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Although several prognostic factors in nivolumab therapy have been reported in recurrent or metastatic head and neck cancer (RM-HNC) patients, these factors remain controversial. Here, we conducted a multicenter retrospective cohort study to investigate the impact of clinico-hematological factors on survival in RM-HNC patients treated with nivolumab. We reviewed 126 RM-HNC patients from seven institutes. We evaluated the prognostic effects of clinico-hematological factors on survival. The median overall survival (OS) was 12.3 months, and the 1 year-OS rate was 51.2%. Patients without immune-related adverse events, lower relative eosinophil count, worse best overall response, higher performance status, and higher modified Glasgow Prognostic Score had worse survival. The score, generated by combining these factors, was associated with survival. Patients with score of 4–5 had worse survival than those with score of 2–3 and 0–1 [adjusted HR for PFS: score of 4–5, 7.77 (3.98–15.15); score of 2–3, 3.44 (1.95–6.06), compared to score of 0–1], [adjusted HR for OS: score of 4–5, 14.66 (4.28–50.22); score of 2–3, 7.63 (2.29–25.37), compared to score of 0–1]. Our novel prognostic score utilizing clinico-hematological factors might be useful to establish an individual treatment strategy in RM-HNC patients treated with nivolumab therapy.

Immune checkpoint inhibitors (ICIs) have become the standard treatment for recurrent or metastatic head and neck cancer (RM-HNC). However, many patients fail to benefit from the treatment. Previous studies have revealed that tumor burden predicts the efficacy of ICIs, but this association remains unclear for RM-HNC. We retrospectively analyzed 94 patients with RM-HNC treated with ICI monotherapy. We estimated the tumor burden using the baseline number of metastatic lesions (BNML) and the baseline sum of the longest diameters of the target lesions (BSLD), and evaluated the association between BNML, BSLD, and standardized uptake value (SUV) and clinical outcomes. The median progression-free survival (PFS) was 7.1 and 3.1 months in the low-BNML and high-BNML groups, respectively (p = 0.010). The median PFS was 9.1 and 3.5 months in the low-BSLD and high-BSLD groups, respectively (p = 0.004). Moreover, patients with high SUVmax levels had worse overall survival (OS) and PFS. BNML, BSLD, and SUVmax are useful prognostic factors in patients with RM-HNC treated with ICIs. Imaging examinations before ICI treatment are recommended to predict the efficacy of ICIs. If the tumor burden is high, cytotoxic anticancer agents may be administered concomitantly with or prior to ICI monotherapy.

Background: Preoperative diagnosis of parotid tumor is mainly performed via imaging and cytology to avoid both facial nerve injury and tumor seeding. Synchronous resection of solitary parotid metastasis with esophagectomy for esophageal squamous cell carcinoma is rarely performed. Case Report: This is a case report of a 58-year-old male patient with a left preauricular tumor, which was cytologically diagnosed as squamous cell carcinoma. Esophageal squamous cell carcinoma was pathologically diagnosed following 18F-fluorodeoxyglucose positron emission tomography with computed tomography. His diagnosis was cT2N0M0 esophageal squamous cell carcinoma with cT3N0M0 parotid carcinoma. Esophagectomy for esophageal cancer, as well as parotidectomy were performed. Pathological diagnosis of pT1bN1M1 (parotid) esophageal squamous cell carcinoma was based on exclusion diagnosis of no primary tumor from several specialists and pathological findings including immunohistochemical staining. Conclusion: Reporting of more cases of rare synchronous metastasectomy and esophagectomy is needed to clarify treatment strategies.

BackgroundThere are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide™ NCC Oncopanel System (NOP) analysis suitability criteria.MethodsIn this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm2.ResultsThirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22–80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients.ConclusionsThe proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.

