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PURPOSE: During follow-up, patients in remission after oral or oropharyngeal cancer are few to express pain, depression or anxiety, their chief complain are dry mouth and difficulties to chewing. The aim of the study is to estimate prevalence of pain, quality of life and their evolution over four years. METHODS: This prospective observational study included 21 patients between June and September 2017. Clinical examination, neurosensory examination and questionnaires (using visual analogic scale DN4, PCS-CF, HADS EORTC QLQ30 and H&N 35) were performed and a second time 4 years later. RESULTS: After 4 years, 17 patients could be reviewed. In 2017 as in 2021, two patients (11.8 %) experience neuropathic pain. In 2017, 14 (82.3 %) reported paresthesia or dysesthesia or hypo/anesthesia, none of them have provoked pain to a mechanical or thermal stimulus. In 2021, only 9 (53 %) still report those symptoms. Global analysis of the questionnaire QLQC30 reveals a significant increase quality of life of all 17 patients (p = 0.0003). For the two questionnaires QLQC30 and QLQ-H&N 35, dry mouth, sticky saliva, difficulties for eating and relation with food, are strong grievances which an absence of amelioration or a degradation. CONCLUSIONS: Neurosensory disturbance is a frequent symptom but pain concerns only 11.8 % of patients. Quality of life increase globally, yet difficulties concerning oral cavity functions endure. IMPLICATIONS FOR CANCER SURVIVORS: For remission patients, pain is an unfrequent situation unlike neurosensory disturbance. Support care improve life quality. In case of onset of pain, recurrence and osteoradionecrosis should be mentioned immediately.
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OBJECTIVES: The management of upper aerodigestive tract cancers is a complex specialty. It is essential to provide an update to establish optimal care. At the initiative of the INCa and under the auspices of the SFORL, the scientific committee, led by Professor Béatrix Barry, Dr. Gilles Dolivet, and Dr. Dominique De Raucourt, decided to develop a reference framework aimed at defining, in a scientific and consensus-based manner, the general principles of treatment for upper aerodigestive tract cancers applicable to all sub-locations. METHODOLOGY: To develop this framework, a multidisciplinary team of practitioners was formed. A systematic analysis of the literature was conducted to produce recommendations classified by grades, in accordance with the standards of the French National Authority for Health (HAS). RESULTS: The grading of recommendations according to HAS standards has allowed the establishment of a reference for patient care based on several criteria. In this framework, patients benefit from differentiated care based on prognostic factors they present (age, comorbidities, TNM status, HPV status, etc.), conditions of implementation, and quality criteria for indicated surgery (operability, resectability, margin quality, mutilation, salvage surgery), as well as quality criteria for radiotherapy (target volume, implementation time, etc.). The role of medical and postoperative treatments was also evaluated based on specific criteria. Finally, supportive care must be organized from the beginning and throughout the patients' care journey. CONCLUSION: All collected data have led to the development of a comprehensive framework aimed at harmonizing practices nationally, facilitating decision-making in multidisciplinary consultation meetings, promoting equality in practices, and providing a state-of-the-art and reference practices for assessing the quality of care. This new framework is intended to be updated every 5 years to best reflect the latest advances in the field.
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Carcinoma de Células Escamosas , Humanos , Carcinoma de Células Escamosas/terapia , Tracto GastrointestinalRESUMEN
BACKGROUND: Stay-at-home injunction during COVID-19 pandemic led to new dynamics in households and increased the risk of domestic accidents involving pets. The aim of the study was to demonstrate an increase of facial dog bites in children during first lockdown period in France, compared to the same period in 2018 and 2019. Secondary objective was to investigate the demographics and circumstances in which dog bites occurred. METHODS: A retrospective multicentric study was conducted nationwide. Patients under 18 years old managed in fifteen oral and maxillofacial surgery departments for a dog bite were included. RESULTS: Eighty-seven patients were included. A significant increase of the number of children managed for facial dog bite was noticed in 2020 (p=0.0005). The male-to-female ratio was significantly reversed in 2020 with more bites in girls than boys (p=0.02). In 2020, children were mostly bitten to cheeks (28.6 %), lips-and-chin region (26.2 %), and eyelids (23.8 %). Severe bites increased in 2020, in comparison with 2018 and 2019. Dog bites occurring while petting or playing significantly increased in 2020 (31 %) (p=0.03). CONCLUSION: The process leading to bites is highly dependent on the balance of dog-owner relationship. This was strongly disrupted during COVID-19 pandemic, resulting in the increase of dog bites in households. Regarding dog bites, face is the most vulnerable area in children. Its injury has lots of esthetic and functional consequences and maxillofacial surgeons have a key role to play in their prevention. Reminders of some of these management and prevention strategies are presented in this article.
