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1.
Head Neck ; 46(6): 1304-1309, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38353175

RESUMEN

BACKGROUND: We used electromyography to characterize hypoglossal nerve function among radiation-treated head and neck cancer survivors with later onset unilateral tongue immobility. METHODS: Patients with unilateral tongue immobility without evidence of recurrent cancer were seen at a tertiary academic institution between February and September 2021. All patients were at least 2 years post-treatment with radiation therapy for head and neck squamous cell carcinoma. Participants were under annual surveillance and displayed no evidence of operative injury to the hypoglossal nerve. RESULTS: The median symptom-free interval for the 10 patients included in this study was 13.2 years (range 2-25 years). Myokymia alone was present in 3 of 10 patients, fibrillation potentials alone were present in 3 of 10 patients, and 1 subject displayed both fibrillation and myokymia. Three out of 10 patients had normal hypoglossal nerve function. DISCUSSION: These findings highlight how disparate mechanisms may underlie similar clinical presentations of radiation-induced neuromuscular dysfunction.


Asunto(s)
Electromiografía , Traumatismos por Radiación , Humanos , Masculino , Femenino , Persona de Mediana Edad , Traumatismos por Radiación/fisiopatología , Anciano , Neoplasias de Cabeza y Cuello/radioterapia , Nervio Hipogloso/efectos de la radiación , Adulto , Lengua/efectos de la radiación , Lengua/inervación , Lengua/fisiopatología , Enfermedades de la Lengua/etiología , Enfermedades de la Lengua/fisiopatología , Carcinoma de Células Escamosas de Cabeza y Cuello/radioterapia
2.
JAMA Otolaryngol Head Neck Surg ; 149(8): 681-689, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-37318816

RESUMEN

Importance: Despite the critical role of caregivers in head and neck cancer (HNC), there is limited literature on caregiver burden (CGB) and its evolution over treatment. Research is needed to address evidence gaps that exist in understanding the causal pathways between caregiving and treatment outcomes. Objective: To evaluate the prevalence of and identify risk factors for CGB in HNC survivorship. Design, Setting, and Participants: This longitudinal prospective cohort study took place at the University of Pittsburgh Medical Center. Dyads of treatment-naive patients with HNC and their caregivers were recruited between October 2019 and December 2020. Eligible patient-caregiver dyads were 18 years or older and fluent in English. Patients undergoing definitive treatment identified a caregiver as the primary, nonprofessional, nonpaid person who provided the most assistance to them. Among 100 eligible dyadic participants, 2 caregivers declined participation, resulting in 96 enrolled participants. Data were analyzed from September 2021 through October 2022. Main Outcomes and Measures: Participants were surveyed at diagnosis, 3 months postdiagnosis, and 6 months postdiagnosis. Caregiver burden was evaluated with the 19-item Social Support Survey (scored 0-100, with higher scores indicating more support), Caregiver Reaction Assessment (CRA; scored 0-5, with higher scores on 4 subscales [disrupted schedule, financial problems, lack of family support, and health problems] indicating negative reactions, and higher scores on the fifth subscale [self-esteem] indicating favorable influence); and 3-item Loneliness Scale (scored 3-9, with higher scores indicating greater loneliness). Patient health-related quality of life was assessed using the University of Washington Quality of Life scale (UW-QOL; scored 0-100, with higher scores indicating better QOL). Results: Of the 96 enrolled participants, half were women (48 [50%]), and a majority were White (92 [96%]), married or living with a partner (81 [84%]), and working (51 [53%]). Of these participants, 60 (63%) completed surveys at diagnosis and at least 1 follow-up. Of the 30 caregivers, most were women (24 [80%]), White (29 [97%]), married or living with a partner (28 [93%]), and working (22 [73%]). Caregivers of nonworking patients reported higher scores on the CRA subscale for health problems than caregivers of working patients (mean difference, 0.41; 95% CI, 0.18-0.64). Caregivers of patients with UW-QOL social/emotional (S/E) subscale scores of 62 or lower at diagnosis reported increased scores on the CRA subscale for health problems (UW-QOL-S/E score of 22: CRA score mean difference, 1.12; 95% CI, 0.48-1.77; UW-QOL-S/E score of 42: CRA score mean difference, 0.74; 95% CI, 0.34-1.15; and UW-QOL-S/E score of 62: CRA score mean difference, 0.36; 95% CI, 0.14-0.59). Woman caregivers had statistically significant worsening scores on the Social Support Survey (mean difference, -9.18; 95% CI, -17.14 to -1.22). The proportion of lonely caregivers increased over treatment. Conclusions and Relevance: This cohort study highlights patient- and caregiver-specific factors that are associated with increased CGB. Results further demonstrate the potential implications for negative health outcomes for caregivers of patients who are not working and have lower health-related quality of life.


