RESUMO
BACKGROUND: In a pilot study involving patients with cutaneous squamous-cell carcinoma, a high percentage of patients had a pathological complete response with the use of two doses of neoadjuvant cemiplimab before surgery. Data from a phase 2 study are needed to confirm these findings. METHODS: We conducted a phase 2, confirmatory, multicenter, nonrandomized study to evaluate cemiplimab as neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma. Patients received cemiplimab, administered at a dose of 350 mg every 3 weeks for up to four doses, before undergoing surgery with curative intent. The primary end point was a pathological complete response (the absence of viable tumor cells in the surgical specimen) on independent review at a central laboratory, with a null hypothesis that a pathological complete response would be observed in 25% of patients. Key secondary end points included a pathological major response (the presence of viable tumor cells that constitute ≤10% of the surgical specimen) on independent review, a pathological complete response and a pathological major response on investigator assessment at a local laboratory, an objective response on imaging, and adverse events. RESULTS: A total of 79 patients were enrolled and received neoadjuvant cemiplimab. On independent review, a pathological complete response was observed in 40 patients (51%; 95% confidence interval [CI], 39 to 62) and a pathological major response in 10 patients (13%; 95% CI, 6 to 22). These results were consistent with the pathological responses determined on investigator assessment. An objective response on imaging was observed in 54 patients (68%; 95% CI, 57 to 78). Adverse events of any grade that occurred during the study period, regardless of whether they were attributed to the study treatment, were observed in 69 patients (87%). Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients (18%). CONCLUSIONS: Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous squamous-cell carcinoma. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov number, NCT04154943.).
Assuntos
Carcinoma de Células Escamosas , Terapia Neoadjuvante , Neoplasias Cutâneas , Humanos , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/cirurgia , Carcinoma de Células Escamosas/patologia , Estadiamento de Neoplasias , Projetos Piloto , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/cirurgia , Indução de Remissão , Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/efeitos adversos , Antineoplásicos Imunológicos/uso terapêuticoRESUMO
OPINION STATEMENT: Neoadjuvant immunotherapy will change the standard of care for advanced resectable cutaneous squamous cell carcinoma (cSCC) and possibly other non-melanoma skin cancers. With pathological complete response rates around 50% for cSCC in early studies, neoadjuvant therapy allows patients the possibility of significant reduction in tumor size, de-escalation of adjuvant therapy, and improved long-term outcomes. Patients must be carefully selected to ensure that there is a margin of safety with respect to resectability, such that if a tumor progresses on neoadjuvant therapy, there remains a curative surgical option that is acceptable to the patient. The optimal treatment paradigm is an area of active research, with many researchers questioning whether adjuvant therapy, or even local therapy, is necessary in patients who seem to have a complete response. The ability to predict who will respond will become even more critical to answer, as a significant number of patients do not want to risk their disease progressing, especially in cosmetically sensitive areas of the head and neck. Recent studies in melanoma show promise for improved response rates using combination therapies, and these strategies may apply to cSCC as well. The use of LAG-3 inhibitors or mRNA vaccine technology may further improve the utility of neoadjuvant strategies.
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Neoplasias de Cabeça e Pescoço , Imunoterapia , Terapia Neoadjuvante , Neoplasias Cutâneas , Humanos , Terapia Neoadjuvante/métodos , Neoplasias Cutâneas/terapia , Neoplasias de Cabeça e Pescoço/terapia , Imunoterapia/métodos , Resultado do Tratamento , Terapia Combinada/métodos , Terapia Combinada/efeitos adversos , Gerenciamento ClínicoRESUMO
Natural killer (NK) cells comprise one subset of the innate lymphoid cell (ILC) family. Despite reported antitumor functions of NK cells, their tangible contribution to tumor control in humans remains controversial. This is due to incomplete understanding of the NK cell states within the tumor microenvironment (TME). Here, we demonstrate that peripheral circulating NK cells differentiate down two divergent pathways within the TME, resulting in different end states. One resembles intraepithelial ILC1s (ieILC1) and possesses potent in vivo antitumor activity. The other expresses genes associated with immune hyporesponsiveness and has poor antitumor functional capacity. Interleukin-15 (IL-15) and direct contact between the tumor cells and NK cells are required for the differentiation into CD49a+CD103+ cells, resembling ieILC1s. These data explain the similarity between ieILC1s and tissue-resident NK cells, provide insight into the origin of ieILC1s, and identify the ieILC1-like cell state within the TME to be the NK cell phenotype with the greatest antitumor activity. Because the proportions of the different ILC states vary between tumors, these findings provide a resource for the clinical study of innate immune responses against tumors and the design of novel therapy.
