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Background@#We evaluated and compared South Korea’s total knee arthroplasty (TKA) reimbursement criteria set by Health Insurance Review and Assessment Service (HIRA) with other TKA appropriateness criteria to find additional criterion to improve its appropriateness by reviewing TKA inappropriate cases. @*Methods@#Two TKA appropriateness criteria and HIRA’s reimbursement criteria for TKA were adapted for use on patients undergoing TKA in one institute from December 2017 to April 2020. Preoperative data including 9 validated questionnaires on knee jointspecific parameters, age, and radiography were used. We categorized cases into appropriate, inconclusive, inappropriate groups and analyzed each group. @*Results@#Data on 448 cases that underwent TKA were examined. According to the HIRA’s reimbursement criteria, 434 cases (96.9%) were appropriate and 14 cases (3.1%) were inappropriate; superior to other TKA appropriateness criteria. The inappropriate group had Knee Injury and Osteoarthritis Outcome score (KOOS) pain, KOOS symptoms, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, and Korean Knee score total score with worse symptoms compared to the appropriate group classified by HIRA’s reimbursement criteria. @*Conclusions@#In terms of insurance coverage, HIRA’s reimbursement criteria was more effective in providing healthcare access to patients who had the most pressing need for TKA compared to other TKA appropriateness criteria. However, we found the lower age limit and patient-reported outcome measures of other criteria as useful tools in improving appropriateness of the current reimbursement criteria.
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With the introduction of coronavirus disease 2019 (COVID-19) vaccines, the Korea Disease Control and Prevention Agency (KDCA) commissioned the National Academy of Medicine of Korea to gather experts to independently assess post-vaccination adverse events. Accordingly, the COVID-19 Vaccine Safety Research Committee (CoVaSC) was launched in November 2021 to perform safety studies and establish evidence for policy guidance. The CoVaSC established 3 committees for epidemiology, clinical research, and communication. The CoVaSC mainly utilizes pseudonymized data linking KDCA’s COVID-19 vaccination data and the National Health Insurance Service’s claims data. The CoVaSC’s 5-step research process involves defining the target diseases and organizing ad-hoc committees, developing research protocols, performing analyses, assessing causal relationships, and announcing research findings and utilizing them to guide compensation policies. As of 2022, the CoVaSC completed this research process for 15 adverse events. The CoVaSC launched the COVID-19 Vaccine Safety Research Center in September 2022 and has been reorganized into 4 divisions to promote research including international collaborative studies, long-/short-term follow-up studies, and education programs. Through these enhancements, the CoVaSC will continue to swiftly provide scientific evidence for COVID-19 vaccine research and compensation and may serve as a model for preparing for future epidemics of new diseases.
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Background@#Although most elderly patients with acute myeloid leukemia (AML) are ineligible for intensive chemotherapy (ICT), treatment options remain limited. CURRENT (UMIN000037786), a real-world, non-interventional, retrospective chart review, evaluated clinical outcomes, clinicopathologic characteristics, and treatment patterns in these patients.We present results from a subanalysis of Korean patients in this study. @*Methods@#Patients were aged ≥ 18 years with primary or secondary AML ineligible for ICT who initiated first-line systemic therapy or best supportive care (BSC) between 2015 and 2018 across four centers in Korea. Primary endpoint was overall survival (OS) from diagnosis.Secondary endpoints included progression-free survival (PFS), time to treatment failure, and response rates. Data analyses were primarily descriptive, with time-to-event outcomes estimated using the Kaplan-Meier method, and Cox regression used to determine prognostic factors for survival. @*Results@#Among 194 patients enrolled, 84.0% received systemic therapy and 16.0% received BSC. Median age at diagnosis was 74 and 78 years, and Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 was reported in 73.0% and 48.4% of patients, respectively;poor cytogenetic risk was reported in 30.1% and 16.1% of patients. Median OS was 7.83 vs.4.50 months, and median PFS was 6.73 vs. 4.50 months in the systemic therapy vs. BSC groups. Prognostic factors affecting OS included secondary AML (hazard ratio, 1.67 [95% confidence interval, 1.13–2.45]), ECOG performance status ≥ 2 (2.41 [1.51–3.83]), poor cytogenetic risk (2.10 [1.36–3.24]), and Charlson comorbidity index ≥ 1 (2.26 [1.43–3.58]). @*Conclusion@#Clinical outcomes are poor in Korean patients with AML ineligible for ICT who are prescribed current systemic therapies or BSC. There is a substantial unmet need for novel agents (monotherapy or in combination) to improve clinical outcomes in this patient population.
