Pregabalin and amitriptyline as first-line drugs among patients with painful peripheraldiabetic neuropathy: a systematic review and meta-analysis.

OBJECTIVE: Painful peripheral diabetic neuropathy (PRDN) is a common disabling condition. Pregabalin and amitriptyline are commonly prescribed as the first-line for PPDN despite the contradicting recommendations. There is a need to inform the scientific community regarding first-line pain control among patients with PPDN. This meta-analysis assessed pregabalin and amitriptyline effects on PPDN. PATIENTS AND METHODS: We searched PubMed, MEDLINE, Cochrane Library, EBSCO, and Google Scholar; the terms used were amitriptyline, pregabalin, painful diabetic neuropathy, antidepressant, gabapentinoids, quality of life, and adverse events. Boolean operators like AND, and OR were used. Six hundred and thirty-one studies were retrieved, and 37 full texts were screened. However, only six randomized controlled trials fulfilled the inclusion and exclusion criteria. RESULTS: No significant statistical differences between amitriptyline and pregabalin regarding pain score and significant pain reduction (odd ratio, -0.82, 95% CI, -2.21-0.58, and odd ratio, 1.16, 95% CI, 0.76-1.76 respectively). Quality of life, total adverse events, and drug discontinuation were not different between the two drugs (odd ratio, 0.89, 95% CI, -2.11-3.89, odd ratio, 0.98, 95% CI, 0.52-1.85, and odd ratio, 0.51, 95% CI, 0.08-3.15, respectively). CONCLUSIONS: No significant statistical differences between amitriptyline and pregabalin regarding their effects on pain and quality of life. The drugs showed similar total adverse events and drug withdrawal. Further larger real-world studies are needed.

Cervical approach for prestyloid parapharyngeal pleomorphic adenoma resection.

OBJECTIVE: To describe the key points of cervical resection for prestyloid parapharyngeal pleomorphic adenoma and to discuss the role of modern imaging. OBSERVATION: Retrospective case series of 10 patients (4 women and 6 men, age 29-63 years) with prestyloid parapharyngeal pleomorphic adenoma with 2 to 8cm largest diameter on MRI, consecutively resected via a cervical approach between 2000 and 2020 in a French tertiary university referral care center. Seven patients had a minimum 10 years' follow-up, and one was lost to follow-up before the fifth postoperative year. Peri- and postoperative complications comprised great auricular nerve transection without subsequent symptomatic neuroma (2 patients), associated transoral approach to free the upper pole of the adenoma (2 patients), capsule effraction (3 patients), and hematoma (1 patient). There were no cases of facial paresis or palsy, other cranial nerve impairment, trismus, auriculotemporal or first-bite syndrome. One of the three patients with capsule effraction showed local recurrence at month 17. CONCLUSION: In agreement with previous reports, the present case series confirmed the role of the cervical approach to resect prestyloid parapharyngeal pleomorphic adenoma, and hence the need to continue teaching it.

Internal mammary pedicle for head-and-neck reconstruction.

Free-flap reconstruction for recurrence of head-and-neck cancer with vessel depletion is a technical challenge, and the literature is sparse. The present technical note describes the key-points of an approach harvesting the internal mammary pedicle. Results are reported in 3 patients, and pros and cons are discussed.

Digastric and sternocleidomastoid muscle flaps after conservative total parotidectomy for cancer: A CARE case report.

OBJECTIVE: To describe, according to the CARE guidelines, an easily reproducible technique using two local muscle flaps to reduce the unsightly retromandibular hollow left by total parotidectomy for cancer. CASE DESCRIPTION: A 40-year-old Caucasian male with T3N1M0 temporal skin melanoma was managed by skin resection, conservative total parotidectomy and ipsilateral level II-IV selective lymph-node dissection. Two rotational muscle flaps were taken from the ipsilateral posterior belly of the digastric and sternocleidomastoid muscles. Postoperative course was uneventful, with 3 days' hospital stay, without facial or spinal palsy. At 3 days, 3 months and 9 months postoperatively, the appearance of the parotid region was similar to the non-operated contralateral region. CONCLUSION: Easy to perform and without associated scars, the approach described here should be included in the armamentarium available to the head and neck surgeon to avoid an unsightly hollow after total parotidectomy for cancer, in an effort to improve quality of life.