The characterization of ultrafine particle emissions from jet aircraft equipped with turbofan engines, which are commonly used in civil aviation, is an important issue in the assessment of the impacts of aviation on climate and human health. We conducted field observations of aerosols and carbon dioxide (CO2) near a runway at Narita International Airport, Japan, in February 2018. We used an ultrafine condensation particle counter (UCPC) and a condensation particle counter (CPC) with unheated and 350 ∘C heated operation modes to investigate the contributions of sub-10 nm size ranges to the total and the non-volatile particle number concentrations. The performance of the 350 ∘C heated mode was tested in the laboratory to verify the consistency with existing methods for non-volatile particle measurements. We also used a scanning mobility particle sizer with unheated and 350 ∘C heated modes and an engine exhaust particle sizer for the measurements of particle number size distributions. Spiked increases in the particle number concentrations and CO2 mixing ratios were observed to be associated with the directions of wind from the runway, which can be attributed to diluted aircraft exhaust plumes. We estimated the particle number emission indices (EIs) for discrete take-off plumes using the UCPC, CPC, and CO2 data. The median values of the total and the non-volatile particle number EIs for diameters larger than 2.5 nm as derived from the UCPC data were found to be 1.1×1017 and 5.7×1015 kg per fuel, respectively. More than half the particle number EIs were in the size range smaller than 10 nm for both the total and the non-volatile particles in most of the cases analyzed in this study. The significance of sub-10 nm size ranges for the total particles in the diluted plumes was qualitatively consistent with previous studies, but that for the non-volatile particles was unexpected. Possible factors affecting the similarities and differences compared with the previous findings are discussed.

BackgroundIn recent years, the number of patients with hepaticojejunostomy anastomotic strictures has increased. Balloon dilation and placement of multiple plastic stents have proven effective for hepaticojejunostomy anastomotic strictures. However, for refractory strictures, there is often a need for repeated endoscopic procedures within a short period. This study aimed to assess the efficacy and safety of the new saddle-cross technique, which uses two fully covered self-expandable metallic stents.MethodsThis was a retrospective analysis of 20 patients with benign hepaticojejunostomy anastomotic strictures who underwent placement of two fully covered self-expandable metallic stents at the National Cancer Center, Japan, from November 2017 to June 2021.ResultsThe technical and clinical success rates were 100% (20/20). The median time of the procedure was 61 (range 25–122) min. The scheduled stent removal rate was 70% (14/20). Spontaneous dislodgement of the stent was observed on computed tomography in five patients (25.0%). The non-restenosis rate 12 months after the saddle-cross technique was 88.2% (15/17). Procedure-related early adverse events included mild ascending cholangitis in three patients (15.0%) and sepsis in one patient (5.0%). Procedure-related late adverse events included mild ascending cholangitis in three patients (15.0%) and bile duct hyperplasia in one patient (5.0%).ConclusionsThe saddle-cross technique performed using two fully covered self-expandable metallic stents resulted in promising long-term stricture resolution with a high technical success rate. Based on these findings, the saddle-cross method can be considered an option for the standard procedure for benign hepaticojejunostomy anastomotic strictures.

Objectives To evaluate the feasibility and safety of endoscopic ultrasound‐guided choledochoduodenostomy (EUS‐CDS) without fistula dilation using a novel self‐expandable metal stent (SEMS). Methods This retrospective study examined patients who underwent EUS‐CDS for malignant distal biliary obstruction between October 2017 and May 2021 at the National Cancer Center, Japan. The primary outcome was a technical success without fistula dilation. Secondary outcomes were the overall technical success, clinical success, adverse events (AEs), procedure time, recurrent biliary obstruction (RBO), and time to RBO (TRBO). Results Forty‐one patients were enrolled; 31 patients underwent EUS‐CDS with fistula dilation using a conventional SEMS with 7.5–8.5‐Fr delivery system (conventional SEMS group), and 10 patients underwent EUS‐CDS without fistula dilation using the novel SEMS with a 5.9‐Fr delivery system (novel SEMS group). In the novel SEMS group, the rate of technical success without fistula dilation was 90%. There were no differences in overall technical success (100% vs. 97%, p = 1.00), clinical success (80% vs. 90%, p = 0.58), and overall AEs (10% vs. 23%, p = 0.65) rates between the novel and conventional SEMS groups. In the novel SEMS group, no early AEs were observed and no bile leakage into the abdominal cavity was observed on the computed tomography scan after the procedure. The median procedure time was significantly shorter in the novel SEMS group (17 min vs. 24 min, p = 0.03). RBO and median TRBO did not differ between the 2 groups. Conclusions EUS‐CDS without fistula dilation using the novel SEMS with a 5.9‐Fr delivery system is technically feasible, straightforward, quick, and safe.