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Purpose@#The optimal tumor mutational burden (TMB) value for predicting treatment response to programmed cell death-1 (PD-1) checkpoint inhibitors in advanced gastric cancer (AGC) remains unclear. We aimed to investigate the optimal TMB cutoff value that could predict the efficacy of PD-1 checkpoint inhibitors in AGC. @*Materials and Methods@#Patients with AGC who received pembrolizumab or nivolumab between October 1, 2020, and July 27, 2021, at Samsung Medical Center in Korea were retrospectively analyzed. The TMB levels were measured using a next-generation sequencing assay. Based on receiver operating characteristic curve analysis, the TMB cutoff value was determined. @*Results@#A total 53 patients were analyzed. The TMB cutoff value for predicting the overall response rate (ORR) to PD-1 checkpoint inhibitors was defined as 13.31 mutations per megabase (mt/Mb) with 56% sensitivity and 95% specificity. Based on this definition, 7 (13.2%) patients were TMB-high (TMB-H). The ORR differed between the TMB-low (TMB-L) and TMB-H (8.7% vs. 71.4%, P=0.001). The progression-free survival and overall survival (OS) for 53 patients were 1.93 (95% confidence interval [CI], 1.600–2.268) and 4.26 months (95% CI, 2.992–5.532). The median OS was longer in the TMB-H (20.8 months; 95% CI, 2.292–39.281) than in the TMB-L (3.31 months; 95% CI, 1.604–5.019; P=0.049). @*Conclusions@#The TMB cutoff value for predicting treatment response in AGC patients who received PD-1 checkpoint inhibitor monotherapy as salvage treatment was 13.31 mt/Mb.When applying the programmed death ligand-1 status to TMB-H, patients who would benefit from PD-1 checkpoint inhibitors can be selected.
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Purpose@#A retrospective descriptive study was performed to develop strategies to manage or prevent pressure ulcers in patients with severe trauma being cared for in the trauma intensive care unit (TICU). @*Methods@#Study data was compiled from 315 patients with severe trauma (injury severity score ≥ 15) who were admitted to a general hospital from January 1, 2020, to February 28, 2021 and were being cared for in the TICU. For patients with pressure ulcers, the characteristics and associated factors of pressure ulcers were examined. @*Results@#There were 42 severe trauma patients (13.3%) with pressure ulcers, of which, 50.0% of cases occurred at the site of the coccyx. In 50% of patients, Stage 2 pressure ulcers were observed. The mean onset day of pressure ulcers was 9.74 days after admission. The occurrence of diabetes, critical care triage score, length of stay in intensive care, death, shock, dialysis, ventilator application, endotracheal intubation, peripheral insertion central catheter insertion, A-line insertion, body protector application, sedatives, blood pressure boosters, nasal cannula, high-flow oxygenators, oxygen tip application, drainage insertion, nasogastric tube nutrition, and ventilator application period were investigated. Logistic regression analysis revealed that the influencing factors for the development of pressure ulcers were endotracheal intubation, length of stay in the TICU, and age, in that order. @*Conclusion@#By identifying the characteristics and risk factors associated with pressure ulcers in patients with severe trauma, strategies can be developed to better prevent or manage pressure ulcers in the future.
