Percutaneous Radiofrequency Ablation of Thyroid Carcinomas Ineligible for Surgery, in the Elderly.

Thirty to 50% of differentiated thyroid carcinomas include papillary thyroid microcarcinomas (mPTC). Most of these tumors remain clinically silent, have a bright prognosis and a disease-specific mortality <1%. Surgery has been recommended as first line-treatment by current guidelines, the standard treatment being lobectomy. However, surgery has some drawbacks, including potential recurrent laryngeal nerve paralysis, hypothyroidism, hypoparathyroidism, in -patient basis hospital stay, lifelong medication, scarring of the neck, and general anesthesia related risks. Moreover, elderly patients who present severe comorbidities, could be ineligible for surgery, and others may refuse invasive surgery. Another option supported by the American Thyroid Association is active surveillance. This option can be considered as unattractive and difficult to accept by European patients, as there is a 2-6% risk of disease progression. Percutaneous image-guided thermal ablation has been successfully applied in the treatment of liver and lung tumors in the 1990s and 2000s; and has recently been proposed as an alternative to surgery in patients presenting with thyroid diseases. This minimally invasive treatment has similar efficacy, fewer complications, better quality of life and cosmetic outcomes than surgery. We report herein two cases of radiofrequency ablation of mPTC and T2 PTC in elderly patients who were ineligible for surgery.

Metachronous second primary neoplasia in oropharyngeal cancer patients: Impact of tumor HPV status. A GETTEC multicentric study.

INTRODUCTION: Patients with oropharyngeal squamous cell carcinoma (OPSCC) display a significant risk to develop a metachronous second primary neoplasia (MSPN). HPV and non-HPV-related OPSCC are 2 distinct entities with biological, clinical and prognostic differences. The aims of our study were to analyze the impact of tumor HPV status and other relevant clinical factors, such as tobacco and/or alcohol (T/A) consumption, on the risk and distribution of MSPN in OPSCC patients and to assess the impact of MSPN on patient survival. MATERIAL AND METHODS: All OPSCC patients treated from 2009 to 2014 were included in this multicentric retrospective study. P16 immunohistochemical expression was used as a surrogate maker of tumor HPV status. The impact of tumor p16 status on the risk of MSPN was assessed in uni- and multivariate analyses. Overall survival (OS) was determined by Kaplan-Meier analysis. RESULTS: Among the 1291 patients included in this study, 138 (10.7%) displayed a MSPN which was preferentially located in the head and neck area (H&N), lung and esophagus. Multivariate analyses showed that p16- tumor status (p = 0.003), T/A consumption (p = 0.005) and soft palate tumor site (p = 0.009) were significantly associated with a higher risk of MSPN. We found no impact of p16 tumor status on the median time between index OPSCC diagnosis and MSPN development, but a higher proportion of MSPN arising outside the H&N, lung and esophagus was found in p16 + than in p16- patients. MSPN development had an unfavorable impact (p = 0.04) on OS only in the p16 + patient group. CONCLUSION: P16 tumor status and T/A consumption were the main predictive factors of MSPN in OPSCC patients. This study provides crucial results with a view to tailoring global management and follow-up of OPSCC patients.

Upfront surgery or definitive radiotherapy for p16+ oropharyngeal cancer. A GETTEC multicentric study.

BACKGROUND: The aim of this study was to assess the impact of the initial therapeutic strategy on oncologic outcomes in patients with HPV-positive OPSCC. METHODS: All p16-positive OPSCCs treated from 2009 to 2014 in 7 centers were retrospectively included and classified according to the therapeutic strategy: surgical strategy (surgery ± adjuvant radiotherapy and chemotherapy) vs. non-surgical strategy (definitive radiotherapy ± chemotherapy). Univariate, multivariate propensity score matching analyses were performed to compare overall (OS), disease-specific (DSS) and recurrence-free survival (RFS). RESULTS: 382 patients were included (surgical group: 144; non-surgical group: 238). Five-year OS, DSS and RFS were 89.2, 96.8 and 83.9% in the surgical group and 84.2, 87.1 and 70.4% in the non-surgical group, respectively. These differences were statistically significant for DSS and RFS after multivariate analysis, but only for RFS after propensity score matching analysis. CONCLUSION: In p16+ OPSCC patients, upfront surgery results in higher RFS than definitive radiotherapy ± chemotherapy but does not impact OS.

Synchronous primary neoplasia in patients with oropharyngeal cancer: Impact of tumor HPV status. A GETTEC multicentric study.

