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In patients with squamous cell carcinoma of the head and neck (SCCHN), delayed surgery can result in poorer postoperative function and prognosis due to the growth of the tumor and extended surgery. Further, delay may even make the tumor unresectable. To prevent tumor growth during the waiting period before surgery, S-1 has been administrated preoperatively at several facilities in Japan. To date, however, the safety and efficacy of preoperative S-1 remain unclear.We conducted a retrospective cohort study of 118 patients with SCCHN treated with S-1 before radical surgery at 2 institutions in Japan. We evaluated the safety of S-1 therapy, which was evaluated by the incidence of grade 3 or greater adverse events (AEs). The rate of achievement of non-growth of tumors was also calculated.Regarding safety, 125 AEs of all grades were recorded in 71 patients (60%). Of these, grade 3 AEs were detected in 3 patients (3%), and no grade 4 or 5 AEs occurred. The nongrowth rate of primary lesions and lymph node metastases was 89% and 85%, respectively.Preoperative S-1 therapy might be useful, with acceptable toxicity, on an outpatient basis in patients with SCCHN.

There are no real-world comparative data of nivolumab doses of 3 mg/kg and 240 mg/body for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We investigated the efficacy and safety of nivolumab in treating recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) at different doses using real-world data.R/M SCCHN patients who received nivolumab were divided into the 3 mg/kg and 240 mg/body groups and retrospectively examined for efficacy and safety.A total of 199 patients (3 mg/kg and 240 mg/body, 88 and 111 patients, respectively) were included. The 3 mg/kg vs. 240 mg/body groups had similar overall response rates (15% vs. 25, p=0.15), disease control rates (46% vs. 57%, p=0.15), overall survival (9.5 months vs. 10.9 months), and progression-free survival (3.7 months vs. 3.8 months, p=0.95). The incidence of immune-related adverse events was also similar in both groups.In R/M SCCHN patients, nivolumab showed similar efficacy and safety at doses of 3 mg/kg and 240 mg/body.

Nivolumab has antitumor efficacy in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) who relapse within 6 months after platinum-based therapy; however, the efficacy of nivolumab for platinum-sensitive R/M HNSCC has not been shown. Therefore, this study compared the efficacy and safety of nivolumab for platinum-refractory and platinum-sensitive R/M HNSCC.This was a retrospective study of patients who received nivolumab for R/M HNSCC who had been previously treated with platinum-based anticancer drugs. Patients were divided into a platinum-sensitive and a platinum-refractory group, and progression-free survival (PFS), overall survival (OS), the overall response rate (ORR) [complete response (CR) + partial response (PR)], the disease control rate (DCR) (CR + PR + stable disease), and the incidence of immune-related adverse events (irAEs) were compared between the two groups.We included 88 patients with squamous cell carcinoma: 60 with platinum-refractory disease and 28 with platinum-sensitive disease. The median PFS in the platinum-refractory and platinum-sensitive groups were 2.7 months and 5.3 months, respectively (p=0.03), and the median OS were 8.8 months and 17.1 months, respectively (p=0.06). There were no significant differences in the ORR, DCR, or incidence of irAEs between the two groups (p0.99, p=0.11, and p0.99, respectively).Nivolumab is a safe and effective treatment for platinum-sensitive R/M HNSCC.

Adenosquamous carcinoma is a rare malignant tumor in the oral region. We encountered a case of T2 adenosquamous carcinoma of the tongue with unusual secondary cervical lymph nodes metastases. A 45-year-old man was admitted to our hospital with a complaint of pain in the right side tongue in November 2016. A partial glossectomy was performed with a diagnosis of right side tongue cancer (cT2N0M0, squamous cell carcinoma) based on image findings and histopathological examination. Postoperative six months, no clear metastasis was observed, but total neck dissection was performed in July 2017 due to subjective symptoms. Histopathological examination of metastatic lymph nodes revealed mucus-producing cells and CK7-positive cells, and the diagnosis was cervical lymph nodes metastases of adenosquamous carcinoma of the tongue. chemoradiotherapy with cisplatin was performed because extranodal extension was observed. After that, cetuximab and paclitaxel combination therapy was started because of left lung metastasis, but in July 2018, he became PD and in September, his general condition deteriorated and he died asleep.

