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Background: Thoracic esophageal cancer surgery using robotic approaches for the thoracic and abdominal parts has recently been reported as total robot-assisted minimally invasive esophagectomy (RAMIE). We herein present the first report of a new technique for esophageal cancer: total RAMIE with three-field lymph node dissection (3FLND) by a simultaneous two-team approach using a new docking method. Methods: We reviewed 20 patients who underwent total RAMIE with 3FLND by a simultaneous two-team approach at the National Cancer Center East Hospital from March 2023 to September 2023. Short-term surgical outcomes and the safety and efficacy of this technique were analyzed. Results: The mean operative time for abdominal surgery with this new docking technique was 135 ± 19.6 min. The total operative time was 488 ± 42.9 min, and the time from the end of abdominal manipulation to the end of surgery was 80.1 ± 15.6 min. The intraoperative blood loss was 116.7 ± 64.4 mL. The incidence of anastomotic leakage, postoperative vocal cord paralysis, and postoperative pneumonia was 10%, 5%, and 10%, respectively. The median postoperative hospital stay was 14 days (range 11–63 days). No in-hospital deaths occurred, and R0 resection was possible in all cases. The average number of lymph nodes dissected was 87.7. Conclusion: These results demonstrate that total RAMIE with a simultaneous two-team approach using the new docking method can be safely introduced. The simultaneous cervical and abdominal manipulation with the new docking method allowed total RAMIE without prolonging the operating time, suggesting that it may be a valuable approach for esophageal cancer surgery. [ABSTRACT FROM AUTHOR]

Although the survival rate of patients with childhood cancer has greatly improved, long‐term survivors face specific problems such as the late effects of cancer treatment. In this study, we estimated the number of people who had experienced childhood cancer to predict their needs for medical care and social resources. Using data from the population‐based Osaka Cancer Registry, we identified children aged 0–14 years who were diagnosed with cancer between 1975 and 2019. We estimated the prevalence on December 31, 2019, and the 5‐ and 10‐year prevalence (i.e., the number of survivors living up to 5 or 10 years after the diagnosis of cancer) over time. The prevalence proportion was age‐standardized using a direct standardization method. The prevalence estimates for Osaka were applied to the national population to determine the national prevalence in Japan. Among 8186 patients diagnosed with childhood cancer in Osaka, 5252 (987 per million) survived until December 31, 2019. The 5‐year prevalence per million increased from 194 in 1979 to 417 in 2019 (+116%), while the 10‐year prevalence increased from 391 in 1984 to 715 in 2019 (+83%). Based on the long‐term registry data, an estimated 73,182 childhood cancer survivors were living in Japan by the end of 2019. The increasing 5‐year and 10‐year prevalence proportions indicate the continued need for cancer survivorship support for children, adolescents, and young adults. These estimates of the prevalence of childhood cancer survivors, including long‐term survivors, may be useful for policymakers and clinicians to plan and evaluate survivorship care. [ABSTRACT FROM AUTHOR]

Simple Summary: Tertiary lymphoid structures (TLS) arise in non-lymphoid tissues due to inflammation or cancer and play a key role in adaptive immune responses. In this study, we analyzed the TLS maturity in 78 patients with pathological T4 colorectal cancer (CRC). Mature TLS, identified by organized T (CD3+) and B (CD20+) lymphocytes with Ki-67-positive B cells, have been linked to microsatellite instability and improved cancer-specific and post-recurrence survival. High tumor Ki-67 expression correlated with poorer outcomes. The absence of mature TLS independently predicted poor survival. Tumors with mature TLS showed a higher infiltration of CD3+ T cells, FOXP3+ T cells, and CD86+ immune cells, including M1-like macrophages. Focusing on the Ki-67 expression pattern, the simultaneous evaluation of TLS maturity and tumor proliferation potency is suggested to be a potential prognostic indicator in CRC. Tertiary lymphoid structures (TLSs) are complex lymphocyte clusters that arise in non-lymphoid tissues due to inflammation or cancer. A mature TLS with proliferating germinal centers is associated with a favorable prognosis in various cancers. However, the effect of TLS maturity on advanced colorectal cancer (CRC) remains unexplored. We analyzed the significance of TLS maturity and tumor Ki-67 expression in surgically resected tumors from 78 patients with pathological T4 CRC. Mature TLS was defined as the organized infiltration of T and B cells with Ki-67-positive proliferating germinal centers. We analyzed the relationship between TLS maturity and intratumoral immune cell infiltration. Mature TLS with germinal center Ki-67 expression was associated with microsatellite instability and improved survival; however, high tumor Ki-67 expression was associated with poor survival in the same cohort. Multivariate analysis identified the absence of mature TLS as an independent predictor of poor post-recurrence overall survival. Intratumoral infiltration of T lymphocytes and macrophages was significantly elevated in tumors with mature TLS compared to those lacking it. High Ki-67 levels and absent mature TLS were identified as poor prognostic factors in advanced CRC. Mature TLS could serve as a promising marker for patients at high-risk of CRC. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with locally advanced or metastatic urothelial carcinoma have a poor prognosis. Enfortumab vedotin, administered after cisplatin-based chemotherapy and followed by immune checkpoint inhibitors, is widely known to prolong overall survival (OS). However, the predictive factors of enfortumab vedotin treatment that prolong OS remain unclear. In this study, patients who received enfortumab vedotin with shrinking tumors showed a significant increase in OS compared to those who received chemotherapy other than enfortumab vedotin or those who did not receive any treatment. Multivariate analysis identified neutrophil-to-lymphocyte ratio and dysgeusia as potential predictors of OS. Patients without these factors had a significantly prolonged OS compared to those with both factors. In real-world practice, enfortumab vedotin therapy is effective for patients with locally advanced or metastatic urothelial carcinoma. Randomized phase III trial results have demonstrated enfortumab vedotin (EV), an antibody–drug conjugate (ADC) consisting of an anti-Nectin-4 human IgG1 monoclonal antibody and monomethyl auristatin E, is a useful treatment for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) that progressed after immune checkpoint inhibitor (ICI) therapies. This multicenter retrospective cohort study aimed to identify predictive factors for the efficacy of EV therapy and prolonged overall survival (OS) of patients in clinical practice. This study included patients with la/mUC who received ICI treatment. Patients who subsequently received EV treatment, those who received non-EV chemotherapy, and those who received no treatment were defined as EV, non-EV, and best supportive care (BSC) groups, respectively. The median OS was 20, 15, and 7 months in the EV, non-EV, and BSC groups, respectively (p < 0.001). Patients with la/mUC who had a complete or partial response after EV treatment had a significantly prolonged OS compared with those with stable or progressive disease. Univariate analysis showed age, neutrophil-to-lymphocyte ratio (NLR), dysgeusia, and rash as independent predictors of OS improvement. NLR and dysgeusia were independent predictors of OS after EV in multivariate analysis. Patients without these factors had a significantly prolonged OS compared to those with both factors. In real-world practice, EV therapy is an effective treatment for patients with la/mUC after ICI treatment. [ABSTRACT FROM AUTHOR]

Summary: This study aimed to complement the results of the REACH-2 study by prospectively evaluating the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma (HCC) in a real-world setting. This was an open-label, nonrandomized, multicenter, prospective study conducted at 13 institutions in Japan (jRCTs031190236). The study included Child–Pugh Class A patients with advanced HCC who had received pretreatment with atezolizumab plus bevacizumab (Atez/Bev) or lenvatinib. Ramucirumab was introduced as a second-line treatment after Atez/Bev or lenvatinib and as a third-line treatment after Atez/Bev and lenvatinib. Between May 2020 and July 2022, we enrolled 19 patients, including 17 who received ramucirumab. Additionally, seven patients received lenvatinib, another seven patients received Atez/Bev, and three patients received Atez/Bev followed by lenvatinib as prior treatment. The primary endpoint was a 6-month progression-free survival (PFS) rate, which was 14.3%. The median PFS and overall survival were 3.7 and 12.0 months, respectively. The most common grade ≥ 3 adverse events (AEs) were hypertension (23.5%), proteinuria (17.6%), and neutropenia (11.8%). The discontinuation rate due to AEs was 29.4%. Six patients progressed from Child–Pugh A to B after treatment with ramucirumab. Thirteen patients were eligible for post-ramucirumab treatment, including systemic therapy. Despite the limited number of patients, the efficacy of ramucirumab was comparable to that observed in the REACH-2 study when used after lenvatinib and Atez/Bev. However, the incidence of AEs was higher than that in the REACH-2 study. [ABSTRACT FROM AUTHOR]

Background: Outcome measures during acute cardiovascular disease (CVD) phases, such as quality of death, have not been thoroughly evaluated. This is the first study that compared the family members' perceptions of quality of death in deceased CVD patients and in deceased cancer patients using a bereaved family survey. Methods: Retrospectively sent questionnaire to consecutive family members of deceased patients with CVD from ten tertiary hospitals from October 2017 to August 2018. We used the short version of the Good Death Inventory (GDI) and assessed overall care satisfaction. Referencing the GDI, the quality of death was compared between CVD patients admitted to a non-palliative care unit (non-PCU) and cancer patients in palliative care units (PCU) and non-PCUs in the Japan Hospice and Palliative Care Evaluation Study (J-HOPE Study). Additionally, in the adjusted analysis, multivariable linear regression was performed for total GDI score adjusted by the patient and participant characteristics to estimate the difference between CVD and other patients. Results: Of the 243 bereaved family responses in agreement (response rate: 58.7%) for CVD patients, deceased patients comprised 133 (54.7%) men who were 80.2 ± 12.2 years old on admission. The GDI score among CVD patients (75.0 ± 15.7) was lower (worse) than that of cancer patients in the PCUs (80.2 ± 14.3), but higher than in non-PCUs (74.4 ± 15.2). After adjustment, the total GDI score for CVD patients was 7.10 points lower [95% CI: 5.22–8.97] than for cancer patients in PCUs and showed no significant differences compared with those in non-PCUs (estimates, 1.62; 95% CI [-0.46 to 5.22]). Conclusions: The quality of death perceived by bereaved family members among deceased acute CVD patients did not differ significantly from that of deceased cancer patients in general wards, however, was significantly lower than that of deceased cancer patients admitted in PCUs. [ABSTRACT FROM AUTHOR]