Asunto(s)
Neoplasias de Cabeza y Cuello , Calidad de Vida , Humanos , Masculino , Femenino , Calidad de Vida/psicología , Carga del Cuidador , Estudios de Cohortes , Estudios Prospectivos , Cuidadores/psicología , Neoplasias de Cabeza y Cuello/terapia
3.
Otolaryngol Head Neck Surg ; 169(3): 514-519, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-36884007

RESUMEN

OBJECTIVE: To report key characteristics and patterns of captive insurance claims not publicly reported in otolaryngology across a large tertiary-level academic health system over the previous 2 decades. STUDY DESIGN: Case series. SETTING: The tertiary care health system. METHODS: The internal captive insurance database at a tertiary level healthcare system was queried to identify otolaryngology-related malpractice claims regardless of final disposition (settled or dismissed) filed from 2000 to 2020. The date of the incident, date of claim, error type, patient outcome, provider subspecialty, total expenses, disposition, and final reward amount were recorded. RESULTS: Twenty-eight claims were identified. There were 11 (39.3%) claims from 2000 to 2010 and 17 (60.7%) claims from 2011 to 2020. Head and neck surgery was the most frequently implicated subspecialty (n = 9, 32.1% of all cases), followed by general otolaryngology (n = 7, 25.0%), pediatrics (n = 5, 17.9%), skull base/rhinology (n = 4, 14.3%), and laryngology (n = 1, 3.6%). Improper surgical performance was cited in 35.7% of cases (n = 10), followed by failure to diagnose (n = 8, 28.6%), to treat (n = 4, 14.3%), and to obtain informed consent (n = 3, 10.7%). While 2 cases are ongoing, a total of 17/26 (65.4%) cases were settled and 20/26 (76.9%) dismissed some or all parties. Dismissed claims had significantly higher expenses (p = .022) and duration from incident to disposition (p = .013) compared to settled claims. CONCLUSION: This study expands the malpractice landscape in otolaryngology by including data not readily available through public sources and compares it to national trends. These findings encourage otolaryngologists to better gauge current quality and safety measures that best protect patients from harm.


Asunto(s)
Mala Praxis , Otolaringología , Niño , Humanos , Otorrinolaringólogos , Revisión de Utilización de Seguros
4.
Health Lit Res Pract ; 7(1): e52-e60, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36888985

RESUMEN

BACKGROUND: After definitive cancer treatment, survivors of head and neck cancer (HNC) are commonly recommended to participate in therapies aimed at reducing the burden of treatment-related side effects. OBJECTIVE: In this study, we evaluated whether adherence to referral to physical therapy (PT) and speech-language pathology therapy (SLPT) is related to patient health literacy (HL). METHODS: This is a retrospective cohort analysis of patients attending a multidisciplinary HNC survivorship clinic between 2017 and 2019. HL was measured using the Brief Health Literacy Screen, with scores below 10 indicating inadequate HL. Chi-square and logistic regression were used to evaluate the association between HL and adherence to PT or SLPT referral. KEY RESULTS: From the overall cohort (N = 454), 80 patients (18%) had inadequate HL. Compared to those with adequate HL, patients with inadequate HL were significantly less likely to complete initial PT evaluation (74% vs. 58%, p = .034) but were not significantly less likely to complete initial SLPT evaluation (70% vs. 61%, p = .37). After adjusting for age, primary tumor site, and treatment stage, we found that patients with inadequate HL were half as likely to follow up for initial PT evaluation (odds ratio 0.45, p = .032). CONCLUSION: Overall, inadequate HL is associated with reduced adherence to PT but is not associated with adherence to SLPT among HNC survivors. These results highlight the clinical importance of HL and underscore the need for interventions to facilitate adherence to treatment for patients with inadequate HL. [HLRP: Health Literacy Research and Practice. 2023;7(1):e52-e60.].


Asunto(s)
Neoplasias de Cabeza y Cuello , Alfabetización en Salud , Humanos , Estudios Retrospectivos , Neoplasias de Cabeza y Cuello/terapia , Estudios de Cohortes , Sobrevivientes
5.
JAMA Surg ; 158(5): 475-483, 2023 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-36811872

RESUMEN

Importance: Patient frailty is a known risk factor for adverse outcomes following surgery, but data are limited regarding whether systemwide interventions related to frailty are associated with improved patient outcomes. Objective: To evaluate whether a frailty screening initiative (FSI) is associated with reduced late-term mortality after elective surgery. Design, Setting, and Participants: This quality improvement study with an interrupted time series analysis used data from a longitudinal cohort of patients in a multihospital, integrated health care system in the US. Beginning in July 2016, surgeons were incentivized to measure frailty with the Risk Analysis Index (RAI) for all patients considering elective surgery. Implementation of the BPA occurred in February 2018. The cutoff for data collection was May 31, 2019. Analyses were conducted between January and September 2022. Exposures: The exposure of interest was an Epic Best Practice Alert (BPA) used to identify patients with frailty (RAI ≥42) and prompt surgeons to document a frailty-informed shared decision-making process and consider additional evaluation by a multidisciplinary presurgical care clinic or the primary care physician. Main Outcomes and Measures: The primary outcome was 365-day mortality after the elective surgical procedure. Secondary outcomes included 30-day and 180-day mortality as well as the proportion of patients referred for additional evaluation based on documented frailty. Results: A total of 50 463 patients with at least 1 year of postsurgical follow-up (22 722 before intervention implementation and 27 741 after) were included (mean [SD] age, 56.7 [16.0] y; 57.6% women). Demographic characteristics, RAI score, and operative case mix, as defined by Operative Stress Score, were similar between time periods. After BPA implementation, the proportion of frail patients referred to a primary care physician and presurgical care clinic increased significantly (9.8% vs 24.6% and 1.3% vs 11.4%, respectively; both P < .001). Multivariable regression analysis demonstrated an 18% reduction in the odds of 1-year mortality (0.82; 95% CI, 0.72-0.92; P < .001). Interrupted time series models demonstrated a significant slope change in the rate of 365-day mortality from 0.12% in the preintervention period to -0.04% in the postintervention period. Among patients triggering the BPA, estimated 1-year mortality changed by -4.2% (95% CI, -6.0% to -2.4%). Conclusions and Relevance: This quality improvement study found that implementation of an RAI-based FSI was associated with increased referrals of frail patients for enhanced presurgical evaluation. These referrals translated to a survival advantage among frail patients of similar magnitude to those observed in a Veterans Affairs health care setting, providing further evidence for both the effectiveness and generalizability of FSIs incorporating the RAI.