INTRODUCTION: Patients with oropharyngeal squamous cell carcinoma (OPSCC) display a significant risk of synchronous primary neoplasia (SPN) which could impact their management. The aims of this study were to evaluate the risk and distribution of SPN in OPSCC patients according to their HPV (p16) status, the predictive factors of SPN and the impact of SPN on therapeutic strategy and oncologic outcomes. MATERIAL AND METHODS: All OPSCC patients treated from 2009 to 2014 were included in this multicentric retrospective study. Univariate analyses were conducted using Chi-2 and Fisher exact tests. For multivariate analyses, all variables associated with a p ≤ 0.10 in univariate analysis were included in logistic regression models. RESULTS: Among the 1291 patients included in this study, 75 (5.8%) displayed a SPN which was preferentially located in the upper aerodigestive tract, lung and esophagus. Comorbidity level (p = 0.03), alcohol (p = 0.005) and tobacco (p = 0.01) consumptions, and p16 tumor status (p < 0.0001) were significant predictors of SPN. In multivariate analysis, p16+ status was significantly associated with a lower risk of SPN (OR = 0.251, IC95% [0.133;0.474]). Patients with a SPN were more frequently referred for non-curative treatment (p = 0.02). In patients treated with curative intent, there was no impact of SPN on the therapeutic strategy (surgical vs. non-surgical treatment). We observed no overall survival differences between patients with or without SPN. CONCLUSION: P16 tumor status is the main predictive factor of SPN in OPSCC patients. This study provides crucial results which should help adapt the initial work-up and the global management of OPSCC patients.

Upfront surgery or definitive radiotherapy for patients with p16-negative oropharyngeal squamous cell carcinoma. A GETTEC multicentric study.

INTRODUCTION: Therapeutic management of oropharyngeal squamous cell carcinomas (OPSCC) is still debated. Since the role of HPV was demonstrated, few studies have focused on HPV-negative OPSCC. The aim of our study was to assess the impact of therapeutic strategy (surgical vs. non-surgical) on oncologic outcomes in patients with HPV-negative OPSCC. MATERIAL AND METHOD: All p16-negative OPSCCs treated from 2009 to 2014 in 7 tertiary-care centers were included in this retrospective study and were classified according to the therapeutic strategy: surgical strategy (surgery ± adjuvant radiotherapy and chemotherapy) vs. non-surgical strategy (definitive radiotherapy ± chemotherapy). Patients not eligible for surgery (unresectable tumor, poor general-health status) were excluded. Univariate, multivariate and propensity score matching analyses were performed to compare overall (OS), disease-specific (DSS) and recurrence-free survival (RFS). RESULTS: Four hundred seventy-four (474) patients were included in the study (surgical group: 196; non-surgical group: 278). Five-year OS, DSS and RFS were 76.5, 81.3 and 61.3%, respectively, in the surgical group and 49.9, 61.8 and 43.4%, respectively, in the non-surgical group. The favorable impact of primary surgical treatment on oncologic outcomes was statistically significant after multivariate analysis. This effect was more marked for locally-advanced than for early-stage tumors. Propensity score matching analysis confirmed the prognostic impact of primary surgical treatment for RFS. CONCLUSION: Therapeutic strategy is an independent prognostic factor in patients with p16-negative OPSCC and primary surgical treatment is associated with improved OS, DSS and RFS. These results suggest that surgical strategy is a reliable option for advanced stage OPSCC.

Oropharyngeal cancer: First relapse description and prognostic factor of salvage treatment according to p16 status, a GETTEC multicentric study.

INTRODUCTION: Although Human Papilloma Virus (HPV)-driven oropharyngeal cancer (OPC) prognosis is significantly better than that of other head and neck cancers, up to 25% of cases will recur within 5 years. Data on the pattern of disease recurrence and efficiency of salvage treatment are still sparse. MATERIAL AND METHOD: Observational study of all recurrent OPCs diagnosed, following a curative intent treatment, in seven French centers from 2009 to 2014. p16 Immunohistochemistry was used to determine HPV status. Clinical characteristics, distribution of recurrence site, and treatment modalities were compared by HPV tumor status. Overall survival was examined using Kaplan-Meier and multivariate Cox regression modeling. RESULTS: 350 recurrent OPC patients (246 p16-negative and 104 p16-positive patients). The site of recurrence was more frequently locoregional for p16-negative patients (65.4% versus 52.9% in p16-positive patients) and metastatic for p16-positive patients (47.1% versus 34.6% in p16-patients, p = 0.03). Time from diagnosis to recurrence did not differ between p16-positive and p16-negative patients (12 and 9.6 months, respectively, p-value = 0.2), as the main site of distant metastasis (all p-values ≥0.10). Overall and relapse-free survival following the first recurrence did not differ according to p16 status (p-values from log-rank 0.30 and 0.40, respectively). In multivariate analysis, prognosis factors for overall survival in p16-negative patients were distant metastasis (HR 2.11, 95% CI 1.30-3.43) and concurrent local and regional recurrences (HR 2.20, 95% CI 1.24-3.88). CONCLUSION: With the exception of the initial site of recurrence, the pattern of disease relapse and the efficiency of salvage treatment are not different between p16-positive and negative OPCs.