Nivolumab immunotherapy rechallenge for progressive laryngeal squamous cell carcinoma after failure of conventional treatment: A CARE case report.

OBJECTIVE: Analysis of rechallenge with nivolumab as 5th-line therapy for locally and nodally failed laryngeal squamous cell carcinoma following conventional therapeutic modalities: radiotherapy, surgery and chemotherapy. OBSERVATION: A 70-year-old male, with local and nodal progression of laryngeal squamous cell carcinoma after treatment with chemoradiotherapy and surgery, was initially treated for recurrence with carboplatin, 5-fluorouracile (FU) and cetuximab, followed by second-line nivolumab, and then two lines of conventional chemotherapy with paclitaxel and cetuximab followed by carboplatin and cetuximab. He underwent rechallenge with nivolumab in 5th line, achieving 12months' response, ongoing at the time of writing, and 42.5months' survival since initiation of exclusive systemic management after failure of conventional treatment. CONCLUSION: This case report highlights the benefit of nivolumab rechallenge in 5th line following previous failure as stand-alone therapy in 2nd line for a patient with laryngeal squamous cell carcinoma locally and nodally uncontrolled after conventional treatment. Clinical trials evaluating the efficacy of this approach are necessary to assess its contribution, as it is currently not a standard therapeutic option.

Mild cognitive impairment effects on diabetes self-care in Tabuk City, Saudi Arabia.

OBJECTIVE: The diabetes epidemic is increasing at an alarming rate in Saudi Arabia. Diabetes and dementia share some pathogeneses, including inflammatory markers, oxidative stress, and insulin resistance. Dementia may substantially influence diabetes self-care activities (DCSAs), thereby initiating a vicious cycle of complications. Therefore, this study aims to assess the effects of mild cognitive impairment (MCI) on DSCA. PATIENTS AND METHODS: This cross-sectional study was conducted among 206 consecutive patients attending the diabetes center in Tabuk City, Saudi Arabia, during the period from December 2021 to November 2022. A structured questionnaire was administered face-to-face, including sociodemographic data, the Diabetes Self-care Questionnaire, the Mini Cognitive Assessment Tool, and the Hospital Anxiety and Depression Questionnaire. All the participants signed a written informed consent form, and both the Ethical Committees of the University of Tabuk and the Directorate General of Health Affairs, Tabuk, approved the research. RESULTS: There were 206 patients with diabetes (63.1% women). Dyslipidemia, hypertension, and depression were reported in 59.8%, 55.9%, and 24.3% of patients, respectively, while MCI was reported in 51.5% of patients. MCI was positively correlated with age. MCI also had negative effects on diabetes self-care activities and HbA1c, but these effects were not statistically significant (odds ratio, 0.750, 95% CI, 0.56-1.00, p-value, 0.055, and odds ratio, 1.21, 95% CI, 0.99-1.08, p-value, 0.081, respectively). No significant relationship was found regarding the duration of diabetes, depression, and dyslipidemia (95% CI, 0.95-1.09, 0.32-4.57, and 0.76-8.30, respectively). CONCLUSIONS: MCI and associated comorbidities were common among patients with diabetes in Tabuk, Saudi Arabia. No association was found between MCI and DSCA, dyslipidemia, hypertension, or duration of diabetes.

Harmful impact of treatment refusal in T3-4M0 endolaryngeal squamous cell carcinoma candidates for total laryngectomy: A STROBE analysis.

