":"Patient-Reported Quality-of-Life Outcome Measure After Parotidectomy.","authors":"Linda X Yin, Christine M Lohse, Kathleen J Yost, Amy M Tuchscherer, Eliot J Martin, Heidi Semann, Gabriela A Calcano, Daniel L Price, Kendall K Tasche, Kathryn M Van Abel, Eric J Moore","doi":"10.1001/jamaoto.2024.5253","DOIUrl":"10.1001/jamaoto.2024.5253","url":null,"abstract":"<p><strong>Importance: </strong>There is a lack of reliable, patient-reported quality-of-life (QOL) instruments to address the multidimensional nature of patient-centered outcomes for patients undergoing parotidectomy. The Parotidectomy Quality of Life Index is a new 35-item validated patient-reported outcome instrument specific to recovery after parotidectomy.</p><p><strong>Objective: </strong>To establish and validate a comprehensive English-language patient-reported QOL instrument specific to parotidectomy.</p><p><strong>Design, setting, and participants: </strong>This survey study was conducted in 2 phases: first, in a single-institution cohort (October 12, 2021, to March 7, 2022), and second, as an anonymous web-based survey enrolled via printed promotional brochures and social media platforms (March 13 to July 31, 2023). Inclusion criteria were age at least 18 years and parotidectomy within the last year. For test-retest reliability, a subset of phase II participants volunteered to answer the survey a second time within 2 weeks. Data were analyzed from March 8, 2022, to November 3, 2023.</p><p><strong>Main outcomes and measures: </strong>Item rankings from phase I participants were used to narrow the original 61-item survey down to 45 items in the phase II survey. To assess construct validity, an exploratory factor analysis was performed. Cronbach α and pairwise Pearson correlation coefficients were used to measure internal consistency, reliability, and redundancy. Test-retest reliability was evaluated using intraclass correlation coefficients.</p><p><strong>Results: </strong>Phase I enrolled 38 individuals, of whom 30 completed the survey (15 women [60%]; 21 participants [84%] aged >40 years). Phase II enrolled 342 participants, of whom 317 completed the survey (305 women [89%]; 284 participants [83%] aged >40 years). A total of 42 items across 7 domains were selected based on exploratory factor analysis. After Cronbach α and pairwise correlation analysis, 33 items across 6 multi-item domains and 2 standalone items were incorporated into the final QOL instrument. Cronbach αs for each of the final 6 domains were at least 0.77, suggesting excellent internal validity. Pairwise correlations did not show strong correlations (ie, none ≥0.80), suggesting minimal redundancy between domains. Younger age was significantly associated with a lower global score. Participants with malignant tumors scored lower on 4 of the 6 multi-item domains. Test-retest reliability coefficients for the domains ranged from 0.82 to 0.93, indicating very good reproducibility over a 2-week interval.</p><p><strong>Conclusions and relevance: </strong>These findings suggest the Parotidectomy Quality of Life Index demonstrated excellent internal validity and test-retest reliability. With further external validation, this instrument may provide opportunity for quality improvement in clinical practice and has potential as a key patient-reported outcome in future parotidectomy c","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gabriel S Dayan, Houda Bahig, Justine Colivas, Antoine Eskander, Stephanie Johnson-Obaseki, Shamir Chandarana, John R de Almeida, Anthony C Nichols, Michael Hier, Mathieu Belzile, Andrea Avagnina, Xinyuan Hong, Marc Gaudet, T Wayne Matthews, Robert Hart, David P Goldstein, Ali Hosni, Danielle MacNeil, James Fowler, Carlos Khalil, Mark Khoury, Gregoire Morand, Khalil Sultanem, Tareck Ayad, Apostolos Christopoulos
{"title":"Preoperative Clinical and Tumor Factors Associated With Adjuvant Therapy for Oral Cavity Cancer.","authors":"Gabriel S Dayan, Houda Bahig, Justine Colivas, Antoine Eskander, Stephanie Johnson-Obaseki, Shamir Chandarana, John R de Almeida, Anthony C Nichols, Michael Hier, Mathieu Belzile, Andrea Avagnina, Xinyuan Hong, Marc Gaudet, T Wayne Matthews, Robert Hart, David P Goldstein, Ali Hosni, Danielle MacNeil, James Fowler, Carlos Khalil, Mark Khoury, Gregoire Morand, Khalil Sultanem, Tareck Ayad, Apostolos Christopoulos","doi":"10.1001/jamaoto.2024.5250","DOIUrl":"10.1001/jamaoto.2024.5250","url":null,"abstract":"<p><strong>Importance: </strong>The standard of care for patients with oral cavity squamous cell carcinoma (OCSCC) is generally primary surgical resection with or without adjuvant therapy (AT), based on pathological factors. Identifying preoperative factors that are associated with the receipt of AT may enhance treatment planning.</p><p><strong>Objective: </strong>To identify preoperative patient and tumor factors associated with receiving AT, either radiation therapy (RT) or chemoradiation therapy (CRT), in patients with OCSCC.</p><p><strong>Design, setting, and participants: </strong>This cohort study, spanning January 2005 to December 2019 at 9 academic centers in Canada, was conducted as part of the Canadian Head & Neck Collaborative Research Initiative, a national network of head and neck surgical oncologists. Participants included patients with oral cavity cancer who underwent surgery. The data analysis was performed in March 2024.</p><p><strong>Exposures: </strong>Preoperative variables, including demographics (age, sex, smoking history, and Charlson Comorbidity Index [CCI]) and tumor characteristics (clinical T and N stage, biopsy grade, tumor size).</p><p><strong>Main outcomes and measures: </strong>The main outcomes were the receipt of AT vs surgery alone; the type of AT, either RT or CRT; and the presence of a strong pathologic indicator for AT.