Background: The incidence of cervical intraepithelial neoplasia is increasing in Japan. Although human papillomavirus (HPV) vaccination and cancer screening are crucial in preventing cancer-related mortality, the cervical cancer screening rate in Japan was only approximately 43.6% in 2022. This study aimed to conduct an epidemiological analysis of cervical cancer by collecting data from individual patients. Methods: A questionnaire survey was administered to patients who visited our hospital between January 2017 and July 2023 owing to abnormal cervical cytological findings or a cancer diagnosis. Patients answered questions regarding their history of cervical cancer screening as well as their knowledge of HPV and cervical cancer. Results: During the study period, 471 patients participated in the survey, with 35 declining to participate. Patients with Stage 1b1–4b primarily sought medical attention due to self-reported symptoms (P < 0.001); however, they were less likely to have undergone cervical cancer screening (P < 0.001). Additionally, older patients were less likely to be aware of the association of HPV with cervical and other cancers. Notably, 28 of the 129 patients with stage 1b1–4b cancer underwent cervical cancer screening within 2 years. The tumor location within the endocervical canal emerged as a significant factor contributing to the difficulty for an accurate diagnosis of precancerous or cervical cancer during cervical screening. Furthermore, non- squamous cell carcinoma (SCC) histology was another possible factor. Conclusions: Our findings suggest the need to widely disseminate information regarding the significance of cancer screening to increase cancer screening rates. Moreover, establishing strategies for improving the accuracy of detecting lesions during screening for non-SCC and endocervical canal tumors is crucial. [ABSTRACT FROM AUTHOR]

Background: The efficacy of anti‐CTLA‐4 antibody (ipilimumab) plus anti‐programmed cell death 1 antibody (nivolumab) in treating advanced non‐small cell lung cancer (NSCLC) is impeded by an elevated risk of severe immune‐related adverse events. However, our understanding of associations among pre‐existing fibrosis, emphysematous changes, and objective indicators as predictive factors is limited for severe pneumonitis in NSCLC patients receiving this combination therapy. Thus, we retrospectively investigated these associations, including overall tumor burden, before treatment initiation in the Japanese population. Methods: We focused on patients (n = 76) with pre‐existing interstitial lung disease (ILD) to identify predictors of severe pneumonitis. Variables included age, sex, smoking status, programmed cell death ligand 1 expression, overall tumor burden, chest computed tomography‐confirmed fibrosis, serum markers, and respiratory function test results. Results: Severe pneumonitis was more frequent in patients with squamous cell carcinoma, fibrosis, low diffusing capacity for carbon monoxide (%DLCO), and high surfactant protein D (SP‐D) level. Notably, squamous cell carcinoma, baseline %DLCO, and SP‐D level were significant risk factors. Our findings revealed the nonsignificance of tumor burden (≥85 mm) in predicting severe pneumonitis, emphasizing the importance of pre‐existing ILD. Conversely, in cases without pre‐existing fibrosis, severe pneumonitis was not associated with %DLCO or SP‐D level (93.2% vs. 91.9%, and 63.3 vs. 40.9 ng/mL, respectively) and was more common in patients with a large overall tumor burden (97.5 vs. 70.0 mm). Conclusion: Vigilant monitoring and early intervention are crucial for patients with squamous cell carcinoma, high SP‐D level, or low %DLCO undergoing ipilimumab plus nivolumab therapy. [ABSTRACT FROM AUTHOR]

Background: To elucidate the treatment and surgery outcomes with or without perioperative therapies in Japanese patients with clinical stage III non‐small cell lung cancer (NSCLC) in real‐world settings. Methods: We performed subset analyses of the SOLUTION study, a multicenter, noninterventional, observational study of Japanese patients diagnosed with clinical stage III NSCLC, for those who started first‐line treatment (surgery±perioperative therapy) between January 2013 and December 2014 (study registration: UMIN000031385). Follow‐up data were obtained using medical records from diagnosis to March 1, 2018. Results: Of 149 eligible patients, 67 underwent surgery alone (median age 71 years) and 82 underwent surgery+perioperative therapy (median age 63 years). Lung resection was performed in 137 patients and the others underwent exploratory thoracotomy or other procedures. Perioperative therapies included adjuvant therapy only (n = 41), neoadjuvant therapy only (n = 24), and neoadjuvant+adjuvant therapy (n = 17). The median overall survival (OS) and 3‐year OS rate were 29.3 months and 44.0%, respectively, in patients who underwent surgery alone, and not reached and 61.1%, respectively, in patients who underwent surgery+perioperative therapy. The 3‐year progression‐free survival (PFS) and disease‐free survival (DFS) rates were 42.4% and 47.1%, respectively, in patients who underwent surgery+perioperative therapy and 28.5% and 28.9%, respectively, in patients who underwent surgery alone. In multivariable Cox regression, perioperative therapy was associated with improved OS (hazard ratio [95% confidence interval] 0.49 [0.29–0.81]), PFS (0.62 [0.39–0.96]), and DFS (0.62 [0.39–0.97]) versus surgery alone. Conclusions: Our study suggested that perioperative therapy may be associated with better survival among patients undergoing surgical treatment of clinical stage III NSCLC. [ABSTRACT FROM AUTHOR]

In this study, we aimed to explore the association between physical activity (PA) and quality of life (QoL) in colorectal cancer (CRC) patients with postoperative defecatory dysfunction. A survey using the European Organization for Research and Treatment of Cancer QLQ-30 and QLQ-29 was conducted among 62 adult outpatients with CRC at two cancer hospitals in Japan. PA and sedentary behavior were evaluated using the Global Physical Activity Questionnaire. Multiple regression analysis was performed, incorporating the QoL as the outcome, with the total PA and its three domains (occupational, transportation, and recreational) and sedentary time as exposures, while controlling for age, sex, and tumor location. The analyses revealed that patients engaged in PA ≥ 150 min/week (67.4 points; 95% confidence interval [CI]: 21.1, 113.8) and recreational PA ≥ 30 min/week (56.0 points; 95% CI: 2.3, 109.7) had significantly higher function scores. Conversely, sedentary time >8 h/day or occupational PA duration ≥30 min/week was associated with poor symptom and function scores. These findings highlight the importance of promoting recreational PA and reducing sedentary behavior to maintain and improve the QoL in CRC patients with defecatory dysfunction. [ABSTRACT FROM AUTHOR]

Objective: In this study, we collected data over 8 years (2012-2019) from the Japan Society of Obstetrics and Gynecology (JSOG) tumor registry to determine the status of endometrial cancer in Japan, and analyzed detailed clinicopathological factors. Methods: The JSOG maintains a tumor registry that gathers information on endometrial cancer treated at the JSOG-registered institutions. Data from the patients whose endometrial cancer treatment was initiated from 2012 to 2019 were analyzed retrospectively. Results: A total of 82,969 patients with endometrial cancer underwent treatment from 2012 to 2019. Chemotherapy alone or in combination with hormonal therapy is more common among endometrial cancer patients under 40 years compared with those over 40 years. The number of patients with endometrial cancer, treated with laparoscopic or robot-assisted surgery was observed to have increased yearly. Small cell carcinomas and undifferentiated carcinomas were more likely to be diagnosed at an advanced stage. Lymphadenectomy was most commonly performed for stage IIIC2 disease, whereas positive peritoneal washing cytology was most common for stage IVB and serous carcinoma. Conclusion: Multi-year summary reports provided detailed clinicopathological information regarding endometrial cancer that could not be obtained in a single year. These reports were useful in understanding treatment strategies and trends over time based on age, histology, and stage. [ABSTRACT FROM AUTHOR]

This study aims to analyze the prevalence trend of esophageal cancer in Japan and China to provide suggestions for the prevention and treatment of esophageal cancer. The results showed that the incidence rate for the years 2010–2018 significantly decreased with an APC of 5.66%, and the mortality rate from 2010 to 2015 had an APC of −5.87% in China. However, the incidence rate of Japanese women showed an upward trend, with an APC of 4.09% from 2010 to 2019. The mortality rate of esophageal cancer in Japan showed a downward trend, with an APC of −2.96% from 2010 to 2021. From 2010 to 2018, Chinese esophageal squamous cell carcinoma accounted for the highest proportion, accounting for 85.96%, with the largest distribution in the middle, accounting for 47.25%. Patients are mostly diagnosed at stage III, and the relative survival rate from 2012 to 2015 was 30.3%. Japan also has the highest proportion of squamous cell carcinoma, and the lesions are also mostly located in the middle segment. While Japanese esophageal cancer patients are mostly diagnosed at stage I, and the relative survival rate was 41.5% in Japan from 2009 to 2011. The results of this article indicate that the current prevalence of esophageal cancer in China and Japan is generally declining, and the quality of life of patients is gradually improving, but effective screening and prevention strategies are still needed to reduce the burden of this disease. [ABSTRACT FROM AUTHOR]

