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In recent years, rapid advancement in gene/protein analysis technology has resulted in target molecule identification that may be useful in cancer treatment. Therefore, "Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition" was published in Japan in September 2021. These guidelines were established to align the clinical usefulness of external diagnostic products with the evaluation criteria of the Pharmaceuticals and Medical Devices Agency. The guidelines were scoped for each tumor, and a clinical questionnaire was developed based on a serious clinical problem. This guideline was based on a careful review of the evidence obtained through a literature search, and recommendations were identified following the recommended grades of the Medical Information Network Distribution Services (Minds). Therefore, this guideline can be a tool for cancer treatment in clinical practice. We have already reported the review portion of "Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition" as Part 1. Here, we present the English version of each part of the Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition. [ABSTRACT FROM AUTHOR]

Recently, oral hypoglycemic agents with newer glucose lowering mechanisms have been on release. This is mostly to meet the diabetic patient's need to avoid hypoglycemia, which is profoundly important for better long-term outcome of the treatment. In this study, we quantified the annual number of patients with type 2 diabetes who experienced hypoglycemia needing the third-party assistance who had random sample plasma glucose<59.4 mg/dl (3.3 mmol/l) on the one hand and analyzed the prescription trend of hypoglycemic agents all over Japan on the other. Analysis of the annual number of hypoglycemic patients visited ER was performed at Aizawa Hospital, a medical center located in the midst of a city. The study duration was over 10 years from 2008 to 2019. We found a clear-cut decreasing trend of hypoglycemia over the 10 years, ca. 61/year to 39/year. Immediately after the release of sodium-glucose co-transporter-2 inhibitors, since 2013 to 2017, the decrease was rather sharp as 81/year to 31/year, and the change of the national number of its prescription inversely correlated with the change of the number of the patients with hypoglycemia. This was not the case immediately after the introduction of dipeptidyl peptidase-4 inhibitors in the Japanese market since 2008 to 2012. There was no significant correlation between its prescription and the number of patients with hypoglycemia. The data strongly suggested that there was a causal relationship exclusively between the introduction of sodium-glucose cotransporter-2 inhibitor, and the reduction of hypoglycemic events among patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background: Although the American Joint Committee on Cancer TNM classification has been amended to include human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC) as an independent entity, to the authors' knowledge the optimized de-escalating treatment modality has not been established to date.Methods: The authors conducted a retrospective, nationwide, observational study in patients with HPV-related OPSCC who were treated from 2011 to 2014 in Japan to determine the best treatment modality.Results: A total of 688 patients who were newly diagnosed with HPV-related OPSCC who were treated with curative intent at 35 institutions and had coherent clinical information and follow-up data available were included in the current study. In patients with T1-T2N0 disease (79 patients), both the 3-year recurrence-free survival and overall survival (OS) rates were 100% in the group treated with radiotherapy (RT) as well as the group receiving concurrent chemoradiotherapy (CCRT). The 3-year OS rates were 94.4% (for patients with T1N0 disease) and 92.9% (for patients with T2N0 disease) among the patients treated with upfront surgery. In patients with stage I to stage II HPV-related OPSCC, the 5-year recurrence-free survival and OS rates were 91.4% and 92%, respectively, in the patients treated with CCRT with relatively high-dose cisplatin (≥160 mg/m2 ; 114 patients) and 74.3% and 69.5%, respectively, in the patients treated with low-dose cisplatin (<160 mg/m2 ; 17 patients).Conclusions: Despite it being a retrospective observational trial with a lack of information regarding toxicity and morbidity, the results of the current study demonstrated that patients with T1-T2N0 HPV-related OPSCC could be treated with RT alone because of the equivalent outcomes of RT and CCRT, and patients with stage I to stage II HPV-related OPSCC other than those with T1-T2N0 disease could be treated with CCRT with cisplatin at a dose of ≥160 mg/m2 . [ABSTRACT FROM AUTHOR]

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 < 3.5 mg/dL. Optimal cutoff point of dichotomized NLR was calculated using the area under the receiver operating characteristic curve (AUROC). Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated by Cox proportional hazard models adjusted by potential confounders. Results: Higher NLR was significantly associated with worse survival (1‐year OS: 45.3% vs 16.3%, log‐rank P‐value <.001, adjusted HR: 4.40 (95% CIs: 1.78‐10.88); one‐year PFS: 39.1% vs 9.0%, P‐value =.001, adjusted HR: 3.37 (95% CI: 1.64‐6.92)). In addition, high mGPS (=2) was significantly associated with worse survival compared to low mGPS (=0) (1‐year OS: 37.4% vs 26.1%, P‐value =.004, adjusted HR: 4.20 (95% CI:1.54‐11.49); 1‐year PFS: 41.5% vs 24.8%, P‐value =.007, adjusted HR: 2.01 (95% CI: 0.87‐4.68)). These associations were consistent with subgroup analyses stratified by potential confounders. Conclusions: Pretreatment NLR and mGPS might be predictive markers of survival in patients with R/M SCCHN treated with nivolumab. [ABSTRACT FROM AUTHOR]