For the development of sustainable energy and a great reduction of CO2 emission into the atmosphere, renewable energy has been rapidly installed and used in the last two decades. Many biomass power...

Parapharyngeal space tumors are rare. Among them, tumors in the prestyloid compartment are particularly suitable for surgery; however, there are no detailed reports of such surgery and their features remain unknown. We conducted a retrospective cohort study. For 67 surgical cases of benign tumors in this compartment, we examined the patient and tumor characteristics, fine-needle aspiration cytology (FNAC), and intraoperative details such as surgical approach, use of complete excision, and postoperative complications. Pleomorphic adenomas (PAs) comprised 73.1% of the lesions. The diagnostic accuracy of FNAC to differentiate benign and malignant tumors was 97.7%. Of the treated lesions, 94.0% were removed via the cervical approach alone, including all PAs. The remaining 6.0% were resected via the cervical–parotid approach. The median operative time and bleeding volume were 89 min and 50 mL, respectively. Operative time using the cervical approach was significantly shorter (p = 0.021). All cases could be treated via complete surgical excision. Postoperative complications occurred in 32.8% of patients, with transient slight facial palsy being the most common. No fatal complications occurred and 92.5% of patients had no sequelae. There was no significant association between complications and surgical approach. Based on diagnosis by FNAC, with a high accuracy rate, most benign prestyloid tumors, especially PAs, were resected using the cervical approach alone, with a shorter operative time and without severe complications.

Chondrosarcoma is accounts for some 10 % of osteogenic malignant tumors, its development from a jawbone is very rare. We have experienced a patient with chondrosarcoma developing in the condyler head as reported below. The patient was a 42-year-old man. elastic hard swelling was observed in a location corresponding to the left condyler head. Radiographically, a neoplastic lesion was detected in the left head of mandible with no bone destruction in the skull base. Histopathological examination was performed under general anesthesia. Based on the diagnosis of suspected condyler head chondrosarcoma, tumor resection,left supraomohyoid neck dissection and reconstruction with an anterolateral thigh flap were performed under general anesthesia of the next month. A histopathologycal observation of removed tissue samples confirmed chondrosa-rcoma. No abnormality such as tumor recurrence has been found for seven years postope-ratively.

A drag model based on the “spatial superposition” assumption is built to better simulate the local heterogeneous structure of the downer in a triple-bed circulating fluidized bed system. Because of this special assumption, fewer structure parameters will be required to describe the local structure, and the number of corresponding governing equations derived to converge the model calculation decreases, significantly saving calculation time when compared with the classic multi-scale model. To improve the efficiency and ensure the stability of the coupling calculation, we calculate the heterogeneous index (Hd) by introducing a matrix and then further couple it with the momentum equation in the two-fluid model. The Hd values exhibit a valley-shaped surface trend, which agrees positively with other reported works. The coupling simulation results indicate that this model can more accurately predict the axial solids holdup distribution than the Gidaspow drag model. Additionally, based on the calculated axial pressure and pressure gradient distribution under different superficial gas velocities or solid mass fluxes, the widely accepted flow pattern in a downer can be clearly captured. Through comparison with results from the classic multi-scale drag model, we confirmed that this developed model is useful and can be further applied to other gas-solid systems with heterogeneous structures.

Background/aim The treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) has remained challenging. The effect of salvage chemotherapy (SCT) after nivolumab has been identified recently in other cancer types. The aim of this study was to examine the efficacy of SCT after nivolumab treatment in patients with R/M HNSCC. Patients and methods A retrospective study was conducted at four institutions in Japan. Fifty-six patients were enrolled in the study. Results The overall survival (OS) in SCT patients was significantly longer than that in best supportive care (BSC) patients. In the SCT patients, the median OS, median progression-free survival (PFS) and objective response rate (ORR) were 7.3 months, 2.3 months and 36%, respectively. Prognostic factor for OS and ORR was performance score (PS) and previous radiation, respectively. Conclusion SCT after nivolumab is associated with better clinical outcomes in patients with R/M HNSCC compared to those receiving BSC.

In recent years, the introduction of a gasification and direct melting system (GDMS) has been promoted for carbon recycle and energy recovery from carbonaceous waste, and for extending the life of ...