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Neoplasias de Cabeça e Pescoço/imunologia , Imunidade Inata/imunologia , Células Matadoras Naturais/imunologia , Linfócitos/imunologia , Microambiente Tumoral/imunologia , Idoso , Idoso de 80 Anos ou mais , Antígenos CD/metabolismo , Antineoplásicos/metabolismo , Diferenciação Celular/imunologia , Linhagem Celular Tumoral , Feminino , Neoplasias de Cabeça e Pescoço/patologia , Humanos , Interleucina-15/metabolismo , Ativação Linfocitária/imunologia , Masculino , Pessoa de Meia-Idade , Membro 1 do Grupo A da Subfamília 4 de Receptores Nucleares , Fenótipo , Carcinoma de Células Escamosas de Cabeça e Pescoço/imunologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologiaRESUMO
BACKGROUND: We previously reported rates of pathological complete responses (51% [95% CI 39-62] per independent central review, the primary endpoint) and major pathological responses (13% per independent central review, a secondary endpoint) to neoadjuvant cemiplimab (an anti-PD-1 inhibitor) among 79 patients with locoregionally advanced, resectable cutaneous squamous cell carcinoma. Here, we present follow-up data, including event-free, disease-free, and overall survival. METHODS: This single-arm, multicentre, phase 2 study included patients aged 18 years or older with resectable stage II-IV (M0) cutaneous squamous cell carcinoma and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received up to four planned doses of neoadjuvant cemiplimab 350 mg intravenously every 3 weeks followed by curative-intent surgery. After surgery, per investigator discretion, patients received either adjuvant cemiplimab for up to 48 weeks, radiotherapy, or observation alone. Secondary endpoints included in this follow-up analysis are event-free survival, disease-free survival, and overall survival, all summarised using the Kaplan-Meier method. Activity and safety endpoints were analysed for all enrolled patients who received at least one dose of neoadjuvant cemiplimab. In this report, safety data are reported for all patients who received at least one dose of adjuvant cemiplimab. This trial is registered with ClinicalTrials.gov, NCT04154943, has completed enrolment and follow-up is ongoing. FINDINGS: Between March 20, 2020, and July 8, 2021, 79 patients were enrolled. Median age was 73 years (IQR 66-81), 67 (85%) patients were male, 12 (15%) were female, 69 (87%) were White, one was Asian (1%), one was other race (1%), and race was not reported for eight (10%). As of data cutoff (Dec 1, 2022), median follow-up was 18·7 months (IQR 15·6-22·1) for all 79 patients. Among 70 patients who had surgery, 65 (93%) had post-surgical management data: 32 (49%) of 65 were observed postoperatively, 16 (25%) received adjuvant cemiplimab, and 17 (26%) received adjuvant radiotherapy. 11 (14%) of 79 patients had event-free survival events, with an estimated 12-month event-free survival of 89% (95% CI 79-94) for all patients. None of 40 patients who had a pathological complete response and one (10%) of ten patients with major pathological response had recurrence. Six (9%) of 70 patients who completed surgery had a disease-free survival event, with an estimated 12-month disease-free survival of 92% (95% CI 82-97). Nine (11%) of 79 patients died, with an estimated 12-month overall survival for all patients of 92% (95% CI 83-96). Four (25%) of 16 patients who received adjuvant cemiplimab treatment had grade 3 adverse events, including one (6%) who had increased blood potassium, one (6%) who had traumatic limb amputation, and two who had serious adverse events (one [6%] cardiomyopathy and one [6%] hypophysitis). There were no grade 4 adverse events or treatment-related deaths. INTERPRETATION: For patients with resectable stage II-IV cutaneous squamous cell carcinoma, neoadjuvant cemiplimab followed by surgery might be a potential treatment option, addressing a substantial unmet need. FUNDING: Regeneron Pharmaceuticals and Sanofi.