Asunto(s)
Fragilidad , Humanos , Femenino , Anciano , Persona de Mediana Edad , Masculino , Fragilidad/complicaciones , Complicaciones Posoperatorias/etiología , Procedimientos Quirúrgicos Electivos/efectos adversos , Factores de Riesgo , Medición de Riesgo/métodos
6.
Otolaryngol Head Neck Surg ; 168(2): 196-202, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35316115

RESUMEN

OBJECTIVE: In the setting of similar outcomes, quality of life (QOL) measures can be utilized to compare treatment modalities in head and neck squamous cell carcinoma (HNSCC). We evaluate QOL and symptoms in patients treated for primary, second primary, and recurrent HNSCC. STUDY DESIGN: Retrospective cohort study. SETTING: Head and neck cancer survivorship clinic. METHODS: We identified patients seen between 2016 and 2019. QOL and symptoms were assessed with the University of Washington Quality of Life (UW-QOL) questionnaire, 10-item Eating Assessment Tool, 8-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and Neck Disability Index. Regression analysis was utilized to explore associations and compare QOL outcomes. RESULTS: Our cohort comprised 662 patients: 546 with primary HNSCC, 34 with second primary HNSCC, and 82 with recurrent HNSCC. Multimodality therapy was associated with lower UW-QOL Physical Subscale (UW-QOL-PS) vs single modality: chemoradiation therapy (-12.17 [95% CI, -16.57 to -7.78]) and surgery + postadjuvant treatment (-12.11 [-16.06 to -8.16]). Multimodality therapy was also associated with lower UW-QOL Social-Emotional Subscale (UW-QOL-SS): chemoradiation therapy (-6.70 [-11.41 to -1.99]) and surgery + postadjuvant treatment (-7.41 [-11.63 to -3.19]). Recurrence (-14.42 [-18.80 to -10.04]) and second primary (-11.15 [-17.71 to -4.59]) demonstrated lower UW-QOL-PS vs primary. Radiation for recurrence or second primary had worse UW-QOL-PS (-10.43 [-19.27 to -1.59]) and UW-QOL-SS (-10.58 [-18.76 to -1.54]) and higher Eating Assessment Tool (6.08 [1.39-10.77]) than surgery alone. Surgery + postadjuvant treatment showed worse UW-QOL-PS (-12.65 [-23.76 to -1.54]) and UW-QOL-SS (-12.20 [-22.38 to -2.03]). CONCLUSION: Multimodality therapy, particularly with recurrent and second primary HNSCC, is more likely to contribute to diminished QOL and symptoms. This important consideration should play a role in framing informed discussions with patients regarding treatment.


Asunto(s)
Neoplasias de Cabeza y Cuello , Calidad de Vida , Humanos , Estudios Retrospectivos , Carcinoma de Células Escamosas de Cabeza y Cuello/terapia , Recurrencia Local de Neoplasia/terapia , Neoplasias de Cabeza y Cuello/terapia , Encuestas y Cuestionarios
7.
Artículo en Inglés | MEDLINE | ID: mdl-36474663

RESUMEN

Objective: This study aimed to compare the historical incidence rate of severe oral mucositis (OM) in head and neck cancer patients undergoing definitive concurrent chemoradiation therapy (CRT) versus a prospective cohort of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) treated with prophylactic photobiomodulation therapy (PBMT). Methods: This US-based, institutional, single-arm, phase Ⅱ prospective clinical trial was initiated in 50 patients (age ≥ 18 years, Karnofsky Performance Scale Index > 60, with locally advanced HNSCC (excluding oral cavity) receiving definitive or adjuvant radiation therapy (RT) with concurrent platinum-based chemotherapy (CT). PBMT was delivered three times per week throughout RT utilizing both an intraoral as well extraoral delivery system. Primary outcome measure was incidence of severe OM utilizing both the National Cancer Institute Common Toxicity Criteria, version 4.0 (NCI-CTCAE) Grade ≥3 and the World Health Organization Mucositis Grading Scale (WHO) Grade ≥3 versus historical controls; secondary outcome measures included time to onset of severe OM following therapy initiation. Results: At baseline, all patients included in final analysis (N = 47) had OM Grade 0. Average RT and CT dose was (66.3 ± 5.1) Gy and (486.1 ± 106.8) mg/m2, respectively. Severe OM was observed in 11 of 47 patients (23%, confidence interval: 12, 38). OM toxicity grade trended upward during treatment, reaching a maximum at 7 weeks (WHO: 1.8 vs. NCI-CTCAE: 1.7). Subsequently, OM grade returned to baseline 3 months following completion of RT. The mean time to onset of severe OM was (35 ± 12) days. The mean time to resolution of severe OM was (37 ± 37) days. Conclusions: Compared to historical outcomes, PBMT aides in decreasing severe OM in patients with locally advanced HNSCC. PBMT represents a minimally invasive, prophylactic intervention to decrease OM as a major treatment-related side effect.