Use of Polyvinyl Alcohol Sponge Cubes for Vagal Nerve Stimulation: A Suggestion for the Wrapping Step. Technical Note and Step-by-Step Operative Technique.

BACKGROUND: Vagal nerve stimulation (VNS) is an approved treatment for epilepsy and depression. Wrapping the helical electrodes around the nerve can prove technically challenging. However, a quick and efficient method to slightly elevate the nerve can highly facilitate this part of the procedure. OBJECTIVE: To provide useful surgical tips to facilitate the procedure. METHODS: Based on experience of more than 150 adult cases for mainly epilepsy (primary lead implant), the authors share their surgical technique to provide the experienced surgeons or newcomers to the field of VNS with some useful tips. All patients signed informed consent according to the local ethics committee guidelines. RESULTS: The article consists of a detailed step-by-step description of the whole procedure illustrated through high-resolution colored photographs of the surgical field. Special reference is made to the usefulness of polyvinyl alcohol (PVA) sponge cubes to elevate the nerve instead of the commonly used silicon vessel loops. CONCLUSION: The use of surgical microscope and PVA sponge cubes to elevate the nerve constitute key points to make VNS an easy surgery.

Design, fabrication, and implantation of tube-shaped devices for the treatment of salivary duct diseases.

Introduction: Starch-based materials were designed using a special extrusion die in order to obtain a tube-shaped device for application to salivary duct treatment in the field of endoscopy, i.e., sialendoscopy . Methods: Extrusion process was used to produce starch tubes. Mechanical properties of the dry tube before implantation were determined using an axial compression test. A finite element study was carried out to simulate the behavior of the hydrated tube under external axial pressure. Hydrolysis of these devices in a simulated salivary solution was studied, as well as its glycerol kinetics release. An animal short-term implantation model for salivary ducts was proposed as a feasibility study for starch tube-shaped devices. Results: A continuous production of regular and size-controlled tubes was obtained. The very small diameter obtained, less than 2 mm, corresponds to the requirement of being insertable in a human salivary duct using sialendoscopy guidewire. Finite element analysis showed that the starch tube can still support an external pressure higher than 0.2 MPa without irreversible damage. After 4 days of implantation, the host response is encouraging and the inflammatory response for this type of procedure remains normal. Conclusion: These devices were adapted to sialendoscopic guidewires and able to be implanted in the salivary ducts of pigs. If a longer lasting tube is required, the crystallinity of the starch material should be improved.

A resorbable shape-memory starch-based stent for the treatment of salivary ducts under sialendoscopic surgery.

OBJECTIVES/HYPOTHESIS: In sialendoscopy, stents are often used to keep the salivary duct open after surgery. These stents need to be removed. Recently, our group developed a new starch-based shape-memory material that is a widespread degradable polymer. Such a device could be manufactured into a deployable resorbable stent to keep the salivary duct open before in situ degradation. An experimental test was performed to establish a methodology and to evaluate the feasibility of the starch stent implantation in an animal model with clinical equipment. STUDY DESIGN: Evaluation of different formulations-potato and high amylose content maize starch without and with plasticizer-with laboratory bench-top testing and in vivo evaluation in a large-animal model. METHODS: Starch-based stents were manufactured. They were evaluated for their shape-memory properties (water, 37°C) and their degradability in simulated saliva in both static and flow conditions mimicking salivary flow in the submandibular duct. A pilot study of stent implantation was then performed in vivo in a large-animal model to assess that the stent dimensions were consistent for implantation in the submandibular duct. RESULTS: Stents made from plasticized starch had the required shape-memory properties to be used as self-deploying stents. However, starch-based stents were rapidly hydrolyzed in simulated saliva. Stents could be directly inserted in the dilated salivary duct in a pig model without harming the epithelium. CONCLUSIONS: Shape-memory stents with suitable geometry for sialendoscopic surgical procedure can be fabricated and inserted in the submandibular duct. Starch-based stents can be used in other pathologies with less α-amylase content in the surrounding medium. LEVEL OF EVIDENCE: NA.