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We report a case about successful surgical treatment of a granular cell tumor in the ascending colon. A 36-year-old man underwent screening colonoscopy. An endoscopic examination revealed a 10-mm yellowish and hemispheric mass in the ascending colon, and lower endoscopic ultrasonography revealed a hypoechoic-to-isoechoic mass invaded the submucosal layer. The mass was suspected to be a colonic carcinoid tumor. Based on the preoperative evaluation, endoscopic complete resection was considered difficult. Therefore, the lesion was removed via laparoscopic right hemicolectomy. Histological examination revealed that the tumor consisted of nests of polygonal cells with abundant granular eosinophilic cytoplasm. Immunohistochemical staining revealed diffuse positivity for S100 and CD68. Therefore, the tumor was diagnosed as a granular cell tumor. We suggest that surgical resection should be considered if it is located in the thin-walled ascending colon prone to perforation, difficult to rule out malignant tumor due to submucosal invasion, or to remove endoscopically.
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Background@#Ergothioneine (EGT) is a natural amino acid derivative in various animal organs and is a bioactive compound recognized as a food and medicine. @*Objectives@#This study examined the effects of EGT supplementation during the in vitro maturation (IVM) period on porcine oocyte maturation and subsequent embryonic development competence after in vitro fertilization (IVF). @*Methods@#Each EGT concentration (0, 10, 50, and 100 µM) was supplemented in the maturation medium during IVM. After IVM, nuclear maturation, intracellular glutathione (GSH), and reactive oxygen species (ROS) levels of oocytes were investigated. In addition, the genes related to cumulus function and antioxidant pathways in oocytes or cumulus cells were investigated. Finally, this study examined whether EGT could affect embryonic development after IVF. @*Results@#After IVM, the EGT supplementation group showed significantly higher intracellular GSH levels and significantly lower intracellular ROS levels than the control group. Moreover, the expression levels of hyaluronan synthase 2 and Connexin 43 were significantly higher in the 10 µM EGT group than in the control group. The expression levels of nuclear factor erythroid 2-related factor 2 (Nrf2) and NAD(P)H quinone dehydrogenase 1 (NQO1) were significantly higher in the oocytes of the 10 µM EGT group than in the control group. In the assessment of subsequent embryonic development after IVF, the 10 µM EGT treatment group improved the cleavage and blastocyst rate significantly than the control group. @*Conclusions@#Supplementation of EGT improved oocyte maturation and embryonic development by reducing oxidative stress in IVM oocytes.
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Counselling and medication are often thought of as the only interventions for psychiatric disorders, but electroconvulsive therapy (ECT) has also been applied in clinical practice for over 80 years. ECT refers to the application of an electric stimulus through the patient’s scalp to treat psychiatric disorders such as treatment-resistant depression, catatonia, and schizophrenia. It is a safe, effective, and evidence-based therapy performed under general anesthesia with muscle relaxation. An appropriate level of anesthesia is essential for safe and successful ECT; however, little is known about this because of the limited interest from anesthesiologists. As the incidence of ECT increases, more anesthesiologists will be required to better understand the physiological changes, complications, and pharmacological actions of anesthetics and adjuvant drugs. Therefore, this review focuses on the fundamental physiological changes, management, and pharmacological actions associated with various drugs, such as anesthetics and neuromuscular blocking agents, as well as the comorbidities, indications, contraindications, and complications of using these agents as part of an ECT procedure through a literature review and our own experiences.
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Ectopic thymic neoplasm, particularly ectopic thymic carcinoma, is a rare disease that presents as a neck mass. Here, we present a case of ectopic thymic squamous carcinoma in a 65-year-old man who presented with persistent hoarseness. After fine needle aspiration cytology, the patient underwent total thyroidectomy with lymph node dissection. The final histopathological examination revealed the ectopic thymic squamous carcinoma. The patient was discharged without any postoperative complications. The patient received adjuvant radiation therapy and did not progress during the 1-year follow-up period.
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Kleefstra syndrome is a rare genetic disease characterized by mental retardation, hypotonia, and a characteristic facial appearance. Furthermore, in some cases, Kleefstra syndrome is associated with various anorectal and genitourinary complications, including imperforated anus, vesicoureteral reflux, hydronephrosis, and chronic kidney disease. Herein, we present a case of Kleefstra syndrome with recurrent urinary tract infections associated with vesicoureteral reflux and rectourethral fistula, which was treated by a multidisciplinary approach.