8.
Laryngoscope Investig Otolaryngol ; 7(3): 757-765, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35734044

RESUMEN

Objectives: Data on the efficacy of including definitive local therapy to the primary site for head and neck squamous cell carcinoma (HNSCC) patients with synchronous distant metastasis are lacking. In multiple different solid tumor types, there has been benefit when using systemic therapy followed by local consolidative therapy (stereotactic ablative radiotherapy or surgery) directed at metastases. We proposed to retrospectively evaluate patients at our institution that received definitive treatment to the primary. Methods: Single institution retrospective study evaluating 40 patients with metastatic HNSCC treated with definitive surgery (55%) or chemoradiation (45%) to the primary site from 2000 to 2020. The major endpoints were overall survival (OS) and progression-free survival (PFS) for the total population and multiple sub-groups. Some variables were evaluated with multiple covariates Cox model. Results: The median PFS was 8.6 months (95% CI, 6.4-11.6), and OS was 14.2 months (95% CI, 10.9-27.5). In 28% of patients that received induction therapy, there was a twofold increase in median overall survival to 27.5 months. In the 33% of patients that received anti-PD-1 mAb as part of their treatment course, the median OS was significantly increased to 41.7 months (95% CI, 8.7-NR) versus 12.1 months (95% CI, 8.4-14.4) with a 5-year OS of 39%. Multivariate analysis for OS showed significance for age at diagnosis, use of IO, and number of metastatic sites. Conclusion: We observed impressive survival outcomes in metastatic HNSCC patients treated with definitive local therapy to the primary site in addition to induction and/or immunotherapy. Further study is warranted.Level of Evidence: 3.

9.
Front Pain Res (Lausanne) ; 3: 910247, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35655749

RESUMEN

Objective: We have previously reported that 55% of head and neck cancer survivors have neck disability. However, it is unclear what factors contribute to their neck disability. Our study aim is to determine if survivors with neck disability have evidence of cervical spine degenerative disease assessed by computed tomography (CT). Materials/Methods: Cross-sectional analysis of patient-reported neck disability, prospectively collected on survivors of squamous cell carcinomas without recurrence or metastasis over one-year post-treatment. Neck disability and its impact on daily life was measured using the Neck Disability Index (NDI) and compared with cervical CT scans within 6 months. Scans were evaluated for degeneration of the disc and facet of the cervical vertebrae rated on a 5-point scale where 5 indicates more severe disease. Multivariable linear regression was used to analyze the association between NDI and radiographic findings. Results: 116 survivors of oropharyngeal carcinomas were identified, predominantly male (81.9%) with an average age of 62.8 ± 8.2 (range 43.8-81.4). Most survivors had advanced stage III-IVa cancer (94.0%) with treatment modalities including surgery (n=26, 52.0%), chemotherapy (n = 45, 90.0%), and radiation therapy (n = 49, 98.0%). Absence of neck disability was observed in 44.0% of survivors, 39.7% had mild disability, and 16.4% moderate disability. The time from treatment to clinic visit was an average of 3.1 ± 2.7 years (range 1.1-13.4). Multivariable analysis of NDI controlling for age, time since treatment, and treatment modality identified an inverse association between NDI and spinal degenerative disease examining cervical discs (-1.46 95% confidence interval (CI) [-2.86, -0.06], p = 0.041) and age (-0.24 95% CI[-0.40, -0.08], p = 0.004). Conclusions: Our study shows that neck impairment and pain in head and neck cancer survivors is not sufficiently explained by cervical degeneration related to age or trauma, supporting the theory that post-treatment neck disability occurs as a side effect of treatment. These results support the further assessment of structure and function of cervical musculature and degeneration following HNC treatment.

11.
Cancer Med ; 11(13): 2561-2575, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35277936

RESUMEN

BACKGROUND: There is a growing cohort of head and neck cancer (HNC) patients affected by late- and long-term posttreatment side effects. Our study evaluates the relationship between the demographics, clinical characteristics, and posttreatment symptom burden with the subjective sense of flourishing among HNC survivors. METHODS: A cross-sectional, single-center study of adult survivors of squamous cell cancer of the oral cavity, oropharynx, and larynx/hypopharynx who completed the Secure Flourishing Index (SFI) and patient-reported outcomes related to depression, anxiety, swallowing dysfunction, neck disability, and insomnia between November 2020 and April 2021. RESULTS: A total of 100, predominantly male (86%), survivors with an average age of 63.0 ± 9.6 were included in the study. Univariable analysis showed a significant association between higher flourishing scores and advanced age (95% CI: [0.011, 0.84], p = 0.0441), normal diet (95% CI: [5.79, 31.18], p = 0.0149), employment (95% CI: [1.24, 17.20], p = 0.0239), higher income (95% CI: [7.30, 27.72], p = 0.0248), and decreased reported difficulty paying for needs (95% CI: [-33.46, -18.88], p < 0.001). Flourishing was inversely associated with higher symptoms of depression (95% CI: [-2.23, -1.15], p < 0.001), anxiety (95% CI: [-1.92,-0.86], p < 0.001), swallowing dysfunction (95% CI: [-0.77, -0.26], p < 0.001), neck disability (95% CI: [-1.05, -0.35], p < 0.001), and insomnia (95% CI: [-1.12, -0.22], p = 0.004) in the multivariable analysis. CONCLUSIONS: Common late- and long-term side effects of HNC treatment and financial hardship are associated with lower levels of flourishing or a more negative perception of life after treatment. Results highlight the importance of symptom burden for survivors' overall evaluation of their quality of life.