Assuntos
Carcinoma de Células Escamosas , Neoplasias Cutâneas , Humanos , Masculino , Feminino , Idoso , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/cirurgia , Carcinoma de Células Escamosas/etiologia , Terapia Neoadjuvante/efeitos adversos , Seguimentos , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/cirurgia , Estadiamento de Neoplasias , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
INTRODUCTION: While minimally invasive surgery (MIS) has transformed the treatment landscape of surgical care, its utilization is not well understood. The newly released Nationwide Ambulatory Surgery Sample allows for more accurate estimates of MIS volume in the United States-in combination with inpatient datasets. MATERIALS AND METHODS: Multiple nationwide databases from the Healthcare Cost and Utilization Project (HCUP) were used: the Nationwide Ambulatory Surgery Sample and National Inpatient Sample. The volume of MIS and robotic procedures were calculated from 2016 to 2018. An online query system, HCUPNet, was queried for inpatient stays from 1993 to 2014. RESULTS: In 2017, 9.8 million inpatient major operating room procedures were analyzed, of which 11.1% were MIS and 2.5% were robotic-assisted, compared with 9.6 million inpatient operating room procedures (11.2% MIS and 2.9% robotic-assisted) in 2018. There were 10.6, 10.6, and 10.7 million ambulatory procedures in 2016, 2017, and 2018, respectively. Ambulatory MIS procedures showed an increasing trend across years, representing 16.9%, 17.4%, and 18%, respectively. HCUPNet data revealed an increase in inpatient MIS cases from 529,811 (8.9%) in 1993 to 1,443,446 (20.7%) in 2014. CONCLUSIONS: This study is the first to estimate national MIS volume across specialties in both inpatient and ambulatory hospital settings. We found a trend toward a higher proportion of MIS and robotic cases from 1997 to 2018. These data may help contribute to a more comprehensive understanding of MIS value within surgery and highlight limitations of current databases, especially when categorizing robotic cases on a national scale.
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Procedimentos Cirúrgicos Robóticos , Robótica , Estados Unidos , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Ambulatórios , Bases de Dados Factuais , Pacientes Internados , Estudos RetrospectivosRESUMO
PURPOSE: Virtual surgical planning (VSP), with custom made implants and guides represents a recent major advance. Nonetheless, knowledge related to practice patterns is limited. The purpose of this study was to provide data from the AHNS Reconstruction Section related to practice patterns, perceived value of VSP, as well as elucidate specific situations which represent high value for the application of VSP. MATERIALS AND METHODS: A multi-center web-based survey consisting of 30 questions regarding practice patterns related to VSP practices delivered via email to 203 members of the AHNS Reconstructive Surgery Section at institutions across North America. RESULTS: There was a 34% response rate (70/203). A majority of the respondents (96%) used VSP in approximately 50% of their mandibular reconstruction cases, and in 42% of maxillary cases. 46% reported using patient specific implants >75% of cases. Respondents estimated that ~17% of patients received dental implant reconstruction. The majority of respondents (71.0%) did not know the cost of VSP at their institution. The remaining respondents indicated the average cost was $6680 per case. VSP was felt to be necessary as a teaching tool by 55.9%. CONCLUSIONS: Our results demonstrate that a majority of respondents frequently utilize VSP in their practice for head and neck reconstruction. Complex, multi-unit reconstructions were felt to offer the greatest value when utilizing VSP. Future work should focus on increasing the rates of dental implant reconstruction in this population, optimizing value of VSP with careful case selection, and understanding the educational value and costs of these platforms.
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Procedimentos Cirúrgicos Otorrinolaringológicos/estatística & dados numéricos , Planejamento de Assistência ao Paciente/estatística & dados numéricos , Procedimentos de Cirurgia Plástica/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Realidade Virtual , Cabeça/cirurgia , Humanos , Reconstrução Mandibular/estatística & dados numéricos , Pescoço/cirurgia , Procedimentos Cirúrgicos Ortognáticos/estatística & dados numéricos , Sociedades Médicas , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Round trip signal latency, or time delay, is an unavoidable constraint that currently stands as a major barrier to safe and efficient remote telesurgery. While there have been significant technological advancements aimed at reducing the time delay, studies evaluating methods of mitigating the negative effects of time delay are needed. Herein, we explored instrument motion scaling as a method to improve performance in time-delayed robotic surgery. METHODS: This was a robotic surgery user study using the da Vinci Research Kit system. A ring transfer task was performed under normal circumstances (no added time delay), and with 250 ms, 500 ms, and 750 ms delay. Robotic instrument motion scaling was modulated across a range of values (- 0.15, - 0.1, 0, + 0.1, + 0.15), with negative values indicating less instrument displacement for a given amount of operator movement. The primary outcomes were task completion time and total errors. Three-dimensional instrument movement was compared against different motion scales using dynamic time warping to demonstrate the effects of scaling. RESULTS: Performance declined with increasing time delay. Statistically significant increases in task time and number of errors were seen at 500 ms and 750 ms delay (p < 0.05). Total errors were positively correlated with task time on linear regression (R = 0.79, p < 0.001). Under 750 ms delay, negative instrument motion scaling improved error rates. Negative motion scaling trended toward improving task times toward those seen in non-delayed scenarios. Improvements in instrument path motion were seen with the implementation of negative motion scaling. CONCLUSIONS: Under time-delayed conditions, negative robotic instrument motion scaling yielded fewer surgical errors with slight improvement in task time. Motion scaling is a promising method of improving the safety and efficiency of time-delayed robotic surgery and warrants further investigation.