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Mordeduras y Picaduras , COVID-19 , Niño , Animales , Humanos , Masculino , Femenino , Perros , Adolescente , Salud Pública , Estudios Retrospectivos , Pandemias , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Accidentes , Mordeduras y Picaduras/epidemiología , Mordeduras y Picaduras/terapiaRESUMEN
Background: Presently, there are few published reports on postoperative radiation therapy for oropharyngeal and oral cavity cancers treated with IMRT/VMAT technique. This study aimed to assess the oncological outcomes of this population treated with postoperative VMAT in our institution, with a focus on loco-regional patterns of failure. Material and methods: Between 2011 and 2019, 167 patients were included (40% of oropharyngeal cancers, and 60% of oral cavity cancers). The median age was 60 years. There was 64.2% of stage IV cancers. All patients had both T and N surgery. 34% had a R1 margin, 42% had perineural invasion. 72% had a positive neck dissection and 42% extranodal extension (ENE). All patients were treated with VMAT with simultaneous integrated boost with three dose levels: 66Gy in case of R1 margin and/or ENE, 59.4-60Gy on the tumor bed, and 54Gy on the prophylactic areas. Concomittant cisplatin was administrated concomitantly when feasible in case of R1 and/or ENE. Results: The 1- and 2-year loco-regional control rates were 88.6% and 85.6% respectively. Higher tumor stage (T3/T4), the presence of PNI, and time from surgery >45 days were significant predictive factors of worse loco-regional control in multivariate analysis (p=0.02, p=0.04, and p=0.02). There were 17 local recurrences: 11 (64%) were considered as infield, 4 (24%) as marginal, and 2 (12%) as outfield. There were 9 regional recurrences only, 8 (89%) were considered as infield, and 1 (11%) as outfield. The 1- and 2-year disease-free survival (DFS) rates were 78.9% and 71.8% respectively. The 1- and 2-year overall survival (OS) rates were 88.6% and 80% respectively. Higher tumor stage (T3/T4) and the presence of ENE were the two prognostic factors significantly associated with worse DFS and OS in multivariate analysis. Conclusion: Our outcomes for postoperative VMAT for oral cavity and oropharyngeal cancers are encouraging, with high rates of loco-regional control. However, the management of ENE still seems challenging.
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BACKGROUND: Sensitive and reproducible detection of residual disease after treatment is a major challenge for patients with locally advanced head and neck cancer. Indeed, the current imaging techniques are not always reliable enough to determine the presence of residual disease. The aim of the NeckTAR trial is to assess the ability of circulating DNA (cDNA), both tumoral and viral, at three months post-treatment, to predict residual disease, at the time of the neck dissection, among patients with partial cervical lymph node response on PET-CT, after potentiated radiotherapy. METHODS: This will be an interventional, multicentre, single-arm, open-label, prospective study. A blood sample will be screened for cDNA before potentiated radiotherapy and after 3 months if adenomegaly persists on the CT scan 3 months after the end of treatment. Patients will be enrolled in 4 sites in France. Evaluable patients, i.e. those with presence of cDNA at inclusion, an indication for neck dissection, and a blood sample at M3, will be followed for 30 months. Thirty-two evaluable patients are expected to be recruited in the study. DISCUSSION: The decision to perform neck dissection in case of persistent cervical adenopathy after radio-chemotherapy for locally advanced head and neck cancer is not always straightforward. Although studies have shown that circulating tumour DNA is detectable in a large proportion of patients with head and neck cancer, enabling the monitoring of response, the current data is insufficient to allow routine use of this marker. Our study could lead to better identification of patients who do not have residual lymph node disease in order to avoid neck dissection and preserve their quality-of-life while maintaining their prospects of survival. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05710679, registered on 02/02/2023, https://clinicaltrials.gov/ct2/show/ . Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID RCB 2022-A01668-35, registered on July 15th, 2022.