Poly (ADP-ribose) polymerase inhibitors have been increasingly used in ovarian cancer treatment. However, the real-world safety data of these drugs in Japanese patients are limited. This retrospective study included 181 patients with ovarian cancer who received olaparib or niraparib at two independent hospitals in Japan between May 2018 and December 2022. Clinical information and blood sampling data were collected. Regarding patient backgrounds, the olaparib group had higher proportions of patients with serous carcinoma, BRCA positivity, homologous recombination deficiency, and those receiving maintenance therapy after recurrence treatment than the niraparib group. Regarding toxicity properties, the most common reasons for discontinuation in the olaparib group were anemia, fatigue, and nausea, while the reason in the niraparib was thrombocytopenia. Thrombocytopenia caused by niraparib treatment occurred earlier than anemia caused by olaparib treatment. Patients with a low body mass index or who had undergone several previous treatment regimens were more likely to discontinue treatment within the first 3 months. Although we analyzed blood collection data, predicting treatment interruptions due to blood toxicity was challenging. In this study, we revealed the characteristics of patients and the timing of interruptions for each drug, highlighting the importance of carefully managing adverse effects. [ABSTRACT FROM AUTHOR]

Purpose: To investigate factors that obstruct and facilitate the use of the foster parent and special adoption systems (i.e., foster systems) by cancer survivors, and examine how to effectively provide information. Methods: This was a cross-sectional study that compared the results of a questionnaire survey of foster parents and adoptive parents (i.e., foster parents) who were and were not cancer survivors belonging to foster parent associations in 33 locations in Japan. This study was supported by a 2022 Ministry of Health, Labor, and Welfare Grant-in-Aid for Scientific Research (Grant No. 20EA1004). Results: "Lack of information," an obstructive factor and "Sympathetic understanding and cooperation from my partner and family," a facilitative factor were the highest score in both groups. Significant differences between the two groups were found in "Support from government agencies and others for foster parents," a facilitative factor, which was lower in the cancer survivors' group. There were no other significant differences between both the groups. Conclusion: This study found that when considering the use of the foster systems, a lack of information was the biggest obstructive factor and family understanding was the most helpful for both cancer survivors and noncancer groups. It was thought that stronger government support for cancer survivors might encourage cancer survivors to consider becoming foster parents. It would be effective for cancer treatment facilities, reproductive medical facilities, the government, and foster parent associations to work together to provide information carefully to cancer survivors. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive surgery (MIS), such as laparoscopic and robotic surgery for rectal cancer, is performed worldwide. However, limited information is available on the advantages of MIS over open surgery for multivisceral resection for cases clinically invading adjacent organs. Patients and methods: This was a retrospective propensity score-matching study of consecutive clinical T4b rectal cancer patients who underwent curative intent surgery between 2006 and 2021 at the University of Tokyo Hospital. Results: Sixty-nine patients who underwent multivisceral resection were analyzed. Thirty-three patients underwent MIS (the MIS group), while 36 underwent open surgery (the open group). Twenty-three patients were matched to each group. Conversion was required in 2 patients who underwent MIS (8.7%). R0 resection was achieved in 87.0% and 91.3% of patients in the MIS and open groups, respectively. The MIS group had significantly less blood loss (170 vs. 1130 mL; p < 0.0001), fewer Clavien–Dindo grade ≥ 2 postoperative complications (30.4% vs. 65.2%; p = 0.0170), and a shorter postoperative hospital stay (20 vs. 26 days; p = 0.0269) than the open group. The 3-year cancer-specific survival rate, relapse-free survival rate, and cumulative incidence of local recurrence were 75.7, 35.9, and 13.9%, respectively, in the MIS group and 84.5, 45.4, and 27.1%, respectively, in the open group, which were not significantly different (p = 0.8462, 0.4344, and 0.2976, respectively). Conclusion: MIS had several short-term advantages over open surgery, such as lower complication rates, faster recovery, and a shorter hospital stay, in rectal cancer patients who underwent multivisceral resection. [ABSTRACT FROM AUTHOR]

Myoclonus is a relatively rare involuntary movement that is often observed in palliative care settings and that can cause patient distress. The purpose of this study is to investigate the occurrence of myoclonus and countermeasures against it in terminally ill patients with cancer diagnosed by palliative care specialists at Komaki City Hospital, Japan. We retrospectively reviewed patients with terminal cancer who received palliative care consultations between January 2018 and May 2019 and who were diagnosed with myoclonus by palliative care specialists, using electronic medical records. Patient demographics, time from onset of myoclonus to death, daily opioid use, countermeasures, and outcome of myoclonus were assessed. Of 360 patients examined during this period, 45 (12.5%) were diagnosed with myoclonus. Median age was 71 (range, 43–88) years; median time from onset of myoclonus to death was 8 days (range, 0–56); opioid usage was present in 39 patients (morphine, oxycodone, and fentanyl: n = 6, 21, and 12, respectively); and median oral morphine equivalent at onset of myoclonus was 60 mg (range, 12–336 mg). Myoclonus treatment was administered to 21 patients (opioid dose reduction, opioid switching, and others: n = 14, 3, and 4, respectively). Myoclonus is a common complication in patients with terminal cancer. [ABSTRACT FROM AUTHOR]

Summary: The aim of the present study was to determine whether the trough plasma concentrations (C0) of regorafenib and its metabolites, the N-oxide metabolite (M-2) and the desmethyl N-oxide metabolite (M-5), in 21 patients receiving regorafenib therapy were affected by albumin-bilirubin (ALBI) grade. Regorafenib was administered at dosages ranging from 40 to 160 mg once daily on a 3-week-on, 1-week-off cycle. C0 values of regorafenib and its major metabolites were measured by high-performance liquid chromatography on day 8 after treatment initiation. The C0 values of regorafenib and metabolites M-2 and M-5 were significantly lower in patients with ALBI grade 2 as compared with grade 1 (P = 0.023, 0.003 and 0.017, respectively). The total C0 of regorafenib and its metabolites was significantly higher in ALBI grade 1 patients relative to grade 2 (3.489 μg/mL vs. 1.48 μg/mL; P = 0.009). The median relative dose intensity (RDI) of patients categorized as ALBI grade 2 was significantly lower than that of grade 1 patients (21.9% vs. 62.9%; P = 0.006). In 15 colorectal cancer patients among the total 21 patients, patients with ALBI grade 2 (n = 9) had a significantly shorter median overall survival time than patients with grade 1 (n = 6; P = 0.013). Administering a low dose of regorafenib to patients with ALBI grade 2 reduces the RDI of regorafenib and lowers treatment efficacy, as an appropriate C0 of regorafenib is not maintained. Monitoring the C0 of regorafenib regularly is necessary to guide dose adjustment. [ABSTRACT FROM AUTHOR]

Central to the pharmacist's role in palliative care is symptom management through direct participation in patient care and the provision of optimal pharmacotherapy to support patient outcomes. Consequently, palliative care requires extensive knowledge and action for patients with cancer. Therefore, this study aimed to evaluate how pharmacists' behavior changed after attending a palliative care educational program. We conducted a web-based questionnaire survey examining the behavior of pharmacists regarding palliative care before participating in the program, two months after participating in the program, and eight months after participating in the program to determine their behavior and changes over time. For all questions, scores were higher at two and eight months after attending the program than before attending the program (p < 0.05). In addition, no significant difference was observed between two and eight months after attending the program for any question (p = 0.504–1.000). The knowledge gained from the educational program was used to repeatedly intervene with patients with cancer in order to address the various symptoms they experienced and maintain their behavior. The proven effectiveness of this program serves as a stepping stone for nationwide rollout across Japan's 47 prefectures. [ABSTRACT FROM AUTHOR]

This study investigated the association of exercise and dietary habits with defecatory dysfunction in patients living with colorectal cancer. We recruited 61 adult patients who had undergone surgery within the past 20 years and attended outpatient clinics at designated cancer hospitals in Japan. Defecatory dysfunction was defined as any symptom caused by issues with colon and anal function, including fecal incontinence, evacuation difficulties, frequent stools, diarrhea, and constipation. Exercise and dietary habits were assessed via a quantitative questionnaire survey. Postoperative defecatory dysfunction occurred in all the patients. Multivariate analysis revealed no association between exercise habits and defecatory dysfunction; however, dietary fiber intake ≥4 times a week was associated with frequent stools (adjusted odds ratio, 5.11; 95% confidence interval, 1.10, 23.70). These findings suggest a need to alleviate defecatory dysfunction by improving one's dietary habits. Interventions aimed at alleviating defecatory dysfunction by improving the dietary habits in patients living with colorectal cancer are needed. [ABSTRACT FROM AUTHOR]

Companion diagnostic (CDx) tests play important roles in identifying oncogenic driver genes and tailoring effective molecularly targeted therapies for lung cancer patients. In Japan, the Oncomine Dx target test (ODxTT) and the AmoyDx pan lung cancer PCR panel (AmoyDx) are prominent CDx tests and only one of these tests is covered by the domestic insurance system. However, these CDx tests cover different target regions and apply different technologies (ODxTT is amplicon-based next-generation sequencing and AmoyDx is multiplex PCR-based assay), which may lead to missing of actionable mutations affecting patient prognosis. Here, we performed a direct comparison analysis of 1059 genetic alterations of eight driver genes from 131 samples and evaluated the concordance between two CDx tests for detecting actionable variants and fusions. When excluding the eight uncovered variants (ODxTT: two variants, AmoyDx: six variants), the overall percent agreement was 97.6% (1026/1051) with 89.0% of overall positive percent agreement (89/100) and 98.5% of overall negative percent agreement (937/951). Of the 25 discordant genetic alterations, two were undetected despite being covered in the AmoyDx (one EGFR variant and one ROS1 fusion). Furthermore, there were potential false positives in the ODxTT (nine MET exon 14 skippings) and in the AmoyDx (five variants, six ROS1 and three RET fusions). These potential false positives in the AmoyDx likely due to non-specific amplification, which was validated by the unique molecular barcoding sequencing. The ODxTT missed two uncovered EGFR rare variants, which was visually confirmed in the raw sequencing data. Our study provides insights into real-world performance of CDx tests for lung cancer and ensures reliability to advance precision medicine. [ABSTRACT FROM AUTHOR]