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Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Movimento (Física) , MovimentoRESUMO
PURPOSE: Planned flap reconstruction, allowing aggressive resections of oral cavity squamous cell carcinoma (OCSCC), may decrease positive surgical margins. The purpose of this study was to determine if length of stay (LOS), as a proxy measure for flap reconstruction, is associated with positive margin rates in OCSCC. MATERIALS AND METHODS: Data from the National Cancer Database was retrospectively collected for patients undergoing surgery for previously untreated clinical T1-3 OCSCC. Post-operative LOS was dichotomized between ≤4 and >4 days as a proxy measure for whether patients may have received flap reconstruction. Patients with LOS >4 days represent a diverse group, but those with a LOS ≤4 days are less likely to have undergone an oral cavity flap reconstruction. RESULTS: 10,107 patients were included, of which 5290 (52%) were clinical T1 and 4852 (48%) were clinical T2-3. 771 (8%) patients had a positive surgical margin. On multivariable logistic regression analysis, LOS ≤4 days was significantly associated with a positive margin resection in patients with clinical T2-3 tumors (OR 1.68, 95%CI 1.37-2.06) compared to patients with LOS >4 days. LOS was not associated with surgical margin status in patients with clinical T1 disease (OR 0.76, 95%CI 0.55-1.06). Patients with positive margin resections demonstrated worse overall survival (cT1: OR 1.35, 95%CI 1.06-1.72; cT2-3: OR 1.52, 95%CI 1.33-1.74). CONCLUSIONS: LOS >4 days after oral cavity cancer resection was significantly associated with negative surgical margins in clinical T2-3 oral cavity cancer, suggesting the possibility that patients undergoing flap reconstruction after resection have fewer positive surgical margins.
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Bases de Dados como Assunto , Neoplasias de Cabeça e Pescoço/cirurgia , Tempo de Internação , Margens de Excisão , Boca/cirurgia , Procedimentos Cirúrgicos Bucais/métodos , Procedimentos de Cirurgia Plástica/métodos , Carcinoma de Células Escamosas de Cabeça e Pescoço/cirurgia , Retalhos Cirúrgicos , Idoso , Idoso de 80 Anos ou mais , Feminino , Neoplasias de Cabeça e Pescoço/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Retrospectivos , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Fatores de TempoRESUMO
BACKGROUND: In the wake of the coronavirus disease 2019 (COVID-19) pandemic, access to surgical care for patients with head and neck cancer (HNC) is limited and unpredictable. Determining which patients should be prioritized is inherently subjective and difficult to assess. The authors have proposed an algorithm to fairly and consistently triage patients and mitigate the risk of adverse outcomes. METHODS: Two separate expert panels, a consensus panel (11 participants) and a validation panel (15 participants), were constructed among international HNC surgeons. Using a modified Delphi process and RAND Corporation/University of California at Los Angeles methodology with 4 consensus rounds and 2 meetings, groupings of high-priority, intermediate-priority, and low-priority indications for surgery were established and subdivided. A point-based scoring algorithm was developed, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN-HN). Agreement was measured during consensus and for algorithm scoring using the Krippendorff alpha. Rankings from the algorithm were compared with expert rankings of 12 case vignettes using the Spearman rank correlation coefficient. RESULTS: A total of 62 indications for surgical priority were rated. Weights for each indication ranged from -4 to +4 (scale range; -17 to 20). The response rate for the validation exercise was 100%. The SPARTAN-HN demonstrated excellent agreement and correlation with expert rankings (Krippendorff alpha, .91 [95% CI, 0.88-0.93]; and rho, 0.81 [95% CI, 0.45-0.95]). CONCLUSIONS: The SPARTAN-HN surgical prioritization algorithm consistently stratifies patients requiring HNC surgical care in the COVID-19 era. Formal evaluation and implementation are required. LAY SUMMARY: Many countries have enacted strict rules regarding the use of hospital resources during the coronavirus disease 2019 (COVID-19) pandemic. Facing delays in surgery, patients may experience worse functional outcomes, stage migration, and eventual inoperability. Treatment prioritization tools have shown benefit in helping to triage patients equitably with minimal provider cognitive burden. The current study sought to develop what to the authors' knowledge is the first cancer-specific surgical prioritization tool for use in the COVID-19 era, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN-HN). This algorithm consistently stratifies patients requiring head and neck cancer surgery in the COVID-19 era and provides evidence for the initial uptake of the SPARTAN-HN.
