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Objective: This study evaluated the very long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position, with particular attention to structural valve deterioration based on echocardiographic criteria., Methods: From 1984 to 2016, 648 patients (mean age 68.8 years; 53.9% female) underwent mitral valve replacement using the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Multiple valve replacements were excluded. Clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.8 ± 5.4 years, for a total of 5043 valve-years. The follow-up data were 98.3% complete (11 patients lost). Structural valve deterioration was determined by strict echocardiographic assessment based on Heart Valve Collaboratory criteria., Results: Operative mortality was 4%. A total of 322 late deaths occurred, for a linearized rate of 6.4%/valve-year. The actuarial survival rate at 15 years was 31.4 ± 2.6%. Age at implantation, male sex, and preoperative New York Heart Association class III or IV were significant risk factors affecting late survival. Actuarial freedoms from complications at 15 years were thromboembolism, 92.5 ± 1.9%; major bleeding, 93.8 ± 1.7%; endocarditis, 93.2 ± 1.3%; and explantation due to structural valve deterioration, 69.3 ± 3.5%. The median survival time for explantation due to structural valve deterioration was 21.7 years for the entire cohort (16.1 years for patients <65 years old). Based on echocardiographic data, actuarial freedom from severe and moderate/severe structural valve deterioration at 15 years were 64.0 ± 3.6% and 52.1 ± 3.6%, respectively., Conclusions: With low 15-year rates of valve-related events and structural valve deterioration based on Heart Valve Collaboratory echocardiographic criteria, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve., Competing Interests: Conflict of Interest Statement F.E. reported Duomed France Solutions: payment for lecture. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the relation between immune microenvironment, survival, and clinicopathological characteristics., Methods: This study was a retrospective, single-center, observational study. Patients with a vulvovaginal melanoma and available archived material were included. All cases underwent pathology review, tumor-infiltrating lymphocyte quantification, and next-generation sequencing analysis, when feasible. Clinical data included demographic, treatment, and prognostic data., Results: Forty-two patients were selected during the study period, but 13 were finally excluded owing to unavailable formalin-fixed, paraffin-embedded material or unknown follow-up data. Twelve of 19 cases (63.2%) had at least one genetic mutation, 3/18 (16.7%) had BRAF, 3/18 (16.7%) had c-KIT mutation, and 4/17 (23.5%) had NRAS mutations. High stromal tumor-infiltrating lymphocytes were identified in 13/28 patients (46.4%), and brisk tumor-infiltrating lymphocytes in 17/28 patients (60.7%). A density of stromal tumor-infiltrating lymphocytes >40% and brisk distribution were the single clinicopathologic factor associated with increased disease-free survival., Conclusion: The study showed that brisk tumor-infiltrating lymphocytes and stromal tumor-infiltrating lymphocytes were a marker for disease progression, and for response to immunotherapy strategies. To validate these findings on a larger scale, further research is warranted through a multicenter study with a larger cohort and additional genetic and translational analysis., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The reporting of adverse events (AEs) is fundamental to characterize safety profiles of novel therapeutic drug classes, however, conventional analysis strategies are suboptimal tools for this task. We therefore attempted to contribute to the modernization of AE analysis by encompassing the dimension of time, the duration and the recurrent nature of AEs induced by these extended treatment durations. This paper presents and highlights the benefits of alternative approaches to modernize AE analysis based on the MOTIVATE prospective study modeling immune-related AEs (irAEs) in patients with solid tumors (regardless of the primary site) treated with immune checkpoint inhibitor irrespective of disease stage. The probability of presenting an irAE over time was estimated using the prevalence function. The time-to-onset (TTO) and the mean number of recurrent irAEs were also assessed. Among the 147 patients analyzed, 39.7% had a melanoma, 37.7% a non-small cell lung cancer (NSCLC) and 74.8% were treated for metastatic disease. Despite a higher proportion of melanoma patients presenting at least one irAE, the prevalence of irAEs was lower in melanoma than in NSCLC patients over time. TTO analysis showed that irAEs occurred earlier in NSCLC patients whereas melanoma patients experienced more recurrent irAEs over the long-term. The prevalence function of non-metastatic and metastatic patients revealed different long-term toxicity profiles. These alternative methodologies capture different toxicity patterns (time-to-onset, recurrent, acute episodic or long-term moderate AEs) and provide a more consistent safety assessment for new therapeutics, thereby assisting clinicians and health authorities in their therapeutic decision-making processes., Competing Interests: Declarations. Ethics approval: The protocol was approved by a French Ethical Research Committee (CPP) and registered in Clinical-Trials.gov (NCT03447483). The study was conducted in accordance with the Declaration of Helsinki and ICH guidelines for Good Clinical Practice. Written informed consent was obtained from all patients prior to inclusion. Consent to participate: Informed consent was obtained from all individual participants included in the study. Competing interests: CGR reported receiving personal fees from BMS, Macomics, Pharmamar, Pierre Fabre, Roche / Genentech outside the submitted work; institutional fees from Amunix, BMS, Hookipa, IDEAYA, Kazia Therapeutics outside the submitted work; research grant from Roche / Genentech outside the submitted work. MV reported receiving personal fees from Lilly, BMS outside the submitted work. DL reported receiving personal fees from Roche, AstraZeneca, Pfizer, Novartis, MSD, Daiichi Sankyo, Lilly, Amgen, EISAI, Exact Sciences, Gilead, Daiichi outside the submitted work; support for attending meetings and/or travel from Roche, AstraZeneca, Pfizer, Novartis, MSD, Gilead outside the submitted work. VS reported receiving personal fees from BMS, MSD, Sanofi, Janssen, Astellas, Incyte, Bayer, Pierre Fabre outside the submitted work. JPD reported receiving institutional fees from BMS, Merck Serono, MSD, Pierre Fabre, Roche ouside the submitted work; research grant from Amgen, AstraZeneca, BMS, Genentech, MSD, Transgene outside the submitted work. TF reported receiving personal fees from Jansen outside the submitted work; institutional fees from Roche, Lilly outside the submitted work. All other authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