Introduction: Since patients with pharyngeal squamous cell carcinoma (SCC) often have multiple pharyngeal lesions, evaluation of pharyngeal lesions before endoscopic resection (ER) is important. However, detailed endoscopic observation of the entire pharyngeal mucosa under conscious sedation is difficult. We examined the usefulness of endoscopic surveillance with narrow band imaging (NBI) and lugol staining for detection of pharyngeal sublesions during ER for pharyngeal SCC under general anesthesia (endoscopic surveillance during treatment; ESDT). Methods: From January 2021 through June 2022, we examined 78 patients who were diagnosed with superficial pharyngeal SCC and underwent ER. They underwent the ESDT and for patients who were diagnosed with new lesions of pharyngeal SCC or high-grade dysplasia (HGD) that were not detected in the endoscopic examination before treatment, ER were performed simultaneously for new lesions and the main lesions. The primary endpoint of this study was the detection rate of new lesions of pharyngeal SCC or HGD in the ESDT. Results: Fifteen of the 78 patients were diagnosed as having undetected new pharyngeal lesions in the ESDT and 10 (12.8%) (95% CI 6.9–22.2%) were histopathologically confirmed to have new lesions of pharyngeal SCC or HGD. Among the 13 lesions of SCC or HGD, 8 were found by NBI observation; however, 5 were undetectable using NBI but detectable by lugol staining. All of the 13 lesions had endoscopic findings of pink color sign on lugol staining. Conclusions: Endoscopic surveillance for pharyngeal sublesions during ER for pharyngeal SCC is feasible and useful. [ABSTRACT FROM AUTHOR]

Background and aims: Conversion to laparotomy is among the serious intraoperative complications and carries an increased risk of postoperative complications. In this cohort study, we investigated whether or not the Endoscopic Surgical Skill Qualification System (ESSQS) affects the conversion rate among patients undergoing laparoscopic surgery for rectal cancer. Methods: We performed a retrospective secondary analysis of data collected from patients undergoing laparoscopic surgery for cStage II and III rectal cancer from 2014 to 2016 across 56 institutions affiliated with the Japan Society of Laparoscopic Colorectal Surgery. Data from the original EnSSURE study were analyzed to investigate risk factors for conversion to laparotomy by performing univariate and multivariate analyses based on the reason for conversion. Results: Data were collected for 3,168 cases, including 65 (2.1%) involving conversion to laparotomy. Indicated conversion accounted for 27 cases (0.9%), while technical conversion accounted for 35 cases (1.1%). The multivariate analysis identified the following independent risk factors for indicated conversion to laparotomy: tumor diameter [mm] (odds ratio [OR] 1.01, 95% confidence interval [CI] 1.01–1.05, p = 0.0002), combined resection of adjacent organs [+/−] (OR 7.92, 95% CI 3.14–19.97, p < 0.0001), and surgical participation of an ESSQS-certified physician [−/+] (OR 4.46, 95% CI 2.01–9.90, p = 0.0002). The multivariate analysis identified the following risk factors for technical conversion to laparotomy: registered case number of institution (OR 0.99, 95% CI 0.99–1.00, p = 0.0029), institution type [non-university/university hospital] (OR 3.52, 95% CI 1.54–8.04, p = 0.0028), combined resection of adjacent organs [+/−] (OR 5.96, 95% CI 2.15–16.53, p = 0.0006), and surgical participation of an ESSQS-certified physician [−/+] (OR 6.26, 95% CI 3.01–13.05, p < 0.0001). Conclusions: Participation of ESSQS-certified physicians may reduce the risk of both indicated and technical conversion. Referral to specialized institutions, such as high-volume centers and university hospitals, especially for patients exhibiting relevant background risk factors, may reduce the risk of conversion to laparotomy and lead to better outcomes for patients. Trial Registration: This study was registered with the Japanese Clinical Trials Registry as UMIN000040645. [ABSTRACT FROM AUTHOR]

Background: Tissue-based comprehensive genomic profiling (CGP) is increasingly being employed for genotype-directed therapies in patients with advanced cancer. However, tissue availability may limit their potential applications. In Japan, the cost of cancer gene panel tests is covered by public insurance for patients diagnosed with advanced solid tumors once in their lifetime. Therefore, it is essential to improve the success rate (reportability) and accuracy of CGP tests. The purpose of this study was to identify the factors associated with efficient and accurate CGP testing using relevant information obtained from real-world data. Methods: This study included 159 samples analyzed using tumor-only panel FoundationOne® CDx cancer genome profiling (F1CDx) and 85 samples analyzed using matched-pair panel OncoGuide™ NCC Oncopanel system (NCCOP) at St. Marianna University Hospital. Sample characteristics (fixation conditions, storage period, histology, tumor cell ratio, and genomic tumor cell content), CGP performance, and quality control status were evaluated across all 244 tested samples. Results: In 237/244 samples (97.1%), CGP testing results were successfully obtained [F1CDx, 99.4% (158/159) and NCCOP, 92.9% (79/85)]. An increased number of fibroblasts, inflammatory cells, and necrotic tumor cells, long-term storage, and/or prolonged fixation of tissue sections were involved in the unreported results and/or qualified CGP results. In addition, a negative correlation between median insert size values and ΔΔCq was observed in the NCCOP system. Conclusion: We identified various factors associated with efficient and accurate CGP testing using relevant information obtained from real-world data, suggesting that thorough selection and preparation of tissue sections could optimize CGP and maximize useful information. [ABSTRACT FROM AUTHOR]

It has been postulated that being breastfed in infancy affects not only health status in childhood but also disease risk in adulthood. To investigate the association of being breastfed with the risks of adult colorectal cancer and benign tumor, we conducted a case–control study including 1190 colorectal cancer and 1585 benign tumor cases and 5301 controls, admitted to a single hospital in Miyagi Prefecture, Japan, between 1997 and 2013. History of having been breastfed was assessed using a self-administered questionnaire, and odds ratios (ORs) were estimated using unconditional logistic regression. There was no association between being breastfed and colorectal cancer risk (breastfed versus formula-only fed, OR = 1.21; 95% CI 0.87–1.67). There was also no association with the risk of benign tumor (OR = 1.04). On the other hand, analyses stratified by sex and birth year found heterogeneous associations. Women born after 1950 who had been breastfed tended to have increased risks of colorectal cancer (OR = 1.58) and benign tumor (OR = 1.51) relative to those who had been formula-only fed, although not statistically significant. In men born after 1950, being breastfed was associated with a significantly decreased risk of benign tumor (OR = 0.57; 95% CI 0.33–0.98). [ABSTRACT FROM AUTHOR]

Background: Pembrolizumab has been widely used in patients since its release, but information on cardiac Adverse Events (AEs) related to pembrolizumab remains lacking, particularly in Japanese populations. Objectives: This study aims to evaluate time to onset, incidence rates, and outcomes for pembrolizumab-induced cardiac AEs in patients with cancer using the Japanese Adverse Drug Event Report database. Methods: We analysed data for the period from April 2004 to March 2022. Data on cardiac AEs were extracted and relative risks of AEs were estimated using the reporting odds ratio. Results: We analysed 2,021,907 reports and identified 15,306 reports of AEs caused by pembrolizumab. Of these, 399 cardiac AEs were associated with pembrolizumab. Signals were detected for six cardiac AEs: myocarditis, immune-mediated myocarditis, pericardial effusion, cardiac tamponade, pericarditis, and pericarditis malignant. A histogram of median times to onset showed occurrence from 33 (21–97) days for immune-mediated myocarditis to 138 (67–168) days for pericarditis malignant, but some cases occurred even more than 1 year after the start of administration. Among these, myocarditis was the most frequently reported (27.1%), with fatal cases also reported. Conclusion: This study focused on cardiac AEs caused by pembrolizumab as post-marketing AEs. Patients should be monitored not only at the time of administration, but also over time for signs of these AEs, especially myocarditis, as some patients may have serious outcomes. [ABSTRACT FROM AUTHOR]

Background: Immune checkpoint inhibitors have recently become the standard of care in the first‐line treatment of extensive‐stage small cell lung cancer. Although immune‐related adverse events have been reported to influence prognosis in non‐small cell lung cancer patients, few studies have investigated the prognostic value of immune‐related adverse events in small cell lung cancer patients. In this study, we evaluated the prognosis of patients who developed immune‐related adverse events after first‐line treatment with immune checkpoint inhibitor‐based chemotherapy for extensive‐stage small cell lung cancer. Methods: We enrolled 90 patients with extensive‐stage small cell lung cancer who received immune checkpoint inhibitor‐based chemotherapy as first‐line treatment from September 2019 to December 2022 in six hospitals in Japan. The patients were categorized into groups with and without immune‐related adverse events. Results: There were 23 patients with and 67 without immune‐related adverse events. Seventeen patients had grade 1–2 immune‐related adverse events, and nine (including overlapping cases) had grade ≥3. The most frequent immune‐related adverse event was a skin rash. The median survival time was 22 months in patients with immune‐related adverse events and 9.3 months in patients without immune‐related adverse events. The hazard ratio was 0.40 (95% confidence interval: 0.19–0.83, p = 0.013). Conclusions: The results of this study show that immune‐related adverse events are associated with improved survival outcomes in patients with extensive‐stage small cell lung cancer. [ABSTRACT FROM AUTHOR]