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Betacoronavirus , Infecções por Coronavirus/epidemiologia , Neoplasias de Cabeça e Pescoço/cirurgia , Recursos em Saúde , Pneumonia Viral/epidemiologia , Triagem/métodos , Algoritmos , COVID-19 , Tomada de Decisão Clínica , Consenso , Infecções por Coronavirus/virologia , Humanos , Cooperação Internacional , Pandemias , Pneumonia Viral/virologia , Reprodutibilidade dos Testes , Projetos de Pesquisa , SARS-CoV-2 , CirurgiõesRESUMO
BACKGROUND: Greater than 100,000 tracheotomies are performed annually in the USA, yet little is known regarding patients who present to the emergency department (ED) with tracheostomy complications. OBJECTIVES: To characterize patient and hospital characteristics, outcomes, and charges associated with tracheostomy complications and to identify predictors of admission and mortality. METHODS: The 2009-2011 Nationwide Emergency Department Sample (NEDS) was queried for patients with a principle diagnosis of tracheostomy complication. A descriptive analysis was performed and multivariable logistic regression was used to identify predictors of admission and mortality. RESULTS: A total of 69,371 nationwide visits to the ED had tracheostomy complication as an associated ICD-9 diagnosis, of which 55.2% (n = 38,293) carried a primary diagnosis of tracheostomy complication. Unspecified tracheostomy complications were most common (61.4%), followed by mechanical complications (31.3%), and lastly by tracheostomy infections (7.3%). Pediatric patients were significantly more likely to have tracheostomy infections than adults (p < 0.0001). A total of 35.5% of patients with tracheostomy complications were admitted to the hospital, and death occurred with 1.4% of visits. Patients from higher-income ZIP codes had increased odds of admission (adjusted odds ratio [OR]: 1.35; p = 0.0009), as did patients with tracheostomy infections (OR: 4.425; p < 0.0001). Patients with tracheostomy infections (OR: 3.14; p = 0.0062) and unspecified tracheostomy complications (OR: 2.00; p = 0.0076) had increased odds of mortality. CONCLUSION: These findings may help improve overall outcomes amongst patients with tracheostomies by preventing unnecessary ED admissions and improving healthcare provider preparedness and awareness.
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Serviço Hospitalar de Emergência , Complicações Pós-Operatórias/epidemiologia , Traqueostomia/efeitos adversos , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Hospitalização , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Traqueostomia/estatística & dados numéricos , Estados Unidos , Adulto JovemRESUMO
PURPOSE: The most common surgical method to remove benign parotid tumors remains the prograde approach. We examined if a retrograde surgical technique offers better outcomes than historical prograde controls. MATERIALS AND METHODS: A retrospective chart review at Stanford Hospital was conducted to identify retrograde parotidectomies between February 2012 and October 2014 that were staffed by the senior author (DS) with resident involvement. Facial nerve (FN) outcomes and other post-surgical parameters were recorded. RESULTS: We identified 44 consecutive cases and found that 18.2% (n=8) of patients experienced temporary paresis and 2.3% (n=1) experienced minor (HB 2) permanent paresis limited to one branch. The average hospital length of stay was 0.64 days and complication rate was 6.8%. CONCLUSION: The retrograde technique has complication rates comparable to historical rates for the prograde technique and is amenable to minimally invasive outpatient superficial parotidectomy.