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Background@#Recently developed imaging techniques, such as cone beam computed tomography (CBCT) and CAD/CAM technology, have facilitated reliable implant planning and implant surgical guide production by 3D printing. This study compared the accuracy of implant-guided surgery using the R2GATE® program with CBCT before and after surgery. @*Patients and methods@#The study included patients who visited the Department of Oral and Maxillofacial Surgery at Chonnam National University Hospital from September 2021 to March 2022. Twenty-four implants were placed in eleven patients. Using R2GATE® Windows (Megagen implant, Daegu, Korea) software, implant placement was planned. The difference was measured by the CBCT before and after surgery. The cervical and apical distance and angular deviation of the implants were measured. Statistical analysis was performed using an independent t-test, Pearson correlation, and multiple regression analyses. @*Results@#The three-dimensional linear distance difference between the planned implant and the placed implant was 0.97 ± 0.37 mm at the cervical and 1.13 ± 0.36 mm at the apical. The difference in angle deviation between the planned implant and the placed implant was 3.42 ± 2.12°. Among the variables affecting the accuracy of implant placement, a statistically significant difference was found when using a tissue-supported implant guide, implant diameter and implant length. @*Conclusion@#Based on these results, using the R2GATE® program is useful to use an implant digital surgical guide, and it will be used in various clinic.
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The traditional approach to diagnosis and management of Zenker’s diverticulum is open surgical treatment. More recently, however, endoscopic technique is also frequently used for Zenker’s diverticulum because it has advantages of shortening operation time, postoperative hospitalization and reducing the complication such as recurrent laryngeal nerve injury. A 75-year-old male, who was diagnosed with Zenker’s diverticulum, underwent a secondary open diverticulectomy after failed attempt at rigid transoral endoscopic diverticulotomy. Here we report this case with a review of literature.
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Aspergillus tracheobronchitis, an uncommon form of invasive pulmonary aspergillosis, is characterized by the development of a pseudomembrane, ulcers, or an obstruction that is predominantly confined to the tracheobronchial tree. Pseudomembranous Aspergillus tracheobronchitis is the most severe form of Aspergillus tracheobronchitis, and only a few cases have been reported in Korea. We report the characteristic chest CT findings in a patient diagnosed with pseudomembranous Aspergillus tracheobronchitis after bronchoscopy and successfully treated by proper antifungal treatment.
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Small intestinal malignant tumor accounts for about 3% of all malignant tumors in the gastrointestinal tract, among which 13% are leiomyosarcoma (LMS). In addition, epithelioid LMS is of very rare occurrence. As small intestinal malignant tumors are initially asymptomatic and nonspecific, diagnosis is often delayed, and this can lead to large tumor at the time of detection and lead to intussusception. We observed ileocolonic intussusception in an 80-year-old male patient who was admitted to the hospital with a complaint of abdominal pain and palpable mass on right lower quadrant. The laparoscopic ileocecectomy was performed by the emergency operation because of obstruction. The pathologic examination revealed that the epithelioid LMS developed in the terminal ileum was the leading point of intussusception. To the best of our knowledge, laparoscopic surgery for ileocolonic intussusception with epithelioid LMS has not yet been reported.
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Background@#Rotator cuff tears can be asymptomatic in some cases; however, even when the tear size is small, clinical symptoms can be very severe. This suggests that symptoms of rotator cuff tears are related to factors other than the size. Although synovitis has been cited as one of the factors, there is no grading system for synovitis in rotator cuff tears. Moreover, there are few studies that evaluated the relationship between synovitis and clinical features in patients with rotator cuff tears. @*Methods@#Patients with medium-sized rotator cuff tears, who were scheduled for arthroscopic repair, were recruited for this study.The glenohumeral joint was divided into 4 quarters. Then, vascularity and hypertrophy of the joint were graded in each quarter using a modified scoring system. Clinical assessment was performed preoperatively and at 3 months and 6 months after surgery.Finally, correlation between the severity of synovitis and clinical features was analyzed. @*Results@#The intraobserver correlation coefficient was 0.815 to 0.918 and the interobserver correlation coefficient was 0.779 to 0.992 for the single measurement. Vascularity was significantly correlated with the range of motion, strength, and constant score within 6 months after surgery. Hypertrophy was correlated with the range of motion within 6 months after surgery. @*Conclusions@#Synovitis in the shoulder with rotator cuff tears can be graded by using our modified scoring system. The severity of synovitis was closely related to the clinical features after surgery. Therefore, when treating patients with rotator cuff tears, treatment of synovitis should also be considered.