Asunto(s)
Supervivientes de Cáncer , Neoplasias de Cabeza y Cuello , Trastornos del Inicio y del Mantenimiento del Sueño , Adulto , Anciano , Estudios Transversales , Femenino , Neoplasias de Cabeza y Cuello/complicaciones , Neoplasias de Cabeza y Cuello/terapia , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Trastornos del Inicio y del Mantenimiento del Sueño/etiología , Sobrevivientes
12.
Oral Oncol ; 126: 105766, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35168191

RESUMEN

OBJECTIVE: Compare survival of head and neck cancer (HNC) patients treated with surgical or non-surgical management according to frailty, quantify frailty with the Risk Analysis Index (RAI), a validated 14-item instrument. MATERIALS AND METHODS: Prospective cohort study of newly diagnosed HNC patients (≥18 years) who had frailty assessment from April 13, 2016 to September 30, 2016. Primary outcome was overall survival at 1- and 3-years. Cox proportional hazard models were utilized to examine mortality with predictor variables. Adjusted and unadjusted (Kaplan-Meier) survival curves stratified by either RAI scores or treatment modality were plotted. Kruskal-Wallis and likelihood ratio chi-square tests were used for comparing clinicodemographic variables. RESULTS: Of 165 patients, 54 (32.7%) were managed non-surgically, 49 (29.7%) were treated with definitive surgery only, and 62 (37.6%) were treated with multimodality (surgery + adjuvant) therapy. Among the full cohort and subgroup analysis of the frail/very frail (RAI ≥ 37), non-surgical patients had worse or similar 3-year survival than those treated with surgery +/- adjuvant therapy. Multivariable Cox proportional hazard models demonstrate that frail patients treated non-surgically experienced worse survival than their counterparts treated with surgery (HR = 2.50, p = 0.015, 95% CI: 1.19, 5.23) or multimodality therapy (HR = 3.91, p < 0.001, 95% CI: 1.94-7.89). CONCLUSION: Across all levels of frailty, long term survival of HNC patients treated without surgery is either worse than or like those treated with surgery. These findings (1) challenge current practices of steering patients "too frail for surgery" towards non-surgical, "non-invasive" therapy, and (2) suggest equipoise warranting randomized trials to clarify treatment of frail patients.


Asunto(s)
Fragilidad , Neoplasias de Cabeza y Cuello , Neoplasias de Cabeza y Cuello/terapia , Humanos , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Estudios Retrospectivos
13.
Clin Cancer Res ; 28(7): 1335-1344, 2022 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-35091445

RESUMEN

PURPOSE: Concurrent radiotherapy with cetuximab, an anti-EGFR mAb, is a standard treatment for locally advanced head and neck squamous carcinoma (HNSCC). Cytotoxic T lymphocyte antigen-4-positive (CTLA-4+) regulatory T cells (Treg) dampen cellular immunity and correlate negatively with clinical outcomes. This phase I study added ipilimumab, an anti-CTLA-4 mAb, to cetuximab-radiotherapy. PATIENTS AND METHODS: A (3 + 3) design was used to establish the recommended phase II dose (RP2D) of ipilimumab, added at week 5 for four, every-3-week doses to fixed, standard cetuximab-radiotherapy. Eligible subjects had stage III to IVb, high-risk [human papillomavirus-negative (HPV-)] or intermediate-risk HPV-positive (HPV+)] HNSCC. Dose-limiting toxicity (DLT) was defined as any grade 4 adverse event (AE) except in-field radiation dermatitis or immune-related (ir) AE requiring ≥2 weeks of systemic steroids. Baseline tumor and serial blood specimens were collected for immune correlatives. RESULTS: From July 2013 to May 2016, 18 patients enrolled. Two of 6 in cohort 1 (ipilimumab 3 mg/kg) experienced grade 3 dermatologic DLTs, triggering deescalation of ipilimumab to 1 mg/kg. Dose level -1 was expanded to N = 12 without DLT. irAE included: grade 1, 2, and 3 dermatitis (2, 1, and 3 cases), grade 4 colitis (1), and grade 1 hyperthyroidism (1). Three-year disease-free survival (DFS) and overall survival were 72% [90% confidence interval (CI), 57-92] and 72% (90% CI, 56-92). High expression of coinhibitory receptors PD1/LAG3/CD39 on baseline tumor-infiltrating Treg was associated with worse DFS (HR = 5.6; 95% CI, 0.83-37.8; P = 0.08). CONCLUSIONS: The RP2D for ipilimumab plus standard cetuximab-radiotherapy is 1 mg/kg in weeks 5, 8, 11, and 14. The regimen is tolerable and yields acceptable survival without cytotoxic chemotherapy.