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Adenoma/cirurgia , Carcinoma/cirurgia , Traumatismos do Nervo Facial/epidemiologia , Paralisia Facial/epidemiologia , Neoplasias Parotídeas/cirurgia , Complicações Pós-Operatórias/epidemiologia , Adenoma/patologia , Carcinoma/patologia , Dissecação/efeitos adversos , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Neoplasias Parotídeas/patologia , Estudos RetrospectivosRESUMO
BACKGROUND: The importance of providing quality care over quantity of care, and its positive effects on health care expenditure and health, has motivated a transition toward value-based payments. The Centers for Medicare and Medicaid Services and private payers are establishing programs linking financial incentives and penalties to adherence to quality measures. As payment models based on quality measures are transitioned into practice, it is beneficial to identify current quality measures that address breast reconstruction surgery as well as understand gaps to inform future quality measure development. METHODS: We performed a systematic review of quality measures for breast reconstruction surgery by searching quality measure databases, professional society clinical practice guidelines, and the literature. Measures were categorized as structure, process, or outcome according to the Donabedian domains of quality. RESULTS: We identified a total of 27 measures applicable to breast reconstruction: 5 candidate quality measures specifically for breast reconstruction surgery and 22 quality measures that relate broadly to surgery. Of the breast reconstruction candidate measures, 3 addressed processes and 2 addressed outcomes. Seventeen of the general quality measures were process measures and 5 were outcome measures. We did not identify any structural measures. CONCLUSIONS: Currently, an overrepresentation of process measures exists, which addresses breast reconstruction surgery. There is a limited number of candidate measures that specifically address breast reconstruction. Quality measure development efforts on underrepresented domains, such as structure and outcome, and stewarding the measure development process for candidate quality measures can ensure breast reconstruction surgery is appropriately evaluated in value-based payment models.
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Mama/cirurgia , Mamoplastia/normas , Qualidade da Assistência à Saúde/normas , Seguro de Saúde Baseado em Valor/estatística & dados numéricos , Feminino , Humanos , Mamoplastia/economia , Satisfação do Paciente , Qualidade da Assistência à Saúde/economia , Mecanismo de Reembolso/estatística & dados numéricosRESUMO
BACKGROUND: Recent changes in head and neck cancer epidemiology have created a need for improved lymph node prognostics. This article compares the prognostic value of the number of positive nodes (pN) with the value of the lymph node ratio (LNR) and American Joint Committee on Cancer (AJCC) N staging in surgical patients. METHODS: The Surveillance, Epidemiology, and End Results database was used to identify cases of head and neck squamous cell carcinomas from 2004 to 2012. The sample was grouped by the AJCC N stage, LNR, and pN and was analyzed with Kaplan-Meier and multivariate Cox proportional hazards models. The sample was also analyzed by the site of the primary tumor. RESULTS: This study identified 12,437 patients. Kaplan-Meier survival curves showed superior prognostic ability for LNR and pN staging in comparison with AJCC staging. Patients with a pN value > 5 had the worst overall survival (5-year survival rate, 16%). Patients with oropharyngeal tumors had better outcomes for all groupings, and a pN value > 5 for oropharyngeal cancers was associated with decreased survival. Multivariate regressions demonstrated larger hazard ratios (HRs) and a lower Akaike information criterion for the pN model versus the AJCC stage and LNR models. The HRs were 1.78 (95% confidence interval, 1.62-1.95) for a pN value of 1, 2.53 (95% confidence interval, 2.32-2.75) for a pN value of 2 to 5, and 4.64 (95% confidence interval, 4.18-5.14) for a pN value > 5. CONCLUSIONS: The pN models demonstrated superior prognostic value in comparison with the LNR and AJCC N staging. Future modifications of the nodal staging system should be based on the pN with a separate system for oropharyngeal cancers. Future trials should consider examining adjuvant treatment escalation in patients with >5 lymph nodes. Cancer 2016;122:1388-1397. © 2016 American Cancer Society.
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Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/patologia , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/patologia , Linfonodos/patologia , Estadiamento de Neoplasias/métodos , Carcinoma de Células Escamosas/secundário , Carcinoma de Células Escamosas/cirurgia , Intervalos de Confiança , Feminino , Neoplasias de Cabeça e Pescoço/cirurgia , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Neoplasias Orofaríngeas/mortalidade , Neoplasias Orofaríngeas/patologia , Neoplasias Orofaríngeas/cirurgia , Prognóstico , Modelos de Riscos Proporcionais , Programa de SEER , Taxa de Sobrevida , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Prospective quality metrics for neck dissection have not been established for patients with head and neck squamous cell carcinoma. The purpose of this study was to investigate the association between lymph node counts from neck dissection, local-regional recurrence, and overall survival. METHODS: The number of lymph nodes counted from neck dissection in patients treated in 2 NRG Oncology trials (Radiation Therapy Oncology Group [RTOG] 9501 and RTOG 0234) was evaluated for its prognostic impact on overall survival with a multivariate Cox model adjusted for demographic, tumor, and lymph node data and stratified by the postoperative treatment group. RESULTS: Five hundred seventy-two patients were analyzed at a median follow-up of 8 years. Ninety-eight percent of the patients were pathologically N+. The median numbers of lymph nodes recorded on the left and right sides were 24 and 25, respectively. The identification of fewer than 18 nodes was associated with worse overall survival in comparison with 18 or more nodes (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.09-1.74; P = .007). The difference appeared to be driven by local-regional failure (HR, 1.46; 95% CI, 1.02-2.08; P = .04) but not by distant metastases (HR, 1.08; 95% CI, 0.77-1.53; P = .65). When the analysis was limited to NRG Oncology RTOG 0234 patients, adding the p16 status to the model did not affect the HR for dissected nodes, and the effect of nodes did not differ with the p16 status. CONCLUSIONS: The removal and identification of 18 or more lymph nodes was associated with improved overall survival and lower rates of local-regional failure, and this should be further evaluated as a measure of quality in neck dissections for mucosal squamous cell carcinoma. Cancer 2016;122:3464-71. © 2016 American Cancer Society.