PURPOSE: To evaluate the consequences of treatment refusal in total laryngectomy (TL) candidates with T3-4M0 endolaryngeal squamous cell carcinoma (SCC). MATERIALS AND METHODS: A retrospective observational study was conducted in an inception cohort of 576 isolated T3-4M0 endolaryngeal SCC candidates for TL consecutively managed between 1970 and 2019 in a French university teaching hospital. The main endpoint was survival time and cause of death in 2 groups. Group A, 4.5% of the cohort, consisted of 26 patients who declined any laryngeal treatment. Group B consisted of 550 patients who accepted TL. Accessory endpoints were causes of TL refusal and associated variables. The STROBE guideline was applied. The significance threshold was set at P<0.005. RESULTS: One-and 3-year actuarial survival estimates increased significantly (P<0.0001) from 39% and 15% in group A, to 83% and 63% in group B, respectively. In group A, 92% of causes of death implicated index SCC progression, whereas in group B intercurrent disease, metachronous second primary, locoregional and/or metastatic SCC progression and postoperative complications accounted for 37%, 31%, 29%, and 2%, respectively. The actuarial survival estimates within group A increased significantly (P=0.0003) from 0% at 1-year in patients managed with isolated supportive care to 56% in patients managed with chemotherapy (reaching 0% at 5years). Reasons for TL refusal were fear of surgery, refusal of tracheostoma, loss of physiologic phonation, and certain comorbidities. Age and chronologic period correlated significantly with TL refusal. Median age decreased (P<0.001) from 69years in group A to 58 years in group B. Percentage TL refusal increased (P<0.0001) from 2% to 11% before and after start 1990, respectively. CONCLUSION: The current study determined loss of survival with refusal of any laryngeal treatment including TL, noted benefit of chemotherapy associated to supportive care, and discussed the possible contribution of immunotherapy.

Successful 10-year outcomes after supracricoid partial laryngectomy for selected glottic squamous cell carcinoma classified as T3N0M0: A STROBE analysis.

PURPOSE: To evaluate long-term oncological outcome for patients with selected glottic squamous cell carcinoma (SCC) classified as T3N0M0 treated by supracricoid partial laryngectomy (SCPL). MATERIALS AND METHODS: Analysis of an inception cohort of 46 patients with isolated untreated SCC classified as T3N0M0 and minimum 10-year follow-up, consecutively treated by SCPL between 1982 and 2012 in a French university teaching hospital. The main endpoint was 5- and 10-year actuarial survival and local control estimates. Accessory endpoints comprised cause of death, screening for variables decreasing survival and increasing risk of local recurrence, oncologic consequences of local recurrence, and laryngeal preservation rate. RESULTS: Five- and 10-year actuarial survival was 78.1%, and 53.3%, respectively. The main causes of death were intercurrent disease and metachronous second primary, each in 33.3% of cases. Postoperative mortality (aspiration pneumonia) was 2.1%. There were no significant correlations between survival and any study variables. Five- and 10-year local control was 90.5%. Overall local recurrence varied significantly (P=0.003), from 2.3% with negative margins (R0) to 100% with positive margins (R1) and/or dysplasia. Local recurrence was associated with a significantly (P<0.005) increased risk of nodal failure and distant metastasis, and reduced survival. Overall laryngeal preservation was 89.1%. CONCLUSION: The present results suggest that SCPL should continue to be taught and that this type of partial laryngeal surgery should be included in the various organ-sparing strategies considered in advanced laryngeal cancer.

Perception of survival/laryngeal preservation trade-off in advanced T-stage laryngeal cancer.