Asunto(s)
Dermatitis , Neoplasias de Cabeza y Cuello , Infecciones por Papillomavirus , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Cetuximab/efectos adversos , Dermatitis/tratamiento farmacológico , Dermatitis/etiología , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Humanos , Ipilimumab/efectos adversos , Infecciones por Papillomavirus/tratamiento farmacológico , Carcinoma de Células Escamosas de Cabeza y Cuello/tratamiento farmacológico , Carcinoma de Células Escamosas de Cabeza y Cuello/etiología
14.
Otolaryngol Head Neck Surg ; 166(4): 676-683, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34253083

RESUMEN

OBJECTIVE: We aim to (1) determine the prevalence and predictors of trismus and (2) examine the relationship of trismus, swallowing dysfunction, and quality of life (QOL) in survivors of head and neck cancer (HNC). STUDY DESIGN: Case series with chart review. SETTING: Multidisciplinary HNC survivorship clinic. METHODS: Data on trismus and patient-reported outcomes were obtained from survivors of HNC between December 2016 and October 2019. Trismus was defined as a maximum interincisal opening ≤35 mm. QOL and swallowing dysfunction were measured with the University of Washington Quality of Life questionnaire and EAT-10 (Eating Assessment Tool-10), respectively. Linear regressions were applied to investigate the relationship of trismus with QOL and swallowing dysfunction. RESULTS: Of the 237 survivors, 22.78% (n = 54) had trismus. Advanced stage of cancer (stage III/IV vs Tis-II, P = .002) and treatment (nonsurgical and surgery + adjuvant treatment vs surgery only, P = .006) were correlated with a higher prevalence of trismus. After controlling for cancer stage and treatment type, EAT-10 scores for survivors with trismus were 9.342 (95% CI, 6.262-12.423; P < .0001) higher than those without trismus. The University of Washington Quality of Life Physical and Social-Emotional subscales for patients with trismus were 14.088 (95% CI, 9.042-19.134; P < .0001) and 10.470 (95% CI, 4.793-16.147; P = .0003) lower than those without trismus, respectively. CONCLUSION: Trismus is a common, treatment-related consequence and is associated with increased symptoms of dysphagia and decreased QOL. Early detection and management of trismus in survivors of HNC are essential to optimize QOL and reduce morbidity.


Asunto(s)
Neoplasias de Cabeza y Cuello , Calidad de Vida , Deglución , Neoplasias de Cabeza y Cuello/complicaciones , Neoplasias de Cabeza y Cuello/terapia , Humanos , Calidad de Vida/psicología , Encuestas y Cuestionarios , Sobrevivientes , Trismo/epidemiología , Trismo/etiología
15.
Laryngoscope Investig Otolaryngol ; 6(5): 983-990, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34667840

RESUMEN

OBJECTIVES: Oropharyngeal squamous cell carcinoma (OPSCC) treatment results in impaired swallowing and quality of life (QOL). We analyzed a cross-section of advanced stage OPSCC patients treated with multimodal therapies at our Survivorship Clinic to investigate treatment factors associated with QOL. METHODS: Retrospective analysis of patient-reported outcomes (PROMs) after primary OPSCC treatment using AJCC seventh edition staging. RESULTS: A total of 73 patients were included (90.1% human papillomavirus positive [HPV+]). There were no QOL differences between robotic surgery with radiation ± chemotherapy patients (n = 29) and those treated by radiation ± chemotherapy (n = 44). Radiation field analysis demonstrated significant correlations between increasing doses to larynx and contralateral parotid and submandibular gland and worse swallowing as measured by the Eating Assessment Tool-10 (P = .02; P = .01; P = .01). CONCLUSIONS: In advanced, mostly HPV+, OPSCC, we did not find clinically significant differences between QOL PROMs between surgical and radiation ± chemotherapy treatment groups. This highlights the need for continued therapy de-escalation along with improved interventions for treatment related toxicities. LEVEL OF EVIDENCE: 4.

16.
BMC Cancer ; 21(1): 1127, 2021 Oct 20.
Artículo en Inglés | MEDLINE | ID: mdl-34670507

RESUMEN

BACKGROUND: Caregivers are invaluable sources of support for individuals recovering from head and neck cancer (HNC). Accordingly, minimizing caregiver distress is essential to promote the well-being of both caregivers and their patients. This study assessed if psychosocial distress (i.e., anxiety and depression) among HNC caregivers is associated with a difference in how caregivers and their patients perceive patients' quality of life (QOL) after treatment completion. METHODS: Caregivers' and patients' perceptions of patient QOL were assessed using the University of Washington QOL Questionaire (UWQOL), a validated HNC-specific health-related QOL questionnaire. The survey is interpreted in terms of its two composite scores: a physical QOL score and a social-emotional QOL score with higher scores indicating better QOL. Caregiver anxiety was assessed using the Generalized Anxiety Questionaire-7 (GAD-7) and caregiver depression was assessed using the Patient Health Questionaire 8 (PHQ-8). Patients completed the UWQOL as part of clinic intake while caregivers were asked to complete the UWQOL for their patients in addition to the PHQ-8 and GAD-7 in private. Linear regression was used to analyze the association between differences in caregivers' and patients' QOL scores (both social-emotional and physical QOL subscale scores) and GAD-7 and PHQ-8 scores. RESULTS: Of 47 caregivers recruited, 42.6% (n = 20) viewed patients' social-emotional QOL more negatively than patients themselves, while 31.9% viewed patients' physical QOL more negatively. After controlling for covariates, differences in perception of social-emotional QOL (p = .01) and differences in perception of physical QOL (p = .007) were significantly associated with caregiver depression, but not anxiety. Caregivers who disagreed with patients regarding patients' social-emotional QOL scored 6.80 points higher on the PHQ8 than agreeing caregivers. Caregivers who disagreed regarding patients' physical QOL scored 6.09 points higher. CONCLUSION: Caregivers commonly view patients' QOL more negatively than patients themselves. These caregivers tend to have greater psychosocial distress than caregivers who agree with their patients. Interventions designed to identify and aid at-risk caregivers are critically needed. We propose screening for differences in perception of patient QOL as a way of identifying distressed caregivers as well as provider-facilitated communication between patients and caregivers as possible interventions that should be examined in future research.