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Oroantral fistula (OAF) is a pathologic, epithelialized communication between the oral cavity and the maxillary sinus. OAF most commonly results from posterior maxillary tooth or molar extraction owing to proximity of the dental roots to the maxillary antrum and the thinness of the adjacent antral floor. It also can arise secondary to implant and orthognathic surgeries, cyst and tumor removal, dental infection, trauma, or as a sequela of radiation therapy. Communications larger than 5 mm are less likely to heal spontaneously and can epithelialize, forming an OAF. When locoregional flaps and grafts are not ideal or have failed, but primary OAF closure is mandated, surgical options are unclear. This report describes a novel method for autologous tissue flap coverage from the nasal septum, pedicled off the posterior septal artery, for successful extension to, and closure of, OAFs.
Assuntos
Autoenxertos/transplante , Mucosa Nasal/transplante , Fístula Bucoantral/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Retalhos Cirúrgicos/transplante , Desbridamento/métodos , Implantes Dentários/efeitos adversos , Falha de Restauração Dentária , Endoscopia/métodos , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Septo Nasal/cirurgiaRESUMO
Importance: Significant insurance status disparities have been demonstrated in head and neck cancer (HNC) outcomes. The effects of insurance status on HNC outcomes may be explained by differential access to high-quality care. Objective: To evaluate the association of insurance status with the quality of the treating hospital and receipt of guideline-compliant care among patients with HNC. Design, Setting, and Participants: This retrospective cohort study of data from the California Cancer Registry dataset linked with discharge records and hospital characteristics from the California Department of Health Care Access and Information included adult patients with HNC diagnosed between January 1, 2010, and December 31, 2019. Data were analyzed from May 10, 2023, to March 25, 2024. Exposures: Insurance status: commercial, Medicare, Medicaid, uninsured, other, or unknown. Main Outcomes and Measures: Quality of the treating hospital (tertiles), receipt of National Comprehensive Cancer Network guideline-compliant care, and overall survival. Results: A total of 23â¯933 patients (mean [SD] age, 64.8 [12.3] years; 75.3% male) met the inclusion criteria. Treatment in top-tertile hospitals (hazard ratio, 0.87; 95% CI, 0.79-0.95) was associated with improved overall survival compared with treatment in bottom-tertile hospitals. Medicare (odds ratio [OR], 0.78; 95% CI, 0.73-0.84), Medicaid (OR, 0.60; 95% CI, 0.54-0.66), and uninsured (OR, 0.38; 95% CI, 0.29-0.49) status were associated with lower likelihood of treatment in high-quality hospitals compared with commercial insurance. Among patients with advanced disease, Medicaid (OR, 0.72; 95% CI, 0.62-0.83) and uninsured (OR, 0.64; 95% CI, 0.44-0.93) patients were less likely to receive dual-modality therapy. Among patients with surgically resected advanced disease, Medicaid coverage (OR, 0.73; 95% CI, 0.58-0.93) was associated with lower likelihood of receiving adjuvant radiotherapy. Conclusions and Relevance: This study found significant insurance disparities in quality of care among patients with HNC. These findings highlight the need for continued health insurance reform in the US to improve the quality of insurance coverage, in addition to expanding access to health insurance.