OBJECTIVES: To evaluate the perception of the survival/laryngeal preservation trade-off in advanced T-stage laryngeal cancer. MATERIAL AND METHODS: The Cochrane, PubMed, Embase, and Science Direct databases were searched using the keywords "cancer, neoplasms, trade-off. One hundred and eighty four articles were found; 176 of these, without data in the Abstract documenting the survival/laryngeal preservation trade-off for advanced T-stage laryngeal cancer, were excluded. Eight articles, totaling 1,052 interviewees, were read to document modalities of evaluation, trade-off thresholds, and variables influencing the perception of trade-off. RESULTS: Evaluation of trade-off was based on responses in group discussions, interviews and questionnaires and on patient file analysis. One study reported that 28.2% of respondents could not make a decision between options, and in 4 studies 22% to 80% of respondents would not consider jeopardizing survival. A mean 2-3 year gain (range, 6 months to 5 years) in survival was required before preferring total laryngectomy to chemoradiotherapy. The percentage loss of disease-free survival tolerated by respondents who would consider a trade-off to preserve the larynx ranged from 5% to 100%, for a median 30%. Variables influencing trade-off comprised respondent status (patient/healthcare provider/healthy subject) and characteristics (job, having children) and treatment data (amount and modalities of information delivered, survival estimates after radiation therapy, health status after treatment). A time for reflection after diagnosis and good quality information were important for respondents. CONCLUSION: Several consequences emerge from these data. The first is to consider induction chemotherapy, to give the patient time to make an informed choice. The second is to not to give up teaching total laryngectomy The third is to determine whether the team's own results match the information delivered to patients.

Positive predictive values of MRI and ultrasound-guided fine-needle aspiration biopsy for isolated parotid swelling in adults: A STARD comparative analysis.

OBJECTIVES: To evaluate positive predictive values (PPVs) of magnetic resonance imaging (MRI) and ultrasound-guided fine-needle aspiration biopsy (UFNAB) in patients with isolated parotid swelling. MATERIAL AND METHODS: Observational study following the STARD guideline, based on a cohort of 212 patients from 18 to 93years of age, with isolated parotid swelling (malignant: 16.9%; benign: 83.1%), consecutively operated on between 2015 and 2020, after work-up including MRI and UFNAB in an otorhinolaryngology department of a university hospital. The main endpoint was PPV for diagnosis of benign tumor, malignant tumor and the most frequent etiology. Secondary endpoints were correlations between PPVs and clinical factors for malignancy, and the impact on PPV of various situations: dynamic analysis on MRI; diagnostic disagreement between MRI and UFNAB; and UFNAB PPV according to MRI diagnosis. RESULTS: PPVs for MRI and UFNAB were respectively 45.4% and 88.8% for malignant tumor, 89.6% and 46.9% for benign tumor, and 88.1% and 85.2% for pleomorphic adenoma (the most frequent etiology). Tumor fixation and history of head and neck radiation therapy PPVs were the only one higher than the MRI one for malignant tumor. MRI PPV did not differ between groups with or without dynamic analysis. PPV for malignant tumor, benign tumor and pleomorphic adenoma on MRI and UFNAB was respectively 42.8% and 33.3%, 42.8% and 100%, and 36.3% and 50% in case of diagnostic discordance. When MRI suggested malignant tumor, UFNAB PPV was 51.8% for malignant tumor, 67.7% for benign tumor, and 37.5% for pleomorphic adenoma; when MRI suggested benign tumor, it was 32.2% for malignant tumor, 91.5% for benign tumor, and 88.5% for pleomorphic adenoma; and, when MRI suggested pleomorphic adenoma, it was 23.5% for malignant tumor, 93.9% for benign tumor, and 92% for pleomorphic adenoma. CONCLUSION: Systematic association of UFNAB to MRI did not fundamentally improve diagnostic accuracy. UFNAB appeared most valuable in case of history of radiation therapy, in case of tumor fixation, and when MRI diagnosis was uncertain and/or suggested malignant tumor and/or the apparent diffusion coefficient (ADC) was low. The contribution of UFNAB when MRI suggested benign tumor or especially pleomorphic adenoma was more limited.

Surgery under COVID: An observational study.

AIM: To evaluate the surgery program strategy adopted in an adult otorhinolaryngology and head and neck surgery department in an area badly affected by the Covid-19 epidemic peak. The main objective was to analyze the reasons for not cancelling surgeries and the postoperative course of operated patients. The secondary objective was to assess the situation of postponed patients. MATERIAL AND METHODS: A single-center observational study carried out during the COVID-19 period in France included 124 patients scheduled for surgery during the period March 21-May 20, 2020. The number and nature of operations, both performed and postponed, were reviewed. RESULTS: A total of 54.0% patients were operated on during the COVID period and 46.0% were postponed. Operations were maintained in urgent or semi-urgent cases. The operated patients did not show any signs of infection during their hospital stay. A total of 29.8% of postponed patients were lost to follow-up and 49.1% were rescheduled. CONCLUSION: The application of national and international recommendations minimized the risk of loss of chance for operated patients without increasing the risk of contamination. The postponement of canceled operations resulted in considerable loss to follow-up. Intensified follow-up is necessary for these patients.