Background Nivolumab monotherapy is the standard second-line treatment for advanced esophageal squamous cell carcinoma (ESCC) after failure of platinum-based chemotherapy without anti-PD-1 antibody. Fixed dosing with 240 mg every 2 weeks was approved initially, followed by fixed dosing with 480 mg every 4 weeks based on pharmacokinetics data. However, information on the comparative efficacy and safety of the two doses remains limited. Methods We compared progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and the incidence of adverse events (AEs) between the two doses in 117 patients who received second-line ( n  = 85) or later-line ( n  = 32) nivolumab monotherapy at our institution between January 2016 and December 2021. Results In the second-line group, patient characteristics for the 240 mg and 480 mg groups were as follows (240 mg vs. 480 mg): performance status (PS) 0/1/2 was 34/61/5% vs. 54/42/4%, and prior fluoropyrimidine plus platinum therapy (FP) was 81.3% vs. 42.3%. In the later-line group, the characteristics were: PS 0/1/2 was 28/60/12% vs. 14/86/0%, and prior FP was 60.0% vs. 42.8%. ORR was 11.9 vs. 24.0% in the second-line group ( p  = 0.19) and 0 vs. 14.3% in the later-line group ( p  = 0.22). Median PFS was 1.7 vs. 4.1 months on second-line (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.35–1.01, p  = 0.056) and 1.4 vs. 1.8 months on later-line (HR 0.58, 95% CI 0.23–1.46, p  = 0.25); AEs of any grade were observed in 58.3 vs. 69.7%, respectively. Conclusions The efficacy and safety of the two doses of nivolumab monotherapy were comparable in patients with advanced ESCC.

Both adiponectin and secreted protein, acidic and rich in cysteine (SPARC) inhibit platelet-derived growth factor-BB (PDGF-BB)-induced and basic fibroblast growth factor (FGF2)-induced angiogenic activities through direct and indirect interactions. Although SPARC enhances nerve growth factor (NGF)-dependent neurogenesis, the physical interaction of NGFβ with adiponectin and SPARC remains obscure. Therefore, we first examined their intermolecular interaction by surface plasmon resonance method. NGFβ bound to immobilized SPARC with the binding constant of 59.4 nM, comparable with that of PDGF-BB (24.5 nM) but far less than that of FGF2 (14.4 µM). NGFβ bound to immobilized full length adiponectin with the binding constant of 103 nM, slightly higher than those of PDGF-BB (24.3 nM) and FGF2 (80.2 nM), respectively. Treatment of PC12 cells with SPARC did not cause mitogen-activated protein kinase (MAPK) activation and neurite outgrowth. However, simultaneous addition of SPARC with NGFβ enhanced NGFβ-induced MAPK phosphorylation and neurite outgrowth. Treatment of the cells with adiponectin increased AMP-activated protein kinase (AMPK) phosphorylation but failed to induce neurite outgrowth. Simultaneous treatment with NGFβ and adiponectin significantly reduced cell size and the number of cells with neurite, even after silencing the adiponectin receptors by their siRNA. These results indicate that NGFβ directly interacts with adiponectin and SPARC, whereas these interactions oppositely regulate NGFβ functions.

Attempts at performing endoscopic ultrasound-guided tissue acquisition (EUS-TA) with a 19G needle are increasing because histological diagnosis and comprehensive genomic profiling are a necessity. However, the diagnostic ability of the 19G fine-needle biopsy (FNB) needle, especially the third-generation FNB needle, is unclear and has been retrospectively reviewed. The 19G TopGain needle was used in 147 patients and 160 lesions between September 2020 and December 2021. The technical success rate of the biopsies was 99.4% (159/160). The early adverse event rate was 4.1% (6/147), and moderate or severe adverse event rate occurrence was 2.0% (3/147). The sensitivity, specificity, and accuracy of the 19G TopGain needle for 157 lesions with a confirmed diagnosis were 96.7%, 100%, and 96.8%, respectively. Rescue EUS-TA using the 19G TopGain needle was performed for nine lesions, and a successful diagnosis was made in six of these lesions (66.7%). The diagnostic ability of EUS-TA using the third-generation 19G TopGain needle was favorable. However, the use of 19G FNB needles may increase adverse events. Therefore, EUS-TA with a 19G FNB needle is mainly indicated in lesions where comprehensive genomic profiling may be necessary or the diagnosis could not be determined via EUS-TA using the 22G needle.