While treatment of localized cutaneous squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) is based on surgery, brachytherapy, which delivers a high dose of radiation to tumor tissue while sparing healthy tissue, is an alternative. Since the withdrawal of iridium wires from the market, brachytherapy has mainly been performed with high-dose-rate iridium-192 (HDR). This study evaluated the efficacy of HDR brachytherapy in terms of local control, survival, toxicity, and quality of life in patients with facial periorificial cutaneous SCC or BCC treated in our center between 2015 and 2021. Sixty-seven patients were treated for SCC ( n = 49) or BCC ( n = 18), on the nose ( n = 29), lip ( n = 28), eyelid ( n = 7), or ear ( n = 3). The majority had Tis or T1 tumors (73.1%). After a median follow-up of 28 months, 8 patients had a local recurrence. The local control rate at 3 years was 87.05% (95% CI 74.6-93.7). All patients developed grade 1-2 acute radio-mucositis or radiodermatitis and one experienced reversible grade 3 acute radio-mucositis. Of the 27 patients who completed the quality-of-life questionnaire, 77.8% recommended the treatment. This study confirms that HDR brachytherapy for facial cutaneous carcinomas provides good local control, good tolerance, and satisfactory functional outcome.

Background: We aimed to assess the effectiveness of a single-institution protocol of videofluoroscopic swallowing study (VFSS) for the detection of pharyngeal leak (PL) and its usefulness to mitigate evolution into subsequent pharyngocutaneous fistula (PCF) after total (pharyngo-) laryngectomy (TL)., Methods: This retrospective single-center study was conducted between February 2014 and December 2022. We included all patients who underwent TL and performed a VFSS between Day 7 and Day 14 postoperatively to detect a subclinical PL., Results: Two-hundred and forty-eight patients met the inclusion criteria. Among the 186 patients (75%) with a negative VFSS, 11 patients (5.9%) developed a secondary PCF after oral intake resumption (false negative of VFSS). Among the 62 patients (25%) with a positive VFSS, the occurrence of a PCF was avoided in 59.7% of cases., Conclusion: This study showed a good effectiveness of VFSS in the detection of PL after TL, alongside a usefulness to mitigate evolution into subsequent PCF., (© 2024 Wiley Periodicals LLC.)