To understand perspective on breast cancer using a survey. Questionnaire was distributed to 304 Japanese radiation oncologists (RadOncs) (response rate: 64.1%). Result was compared with a similar US survey. In a scenario with an 81-year-old patient with comorbidities, while most US RadOncs chose to tell that radiation might not be necessary, 2% of Japanese chose it. In a scenario with a healthy 65-year-old breast cancer patient with lumpectomy, while most US RadOncs chose to discuss omission of radiation, 24.5% of Japanese chose it. Differences were observed on radiotherapy for older early-stage breast cancer. [ABSTRACT FROM AUTHOR]

Simple Summary: The clinical course of classic Hodgkin lymphoma arising in immune deficiency/dysregulation (CHL-IDD) differs from that of CHL arising in immunocompetent cases and typically exhibits aggressive clinical behaviors. This study investigated the genetic aberration of 9p24.1 and protein expression of PD-L1 and also analyzed the clinicopathological association of these genetic lesions in CHL-IDD. Our findings showed that PD-L1 expression and 9p24.1 copy number alterations were observed in all patients analyzed in this study. Though it is recognized that an increase in 9p24.1 copy number alteration is associated with a more aggressive clinical course in immunocompetent CHL patients, we identified a subset of the 9p24.1 copy gain group, which had less 9p24.1 copy number alteration than the amplification group, exhibited more extensive extranodal lesions and had higher clinical stages in CHL-IDD cases. This finding speculates the presence of a genetically distinct subgroup within CHL-IDD patients, which may explain certain characteristic features. A subset of patients with rheumatoid arthritis receiving methotrexate develop immune deficiencies and dysregulation-associated lymphoproliferative disorders. Patients with these disorders often exhibit spontaneous regression after MTX withdrawal; however, chemotherapeutic intervention is frequently required in patients with classic Hodgkin lymphoma arising in immune deficiency/dysregulation. In this study, we examined PD-L1 expression levels and 9p24.1 copy number alterations in 27 patients with classic Hodgkin lymphoma arising from immune deficiency/dysregulation. All patients demonstrated PD-L1 protein expression and harbored 9p24.1 copy number alterations on the tumor cells. When comparing clinicopathological data and associations with 9p24.1 copy number features, the copy gain group showed a significantly higher incidence of extranodal lesions and clinical stages than the amplification group. Notably, all cases in the amplification group had latency type II, while 6/8 (75%) in the copy gain group had latency type II, and 2/8 (25%) had latency type I. Thus, a subset of the copy-gain group demonstrated more extensive extranodal lesions and higher clinical stages. This finding speculates the presence of a genetically distinct subgroup within the group of patients who develop immune deficiencies and dysregulation-associated lymphoproliferative disorders, which may explain certain characteristic features. [ABSTRACT FROM AUTHOR]

Background: Cancer cachexia is a multifactorial syndrome leading to progressive functional impairment. How cachexia affects the treatment course of chemotherapy in patients with pancreatic cancer has not been well understood. Methods: This is an exploratory, retrospective, observational cohort study using the Japanese medical claims database from Medical Data Vision Co., Ltd. The study population included patients diagnosed with pancreatic cancer in whom first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (GnP) was initiated between October 1, 2018, and September 30, 2020. In this study, we defined patients with cancer cachexia as those who had a weight loss of ≥ 5% in the preceding 6 months. The primary outcome was time-to-treatment failure (TTF). The observation period was six months from the initiation of first-line FFX or GnP treatment. Results: A total of 1897 patients (421 patients into the cachexia group; 1476 patients into the non-cachexia group) were analyzed in this study. The median TTF was 121 days (95% confidence interval [CI] 94–146) in the cachexia group and 143 days (95% CI 134–152) in the non-cachexia group. The hazard ratio for TTF of the cachexia versus non-cachexia group was 1.136 (95% CI 0.979–1.319). The median number of doses was two doses fewer in the cachexia group than in the non-cachexia group for both FFX and GnP. Conclusion: Cancer cachexia was suggested to be associated with shorter TTF and a reduced number of doses in patients with pancreatic cancer who received first-line FFX or GnP treatment. Clinical Trial Registration clinicaltrials.jp: UMIN000045820. [ABSTRACT FROM AUTHOR]

Background: Poly (ADP‐ribose) polymerase (PARP) inhibitors have been increasingly used in the treatment of ovarian cancer, with BRCA positivity and homologous recombination deficiency (HRD) being common biomarkers used for predicting their efficacy. However, given the limitations of these biomarkers, new ones need to be explored. Methods: This retrospective study included 181 ovarian cancer patients who received olaparib or niraparib at two independent hospitals in Japan between May 2018 and December 2022. Clinical information and blood sampling data were collected. Patient characteristics, treatment history, and predictability of treatment duration based on blood data before treatment initiation were examined. Results: High‐grade serous carcinoma, BRCA positivity, HRD, and maintenance therapy after recurrence treatment were observed more frequently in the olaparib group than in the niraparib group. The most common reasons for treatment interruption were anemia, fatigue, and nausea in the olaparib group and thrombocytopenia in the niraparib group. Regarding response to olaparib treatment, complete response to the most recent treatment, maintenance therapy after the first chemotherapy, high‐grade serous carcinoma, and germline BRCA positivity were observed significantly more frequently among responders than among non‐responders. Furthermore, neutrophil counts were significantly higher among responders than among non‐responders. Conclusions: Inflammation‐related blood data, such as neutrophil count, obtained at the initial pre‐treatment visit might serve as potential predictors for prolonged olaparib treatment. While this study offers valuable insights into potential indicators for prolonged olaparib treatment, it underscores the need for more expansive research to strengthen our understanding of PARP inhibitors and optimize treatment strategies in ovarian cancer. [ABSTRACT FROM AUTHOR]

Background: Preoperative education can improve postoperative quality of life in patients undergoing stoma surgery. However, the prevalence and when, where, and how preoperative education is implemented are unclear. Therefore, this study aimed to assess the current status of outpatient preoperative education for patients undergoing stoma surgery for rectal cancer as perceived by nurses. Additionally, it sought to identify the information provided by Japanese healthcare providers as a part of preoperative education. Methods: This cross-sectional study included 1,716 wound, ostomy, and continence nurses (WOCNs) in charge of stoma clinics at Japanese hospitals. Unsigned self-administered survey forms were mailed to the participants, and paper- or web-based responses were obtained. The main questions included: overview of the participants and their facilities, provision of outpatient preoperative education, status of implementation, and preoperative education components. To examine the factors associated with preoperative education, the independent variable was the presence or absence of preoperative education in the clinic, and the explanatory variables were the years of experience as a nurse, years of experience as a WOCN, type of hospital, number of beds, and number of intestinal stoma surgeries per year. Regression analysis was performed. Results: We received 773 valid responses (valid response rate: 45%). Duration of experience as a nurse and as a WOCN were 24.6 and 10.9 years, respectively. Outpatient preoperative education was provided by 24% of the participants. Most preoperative education sessions were conducted for patients or caregivers. Preoperative education took 31–60 min per patient, and one to five patients received preoperative education each month. Booklets, ostomy appliances, and stoma models/dolls were used as supplementary materials for preoperative education. The most frequently mentioned components of preoperative education were stoma care, daily life, social security, stoma clinic, traveling and going out, quality of life after stoma surgery, and precautions for medical treatment. In addition, education on the use of restrooms on the go, disaster preparedness, defecation disorders after restorative proctectomy, and complications after stoma closure were considered necessary. Conclusions: The implementation rate of outpatient preoperative education was low (24%). Future challenges include the development of specific educational content and procedures suitable for the Japanese medical environment and the establishment of preoperative medical care teams for stoma surgery to promote the provision of outpatient preoperative education. [ABSTRACT FROM AUTHOR]

Introduction: Patients with the head and neck squamous cell carcinoma (SCC) are often treated with immune checkpoint inhibitors (ICIs). Recently, antibiotic intake was reported to lower the efficacy of ICIs in patients with several types of cancers. However, it is unclear if antibiotics affect the efficacy of ICIs in patients with head and neck SCC. We retrospectively assessed the influence of antibiotics on the treatment efficacy of nivolumab, an ICI, in patients with head and neck SCC. Methods: We reviewed the medical records of patients with head and neck SCC treated with nivolumab at the Department of Medical Oncology, Tohoku University Hospital, between 2017 and 2021. Patients who received oral or intravenous antibiotics from a month before the day of nivolumab initiation to the day of the first imaging evaluation of ICI efficacy were assigned to the antibiotic-treated group. The remaining patients were assigned to the antibiotic-untreated group. The response rate (RR), progression-free survival (PFS), and overall survival time (OS) of both groups were compared. Results: Forty-five patients were assigned to the antibiotic-treated group and 19 to the antibiotic-untreated group. The RR, median PFS, and median OS of the antibiotic-treated group were 23.7%, 3.2 months (95% confidential interval [CI]: 2.0–4.1), and 8.4 months (95% CI: 5.3–15.1) and those of the antibiotic-untreated group were 42.1%, 5.8 months (95% CI: 2.3–16.7), and 18.4 months (95% CI: 6.2–23.1), respectively. The PFS of the antibiotic-untreated group was significantly longer than that of the antibiotic-treated group. Conclusion: Our findings indicate that antibiotic treatment significantly shortens the PFS with nivolumab therapy in patients with head and neck SCC. [ABSTRACT FROM AUTHOR]