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Carcinoma de Células Escamosas , Ácidos Nucleicos Libres de Células , Neoplasias de Cabeza y Cuello , Humanos , Carcinoma de Células Escamosas/patología , ADN Complementario , Neoplasias de Cabeza y Cuello/genética , Neoplasias de Cabeza y Cuello/radioterapia , Estudios Multicéntricos como Asunto , Tomografía Computarizada por Tomografía de Emisión de Positrones , Estudios ProspectivosRESUMEN
Pregnancy epulis is a common and benign vascular tumor that reaches 5% of pregnant women; it respects adjacent structures, such as bone, teeth, and sinus mucosa. This paper reports a rare case of extensive pregnancy epulis with alveolar bone lysis, tooth displacement, and sinusal floor lysis. A 23-year-old pregnant woman with 23 weeks of amenorrhea was referred to the Department of Oral and Maxillofacial Surgery with a large maxillary mass and spontaneous bleeding, causing difficulty in speaking and swallowing. Due to the rapid development, the stage of pregnancy, and the need for a sure diagnosis of a benign lesion, a surgical excision was performed. After 1 month, the patient recovered from swallowing and speaking. Pregnancy epulis can be locally aggressive and involve alveolar bone. Biopsy allows to confirm the diagnosis. Surgery during pregnancy or birth waiting should be well ponderated in correlation with the size of the tumor and the delay to birth.
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Resorción Ósea , Enfermedades de las Encías , Neoplasias , Humanos , Embarazo , Femenino , Adulto Joven , Adulto , PartoRESUMEN
BACKGROUND: Foramen of Huschke is a bone defect with wide clinical symptoms which ca can be responsible for severe complications. Clinical history and imaging are unspecific, it is therefore essential to recognize and treat the pathology related to the persistence of this foramen, to avoid destruction of the TMJ, chronic pain or OBJECTIVE: The aim of this review was to summarise the clinical manifestations and complications of persistent foramen of Huschke in adult patients, through a review of the cases reported in the literature. METHODS & MATERIALS: A literature search of the PubMed, Cochrane Library, ScienceDirect and Embase databases was conducted for all articles published up to November 2022 to identify studies and case reports concerning clinical manifestations and complications of persistent foramen of Huschke in adult patients, with the key words "foramen of Huschke" or "foramen tympanicum". RESULTS: 74 papers where firstly identify, and 21 were selected. This correspond to 46 patients with the additional case from our department. Symptoms mostly reported consisted of otitis (63%, 29/46), otorrhea (28.26%, 13/46), and masticatory tinnitus (19.57%, 9/46). Diagnosis was priority made by CT-scan (95.65%, 44/46). Surgery was the most performed treatment (28.26%, 13/46). In our case, the use of FLUOBEAM® NIR camera was help-full for TMJ surgery. CONCLUSION: Persistent foramen of Huschke should be suspected in the presence of otitis, otorrhea and masticatory tinnitus. Knowledge of this anatomical variation could help to treat certain pathology like TMJ disorders or TMJ septic arthritis.