Background There is increasing evidence that immunotherapy with nivolumab, an anti‐programmed death 1 monoclonal antibody, is effective in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). However, the predictive role of hematological inflammatory markers such as neutrophil‐to‐lymphocyte ratio (NLR) and the modified Glasgow prognostic score (mGPS) in patients with R/M SCCHN treated with nivolumab remains unclear. Methods We conducted a multi‐institutional cohort study to evaluate the impact of pretreatment NLR and mGPS on overall survival (OS) and progression‐free survival (PFS) in patients with R/M SCCHN treated with nivolumab in Japan. From 2012 to 2013, 102 patients were eligible, of whom 88 were finally included in the analysis. mGPS was calculated as follows: mGPS of 0, C‐reactive protein (CRP) ≤1.0 mg/dL; 1, CRP > 1.0 mg/dL; and 2, CRP > 1.0 mg/dL and albumin, Immunotherapy with nivolumab is effective in the treatment of R/M SCCHN. However, reliable predictive markers have remained unclear. Higher pre‐treatment NLR and mGPS were significantly associated with worse survival, suggesting that these markers may be predictors of treatment with nivolumab.

A Eulerian-Eulerian model incorporating the kinetic theory of granular flow was adopted to simulate the gas-solids flow behaviors in a dense downer below a conventional downer, which could be used for the further pyrolysis of coal and/or decomposition of tar on the generated char before the char and tar are completely separated in a triple-bed combined circulating fluidized bed (TBCFB) system. The high solids holdup in the dense downer can enhance the heat transfer to completely pyrolyze coal as well as decompose the heavy tar, avoiding the negative impact of pyrolysis products on char gasification. In order to obtain the optimal structural parameters and operating conditions and evaluate the performance of this dense downer, the influences of downer diameter, cone angle and solids mass flux on the hydrodynamic behaviors were investigated in details. The results demonstrate that the solids holdup in the dense downer can be increased, however, the maximum solids holdup is limited to approximately 0.4 owing to the ultimate carrying capacity. Moreover, it is found that there is a peak solids holdup in the annular region near the wall whereas many particles concentrate at the center in the high-density operation states. Meanwhile, the unique solids radial distribution could be caused by the radial movement of particles. Moreover, the intense collisions and turbulence caused by high velocity could inhibit agglomerates, which should be benefit for the heat transfer. It is expected that these results could offer a guidance for the design of such a dense downer for effective improvement of the efficiency of the pyrolyzer.

Background: In patients with squamous cell carcinoma of head and neck (SCCHN), delayed surgery can result in poorer postoperative function and prognosis due to the growth of the tumor and the extended surgery. Further, delay may even make the tumor unresectable. To prevent tumor growth during the waiting period before surgery, S-1 has been administrated preoperatively at several facilities in Japan. To date, however, the safety and efficacy of preoperative S-1 remains unclear.Methods: We conducted a retrospective cohort study of 118 patients with SCCHN treated with S-1 before radical surgery at 2 institutions in Japan. We evaluated the safety of S-1 therapy, which was evaluated by the incidence of grade 3 or greater adverse events (AEs). The rate of achievement of the non-growth of tumors was also calculated.Results: Regarding safety, 125 AEs of all grades were recorded in 71 patients (60%). Of these, grade 3 AEs were detected in 3 patients (3%), and no grade 4 or 5 AEs occurred. The non-growth rate of primary lesions and lymph node metastases was 89% and 85%, respectively. Conclusion: Our data showed that preoperative S-1 therapy might be useful with acceptable toxicity on an outpatient basis in patients with SCCHN.