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Purpose@#This study aimed to validate the Sheffield Profile for Assessment and Referral to Care (SPARC) as an effective tool for screening palliative care needs among Korean cancer patients. @*Materials and Methods@#The English version of the SPARC was translated by four Korean oncologists and reconciled by a Korean language specialist and a medical oncologist fluent in English. After the first version of the Korean SPARC (K-SPARC) was developed, back-translation into English was performed by a professional translator and bilingual oncologist. The back-translated version was reviewed by the original author (S.H.A.), and modifications were made (ver. 2). The second version of the K-SPARC was tested against other questionnaires, including the Functional Assessment of Cancer Therapy-General (FACT-G) and the Edmonton Symptom Assessment System (ESAS). @*Results@#Thirty patients were enrolled in the pilot trial. Fifteen were male, and the median age was 64.5 years. Six patients had an Eastern Cooperative Oncology Group performance status of 2 or more. All patients except one were receiving chemotherapy. Regarding internal consistency, the Cronbach’s α scores for physical symptoms, psychological issues, religious and spiritual issues, independency and activity, family and social issues, and treatment issues were 0.812, 0.804, 0.589, 0.843, 0.754, and 0.822, respectively. The correlation coefficients between the SPARC and FACT-G were 0.479 (p=0.007) for the physical domain and –0.130 (p=0.493) for the social domain. @*Conclusion@#This pilot study indicates that the K-SPARC could be a reliable tool to screen for palliative care needs among Korean cancer patients. A further study to validate our findings is ongoing.
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Background@#Vaccine safety surveillance is important because it is related to vaccine hesitancy, which affects vaccination rate. To increase confidence in vaccination, the active monitoring of vaccine adverse events is important. For effective active surveillance, we developed and verified a machine learning-based active surveillance system using national claim data. @*Methods@#We used two databases, one from the Korea Disease Control and Prevention Agency, which contains flu vaccination records for the elderly, and another from the National Health Insurance Service, which contains the claim data of vaccinated people. We developed a casecrossover design based machine learning model to predict the health outcome of interest events (anaphylaxis and agranulocytosis) using a random forest. Feature importance values were evaluated to determine candidate associations with each outcome. We investigated the relationship of the features to each event via a literature review, comparison with the Side Effect Resource, and using the Local Interpretable Model-agnostic Explanation method. @*Results@#The trained model predicted each health outcome of interest with a high accuracy (approximately 70%). We found literature supporting our results, and most of the important drug-related features were listed in the Side Effect Resource database as inducing the health outcome of interest. For anaphylaxis, flu vaccination ranked high in our feature importance analysis and had a positive association in Local Interpretable Model-Agnostic Explanation analysis. Although the feature importance of vaccination was lower for agranulocytosis, it also had a positive relationship in the Local Interpretable Model-Agnostic Explanation analysis. @*Conclusion@#We developed a machine learning-based active surveillance system for detecting possible factors that can induce adverse events using health claim and vaccination databases. The results of the study demonstrated a potentially useful application of two linked national health record databases. Our model can contribute to the establishment of a system for conducting active surveillance on vaccination.