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Artritis Infecciosa , Otitis , Trastornos de la Articulación Temporomandibular , Acúfeno , Adulto , Humanos , Otitis/complicaciones , Trastornos de la Articulación Temporomandibular/diagnóstico , Trastornos de la Articulación Temporomandibular/epidemiología , Trastornos de la Articulación Temporomandibular/etiología , Acúfeno/complicaciones , Tomografía Computarizada por Rayos XRESUMEN
Background and purpose: The STEREO POSTOP GORTEC 2017-03 phase 2 trial (NCT03401840) evaluates postoperative stereotactic body radiotherapy (SBRT) in case of high-risk margins for pT1-T2/N0 oropharyngeal and oral cavity tumors. The present ancillary study aimed to compare the dosimetric impact of adding non-coplanar arcs to the volumetric modulated arc therapy (VMAT) technique and to evaluate acute toxicities on the first patients included in this trial. Materials and methods: Ten patients were included. Patients were treated with Novalis TX®. The total dose was 36 Gy (100 % isodose line) in 6 fractions, treated every other day. Two treatment plans were created for each patient: one plan using 2 coplanar arcs only (VMATc) and one plan using coplanar and 3 non-coplanar arcs (VMATc + nc). Acute toxicity was evaluated according to NCI CTCAE criteria V4.03. Results: Median age was 62 years. Localization of tumor was the mobile tongue for 6 patients, floor of mouth for 2, cheek for 1, and gingiva for 1. Six patients had pT2N0 tumors (AJCC 7th edition) and 4 had pT1N0. Mean CTV and PTV volumes were 36.4 and 56.1 cc respectively. Mean PTV coverage by the 36 Gy isodose was 98.2 % for both techniques (p = ns), with comparable conformity indexes (1.1 for VMATc vs 1.07 for VMATc + nc; p = 0.23). VMATc + nc had a significantly better gradient index (3.45 vs 2.97; p = 0.01), resulting in a significantly better sparing of most organs at risk. For example, mean Dmean to the oral cavity, lips, and homolateral parotid were respectively of 16.8 Gy, 11.1 Gy, and 10.4 Gy for VMATc vs 14.8 Gy (p = 0.005), 8.1 Gy (p = 0.001), 6.5 Gy (p = 0.04) for VMATc + nc. No grade ≥ 4 or higher acute toxicity was reported. The most common acute toxicity was grade ≥ 2 mucositis. Conclusion: VMATc + nc had better dosimetric outcomes than VMATc and has become the standard technique for patients treated in the STEREO POSTOP GORTEC 2017-03 trial (NCT03401840) in our institution. Acute toxicity appears acceptable.
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We report a case of a needlefish jaws retained near the C5-C6 joint that was associated with chronic pain and inflammation and seen confirmed by FDG-PET scan. Two unsuccessful surgeries using an anterior approach were complicated by vascular and nerve injuries. We used image-guided surgery with a posterior approach.
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Beloniformes , Cuerpos Extraños , Animales , Humanos , Tomografía Computarizada por Rayos X , Cuerpos Extraños/diagnóstico por imagen , Cuerpos Extraños/cirugía , MaxilaresRESUMEN
BACKGROUND: Eyelid basal cell carcinoma (BCC) is usually cured by surgery. However, for a minority of patients, extensive disease progression and recurrence contraindicate surgery or radiotherapy because of severe ocular morbidity. The hedgehog signaling pathway inhibitor vismodegib is becoming the key treatment for this specific form. OBJECTIVE: The aim of this review was to define the role of surgery after vismodegib treatment. MATERIALS AND METHODS: A literature search of the PubMed, Cochrane Library, ScienceDirect, and Embase databases was conducted for all articles published up to March 2021 to identify studies that examined treatment of BCC of the eyelid by vismodegib. RESULTS: Level 1 evidence was found for the use of vismodegib as neoadjuvant therapy in locally advanced eyelid BCC contraindicated to surgery and/or radiotherapy with a rather good tolerance of treatment. Level 3 evidence was found for the role of surgical excision of residual clinically suspicious lesions as for the indication of eyelid reconstruction after mapping or during residual tumoral resection if frozen sections or Mohs surgery were performed. CONCLUSION: Vismodegib is a well-tolerated treatment for advanced periorbital BCC. The hedgehog signaling pathway inhibitor vismodegib is a potential treatment option in patients with these challenging tumors.