ObjectiveSalivary duct carcinoma (SDC) is a highly aggressive and uncommon tumor arising not only de novo but also in pleomorphic adenoma. Androgen receptor (AR)- and HER2-targeted therapy have recently been introduced for SDC as promising treatment options; however, no predictive biomarkers have yet been established. EZH2 and H3K27me3 are closely linked to the development and progression of various cancers, and EZH2 is also expected to be a desirable therapeutic target. We therefore explored the clinicopathological and prognostic implications of EZH2 and H3K27me3 in a large cohort of SDC patients, focusing on their impact on the therapeutic efficacy of AR- or HER2-targeted therapy.Materials and MethodsThe EZH2 and H3K27me3 immunohistochemical expression and EZH2 Y646 gain-of-function mutation status were examined in 226 SDCs, and the relationship with the clinicopathological factors as well as clinical outcomes were evaluated within the three groups depending on the treatment: AR-targeted (combined androgen blockade with leuprorelin acetate and bicalutamide; 89 cases), HER2-targeted (trastuzumab and docetaxel; 42 cases), and conventional therapy (112 cases).ResultsEZH2 and H3K27me3 were variably immunoreactive in most SDCs. A positive correlation was found between the expression of EZH2 and H3K27me3. The EZH2 expression in the SDC component was significantly higher than that in the pre-existing pleomorphic adenoma component. EZH2 Y646 was not identified in any cases. EZH2-high cases more frequently had an advanced clinical stage and aggressive histological features than EZH2-low cases. An EZH2-high status in patients treated with AR-targeted therapy was associated with a significantly shorter progression-free and overall survival as well as a lower objective response rate and clinical benefit rate. In addition, a H3K27me3-high status in patients treated with AR-targeted therapy was related to a shorter overall survival. Conversely, there was no association between the EZH2 and H3K27me3 expression and the clinical outcomes in the conventional or HER2-targeted therapy groups.ConclusionsA high expression of EZH2 and H3K27me3 in SDC might be a predictor of a poor efficacy of AR-targeted therapy. Our data provide new insights into the role of EZH2 and H3K27me3 in therapeutic strategies for SDC.

Molecular targets and predictive biomarkers for prognosis in salivary duct carcinoma (SDC) have not been fully identified. We conducted comprehensive molecular profiling to discover novel biomarkers for SDC. A total of 67 SDC samples were examined with DNA sequencing of 464 genes and transcriptome analysis in combination with the clinicopathological characteristics of the individuals. Prognostic biomarkers associated with response to combined androgen blockade (CAB) treatment were explored using mRNA expression data from 27 cases. Oncogenic mutations in receptor tyrosine kinase (RTK) genes or genes in the MAPK pathway were identified in 55 cases (82.1%). Alterations in the phosphatidylinositol 3-kinase (PI3K)/AKT signaling pathway were identified in 38 cases (56.7%). Interestingly, patient prognosis could be predicted using mRNA expression profiles, but not genetic mutation profiles. The risk score generated from the expression data of a four-gene set that includes the ADAMTS1, DSC1, RNF39, and IGLL5 genes was a significant prognostic marker for overall survival in the cohort (HR = 5.99, 95% confidence interval (CI) = 2.73–13.1, p = 7.8 × 10−6). Another risk score constructed from the expression of CD3E and LDB3 was a strong prognostic marker for progression-free survival for CAB treatment (p = 0.03). Mutations in RTK genes, MAPK pathway genes, and PI3K/AKT pathway genes likely represent key mutations in SDC tumorigenesis. The gene expression profiles identified in this study may be useful for stratifying patients who are good candidates for CAB treatment and may benefit from additional systemic therapies.

Background/aim Prognostic factors of hypopharyngeal carcinoma have been reported previously. However, recurrent cases of this disease occurring within 6 months of treatment have been excluded or poorly documented in many studies. We aimed to evaluate the prognostic factors of hypopharyngeal carcinoma recurrence within 6 months. Patients and methods A total of 120 patients were eligible for this retrospective study. Recurrent cases of hypopharyngeal carcinoma occurring within 6 months of treatment were evaluated and compared with non-recurrent cases. Results Recurrence within 6 months was detected in 28/50 cases. In univariate analyses, classification markers (pT≥4a and cN≥2b) were statistically significant prognostic factors for early recurrence (p=0.04 and p=0.04, respectively); however, only pT≥4a was predictive of recurrence in multivariate analyses (p=0.02). Conclusion Risk stratification according to the prognostic factor pT≥4a will allow physicians to identify patients who should be followed meticulously within the first 6 months.