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Background and Objectives@#The aim of this study was to determine the clinical effectiveness of parotid gland (PG) massage for the prevention of PG dysfunction after administration of radioiodine (I-131) therapy for treatment of differentiated thyroid cancer (DTC). @*Materials and Methods@#One hundred patients with DTC with planned high-dose I-131 therapy were enrolled in the clinical trial and randomized into two groups (massage and non-massage group). Serum amylase values were obtained before and 24 h after I-131 therapy, and salivary gland scintigraphy (SGS) were taken before and at eight months after the I-131 therapy. Additional SGS (addSGS) were taken when the patients complained symptoms related to salivary gland dysfunction. Questionnaire surveys were performed before and until two years after I-131 therapy. @*Results@#Ninety-five of 100 patients finished the study protocol. Changes in survey scores tended to be higher in the non-massage group. The non-massage group had more severe symptoms related to salivary gland dysfunction. Among 32 patients who underwent addSGS, 27 had normal 8-month SGS. Of these 27 patients, 18 (66.7%) had salivary gland dysfunction on the addSGS. Amylase values were significantly increased in patients with normal 8-month SGS but abnormal addSGS, as compared to patients who were normal on both 8-month SGS and addSGS (p=0.046). Amylase difference values were a significant predictor of abnormal addSGS (p=0.002). Conclusion: PG massage reduced symptoms related to salivary gland dysfunction. The PG massage may be helpful in preventing damage to salivary glands caused by I-131 therapy.
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Background/Aims@#Several prediction models for evaluating the prognosis of nonmetastatic resected pancreatic ductal adenocarcinoma (PDAC) have been developed, and their performances were reported to be superior to that of the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. We developed a prediction model to evaluate the prognosis of resected PDAC and externally validated it with data from a nationwide Korean database. @*Methods@#Data from the Surveillance, Epidemiology and End Results (SEER) database were utilized for model development, and data from the Korea Tumor Registry System-Biliary Pancreas (KOTUS-BP) database were used for external validation. Potential candidate variables for model development were age, sex, histologic differentiation, tumor location, adjuvant chemotherapy, and the AJCC 8th staging system T and N stages. For external validation, the concordance index (C-index) and time-dependent area under the receiver operating characteristic curve (AUC) were evaluated. @*Results@#Between 2004 and 2016, data from 9,624 patients were utilized for model development, and data from 3,282 patients were used for external validation. In the multivariate Cox proportional hazard model, age, sex, tumor location, T and N stages, histologic differentiation, and adjuvant chemotherapy were independent prognostic factors for resected PDAC. After an exhaustive search and 10-fold cross validation, the best model was finally developed, which included all prognostic variables. The C-index, 1-year, 2-year, 3-year, and 5-year time-dependent AUCs were 0.628, 0.650, 0.665, 0.675, and 0.686, respectively. @*Conclusions@#The survival prediction model for resected PDAC could provide quantitative survival probabilities with reliable performance. External validation studies with other nationwide databases are needed to evaluate the performance of this model.
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Mutation signatures represent unique sequence footprints of somatic mutations resulting from specific DNA mutagenic and repair processes. However, their causal associations and the potential utility for genome research remain largely unknown. In this study, we performed PanCancer-scale correlative analyses to identify the genomic features associated with tumor mutation burdens (TMB) and individual mutation signatures. We observed that TMB was correlated with tumor purity, ploidy, and the level of aneuploidy, as well as with the expression of cell proliferation-related genes representing genomic covariates in evaluating TMB. Correlative analyses of mutation signature levels with genes belonging to specific DNA damage-repair processes revealed that deficiencies of NHEJ1 and ALKBH3 may contribute to mutations in the settings of APOBEC cytidine deaminase activation and DNA mismatch repair deficiency, respectively. We further employed a strategy to identify feature-driven, de novo mutation signatures and demonstrated that mutation signatures can be reconstructed using known causal features. Using the strategy, we further identified tumor hypoxia-related mutation signatures similar to the APOBEC-related mutation signatures, suggesting that APOBEC activity mediates hypoxia-related mutational consequences in cancer genomes. Our study advances the mechanistic insights into the TMB and signature-based DNA mutagenic and repair processes in cancer genomes. We also propose that feature-driven mutation signature analysis can further extend the categories of cancer-relevant mutation signatures and their causal relationships.