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Antineoplásicos , Carcinoma Basocelular , Neoplasias Cutáneas , Anilidas , Carcinoma Basocelular/tratamiento farmacológico , Carcinoma Basocelular/cirugía , Proteínas Hedgehog , Humanos , Piridinas , Neoplasias Cutáneas/tratamiento farmacológico , Neoplasias Cutáneas/cirugíaRESUMEN
Intensity-modulated radiotherapy has been widely used routinely in recent past years for post-operative radiotherapy of salivary gland cancers Because of the sharp dose fall off outside of target volumes with IMRT, each volume must be strictly and rigorously defined, as the areas not specifically included in the target volume will not be treated to a therapeutic dose. The selection and delineation of these volumes is complex and requires extensive knowledge of parotid and submandibular gland cancer radiographic-anatomy, natural history and extension pathways (including local tumor spread, PNI risks and regional spread), which are detailed in the present article.
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Neoplasias de Cabeza y Cuello , Radioterapia de Intensidad Modulada , Neoplasias de las Glándulas Salivales , Xerostomía , Neoplasias de Cabeza y Cuello/metabolismo , Humanos , Glándula Parótida/diagnóstico por imagen , Glándula Parótida/metabolismo , Dosificación Radioterapéutica , Radioterapia de Intensidad Modulada/efectos adversos , Glándula Submandibular/diagnóstico por imagen , Xerostomía/etiologíaRESUMEN
3D-printing is part of the daily practice of maxillo-facial surgeons, stomatologists and oral surgeons. To date, no French health center is producing in-house medical devices according to the new European standards. Based on all the evidence-based data available, a group of experts from the French Society of Stomatology, Maxillo-Facial Surgery and Oral Surgery (Société Française de Chirurgie Maxillofaciale, Stomatologie et Chirurgie Orale, SFSCMFCO), provide good practice guidelines for in-house 3D-printing in maxillo-facial surgery, stomatology, and oral surgery. Briefly, technical considerations related to printers and CAD software, which were the main challenges in the last ten years, are now nearly trivial questions. The central current issues when planning the implementation of an in-house 3D-printing platform are economic and regulatory. Successful in-house 3D platforms rely on close collaborations between health professionals and engineers, backed by regulatory and logistic specialists. Several large-scale academic projects across France will soon provide definitive answers to governance and economical questions related to the use of in-house 3D printing.
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Medicina Oral , Procedimientos Quirúrgicos Orales , Cirugía Bucal , Francia , Humanos , Impresión TridimensionalRESUMEN
BACKGROUND: The advent of digital medical imaging, medical image analysis and computer vision has opened the surgeon horizons with the possibility to add virtual information to the real operative field. For oral and maxillofacial surgeons, overlaying anatomical structures to protect (such as teeth, sinus floors, inferior and superior alveolar nerves) or to remove (such as cysts, tumours, impacted teeth) presents a real clinical interest. MATERIAL AND METHODS: Through this work, we propose a proof-of-concept markerless augmented reality system for oral and maxillofacial surgery, where a virtual scene is generated preoperatively and mixed with reality to reveal the location of hidden anatomical structures intraoperatively. We devised a computer software to process still video frames of the operating field and to display them on the operating room screens. RESULTS: Firstly, we give a description of the proposed system, where virtuality aligns with reality without artificial markers. The dental occlusion plan analysis and cusps detection allow us to initialise the alignment process. Secondly, we validate the feasibility with an experimental approach on a 3D printed jaw phantom and an ex-vivo pig jaw. Thirdly, we evaluate the potential clinical benefit on a patient. CONCLUSION: this proof-of-concept highlights the feasibility and the interest of augmented reality for hidden anatomical structures visualisation without artificial markers.