Salivary duct carcinoma (SDC) is a rare, aggressive malignancy that histologically resembles high-grade mammary duct carcinoma. Because of the rarity of this entity, data verifying the association between histologic features and patient survival are limited. We conducted a comprehensive histologic review of 151 SDC cases and performed an analysis of the association between various histomorphologic parameters and the clinical outcome with the aim of developing a histologic risk stratification model that predicts the prognosis of SDC patients. A multivariate analysis revealed that prominent nuclear pleomorphism (overall survival [OS]: P=0.013; progression-free survival [PFS]: P=0.019), ≥30 mitoses/10 HPF (PFS: P=0.013), high tumor budding (OS: P=0.011; PFS: P

Circulating fluidized beds (CFB)s are important technical equipment to treat gas–solid systems for fluid catalytic cracking, combustion, gasification, and high-temperature heat receiving because their mass and heat transfer rates are large. Cyclones are important devices to control the performance of CFBs and ensure their stable operation; heat-carrying and/or solid catalyst particles being circulated in a CFB should be efficiently separated from gas at a reduced pressure loss during separation. In commercial CFBs, a large amount of solids (> 1 kg-solid (m3-gas)−1 or > 1 kg-solid (kg-gas)−1) is circulated and should be treated. Thus, gas–solid cyclones with a high solids loading should be developed. A large number of reports have been published on gas–solid separators, including cyclones. In addition, computational fluid dynamics (CFD) technology has rapidly developed in the past decade. Based on these observations, in this review, we summarize the recent progress in experimental and CFD studies on gas–solid cyclones. The modified pressure drop model, scale-up methodology, and criteria for a single large cyclone vs. multiple cyclones are explained. Future research perspectives are also discussed.

In order to achieve power-generation efficiency higher than those of integrated coal gasification combined cycle plants, advanced integrated coal gasification combined cycle systems have been developed. Here, we developed a triple-bed combined circulating fluidized bed gasifier model using the commercial process simulator Aspen Plus® (version 8.6) and Excel®. The heat balance and reaction kinetics, including the inhibition of steam gasification by H2, were simulated for a combustor temperature of 950 °C using porous alumina particles as heat-carrying particles. The theoretical maximum cold gas efficiency of the triple-bed combined circulating fluidized bed gasifier model was 85.0% for a gasification temperature of 800 °C. However, when the temperature was increased to 900 °C, the efficiency decreased to 80.9%. This indicates that, for triple-bed combined circulating fluidized bed gasifiers, a relatively low gasification temperature is suitable for ensuring higher cold gas efficiency and reducing the amount of circulating heat-carrying particles needed. On the other hand, gasification temperatures lower than 850 °C resulted in significantly higher bubbling fluidized bed gasifier volumes even when an effective Ca-based catalyst was used. The cold gas efficiency can be increased further by 8.6% by converting and recovering the missing hydrogen as H2 gas. Hence, there is a trade-off between the cold gas efficiency, gasifier size, and heat-carrying particle/coal ratio. The optimal gasification temperature for triple-bed combined circulating fluidized bed gasifier is 850 °C.

Solids volumetric flux (Vs), which is expected to replace the solids mass flux (Gs) as the key factor influencing solids holdup in circulating fluidized beds, was proposed to investigate the solids holdup variation and predict the extreme operation conditions in the downers. In this work, by using more than 400 sets of experimental data from different literature in Response Surface Methodology (RSM) analysis, it is found that the overestimation of particle density effect on the solids holdup can be avoided by converting the Gs into Vs. Further studies indicated that the difference of solids holdup (Δes) resulted from the different types of particles increased with the increase in Vs as well as the decrease in superficial gas velocity (Ug). Based on the normalized fitting results, the effects of different factors on the solids holdup were characterized. It is concluded that the effect extent was in the order of Vs > Ug >> particle size (dp) > particle density (ρp), which provided a guidance to control the solids holdup to satisfy the requirements in the downer by adjustment of various parameters, that is, Vs and Ug can adjust solids holdup roughly whereas dp and ρp can adjust solids holdup finely. Meanwhile, it is found that the upper limit of solids volumetric flux (Vs,max) can be increased by the increase of Ug, dp and/or ρp. In addition, it is considered that using Vs to replace Gs to define high-density operation in the downer could be more suitable in this study.