Impact of the first month of Covid-19 lockdown on oncologic surgical activity in the Ile de France region university hospital otorhinolaryngology departments.

OBJECTIVE: To evaluate the impact of the first month of lockdown related to the Covid-19 epidemic on the oncologic surgical activity in the Ile de France region university hospital otorhinolaryngology departments. MATERIAL AND METHODS: A multicenter prospective observational assessment was conducted in 6 university hospital otorhinolaryngology departments (Paris Centre, Nord, Est and Sorbonne) during the 1-month periods before (Month A) and after (Month B) lockdown on March 17, 2020. The main goal was to evaluate lockdown impact on oncologic surgical activity in the departments. Secondary goals were to report population characteristics, surgery conditions, postoperative course, progression of Covid status in patients and surgeons, and adverse events. RESULTS: 224 procedures were performed. There was 10.9% reduction in overall activity, without significant difference between departments. Squamous cell carcinoma and larynx, hypopharynx, oropharynx, oral cavity and nasal cavity and sinus locations were predominant, at 79% and 75.8% of cases respectively, with no significant differences between months. T3/4 and N2/3 tumors were more frequent in Month B (P=.002 and .0004). There was no significant difference between months regarding surgical approach, type of reconstruction, postoperative course, tracheotomy and nasogastric feeding-tube time, intensive care stay or hospital stay. None of the Month A patients were Covid-19-positive, versus 3 in Month B, without adverse events. None of the otorhinolaryngologists involved in the procedures developed symptoms suggesting Covid-19 infestation. CONCLUSION: The present study underscored the limited impact of the Covid-19 epidemic and lockdown on surgical diagnosis and cancer surgery in the Ile de France university otorhinolaryngology departments, maintaining chances for optimal survival without spreading the virus.

[Oral cavity cancers among young people: Clinical results and prognostic analysis]. / Cancers de la cavité buccale chez les sujets jeunes: résultats thérapeutiques et analyse de facteurs pronostiques.

PURPOSE: Squamous cell carcinomas of the oral cavity occurring in young people represent a specific entity. Its management and prognosis are controversial. We performed a retrospective chart review of all patients aged less than 40 years old and treated at Gustave-Roussy Cancer Centre for a squamous cell carcinomas of the oral cavity between 1999 and 2011. METHODS: Patients and tumour characteristics, type of treatment and follow-up data were collected. Survival data were analysed according to the methods of Kaplan-Meier and both univariate and multivariate analyses were performed to look for prognostic factors regarding overall survival and progression-free survival. RESULTS: Sixty-three patients were identified. Median follow-up was 64 months. Most of the tumours were initially located in the mobile tongue (n=54, 85.7%). Overall 17 patients had died, including 15 from the treated cancer. Overall and progression-free survival rates at 5 years were respectively 79.6% and 68.6%. The corresponding 5 years local, regional and metastatic relapse free survival rates were 80%, 91% and 89% respectively. In the multivariate analysis only the absence of initial surgery (hazard ratio [HR]: 13.5 [2.0; 90.5]; P=0.007) was prognostic for overall survival, while alcohol abuse (HR: 0.37 [0.15; 0.9]; P=0.03) and the absence of surgery (HR: 13.6 [2.5; 74.2]; P=0.002) were associated with a decreased progression-free survival. A younger age (less than 30 year old) was not associated with the risk of recurrence or death. CONCLUSION: Survival rates and tumour control probabilities are relatively high among young patients suffering from squamous cell carcinomas of the oral cavity treated at a tertiary centre. The early identification of patients at risk of relapse is currently difficult. The balance between recurrence and treatment toxicity warrants further studies, both on the clinical level and for the development of prognostic biomarkers.