Background: Although the da Vinci™ Surgical System is the most predominantly used surgical robot worldwide, other surgical robots are being developed. The Japanese surgical robot hinotori™ Surgical Robot System was launched and approved for clinical use in Japan in November 2022. We performed the first robotic gastrectomy for gastric cancer using hinotori in the world. Here, we report our initial experience and evaluation of the feasibility and safety of robotic gastrectomy for gastric cancer using hinotori. Methods: A single-institution retrospective study was conducted. Between November 2022 and October 2023, 24 patients with gastric cancer underwent robotic gastrectomy with hinotori. Five ports, including one for an assistant, were placed in the upper abdomen, and gastric resection with standard lymphadenectomy and intracorporeal reconstruction were performed. The primary endpoint was the postoperative complication rate within 30 days after surgery. The secondary outcomes were surgical outcomes, including intraoperative adverse events, operative time, blood loss, and the number of dissected nodes. Results: Of the 24 patients, 16 (66.7%) were male. The median age and body mass index were 73.5 years and 22.9 kg/m2, respectively. Twenty-three patients (95.8%) had tumors in the middle to lower stomach. Sixteen (66.7%) and seven (29.2%) patients had clinical stage I and II diseases, respectively. Twenty-three (95.8%) patients underwent distal gastrectomy. No patient had postoperative complications of Clavien–Dindo classification IIIa or higher, whereas two (8.3%) had the grade II complications (enteritis and pneumonia). No intraoperative adverse events, including conversion to other approaches, were observed. All patients received R0 resection. The median operative and console times were 400 and 305 min, respectively. The median blood loss was 14.5 mL, and the number of lymph nodes dissected was 51.5. Conclusions: This study found that robotic gastrectomy with standard lymphadenectomy for gastric cancer using hinotori can be safely performed. [ABSTRACT FROM AUTHOR]

Background: We investigated the impact of the COVID‐19 pandemic on oral cancer (OC), comparing diagnosis and number of pre‐operative days in the diagnosis of OC in 2019 (pre‐COVID‐19) and that in 2020 (during the COVID‐19 pandemic). Methods: Using data from a cancer registry‐based study on the impact of COVID‐19 on cancer care in Osaka (CanReCO), we collected details of sex, age, residential area, cancer site, date of diagnosis, clinical stage at first treatment and number of pre‐operative days in OC patients. Results: A total of 1470 OC cases were registered. Incidence of OC before and during COVID‐19 was 814 and 656 cases, respectively. During the first wave of the pandemic (March to May 2020), incidence was about half that in the same period in 2019 (2019; n = 271, 2020; n = 145). Number of pre‐operative days (median number of days between the first hospital visit and surgery date) was significantly shorter during the COVID‐19 year (24.5 days) than in the pre‐COVID‐19 year (28 days, p = 0.0015). Conclusions: Incidence of OC during the COVID‐19 pandemic was lower than in pre‐COVID‐19. Despite disruption in the healthcare system, the number of pre‐operative days for OC cases was shorter during the pandemic. [ABSTRACT FROM AUTHOR]

Objective: Tumor cells can acquire a large amount of energy and structural components by reprogramming energy metabolism; moreover, metabolic profiles slightly differ according to cancer type. This study compared and assessed the metabolic profile of head and neck squamous cell carcinoma (HNSCC) and normal tissues, which were collected from patients without cancer. Subjects and Methods: Overall, 23 patients with HNSCC and 6 patients without cancer were included in the analysis. Metabolomic profiles were analyzed using capillary electrophoresis‐mass spectrometry. Gene expression was evaluated using real‐time reverse transcription‐polymerase chain reaction. Results: Glycolysis, the pentose phosphate pathway, tricarboxylic acid cycle, and glutamine metabolism were upregulated in HNSCC tissues based on gene expression analysis. HNSCC could then have enhanced energy production and structural component. The levels of lactate, succinate, glutathione, 2‐hydroxyglutarate, and S‐adenosylmethionine, considered as oncometabolites, increased and these had accumulated in HNSCC tissues. Conclusions: The level of metabolites and the expression of enzymes differ between HNSCC and normal tissues. Reprogramming metabolism in HNSCC provides an energy source as well as structural components, creating a system that offers rapid proliferation, progression, and is less likely to be eliminated. [ABSTRACT FROM AUTHOR]

Polypharmacy is becoming increasingly troublesome in the treatment of cancer. The aim of this study was to explore the effects of concomitant polypharmacy comprising drugs that inhibit CYP3A4 and/or CYP2D6 on the oxycodone tolerability in patients with cancer. We conducted a multicenter retrospective study encompassing 20 hospitals. The data used for the study were obtained during the first 2 wk of oxycodone administration. The incidence of oxycodone discontinuation or dose reductions due to side effects and oxycodone-induced nausea and vomiting (OINV) were compared between patients not treated with either inhibitor and those treated with concomitant CYP3A4 or CYP2D6 inhibitors. The incidence of oxycodone discontinuation or dose reductions in patients treated with ≥3 concomitant CYP2D6 inhibitors (18.2%) tended to be higher than that in patients without this treatment (8.2%; p = 0.09). Moreover, the incidence of OINV in patients treated with 2 concomitant CYP3A4 inhibitors (29.8%) was significantly higher than that in patients without this treatment (15.5%; p = 0.049). Multivariate analysis showed that more than two concomitant CYP3A4 inhibitors and no concomitant use of naldemedine were independent risk factors for OINV. Concomitant polypharmacy involving CYP3A4 inhibitors increases the risk of OINV. Therefore, medications concomitantly used with oxycodone should be optimized. [ABSTRACT FROM AUTHOR]

With the International Commission on Radiological Protection's (ICRP) reduction in the radiation dose threshold for cataracts, evaluating and preventing radiation exposure to the lens of the eye among interventional radiology (IR) staff have become urgent tasks. In this study, we focused on differences in lens-equivalent dose (HT Lens) to which IR nurses in three hospitals were exposed and aimed to identify factors underlying these differences. According to analyses of time-, distance-, and shielding-related factors, the magnitude of the HT Lens dose to which IR nurses were exposed could be explained not by time or shielding but by the distance between the X-ray exposure field and the location of the IR nurse. This distance tended to be shorter in hospitals with fewer staff. The most effective means of reducing the exposure of the lenses of IR nurses' eyes to radiation is to position them at least two meters from the radiation source during angiography procedures. However, some hospitals must provide IR departments with comparatively few staff. In work environments where it is infeasible to reduce exposure by increasing distance, interventions to reduce time by managing working practices and investment in shielding equipment are also important. This study was not registered. [ABSTRACT FROM AUTHOR]

This study aimed at examining the effect of continued use of home health care resources on end-of-life care at home in older patients with cancer. This retrospective cohort study was conducted using medical and long-term care claims data of 6435 older patients with cancer who died between April 2016 and March 2019 in Fukuoka Prefecture. The main explanatory variables were enhanced home care support clinics and hospitals (HCSCs), enhanced HCSCs with beds, conventional HCSCs, other HCSCs, and home visit nursing care. The covariates were sex, age, required level of care, and the Charlson Comorbidity Index. A logistic regression model was used. The results of the multilevel logistic regression analysis showed that the following were significantly associated with end-of-life care at home: use of enhanced HCSCs with beds (odds ratio, OR: 8.66; 95% confidence interval, CI: [4.31–17.40]), conventional HCSCs (OR: 5.78; 95% CI: [1.86–17.94]), enhanced HCSCs (OR: 4.44; 95% CI: [1.47–13.42]), home-visit nursing care (OR: 1.86; 95% CI: [1.42–2.44]), and a severe need for care (OR: 3.89; 95% CI: [2.92–5.18]). The results suggest that the continued use of home health care resources in older patients with cancer who require out-of-hospital care may lead to increased end-of-life care at home. Particularly, use of enhanced HCSCs with beds is most strongly associated with end-of-life care at home. [ABSTRACT FROM AUTHOR]

Purpose: The present study evaluated the sex-specific susceptibility to the development of emphysema in patients with smoking histories who underwent lung cancer surgeries. Methods: Lung cancer patients with smoking histories who underwent lung resection at the University of Tsukuba Hospital, Japan, were enrolled. Radiologic emphysematous changes were analyzed using three-dimensional computed tomography (3D-CT). The volume proportion of emphysematous lung per unit of smoking and the relationship between emphysematous change and clinicopathologic factors were evaluated. Results: Radiologic emphysematous changes analyzed using 3D-CT per pack-year smoked, defined as the Smoking-Emphysema Index (SEI), were greater in females than males. The difference was more profound in adenocarcinoma patients than in non-adenocarcinoma patients (0.70 ± 2.30 vs. 0.21 ± 0.28, P = 0.037). Conclusion: Female lung cancer patients are more susceptible to smoking-induced emphysema than males. The SEI may be an effective indicator for evaluating smoking-induced emphysema. [ABSTRACT FROM AUTHOR]