Purpose Clinical evidence demonstrating the effectiveness of systemic therapy for advanced salivary duct carcinoma (SDC) is lacking because of the disease’s rarity. We assessed the efficacy and toxicity of trastuzumab plus docetaxel in patients with locally advanced and/or recurrent or metastatic human epidermal growth factor receptor 2–positive SDC. Patients and Methods This was a single-center, single-arm, open-label, phase II study in Japan. The patients received trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks. Docetaxel 70 mg/m2 was administrated every 3 weeks. The primary end point was the overall response rate; the secondary end points included the clinical benefit rate, progression-free survival, overall survival, and toxicity. This study is registered with the University Hospital Medical Information Network Clinical Trials Registry (Identification No. UMIN000009437). Results Fifty-seven eligible patients with SDC were enrolled. The overall response rate was 70.2% (95% CI, 56.6% to 81.6%), and the clinical benefit rate was 84.2% (95% CI, 72.1% to 92.5%). Median progression-free and overall survival times were 8.9 months (95% CI, 7.8 to 9.9 months) and 39.7 months (95% CI, not reached), respectively. The most frequent adverse event was anemia (52 patients [91%]), followed by a decreased WBC count (51 patients [89%]) and neutropenia (50 patients [88%]). The most frequently observed grade 4 adverse event was a decreased neutrophil count (34 patients [60%]). Grade 3 febrile neutropenia was reported in eight patients (14%). No grade 2 or greater adverse events of heart failure or left ventricular ejection fraction decline to less than 50% occurred. Conclusion Our data show encouraging efficacy of trastuzumab plus docetaxel therapy in patients with human epidermal growth factor receptor 2–positive SDC, with a manageable toxicity profile.

Simple Summary Androgen receptor signaling seems pivotal in aggressive salivary duct carcinoma. However, androgen deprivation therapy (ADT) frequently fails, emphasizing the need for biomarkers to predict treatment response. Here, the activities of several possible tumor-driving pathways were quantified and related to clinical outcome in a large cohort of SDC patients. Our results indicated that AR pathway activity and SRD5A1 expression levels can be used to predict response to ADT, which could prevent overtreatment in clinical practice. Abstract Patients suffering from recurrent or metastatic (R/M) salivary duct carcinoma (SDC) are often treated with combined androgen blockade (CAB). However, CAB frequently fails, resulting in a worse prognosis. Therefore, biomarkers that can predict treatment failure are urgently needed. mRNA from 76 R/M androgen receptor (AR)-positive SDC patients treated with leuprorelin acetate combined with bicalutamide was extracted from pre-treatment tumor specimens. AR, Notch, MAPK, TGFβ, estrogen receptor (ER), Hedgehog (HH), and PI3K signaling pathway activity scores (PAS) were determined based on the expression levels of target genes. Additionally, 5-alpha reductase type 1 (SRD5A1) expression was determined. These markers were related to clinical benefit (complete/partial response or stable disease ≥6 months) and progression-free and overall survival (PFS/OS). SRD5A1 expression had the highest general predictive value for clinical benefit and positive predictive value (PPV: 85.7%). AR PAS had the highest negative predictive value (NPV: 93.3%). The fitting of a multivariable model led to the identification of SRD5A1, TGFβ, and Notch PAS as the most predictive combination. High AR, high Notch, high ER, low HH PAS, and high SRD5A1 expression were also of prognostic importance regarding PFS and SRD5A1 expression levels for OS. AR, Notch PAS, and SRD5A1 expression have the potential to predict the clinical benefit of CAB treatment in SDC patients. SRD5A1 expression can identify patients that will and AR PAS patients that will not experience clinical benefit (85.7% and 93.3% for PPV and NPV, respectively). The predictive potential of SRD5A1 expression forms a rational basis for including SRD5A1-inhibitors in SDC patients’ treatment.

Simple Summary No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy. We also evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. The development of irAEs and better BOR were significantly associated with longer survival. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival. Abstract No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy and investigated prognostic factors associated with survival. Further, we evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Median progression-free survival (PFS) was 3.7 months, and two-year PFS rate was 19.6%. BOR was assessed as complete response (CR) in 6%, partial response (PR) in 13%, stable disease (SD) in 30%, and progressive disease (PD) in 52% of the patients. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. On multivariate analysis, the development of irAEs was significantly associated with better OS and PFS. Better BOR was significantly associated with longer OS and PFS. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.