Asunto(s)
Carga del Cuidador/psicología , Cuidadores/psicología , Neoplasias de Cabeza y Cuello/psicología , Distrés Psicológico , Calidad de Vida/psicología , Anciano , Ansiedad/diagnóstico , Ansiedad/psicología , Cuidadores/estadística & datos numéricos , Estudios Transversales , Depresión/diagnóstico , Depresión/psicología , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Percepción , Encuestas y Cuestionarios
17.
Oral Oncol ; 123: 105574, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34715452

RESUMEN

OBJECTIVES: To determine which surgical factors are associated with quality-of-life (QOL) outcomes in oral cavity cancer survivors after free flap reconstruction of the oral cavity. PATIENTS AND METHODS: A cross-sectional study was conducted from a multidisciplinary head and neck cancer (HNC) survivorship clinic. Oral cavity cancer survivors with at least 6-months of postoperative follow-up from ablation and free flap reconstruction were included. Primary outcome measures were validated patient-reported outcome measures (PROMs) including the Eating Assessment Tool-10 (EAT-10) measure of swallowing-specific QOL, University of Washington Quality of Life (UW-QOL) physical and social-emotional subscale scores and feeding tube dependence. RESULTS: Extent of tongue resection was associated with EAT-10 and the UW-QOL Physical subscale scores. Patients with oral tongue defects reported worse scores than with composite defects in the EAT-10 and UW-QOL physical domain (p = 0.0004, 0.0025, respectively). This association no longer applies when controlling for differences in extent of tongue resection. Patients with anterior composite resections reported worse EAT-10 scores than lateral resections (p = 0.024). This association no longer applies when controlling for extent of tongue resection (p = 0.46). Gastric tube dependence demonstrates similar trends to PROMs. CONCLUSION: Extent of tongue resection was strongly associated with poor QOL outcomes after free tissue reconstruction of the oral cavity and mediates the associations between other defect characteristics and QOL. These findings demonstrate the need for emphasis on expected oral tongue defects when counseling patients and highlight the need to address QOL in a multidisciplinary fashion post-operatively.


Asunto(s)
Colgajos Tisulares Libres , Procedimientos de Cirugía Plástica , Neoplasias de la Lengua , Estudios Transversales , Colgajos Tisulares Libres/cirugía , Humanos , Medición de Resultados Informados por el Paciente , Calidad de Vida/psicología , Encuestas y Cuestionarios , Neoplasias de la Lengua/cirugía
18.
Laryngoscope ; 131(9): 2015-2022, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-33656195

RESUMEN

OBJECTIVE/HYPOTHESIS: The intensification of treatment for head and neck cancers (HNCs) has created a cohort of patients living with short- and long-term comorbidities and functional deficits. This study aimed to determine whether there is a relationship between patient-reported outcomes (PROs) and objective measures of neck function in survivors of HNCs. STUDY DESIGN: Cross-sectional study. METHODS: Thirty-one subjects (aged 64 ± 8.7 years; 28 males and three females) were recruited and completed the Neck Disability Index (NDI) and a numeric pain scale. At the same visit, subjects were fitted with two portable motion sensors to collect range of motion (ROM) and velocity data. Differences between ROM, velocity, and PRO subgroups were assessed using a one-tailed t test (*P < .05). The Pearson correlation coefficient (r) was calculated between the NDI values and the ROM and velocity values for each motion. RESULTS: A moderate correlation (r = 0.507) was observed between NDI and neck pain. Patients with no disability according to the NDI had significantly higher ROM and velocity than patients with mild to moderate disability. Velocity in all degrees of freedom (axial rotation, flexion and extension, and lateral bending) was significantly lower for patients who perceived higher levels of neck pain and neck disability. CONCLUSIONS: This study notes that patients who report neck disability and pain have more limited ROM and velocity following HNC treatment. These data may improve treatment planning and care delivery by facilitating an understanding of the experiences of HNC survivors and the pathophysiology that must be targeted to address their psychosocial and functional deficits. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2015-2022, 2021.


Asunto(s)
Fenómenos Biomecánicos/fisiología , Neoplasias de Cabeza y Cuello/fisiopatología , Cuello/fisiopatología , Dimensión del Dolor/psicología , Rango del Movimiento Articular/fisiología , Anciano , Estudios de Casos y Controles , Estudios Transversales , Evaluación de la Discapacidad , Femenino , Neoplasias de Cabeza y Cuello/complicaciones , Humanos , Masculino , Persona de Mediana Edad , Cuello/patología , Dimensión del Dolor/estadística & datos numéricos , Medición de Resultados Informados por el Paciente , Calidad de Vida , Supervivencia
19.
Laryngoscope ; 131(7): 1535-1541, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33428218