Study Objective: Few data are available on the association between the use of oxycodone in patients with chronic kidney disease (CKD) and acute respiratory conditions. The aim of this study was to investigate whether oxycodone is associated with an increased risk of acute respiratory conditions in patients with cancer and CKD compared with other opioids. Design and Setting: The data were obtained from a claims database in Japan. Patients with cancer and CKD who had received sustained‐release opioids, including oral oxycodone, oral morphine, or transdermal fentanyl, between April 2014 and May 2021 were selected. The primary outcome was defined as an acute respiratory condition. Data for age and sex, morphine equivalent daily dose, concomitant use of specified medications, comorbidities defined based on the modified Charlson comorbidity index, substance use disorder, and lung cancer or metastatic lung cancer were investigated as covariates. Distribution of acute respiratory conditions was compared among the three sustained‐release opioid groups using the log‐rank test. Estimates of the incidence of acute respiratory conditions were compared among the groups using a Cox proportional hazards model with time‐varying variables. Main Results: A significant difference in the distribution of acute respiratory conditions was found among the three groups (p < 0.01). Cox regression analysis showed a significantly higher risk of acute respiratory conditions with morphine (hazard ratio [HR]: 3.04, 95% confidence interval [CI]: 1.07–8.65, p = 0.04) compared with oxycodone but no significant difference in risk with oxycodone (HR 0.67, 95% CI: 0.32–1.38, p = 0.27) compared with fentanyl. Conclusions: The findings suggest that the risk of acute respiratory conditions may be lower in patients with CKD who use oxycodone for cancer pain than in those who use morphine. Additionally, no difference in the risk of acute respiratory conditions was found between oxycodone and fentanyl use. [ABSTRACT FROM AUTHOR]

Simple Summary: The efficacy of abiraterone plus prednisolone (ABI) against nonmetastatic castration-resistant prostate cancer (CRPC) remains unclear. To evaluate enzalutamide and ABI as the first-line treatment for CRPC, we conducted the randomized controlled trial including both metastatic and nonmetastatic CRPC. As a sub-analysis, we focused on nonmetastatic CRPC in this study. ABI and enzalutamide had similar efficacy and safety profiles in patients with nonmetastatic CRPC. Enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) can improve the survival of patients with castration-resistant prostate cancer (CRPC). However, the agent that is more effective against nonmetastatic CRPC remains unclear. To evaluate the agent that can be used as the first-line treatment for CRPC, an investigator-initiated, multicenter, randomized controlled trial (ENABLE Study for PCa) including both metastatic and nonmetastatic CRPC was conducted in Japan. The prostate-specific antigen (PSA) response rate, overall survival, some essential survival endpoints, and safety of patients with nonmetastatic CRPC were also analyzed. In this subanalysis, 15 and 26 patients in the ENZ and ABI arms, respectively, presented with nonmetastatic CRPC. There was no significant difference in terms of the PSA response rate between the ENZ and ABI arms (80% and 64%, respectively; p = 0.3048). The overall survival did not significantly differ between the two arms (HR: 0.68; 95% CI: 0.22–2.14, p = 0.5260). No significant differences were observed in terms of radiographic progression-free survival and cancer-specific survival between the ENZ and ABI arms (HR: 0.81; 95% CI: 0.35–1.84; p = 0.6056 and HR: 0.72; 95% CI: 0.19–2.73; p = 0.6443, respectively). Only four and six patients in the ENZ and ABI arms, respectively, had ≥grade 3 adverse events. ABI and ENZ had similar efficacy and safety profiles in patients with nonmetastatic CRPC. [ABSTRACT FROM AUTHOR]

Background: Although there is insufficient evidence for the treatment of older patients with advanced gastric cancer, fluorouracil combined with platinum chemotherapy has been recognized as a standard first-line treatment for such populations in Japan despite the lack of efficacy and toxicity data. Methods: Patients aged 75 years or older with advanced gastric cancer were enrolled. S-1 plus docetaxel (docetaxel: 40 mg/m2, day 1; S-1: 80 mg/m2, days 1–14; q21 days) was repeated every 3 weeks. The primary endpoint was overall response rate. Secondary endpoints were safety, progression-free survival, time to treatment failure, and overall survival. The sample size was calculated as 30 under the hypothesis of an expected response rate of 40% and a threshold response rate of 20%, at a power of 90% and a two-sided alpha value of 5%. Results: From February 2010 to January 2015, 31 patients were enrolled and assessed for efficacy and toxicity. The response rate was 45.2% (95% CI 27.3%–64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months. The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%). Conclusions: These findings indicate that S-1 plus docetaxel as first-line treatment for older patients is feasible and that it has promising efficacy against advanced gastric cancer. [ABSTRACT FROM AUTHOR]

Background The impact of computed tomography (CT)-detected extramural venous invasion on the recurrence of colon cancer is not fully understood. The aim of this study was to investigate the clinical significance of extramural venous invasion diagnosed before surgery by contrast-enhanced CT colonography using three-dimensional multiplanar reconstruction images. Methods Patients with colon cancer staged greater than or equal to T2 and/or stage I–III who underwent contrast-enhanced CT colonography between 2013 and 2018 at the National Cancer Center Hospital in Japan were retrospectively investigated for CT-detected extramural venous invasion. Inter-observer agreement for the detection of CT-detected extramural venous invasion was evaluated and Kaplan–Meier survival curves were plotted for recurrence-free survival using CT-TNM staging and CT-detected extramural venous invasion. Preoperative clinical variables were analysed using Cox regression for recurrence-free survival. Results Out of 922 eligible patients, 544 cases were analysed (50 (9.2 per cent) were diagnosed as positive for CT-detected extramural venous invasion and 494 (90.8 per cent) were diagnosed as negative for CT-detected extramural venous invasion). The inter-observer agreement for CT-detected extramural venous invasion had a κ coefficient of 0.830. The group positive for CT-detected extramural venous invasion had a median follow-up of 62.1 months, whereas the group negative for CT-detected extramural venous invasion had a median follow-up of 60.7 months. When CT-TNM stage was stratified according to CT-detected extramural venous invasion status, CT-T3 N(−)extramural venous invasion(+) had a poor prognosis compared with CT-T3 N(−)extramural venous invasion(−) and CT-stage I (5-year recurrence-free survival of 50.6 versus 89.3 and 90.1 per cent respectively; P < 0.001). In CT-stage III, the group positive for CT-detected extramural venous invasion also had a poor prognosis compared with the group negative for CT-detected extramural venous invasion (5-year recurrence-free survival of 52.0 versus 78.5 per cent respectively; P = 0.003). Multivariable analysis revealed that recurrence was associated with CT-T4 (HR 3.10, 95 per cent c.i. 1.85 to 5.20; P < 0.001) and CT-detected extramural venous invasion (HR 3.08, 95 per cent c.i. 1.90 to 5.00; P < 0.001). Conclusion CT-detected extramural venous invasion was found to be an independent predictor of recurrence and could be used in combination with preoperative TNM staging to identify patients at high risk of recurrence. [ABSTRACT FROM AUTHOR]

Background: An increased relative eosinophil count (REC) has potential as a predictive biomarker for a beneficial clinical response and outcome to cancer immunotherapies. Therefore, the present study investigated the impact of an increased posttreatment REC on the prognosis of non‐small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs). Methods: We retrospectively reviewed all 151 patients diagnosed with NSCLC and treated with ICI monotherapy and blood test data between March 2016 and August 2021 at National Hospital Organization Kochi Hospital and Tokushima University. Results: A total of 151 patients with a mean age of 69 years were included. REC after 4 weeks of initial ICI monotherapy was higher than pretreatment REC in 87 patients but not in 64. REC after 4 weeks of the ICI treatment with and without an increased REC were 4.4 and 1.8%, respectively (p < 0.001). Disease control rates (DCR) were significantly higher in patients with than in those without an increased REC (84% vs. 47%, p < 0.001). The median overall survival (OS) of lung cancer patients with or without an increased REC were 674 and 234 days, respectively. A Kaplan–Meier univariate analysis revealed a significant difference in OS between the two groups (p < 0.001). A Cox proportional regression analysis identified an increased REC as an independent predictor of OS (p = 0.003). Conclusion: ICI‐treated NSCLC patients with an increased REC after 4 weeks of treatment had a better DCR and prognosis than the other patients examined. [ABSTRACT FROM AUTHOR]

Simple Summary: Molecular targeted therapies are very effective as a treatment for postoperative recurrence of non-small cell lung cancer (NCSLC) with driver mutations. On the other hand, the efficacy of local therapies for oligo-recurrence has also been reported. To investigate the optimal treatment strategy for oligo-recurrence in NSCLC patients with driver mutations, we retrospectively evaluated 66 NSCLC patients with driver mutations who were treated with local or molecular targeted therapies as the initial treatment after recurrence. Patients treated with local therapies as a first-line treatment did not show statistically significant differences in post-recurrence survival and progression-free survival compared with those treated with molecular targeted therapies. However, local therapies as an initial treatment should be considered preferably, as they can be curative after recurrence and can delay the start of the administration of molecular targeted therapies. Background: The efficacy of local therapies for lung cancer patients with postoperative oligo-recurrence has been reported. However, whether local therapies should be chosen over molecular targeted therapies for oligo-recurrence patients with driver mutations remains controversial. Therefore, we aimed to investigate the optimal initial treatment strategy for oligo-recurrence in lung cancer patients with driver mutations. Methods: Among 2152 patients with lung adenocarcinoma who underwent surgical resection at our institute between 2008 and 2020, 66 patients with driver mutations who experienced cancer oligo-recurrence after surgery and were treated with local or molecularly targeted therapy as an initial therapy after recurrence were evaluated. Oligo-recurrence was characterized by the presence of 1 to 3 recurrent lesions. These patients were investigated, focusing on their post-recurrence therapies and prognoses. Results: The median follow-up period was 71 months. Local and molecular targeted therapies were administered to 41 and 25 patients, respectively. The number of recurrence lesions tended to be lower in the initial local therapy group than in the molecular targeted therapy group. In the initial local therapy group, 23 patients (56%) subsequently received molecular targeted therapies. The time from recurrence to the initiation of molecular targeted therapy was significantly longer in the local therapy group than in the molecular targeted therapy group (p < 0.001). There was no significant difference in post-recurrence overall survival (hazard ratio, 1.429; 95% confidence interval, 0.701–2.912; log-rank, p = 0.324) and post-recurrence progression-free survival (hazard ratio, 0.799; 95% confidence interval, 0.459–1.390; log-rank, p = 0.426) in the initial local ablative therapy group compared with the initial molecular targeted therapy group. Conclusions: Local therapies as a first-line treatment did not show statistically significant differences in post-recurrence survival or progression-free survival compared with molecular targeted therapies. However, local therapies as an initial treatment should be considered preferably, as they can cure the recurrence and can delay the start of administration of molecular targeted therapies. [ABSTRACT FROM AUTHOR]