For doctors and other medical staff treating oral cancer, it is necessary to standardize the basic concepts and rules for oral cancer to achieve progress in its treatment, research, and diagnosis. Oral cancer is an integral part of head and neck cancer and is treated in accordance with the general rules for head and neck cancer. However, detailed rules based on the specific characteristics of oral cancer are essential. The objective of this article was to contribute to the development of the diagnosis, treatment, and research of oral cancer, based on the correct and useful medical information of clinical, surgical, pathological, and imaging findings accumulated from individual patients at various institutions. Our general rules were revised as the UICC was revised for the 8th edition and were published as the Japanese second edition in 2019. In this paper, the English edition of the “Rules” section is primarily presented.

Parapharyngeal space tumors are rare. Among them, tumors in the prestyloid compartment are particularly suitable for surgery; however, there are no detailed reports of such surgery and their features remain unknown.We conducted a retrospective cohort study. For 67 surgical cases of benign tumors in this compartment, we examined the patient and tumor characteristics, fine-needle aspiration cytology (FNAC), and intraoperative details such as surgical approach, use of complete excision, and postoperative complications.Pleomorphic adenomas (PAs) comprised 73.1% of the lesions. The diagnostic accuracy of FNAC to differentiate benign and malignant tumors was 97.7%. Of the treated lesions, 94.0% were removed via the cervical approach alone, including all PAs. The remaining 6.0% were resected via the cervical-parotid approach. The median operative time and bleeding volume were 89 min and 50 mL, respectively. Operative time using the cervical approach was significantly shorter (p = 0.021). All cases could be treated via complete surgical excision. Postoperative complications occurred in 32.8% of patients, with transient slight facial palsy being the most common. No fatal complications occurred and 92.5% of patients had no sequelae. There was no significant association between complications and surgical approach.Based on diagnosis by FNAC, with a high accuracy rate, most benign prestyloid tumors, especially PAs, were resected using the cervical approach alone, with a shorter operative time and without severe complications.

Although immune-checkpoint inhibitors (ICIs) are effective against various cancers, little is known regarding their role in salivary gland carcinoma (SGC) treatment. Therefore, we evaluated the efficacy and safety of nivolumab monotherapy in patients with recurrent and/or metastatic SGC. In this multicentre retrospective study, nivolumab (240 mg) was administered every 2 weeks. The overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety were examined; the correlation between treatment outcomes and clinicopathological factors was analysed. Twenty-four patients were enrolled; the most common histopathology was salivary duct carcinoma. Eleven tumours were PD-L1-positive; no tumour was microsatellite instability-high. The ORR was 4.2%, and the median PFS and OS were 1.6 and 10.7 months, respectively. One patient continued nivolumab for 28 months without disease progression. One patient showed grade 4 increase in creatine phosphokinase levels and grade 3 myositis. Biomarker analysis revealed significantly increased OS in patients with performance status of 0; modified Glasgow prognostic score of 0; low neutrophil-to-lymphocyte ratio, lactate dehydrogenase, and C-reactive protein; and high lymphocyte-to-monocyte ratio and in patients who received systemic therapy following nivolumab. Although nivolumab’s efficacy against SGC was limited, some patients achieved long-term disease control. Further studies are warranted on ICI use for SGC.

This study compared the incidence of perioperative complications and swallowing function between free jejunal flap reconstruction and cutaneous free tissue flap construction. We included 223 patients who underwent hypopharyngeal reconstruction using free flap. At discharge, +the free jejunal flap was associated with a Functional Oral Intake Scale (FOIS) score of 1–6 in 132 cases (70%) and a score of 7 in 56 cases (30%). Regarding the cutaneous free tissue flaps, FOIS scores of 1–6 were observed in 18 cases (51%), and a score of 7 was noted in 17 cases (49%). Donor site complications occurred in 12% of the patients who underwent free jejunal flap procedures and in none of the patients who underwent cutaneous free tissue flap procedures. We found that the free jejunal flap had a regular dietary intake rate in 56 patients (30%), whereas cutaneous free tissue flaps had a regular dietary intake rate in 17 patients (49%). Cutaneous free tissue flaps had a significantly higher regular dietary intake rate at discharge and a significantly lower incidence of donor site complications than free jejunal flaps. In conclusion, free-flap reconstruction may be a better method than free jejunal flap reconstruction for the treatment of hypopharyngeal cancer.