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Realidad Aumentada , Cirugía Asistida por Computador , Cirugía Bucal , Animales , Humanos , Imagenología Tridimensional , Programas Informáticos , PorcinosRESUMEN
BACKGROUND: The rate of toxic deaths related to induction chemotherapy in the treatment of locally advanced head and neck cancers is unacceptable and calls into question this therapeutic strategy, which is however highly effective in terms of rate and speed of response. The purpose of the study was to investigate predictive factors of toxicity of induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (TPF) in locally advanced head and neck cancers (LAHNC). METHODS: Between June 2009 and December 2017, 113 patients treated consecutively with TPF were included retrospectively. Patients were receiving induction chemotherapy for either an inoperable cancer or laryngeal preservation. For inoperable cancer, induction chemotherapy was proposed to patients presenting either a large tumor with strong symptoms (dyspnea, dysphagia, pain) or a tumor with rapid progression. Risk factors were chosen among the initial patient and tumour characteristics and chemotherapy modalities. RESULTS: Eighty-nine patients (79%) were male; the median age was 58 years [32-71]. Sixty-nine (61%) patients were treated for inoperable cancer and 44 (39%) for laryngeal preservation. 45% had stage IVa cancer, 28% stage III and 25% stage IVb. Sixty percent of patients had a partial response after TPF, 22% had a complete response, 12% were stable, 5% were progressing, and 1% had a discordant response. Thirty-four patients (30%) received enteral feeding during induction chemotherapy with TPF. The possibility of oral feeding without a tube was predictive of a better response (p = 0.003). Seven (6%) patients died during TPF. There was an increased risk of death with preexisting liver dysfunction (liver dysmorphia on imaging or decrease prothrombin rate) (p = 0.032). There was an increased risk of grade ≥ 3 infection if an enteral feeding occurred during the period of induction chemotherapy (p = 0.03). CONCLUSIONS: TPF induction chemotherapy had an 82% objective response rate with 6% toxic deaths. Nutritional status and the presence of hepatic dysfunction are significant risk factors to be taken into account in therapeutic decisions.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Quimioterapia de Inducción/métodos , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/farmacología , Cisplatino/farmacología , Cisplatino/uso terapéutico , Femenino , Fluorouracilo/farmacología , Fluorouracilo/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Taxoides/farmacología , Taxoides/uso terapéuticoRESUMEN
Background: Dental cellulitis management is no longer a simple procedure, as more and more patients are needing long-time hospitalization, several surgeries and intensive care follow-up. This prospective study seeks to highlight criteria that can split patients with severe odontogenic infection into two groups: those with simple evolution and those for whom complex management is necessary. Methods: In this observational study, all patients considered with a severe odontogenic infection (which necessitated hospital admission, intravenous antibiotics and general anaesthesia) were enrolled between January 2004 and December 2014 from Clermont-Ferrand University Hospital (France). They were split into two groups: those who needed one surgical intervention with tooth extraction and collection drainage combined with probabilistic antibiotic to treat infection and those who need several surgeries, intensive care unit follow-up or tracheotomy to achieve healing. Results: 653 patients were included, of which 611 (94%) had one surgery, 42 (6%) had more than one surgery before healing. Penicillin allergy (p < 0.001), psychiatric disorders (p = 0.005), oropharyngeal oedema (p = 0.008), floor oedema (p = 0.004), fever (p = 0.04) and trismus (p = 0.018) on admission were the most relevant predictors of complex evolution. A conditional inference tree (CTREE) illustrated the association of prognostic factors and the need of multiple surgery. Conclusions: Besides clinical symptoms of severity, complications of severe odontogenic infection are predicted by measurables and objectives criteria as penicillin allergy, mandibular molar, C-reactive protein level, psychiatric disorders and alcohol abuse. Their specific association potentialize the risks. IRB number: CE-CIC-GREN-12-08.