Simple Summary: Cervical lymph node (LN) metastasis is a critical prognostic factor for patients with head and neck squamous cell carcinoma (HNSCC), rendering accurate diagnosis of LN metastasis crucial for improving patient outcomes. Our study aimed to develop deep learning models for metastatic LN detection using YOLOv7, the fastest single-stage object detection model, on B-mode and power Doppler (D-mode) ultrasonography in patients with HNSCC and investigate their utility in supporting the diagnosis by comparing their performance to that of highly experienced radiologists and less experienced residents. A total of 462 B- and D-mode ultrasound images were used to train, validate, and test the B- and D-mode models, respectively. The detection performances of the B- and D-mode models for metastatic LNs were higher than those of less experienced residents; the performance of the D-mode model was comparable to that of highly experienced radiologists, suggesting that YOLOv7-based models are useful for supporting the diagnosis. Ultrasonography is the preferred modality for detailed evaluation of enlarged lymph nodes (LNs) identified on computed tomography and/or magnetic resonance imaging, owing to its high spatial resolution. However, the diagnostic performance of ultrasonography depends on the examiner's expertise. To support the ultrasonographic diagnosis, we developed YOLOv7-based deep learning models for metastatic LN detection on ultrasonography and compared their detection performance with that of highly experienced radiologists and less experienced residents. We enrolled 462 B- and D-mode ultrasound images of 261 metastatic and 279 non-metastatic histopathologically confirmed LNs from 126 patients with head and neck squamous cell carcinoma. The YOLOv7-based B- and D-mode models were optimized using B- and D-mode training and validation images and their detection performance for metastatic LNs was evaluated using B- and D-mode testing images, respectively. The D-mode model's performance was comparable to that of radiologists and superior to that of residents' reading of D-mode images, whereas the B-mode model's performance was higher than that of residents but lower than that of radiologists on B-mode images. Thus, YOLOv7-based B- and D-mode models can assist less experienced residents in ultrasonographic diagnoses. The D-mode model could raise the diagnostic performance of residents to the same level as experienced radiologists. [ABSTRACT FROM AUTHOR]

Objectives: Insufficient preparedness for bereavement can affect a family's psychological health status after bereavement. However, factors associated with preparedness remain unclear. This study aimed to identify factors associated with preparedness for bereavement in families of patients with cancer. Methods: We conducted a secondary analysis of a nationwide bereaved family survey in Japan, analyzing data from 9123 family members of patients with cancer. Logistic regression analysis was conducted to explore how sociodemographic factors, health status, and perceived care for patients and families were associated with preparedness for bereavement. Results: Of the 9123 families, 1338 (15.1%) were not prepared for bereavement. Factors associated with insufficient preparedness for bereavement (all p < 0.001) were found as follows: patients' spouses (OR = 2.54), receiving care in acute hospitals (OR = 1.83), worse psychological health status during caregiving (OR = 2.13), lower social support for family members (OR = 1.90), wrong patients' awareness of medical condition from family's perspective (OR = 1.75–2.12), family preference of more aggressive treatment rather than palliative care (OR = 1.71) or not sure (OR = 2.31), not wanting to know information about the patient's prognosis (OR = 1.64–1.77), end‐of‐life discussion with physician 1 month before patient's death (OR = 1.45), and late or early end‐of‐life discussions with physician and family (OR = 1.78–1.95). Conclusions: This study's results might assist clinicians in assessing and identifying families who are not prepared for bereavement; however, preparedness for bereavement may have been associated with other factors. [ABSTRACT FROM AUTHOR]

Objective: Gynecologic cancer chemotherapy impacts the quality of life (QOL) of patients, with lasting adverse events that may require treatment adjustments or discontinuation. Consequently, real‐time symptom monitoring before outpatient visits has resulted in improved QOL for patients and extended survival times. This study investigated whether there are differences between electronic patient‐reported outcomes (e‐PRO‐CTCAE) and physician‐assessed outcomes (NCI‐CTCAE) evaluated in an outpatient setting in gynecologic cancer chemotherapy. Methods: The study was conducted on 50 patients who received their first chemotherapy treatment at St. Marianna University Hospital Obstetrics and Gynecology from July 1, 2021 to December 31, 2022. PRO‐CTCAE and NCI‐CTCAE were evaluated at each instance of chemotherapy and 2 weeks after. The PRO‐CTCAE was additionally collected weekly using e‐PRO. Results: The values for "Joint Pain," "Nausea," "Taste Disturbance," "Constipation," "Insomnia," "Fatigue," "Limb Edema," and "Concentration Impairment" were consistently higher in PRO‐CTCAE than in NCI‐CTCAE, indicating that physicians underestimated the severity of adverse events. In contrast, there was no significant difference in "Peripheral Neuropathy," demonstrating that physicians had a good understanding of this condition in patients. The weekly responses obtained from e‐PRO revealed that symptom exacerbations peaked outside of clinic visits. Conclusions: This study demonstrated physicians tend to underestimate most adverse events. Moreover, the responses using e‐PRO revealed peak symptom deterioration occurred outside of outpatient visits. This suggested that e‐PRO and actions taken in response to them can improve patients' QOL. [ABSTRACT FROM AUTHOR]

INTRODUCTION: The impact of adjuvant chemotherapy (ACT) using regimens including gemcitabine and platinum on the improvement of the prognosis of patients with locally advanced upper tract urothelial carcinoma (UTUC) has been recently demonstrated. This study aimed to determine the utility of ACT for patients with locally advanced UTUC in real-world clinical practice and the differences in efficacy among regimens. METHODS: Of 206 UTUC patients who underwent radical nephroureterectomy, 78 were pathologically diagnosed as T3 or higher and/or had pathologically identified lymph node metastasis; 36 in the ACT group and 42 in the non-ACT group were evaluated for patient background, recurrence, and prognosis. In the ACT group, either cisplatin (GC group, 12 cases) or carboplatin (GCa group, 24 cases) was administered as the platinum agent to be combined with gemcitabine. RESULT: The median patient age in the ACT group and that in the non-ACT group was 71 and 79 years, respectively (p<0.0001). There was no significant difference between these two groups in terms of other patient parameters. The two- and five-year cancer-specific survival (CSS) and the two- and five-year disease-free survival (DFS) for the ACT group were 81.7%, 66.0%, 60.6%, and 56.6%, respectively, and for the non-ACT group were 68.4%, 40.5%, 42.8%, and 29.3%, respectively (p=0.0399 for CSS and p=0.0814 for DFS). There was no significant difference in CSS and DFS between the GC group and GCa group (p=0.9846 and p=0.9389, respectively). CONCLUSIONS: In real-world clinical practice in Japan, UTUC patients who receive ACT after radical nephroureterectomy may be expected to have better cancer control than those who do not receive ACT. [ABSTRACT FROM AUTHOR]

Simple Summary: This study comprehensively investigated the genomic landscape of >3000 gynecological malignancies (endometrial, cervical, and ovarian cancers) in Japan. The Center for Cancer Genomics and Advanced Therapeutics database used in this study is a useful tool containing real-world data of patients with poor prognoses, as comprehensive genomic profiling tests are limited to patients with cancer who have completed standardized treatments in Japan. Genomic profiling based on histological subtypes, tumor mutational burden, and microsatellite instability highlights actionable mutations for future drug development for each gynecological cancer. This study aimed to comprehensively clarify the genomic landscape and its association with tumor mutational burden-high (TMB-H, ≥10 mut/Mb) and microsatellite instability-high (MSI-H) in endometrial, cervical, and ovarian cancers. We obtained genomic datasets of a comprehensive genomic profiling test, FoundationOne® CDx, with clinical information using the "Center for Cancer Genomics and Advanced Therapeutics" (C-CAT) database in Japan. Patients can undergo the tests only after standardized treatments under universal health insurance coverage. Endometrial cancers were characterized by a high frequency of TMB-H and MSI-H, especially in endometrioid carcinomas. The lower ratio of POLE exonuclease mutations and the higher ratio of TP53 mutations compared to previous reports suggested the prognostic effects of the molecular subtypes. Among the 839 cervical cancer samples, frequent mutations of KRAS, TP53, PIK3CA, STK11, CDKN2A, and ERBB2 were observed in adenocarcinomas, whereas the ratio of TMB-H was significantly higher in squamous cell carcinomas. Among the 1606 ovarian cancer samples, genomic profiling of serous, clear cell, endometrioid, and mucinous carcinomas was characterized. Pathogenic mutations in the POLE exonuclease domain were associated with high TMB, and the mutation ratio was low in both cervical and ovarian cancers. The C-CAT database is useful for determining the mutational landscape of each cancer type and histological subtype. As the dataset is exclusively collected from patients after the standardized treatments, the information on "druggable" alterations highlights the unmet needs for drug development in major gynecological cancers. [ABSTRACT FROM AUTHOR]