Organ preservation is a goal of head and neck squamous cell cancer (HNSCC) treatment. chemoradiotherapy remains one of the main treatment options and is widely recognized as a method with organ-preserving potential and outcomes comparable to those of surgery. However, few studies have investigated the quality of life (QOL) of patients with HNSCC treated using chemoradiotherapy, therefore, we aimed to retrospectively evaluate how QOL changes pre and post-chemoradiotherapy. We evaluated QOL outcomes in patients who underwent initial radical chemoradiotherapy for HNSCC at the Department of Otolaryngology and Head and Neck Surgery Kitasato University Hospital from 2018 to 2021. We used the Cancer Fatigue Scale (CFS) and the combined European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 questionnaires at pre-treatment, three months and six months post-treatment. We obtained 37 and 29 responses from the CFS and EORTC QLQ-C30/H&N35 questionnaire, respectively. From the CFS, the physical fatigue score at three months post-treatment deteriorated more than that at pre-treatment, and significantly improved by six months post-treatment. The total score worsened significantly at three months and there was a trend toward improvement at six months. In the EORTC QLQ-C30, physical and social functioning declined in three months and did not improve within six months. Fatigue was substantially worse at three months and significantly improved at six months but did not reach the same level as that before treatment. Appetite loss was also significantly worse at three months. In the QLQ-H&N35 questionnaire, sensory issues, trouble with social contact, and dry mouth were significantly worse at three months and did not improve within six months. Sticky saliva also worsened at three months and significantly improved at six months. There were some problems associated with chemoradiotherapy. Some patients showed an improvement, while others continued to have challenges. In Japan, chemoradiotherapy was shown to have a long-term impact on the patient's life. [ABSTRACT FROM AUTHOR]

Some studies have directly compared the National Acoustic Laboratories' prescription for non-linear hearing aids (HAs) version 2 (NAL-NL2) and Desired Sensation Level for non-linear HAs version 5 (DSLv5), although none were performed in Japan. As the Japanese language is a tonal language that has different linguistic characteristics than those of the studied languages, we compared the outcomes of the NAL-NL2 and DSLv5 in hearing-impaired Japanese participants. A crossover-controlled trial was conducted on 18 first-time HA users with bilateral moderate sensorineural hearing loss. Participants wore HAs adjusted with each prescriptive method for four weeks. The prescriptions were assessed using speech discrimination testing and the abbreviated profile of hearing aid benefit (APHAB). Consequently, participants were asked to select their preferred prescription and determine which was better for "listening to a conversation" and when "noisy." The mean DSLv5 real ear insertion gain for an input level of 65 dB sound pressure level (SPL) was higher than that of the NAL-NL2 at 250 and 500 Hz. The average speech discrimination score was 78 ± 14% at a 65-dB SPL and 75 ± 17% at an 80-dB SPL for the NAL-NL2, and 79 ± 11% at a 65-dB SPL and 77 ± 17% at an 80-dB SPL for the DSLv5. These differences were not significant. No significant differences were observed in APHAB subscale scores between the two prescription methods. Ultimately, 11 (61%) and 7 (39%) participants preferred the NAL-NL2 and DSLv5, respectively, with no significant differences. Although the gain of the NAL-NL2 is smaller than that of the DSLv5, both had the same hearing effect. Therefore, the NAL-NL2 may be more useful than the DSLv5 in Japanese. [ABSTRACT FROM AUTHOR]

Objective: We used real-ear insertion gain (REIG), with the international speech test signal (ISTS), to evaluate the amplifying characteristics of hearing aids, set for patients who have been wearing such aids for a long time in a stable manner. We further compared this to the target values of the DSLv5 and NAL-NL2 methods.Methods: The subjects were adults with moderate sensorineural hearing loss. We examined 40 ears in 25 individuals (15 people wearing hearing aids in both ears and ten people wearing aid in only one ear). Fit assessments were performed based on the speech performance-intensity functions and tolerance of environmental noise, and the ears studied were categorized as either ears with sufficient benefit or ears with insufficient benefit. Additionally, we evaluated the REIG for international speech test signals at 65-dB and 80-dB sound pressure level (SPL). We compared the REIG and target values for voice input at 65-dB and 80-dB SPL, calculated from the DSLv5 and NAL-NL2 methods.Results: Among the 40 ears, 34 received sufficient benefit and six received an insufficient benefit from hearing aids. The REIG for ISTS at 65-dB in the sufficient benefit ears, at frequencies of 1,000 Hz and 2,000 Hz, were similar to the target values of NAL-NL2 and DSLv5 but were significantly lower at 250 Hz, 500 Hz, and 4,000 Hz frequencies. The compression ratio of REIG for sufficient benefit ears was similar to that of DSLv5. The REIG for ISTS at 65-dB in the insufficient benefit ears was smaller than that in the sufficient benefit ears at frequencies of 2,000 Hz and 4,000 Hz.Conclusion: This study suggested that the target values of NAL-NL2 and DSLv5 are appropriate, even for Japanese-speaking individuals, at mid-pitch sounds. Although it is necessary to investigate the necessity for low-pitch and high-pitch gains further in the future, this study provides meaningful data regarding the amplifying characteristics in Japanese-speaking individuals who have been wearing hearing aids in a stable manner. [ABSTRACT FROM AUTHOR]