Background: Data suggest an association between positron emission tomography/CT (PET/CT) metabolic metrics and tumor microenvironment in several malignancies, and a potential role of PET/CT to monitor response to immunotherapy., Objective: To evaluate the correlation between tumor loco-regional extension and tumor-infiltrating lymphocyte infiltration in locally advanced cervical cancer prior to concurrent chemo-radiotherapy.The secondary objective was to assess the association between tumor-infiltrating lymphocytes and PET/CT metabolic metrics., Methods: Patients with locally advanced cervical cancer and negative para-aortic extensions on PET/CT were included. Two senior nuclear medicine physicians specializing in gynecologic oncology reviewed all PET/CT exams, and extracted tumor maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis, as well as pelvic lymph node involvement. One senior gynecologic oncology pathologist assessed intraepithelial tumor-infiltrating lymphocytes and stromal tumor-infiltrating lymphocytes. Intraepithelial tumor-infiltrating lymphocytes were categorized following previous studies as <1% and >1%. The cut-off for stromal tumor-infiltrating lymphocytes was chosen empirically: intermediate <60% and high >60%., Results: 86 patients were included. Intraepithelial tumor-infiltrating lymphocytes were not significantly associated with tumor metabolic metrics. Intraepithelial tumor-infiltrating lymphocytes were not significantly associated with maximum standard uptake value (p=0.16), or metabolic tumor volume (p=0.19). Tumors with <1% intraepithelial tumor-infiltrating lymphocytes score were associated with a higher MRI tumor size (≥ median) (63.3% vs 39.3%, p=0.04). Patients with pelvic lymph node uptake were significantly more frequent in patients with high stromal tumor-infiltrating lymphocytes score (≥60%) (61.5% vs 31.7%, p=0.009)., Conclusions: Poor or absent intraepithelial tumor-infiltrating lymphocytes were associated with more advanced disease at diagnosis and larger tumor size. Tumor-infiltrating lymphocytes were not associated with tumor metabolic activity. Intraepithelial and stroma tumor-infiltrating lymphocytes are not redundant and should be assessed separately. Further work is needed to evaluate the association between tumor metabolic profile and immune populations, including different T-cell subtypes for patient selection for immunotherapy strategies., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The authors report on 48 patients operated by hemi-laryngo-pharyngectomy for spinous carcinoma of the piriform sinus. They try to precise the indications by analysing the factors influencing survival and relapses. They compare surgery to the other methods. In a second part, they report 3 cases of posterior pharyngectomy by bilateral cervical incision.

Use of a moulded aponeurotic graft, shapened and then made rigid by heat and formalin, is a seductive method of tympanic reconstruction because of its simplicity and availability. Indications for and results of the application of this method are analyzed based on experience of 158 cases, with sufficient follow up in 90. The principal indication for use is large perforations, when it is possible to exteriorize the whole canal and almost all the tympanic remains, while doubt exists as to its advantages for treatment of small perforations. Its essential advantage is in fact the ease with which the graft can be positioned on external surface of malleus and inside the remains of tympanic membrane. Overall anatomical results were very satisfactory (83.5%) if one includes in failures of treatment the apparent lateralizations of graft. Functional results were poorer, with rarely complete recovery of hearing and a certain number of labyrinthizations possibly due to injury to handle of malleus or even perforation of canal. Secondary degradation of favorable results may develop because of some degree of lateralization of the newly formed tympanic membrane. These could perhaps be avoided by the technical artifices proposed by other authors.

Fistula of the fourth endobrachial pouch, a congenital malformation, can be defined as an abnormal persistence of the canal joining the base of the piriform sinus and the deep surface of the lateral lobe of the thyroid. These fistulae, which have been more clearly understood over the last ten years, still constitute a delicate surgical problem, which is rarely discussed in the literature, based on the detection of their tract at their origin, the piriform sinus. The 8 cases operated at Hôpital Necker since 1981 reveal the variability of their tract, which, according to the authors, warrants an anatomosurgical analysis.

A total of 434 functional évidements of neck were conducted in 313 patients, taking into account all primary localizations. Details of the procedure used are described while emphasizing the need for an évidement tending towards one as complete as a radical operation. Surgery was usually elective (89% of cases) but in 11% considered as essential. A high proportion of lymph nodes classified as no were, however, found to be invaded (22.8%, including 27.5% of these with capsule rupture). Despite this, glandular recurrence on the side of functional évidement was extremely low (less than 7%) even when recurrence was epithelial or involved a second localization. These findings emphasize the validity of functional évidement and confirm published data, known to be difficult to analyze. Although the value of this operation with respect to the cancer is well established, the actual functional interest, particularly in relation, to external branch of XI th nerve is debatable.