Do high-risk human papillomaviruses cause oral cavity squamous cell carcinoma?

High-risk human papillomaviruses (HR-HPV) are an established etiologic factor for a growing number of oropharyngeal cancers. However, their potential role in other upper aerodigestive tract locations is still a matter of debate, particularly in the oral cavity. This is of paramount importance as in the future diagnosis, treatment and follow up in head and neck squamous cell carcinoma may vary according to HPV status. This article reviews the recent published data and highlights some of the pitfalls that have hampered the accurate assessment of HR-HPV oncological role outside the oropharynx. We demonstrate that, in contrast to the oropharynx, only a small fraction of cancers located in the oral cavity seem to be HPV-related even in young non-smoking non-drinking patients. We emphasize several relevant factors to consider in assumed HPV-induced oral cavity cancers and discuss the current theories that explain why HPV-induced cancers arise preferentially in the oropharynx.

Treatment de-escalation in HPV-positive oropharyngeal carcinoma: ongoing trials, critical issues and perspectives.

Due to the generally poor prognosis of head and neck squamous cell carcinoma (HNSCC), treatment has been intensified, these last decades, leading to an increase of serious side effects. High-risk human papillomavirus (HR-HPV) infection has been recently etiologically linked to a subset of oropharyngeal squamous cell carcinoma (OPSCC), which is on the increase. These tumors are different, at the clinical and molecular level, when compared to tumors caused by traditional risk factors. Additionally, their prognosis is much more favorable which has led the medical community to consider new treatment strategies. Indeed, it is possible that less intensive treatment regimens could achieve similar efficacy with less toxicity and improved quality of life. Several clinical trials, investigating different ways to de-escalate treatment, are currently ongoing. In this article, we review these main approaches, discuss the rationale behind them and the issues raised by treatment de-escalation in HPV-positive OPSCC.

Squamous cell carcinoma of the larynx with subglottic extension: is larynx preservation possible?

PURPOSE: Squamous cell carcinoma of larynx with subglottic extension (sSCC) is a rare location described to carry a poor prognosis. The aim of this study was to analyze outcomes and feasibility of larynx preservation in sSCC patients. PATIENTS AND METHODS: Between 1996 and 2012, 197 patients with sSCC were treated at our institution and included in the analysis. Stage III-IV tumors accounted for 76%. Patients received surgery (62%), radiotherapy (RT) (18%), or induction chemotherapy (CT) (20%) as front-line therapy. RESULTS: The 5-year actuarial overall survival (OS), locoregional control (LRC), and distant control rate were 59% (95% CI 51-68), 83% (95% CI 77-89), and 88% (95% CI 83-93), respectively, with a median follow-up of 54.4 months. There was no difference in OS and LRC according to front-line treatments or between primary subglottic cancer and glottosupraglottic cancers with subglottic extension. In the multivariate analysis, age > 60 years and positive N stage were the only predictors for OS (HR 2, 95% CI 1.2-3.6; HR1.9, 95% CI 1-3.5, respectively). A lower LRC was observed for T3 patients receiving a larynx preservation protocol as compared with those receiving a front-line surgery (HR 14.1, 95% CI 2.5-136.7; p = 0.02); however, no difference of ultimate LRC was observed according to the first therapy when including T3 patients who underwent salvage laryngectomy (p = 0.6). In patients receiving a larynx preservation protocol, the 5-year larynx-preservation rate was 55% (95% CI 43-68), with 36% in T3 patients. The 5-year larynx preservation rate was 81% (95% CI 65-96) and 35% (95% CI 20-51) for patients who received RT or induction CT as a front-line treatment, respectively. CONCLUSION: Outcomes of sSCC are comparable with other laryngeal cancers when managed with modern therapeutic options. Larynx-preservation protocols could be a suitable option in T1-T2 (RT or chemo-RT) and selected T3 sSCC patients (induction CT).