</p><p><strong>Results: </strong>Of the 3980 patients, 2438 underwent surgery alone (61%) and 1542 received AT (39%). Of these, 1907 (48%) had a strong pathologic indicator for AT. The mean (SD) age was 63 (13) years, and 1498 participants (38%) were female. On multivariable analysis, factors independently associated with AT included being older than 65 years (odds ratio [OR], 0.50 [95% CI, 0.38-0.64]), CCI of 4 or higher (OR, 1.83 [95% CI, 1.26-2.65]), previous head and neck cancer (OR, 0.40 [95% CI, 0.26-0.62]), maxillary alveolus (OR, 2.16 [95% CI, 1.11-4.22]) and retromolar trigone (OR, 1.85 [95% CI, 1.04-3.29) subsites, tumor dimension (OR, 1.35 [95% CI, 1.22-1.50] per cm), increasing clinical T and N stages, and worse grade on biopsy (poorly differentiated: OR, 1.89 [95% CI, 1.25-2.84]). Among those receiving AT, poorly differentiated grade (OR, 2.40 [95% CI, 1.34-4.30]) and advanced N stage were associated with CRT rather than RT. Among patients with strong pathologic indicators for AT, factors associated with not receiving AT included age, CCI, grade, stage, and tumor dimension. The prediction model showed good discriminatory power (area under the receiver operating characteristic curve, 0.84 [95% CI, 0.82-0.86]).</p><p><strong>Conclusions and relevance: </strong>The results of this cohort study suggest that preoperative variables can help to identify patients with OCSCC who are more likely to receive AT, despite many factors not being predictable until the postoperative period. Early identification of patients at high risk may improve treatment planning and reduce delays in initiating A","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143719384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Further Clarifications for Interpretation of Study of Lobectomy vs Total Thyroidectomy With Ipsilateral Lateral Neck Dissection.","authors":"Keyu Shen, Xiequn Xu","doi":"10.1001/jamaoto.2025.0158","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0158","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143719378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Further Clarifications for Interpretation of Study of Lobectomy vs Total Thyroidectomy With Ipsilateral Lateral Neck Dissection.","authors":"Pierpaolo Trimboli, Gianluca Bottoni, Arnoldo Piccardo","doi":"10.1001/jamaoto.2025.0156","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0156","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143719376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Juliana Bonilla-Velez, Carrie L Heike, Larry G Kessler, Xing Wang, Tara L Wenger, Bonnie W Ramsey, Jonathan A Perkins
{"title":"Incidence and Factors Associated With Spontaneous Regression in Head and Neck Lymphatic Malformations.","authors":"Juliana Bonilla-Velez, Carrie L Heike, Larry G Kessler, Xing Wang, Tara L Wenger, Bonnie W Ramsey, Jonathan A Perkins","doi":"10.1001/jamaoto.2025.0104","DOIUrl":"10.1001/jamaoto.2025.0104","url":null,"abstract":"<p><strong>Importance: </strong>Head and neck lymphatic malformations (HNLMs) demonstrate considerable variability in their natural history. While some malformations cause chronic severe functional impairment, others are asymptomatic and spontaneously regress. Understanding the frequency and features associated with regression will aid clinicians and families in making informed treatment choices and avoid unnecessary risks of intervention for a subset of patients.</p><p><strong>Objective: </strong>To assess the incidence, timing, and factors associated with spontaneous regression of HNLMs.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study across a single regional pediatric tertiary care academic center included patients aged 0 to 21 years with HNLM who were evaluated in the vascular anomalies clinic and prospectively enrolled in an institutional quality improvement database between 2003 and 2022. Observation was offered to patients without symptoms or functional compromise. Treatment decisions were made during routine clinical care.</p><p><strong>Exposures: </strong>Age of HNLM onset and HNLM location, distribution, cystic structure, grade, and de Serres staging.</p><p><strong>Main outcome and measures: </strong>The incidence of complete spontaneous regression was estimated. The strength of the association between exposures and regression was assessed using risk ratios, Cliff Δ, and Cramer V. A Kaplan-Meier curve was used to estimate the probability of spontaneous regression over time. The association of the exposures on the likelihood of spontaneous regression were assessed using 2-sided log-rank tests and Cox proportional hazards models.</p><p><strong>Results: </strong>Of 298 patients with HNLMs, 173 (58.1%) were male, and most HNLMs were diagnosed prenatally or at birth (137 patients [46.0%]). Among HNLMs, 189 (63.4%) had a focal distribution, 228 (76.5%) were de Serres stage I or II, and 128 (43.0%) were macrocystic. Complete spontaneous regression occurred in 27 patients (9.1%) at a median (IQR) time of 12.0 (6.7-27.4) months from onset. Factors associated with a large difference in the rate of complete spontaneous regression included macrocystic structure, neck location, focal distribution, and grade 1 or de Serres I stage. HNLMs of the upper face or midface, with mixed or microcystic composition, or with extensive unilateral or bilateral involvement did not regress.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, HNLMs that were macrocystic, of limited extent, and/or in the neck were more likely to completely spontaneously regress. A 1-year observation period for asymptomatic HNLM, particularly when favorable features are present, should be considered, as nonintervention may be curative. Future studies will examine interaction among these factors. This work contributes to a deeper understanding of HNLM natural history that can directly inform clinical decision-making, decrease","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143719382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}