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Celulitis (Flemón) , Enfermedades Transmisibles , Antibacterianos/uso terapéutico , Celulitis (Flemón)/tratamiento farmacológico , Francia , Humanos , Masculino , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
BACKGROUND: Primary surgery is usually the mainstay treatment in early-stage oropharyngeal and oral cavity cancer. Typically, neck surgery is performed. Negative tumor margins are recommended (> 5 mm). If feasible, re-resection of any positive margin is preferred. Otherwise, postoperative radiotherapy is required. Adjuvant postoperative radiotherapy can be limited to the primary site for patients with pT1-T2 tumors and negative neck exploration. Currently, both fractionated external beam radiotherapy and brachytherapy can have a role in the postoperative management of early-stage oropharyngeal and oral cavity cancer with high risk margins. Another possible alternative could be postoperative stereotactic body radiotherapy (SBRT). The aim of this study is to evaluate postoperative SBRT in the treatment of early-stage oropharyngeal and oral cavity cancer with high risk margins. METHODS: The STEREO POSTOP study is a national, open-label, non-randomized phase II trial within the GORTEC network. Patients with early-stage oropharyngeal and oral cavity cancers with high risk margins indicating the need for postoperative radiation are eligible for enrollment. SBRT consists of a total dose of 36 Gy in 6 fractions over 2 weeks. The primary endpoint is severe late toxicity defined as 2-year toxicity of grade ≥ 3 according to CTCAE V4.03 classification. The secondary endpoints include acute toxicity (≤ 3 months), local and locoregional control, disease-free and overall survival, quality of life of patients, nutritional impact and predictive factors of toxicity. The experimental design chosen is a one-step Fleming plan design without interim analysis as the primary endpoint will be evaluated at a 2-year follow-up. Ninety patients will be recruited. The study was started in January 2018 with a 4-year enrollment period and an estimated completion in January 2024. DISCUSSION: This study is the first prospective trial to evaluate head and neck cancer postoperative SBRT in the setting of early-stage oropharyngeal and oral cavity cancers with high risk margins. SBRT is an attractive option because it delivers a highly conformal dose of radiation in a limited number of fractions (like brachytherapy but with less contraindication), with steep dose gradients resulting in reduced normal tissue irradiation and with a short overall treatment time. TRIAL REGISTRATION: Clinicaltrials.gov : NCT03401840 , registered on 17-1-2018. Identifier in French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID - RCB 2017-A02058-45, registered on July 2017. Protocol version: Version 3 dated from 25th November 2019.
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Neoplasias de la Boca/radioterapia , Neoplasias Orofaríngeas/radioterapia , Radiocirugia/métodos , Carcinoma de Células Escamosas de Cabeza y Cuello/radioterapia , Adulto , Fraccionamiento de la Dosis de Radiación , Francia , Humanos , Márgenes de Escisión , Neoplasias de la Boca/patología , Neoplasias de la Boca/cirugía , Ensayos Clínicos Controlados no Aleatorios como Asunto , Neoplasias Orofaríngeas/patología , Neoplasias Orofaríngeas/cirugía , Estudios Prospectivos , Radiocirugia/efectos adversos , Radioterapia Adyuvante , Carcinoma de Células Escamosas de Cabeza y Cuello/patología , Carcinoma de Células Escamosas de Cabeza y Cuello/cirugíaRESUMEN
OBJECTIVE: The dental and periodontal impact of GH/IGF-1 hypersecretion has been poorly investigated until now. Our aim is to precisely describe the oro-dental state of acromegalic patients and to study the impact of GH/IGF-1 hypersecretion on patients' reported oral health-related quality of life (OHRQoL). METHODS: After collecting characteristics of their disease, acromegalic patients answered the GOHAI questionnaire assessing their OHRQoL, the AcroQoL questionnaire and then benefited from a complete stomatological and radiological examination (orthopantomogram systematically, retro-alveolar radiography or Cone Beam CT if necessary). RESULTS: In total, 29 patients aged 59.1 ± 16.0 years were included. The average DMFT index (sum of Decayed, Missing and Filled Teeth per patient) was 19.0 ± 7.8. 16/29 patients had a gingivitis and 18/29 a mild to moderate chronic periodontitis, but no case of severe chronic periodontitis was found, probably because the frequency of a protective thick gingival biotype was increased (9/29). No case of generalized gingival hypertrophy or diffuse hypercementosis was observed. According to the Add-GOHAI score, only 8/26 patients had a satisfactory OHRQoL. This parameter was correlated to the acromegaly-specific quality of life according to the AcroQoL score. Interestingly, 11/29 patients had bulky oral bony outgrowths (OBO), such as large maxillary or mandibular tori and multiple vestibular exostosis. CONCLUSIONS: The unsatisfactory OHRQoL reported by acromegalic patients contrasts with a rather good objective oro-dental state and annual oral examination seems relevant in this population. Finally, we report that huge OBO could be helpful signposts for the diagnosis of acromegaly.