RESUMEN

OBJECTIVE: The American Joint Committee on Cancer (AJCC) 8th edition introduced distinct clinical and pathological staging paradigms for human papilloma virus positive (HPV+) oropharyngeal squamous cell carcinoma (OPSCC). Treatment planning for OPSCC often utilizes positron emission tomography/computed tomography (PET/CT) to assess clinical stage. We hypothesize that PET/CT will accurately predict final pathologic AJCC 8th edition staging in patients with HPV+ OPSCC. METHODS: All patients with primary HPV+ OPSCC with preoperative PET/CT who underwent transoral robotic surgery and neck dissection between 2011 and 2017 were identified. Data were collected via chart review. Two neuroradiologists performed blinded re-evaluation of all scans. Primary tumor size and cervical nodal disease characteristics were recorded and TNM staging was extrapolated. Cohen's kappa statistic was used to assess interrater reliability. Test for symmetry was performed to analyze discordance between radiologic and pathologic staging. RESULTS: Forty-nine patients met inclusion criteria. Interrater reliability was substantial between radiologists for nodal (N) and overall staging (OS) (κ = 0.715 and 0.715). Radiologist A review resulted in identical OS for 67% of patients, overstaging for 31%, and understaging for 2%. Radiologist B review resulted in 61% identical OS, 39% overstaging, and 0% understaging. In misclassified cases, the test of symmetry shows strong bias toward overstaging N stage and OS (P < .001). Radiologic interpretation of extracapsular extension showed poor interrater reliability (κ = 0.403) and poor accuracy. CONCLUSION: PET/CT predicts a higher nodal and overall stage than pathologic staging. PET/CT should not be relied upon for initial tumor staging, as increased FDG uptake is not specific for nodal metastases. PET/CT is shown to be a poor predictor of ECE. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1535-1541, 2021.


Asunto(s)
Metástasis Linfática/diagnóstico , Neoplasias Orofaríngeas/diagnóstico , Infecciones por Papillomavirus/diagnóstico , Tomografía Computarizada por Tomografía de Emisión de Positrones , Carcinoma de Células Escamosas de Cabeza y Cuello/diagnóstico , Adulto , Anciano , Extensión Extranodal/diagnóstico por imagen , Extensión Extranodal/patología , Femenino , Humanos , Ganglios Linfáticos/diagnóstico por imagen , Ganglios Linfáticos/patología , Metástasis Linfática/patología , Metástasis Linfática/terapia , Masculino , Persona de Mediana Edad , Cuello , Estadificación de Neoplasias , Neoplasias Orofaríngeas/patología , Neoplasias Orofaríngeas/cirugía , Neoplasias Orofaríngeas/virología , Orofaringe/diagnóstico por imagen , Orofaringe/patología , Orofaringe/cirugía , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/patología , Infecciones por Papillomavirus/cirugía , Infecciones por Papillomavirus/virología , Periodo Preoperatorio , Pronóstico , Reproducibilidad de los Resultados , Estudios Retrospectivos , Carcinoma de Células Escamosas de Cabeza y Cuello/patología , Carcinoma de Células Escamosas de Cabeza y Cuello/cirugía , Carcinoma de Células Escamosas de Cabeza y Cuello/virología
20.
Ann Surg ; 274(6): e1230-e1237, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-32118596

RESUMEN

OBJECTIVE: The goal of this project was to first address barriers to implementation of the Risk Analysis Index (RAI) within a large, multi-hospital, integrated healthcare delivery system, and to subsequently demonstrate its utility for identifying at-risk surgical patients. BACKGROUND: Prior studies demonstrate the validity of the RAI for evaluating preoperative frailty, but they have not demonstrated the feasibility of its implementation within routine clinical practice. METHODS: Implementation of the RAI as a frailty screening instrument began as a quality improvement initiative at the University of Pittsburgh Medical Center in July 2016. RAI scores were collected within a REDCap survey instrument integrated into the outpatient electronic health record and then linked to information from additional clinical datasets. NSQIP-eligible procedures were queried within 90 days following the RAI, and the association between RAI and postoperative mortality was evaluated using logistic regression and Cox proportional hazards models. Secondary outcomes such as inpatient length of stay and readmissions were also assessed. RESULTS: RAI assessments were completed on 36,261 unique patients presenting to surgical clinics across five hospitals from July 1 to December 31, 2016, and 8,172 of these underwent NSQIP-eligible surgical procedures. The mean RAI score was 23.6 (SD 11.2), the overall 30-day and 180-day mortality after surgery was 0.7% and 2.6%, respectively, and the median time required to collect the RAI was 33 [IQR 23-53] seconds. Overall clinic compliance with the recommendation for RAI assessment increased from 58% in the first month of the study period to 84% in the sixth and final month. RAI score was significantly associated with risk of death (HR=1.099 [95% C.I.: 1.091 - 1.106], p < 0.001). At an RAI cutoff of ≥37, the positive predictive values for 30- and 90-day readmission were 14.8% and 26.2%, respectively, and negative predictive values were 91.6% and 86.4%, respectively. CONCLUSIONS: The RAI frailty screening tool can be efficiently implemented within multi-specialty, multi-hospital healthcare systems. In the context of our findings and given the value of the RAI in predicting adverse postoperative outcomes, health systems should consider implementing frailty screening within surgical clinics.


Asunto(s)
Fragilidad/clasificación , Periodo Preoperatorio , Medición de Riesgo/métodos , Anciano , Anciano de 80 o más Años , Femenino , Hospitales , Humanos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Pennsylvania , Estudios Prospectivos , Mejoramiento de la Calidad
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