Assuntos
Neoplasias de Cabeça e Pescoço , Disparidades em Assistência à Saúde , Cobertura do Seguro , Qualidade da Assistência à Saúde , Humanos , Feminino , Masculino , Neoplasias de Cabeça e Pescoço/terapia , Neoplasias de Cabeça e Pescoço/mortalidade , Pessoa de Meia-Idade , Estudos Retrospectivos , California , Cobertura do Seguro/estatística & dados numéricos , Estados Unidos , Idoso , Medicaid , Medicare , Sistema de Registros , Seguro Saúde/estatística & dados numéricos , Fidelidade a Diretrizes/estatística & dados numéricosRESUMO
OBJECTIVE: Chat Generative Pretrained Transformer (ChatGPT) is the newest iteration of OpenAI's generative artificial intelligence (AI) with the potential to influence many facets of life, including health care. This study sought to assess ChatGPT's capabilities as a source of medical knowledge, using Google Search as a comparison. STUDY DESIGN: Cross-sectional analysis. SETTING: Online using ChatGPT, Google Seach, and Clinical Practice Guidelines (CPG). METHODS: CPG Plain Language Summaries for 6 conditions were obtained. Questions relevant to specific conditions were developed and input into ChatGPT and Google Search. All questions were written from the patient perspective and sought (1) general medical knowledge or (2) medical recommendations, with varying levels of acuity (urgent or emergent vs routine clinical scenarios). Two blinded reviewers scored all passages and compared results from ChatGPT and Google Search, using the Patient Education Material Assessment Tool (PEMAT-P) as the primary outcome. Additional customized questions were developed that assessed the medical content of the passages. RESULTS: The overall average PEMAT-P score for medical advice was 68.2% (standard deviation [SD]: 4.4) for ChatGPT and 89.4% (SD: 5.9) for Google Search (p < .001). There was a statistically significant difference in the PEMAT-P score by source (p < .001) but not by urgency of the clinical situation (p = .613). ChatGPT scored significantly higher than Google Search (87% vs 78%, p = .012) for patient education questions. CONCLUSION: ChatGPT fared better than Google Search when offering general medical knowledge, but it scored worse when providing medical recommendations. Health care providers should strive to understand the potential benefits and ramifications of generative AI to guide patients appropriately.
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BACKGROUND: Recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) has poor survival rates. Immunotherapy is the standard of care for R/M HNSCC, but objective responses occur in a minority of patients. Toll-like receptor (TLR) agonists promote antitumor immune responses and have been explored in clinical trials. METHODS: A search for clinical trials using TLR agonists in HNSCC was performed under PRISMA guidelines. Data on patient characteristics, safety, and efficacy were collected and analyzed. RESULTS: Three phase 1b trials with 40 patients and three phase 2 trials with 352 patients studying TLR8 and TLR9 agonists in combination with other treatment regimens for HNSCC were included. In phase 2 trials, there was no significant change in the objective response rate (RR = 1.13, CI 0.80-1.60) or association with increased grade 3+ adverse events (RR = 0.91, CI 0.76-1.11) associated with TLR agonist use. CONCLUSION: TLR agonists do not appear to provide additional clinical benefits or increase adverse events in the treatment of HNSCC. Given these results across multiple clinical trials and drug regimens, it is unlikely that additional trials of TLR agonists will demonstrate clinical benefits in HNSCC.
RESUMO
To understand perioperative practices for transoral robotic surgery (TORS) among academic medical centers. An electronic cross-sectional survey was distributed to fellows and program directors participating in 49 American Head and Neck Society fellowships. Operative decisions, medical and swallowing management, and disposition planning were assessed. Thirty-eight responses were collected (77.6%). Twenty-three centers (60.5%) performed > 25 cases annually with the remainder performing fewer. The da Vinci Si was the most commonly used platform (n = 28, 73.7%). A majority of institutions advocated tailored resection to adequate margins (n = 27, 71.1%) over fixed subunit-based resection (n = 11, 28.9%). Most surgeons (n = 29, 76.3%) performed neck dissection concurrent with TORS, and 89.5% (n = 34) routinely ligated external carotid artery branches. A minority of institutions (n = 17, 45.9%) endorsed a standardized TORS care pathway. Antibiotic choices and duration varied, the most common choice being ampicillin/sulbactam (n = 21, 55.3%), and the most common duration being 24 h or less (n = 22, 57.9%). Multimodal analgesia was used at 36 centers (94.7%), steroids at 31 centers (81.6%), and pharmacologic venous thromboembolic prophylaxis at 29 centers (76.3%). Nasogastric feeding tubes were placed during surgery at 20 institutions (54.1%). Speech-language pathologists routinely performed postoperative swallow evaluations at 29 (78.4%) sites. Practice patterns are variable among institutions performing TORS. While certain surgical and postoperative practices were quite common, many institutions reported no standard TORS care pathway. Further understanding of the impact of individual practices on outcomes is necessary to develop evidence-based perioperative protocols for TORS.