Péter Bacsur, Tamás Resál, Patrícia Sarlós, Ákos Iliás, Liza Dalma Sümegi, Diána Kata, Anett Dávid, Bernadett Farkas, Emese Ivány, Anita Bálint, Zsófia Bősze, Anna Fábián, Renáta Bor, Zoltán Szepes, Waqqas Afif, Talat Bessissow, Klaudia Farkas, Péter L Lakatos, Tamás Molnár
{"title":"Outcomes of treatment cessation after switching to subcutaneous vedolizumab treatment in inflammatory bowel diseases.","authors":"Péter Bacsur, Tamás Resál, Patrícia Sarlós, Ákos Iliás, Liza Dalma Sümegi, Diána Kata, Anett Dávid, Bernadett Farkas, Emese Ivány, Anita Bálint, Zsófia Bősze, Anna Fábián, Renáta Bor, Zoltán Szepes, Waqqas Afif, Talat Bessissow, Klaudia Farkas, Péter L Lakatos, Tamás Molnár","doi":"10.1177/17562848241290636","DOIUrl":"10.1177/17562848241290636","url":null,"abstract":"<p><strong>Background: </strong>The usability of subcutaneous vedolizumab (s.c. VDZ) treatment in inflammatory bowel diseases (IBD; ulcerative colitis (UC), Crohn's disease (CD)) has been proven via clinical trials while real-world data collection is ongoing.</p><p><strong>Objectives: </strong>Our study evaluates the effectiveness, safety, patients' preferences, and psychological factors associated with s.c. VDZ treatment, after switching from intravenous (i.v.) formulation.</p><p><strong>Design: </strong>Prospective, multicenter cohort study including IBD patients switching from i.v. VDZ to s.c. treatment and were evaluated over 52 weeks.</p><p><strong>Methods: </strong>Serum VDZ levels and C-reactive protein (CRP) were measured at the baseline and w52. At w12, a questionnaire on the patient's satisfaction and psychological characteristics was administered. The primary outcome was the drug persistence rate (cessation was due to loss of response (LOR), adverse events, patient request, and other causes) at w52, while the secondary outcomes were the changes in the clinical corticosteroid-free remission (CSFR) and biochemical remission (BR; CRP ⩽ 5 mg/L) rates, safety issues, serum drug levels, patients' preferences, and psychological features.</p><p><strong>Results: </strong>In total, 70 IBD patients were evaluated (32 CD patients, 38 UC patients; male/female ratio: 41.4%; median age: 43.2 years). In the CD group, 81.3% were in CSFR and 65.6% were in BR, while in the UC group, 71.7% were in CSFR and 69.4% were in BR. Overall, 17.1% of the patients ceased s.c. VDZ treatment after a median of 26.2 (interquartile range 20-47) weeks. LOR was registered in 3/12 ceased patients. In addition, CSFR and BR rates were stable, while serum VDZ levels increased by w52 (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>The transition from i.v. to s.c. VDZ treatment was effective, the overall persistence rate was associated with high serum drug levels, and no novel safety issues were reported. Although s.c. administration after induction can save resources, some patients still insisted on i.v. VDZ treatment, due to its proven formulation.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lijuan Feng, Xunchao Cai, Qian Zou, Yao Peng, Long Xu, Linlin Wang, Qing Liu, Ting Lou
{"title":"Exploring the management and treatment of IBD from the perspective of psychological comorbidities.","authors":"Lijuan Feng, Xunchao Cai, Qian Zou, Yao Peng, Long Xu, Linlin Wang, Qing Liu, Ting Lou","doi":"10.1177/17562848241290685","DOIUrl":"https://doi.org/10.1177/17562848241290685","url":null,"abstract":"<p><p>The prevalence of anxiety, depression, and other psychological comorbidities among patients with inflammatory bowel disease (IBD) significantly exceeds that of the general population. Moreover, a bidirectional relationship exists between psychological comorbidities and IBD. This intricate interplay has substantial clinical implications, impacting treatment adherence, therapeutic efficacy, and disease recurrence rates. In this review, we explore the multifaceted mechanisms through which psychological factors influence IBD progression, treatment response, and prognosis. Specifically, we delve into the involvement of the hypothalamic-pituitary-adrenal axis, autonomic nervous system, enteric nervous system, microbiota-gut-brain axis, systemic inflammatory cytokines, and immune cell function. Additionally, we discuss the potential benefits of antidepressant therapy in mitigating IBD risk and the role of psychotropic drugs in reducing peripheral inflammation. Recognizing and addressing psychological comorbidity is pivotal in comprehensive IBD management. We advocate for the integration of biopsychosocial approaches into IBD treatment strategies, emphasizing the need for innovative psychological interventions as adjuncts to conventional therapies. Rigorous research investigating the impact of antidepressants and behavioral interventions on IBD-specific outcomes may herald a paradigm shift in IBD management.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A retrospective real-world study on the safety and efficacy of budesonide orodispersible tablets for the induction therapy of eosinophilic oesophagitis.","authors":"Rachel Geow, Gina Arena, Chiang Siah, Sherman Picardo","doi":"10.1177/17562848241290346","DOIUrl":"https://doi.org/10.1177/17562848241290346","url":null,"abstract":"<p><strong>Background: </strong>An orodispersible form of budesonide has recently been approved for the targeted treatment of eosinophilic oesophagitis in the United Kingdom, Europe, Australia, Canada and the United States, following favourable results from a randomised controlled trial. This is the first dedicated real-world study exploring the safety and efficacy of budesonide orodispersible tablets for induction therapy in the treatment of eosinophilic oesophagitis while providing insights into its management.</p><p><strong>Objectives: </strong>The primary objective was histologic remission, defined as less than 5 eosinophils per high-powered field. The secondary objectives included histologic response (>50% reduction in peak eosinophil count), clinical remission (complete resolution of symptoms documented on clinic letters), clinical response (improvements in symptoms as reported on clinical letters), endoscopic remission (Endoscopic Reference Score (EREFS) score = 0), and endoscopic response (improvement in EREFS score). The EREFS scores were calculated based on the severity and presence of rings, longitudinal furrows, strictures, oedema and exudates on endoscopic images. Adverse events and safety profiles were also recorded.</p><p><strong>Design: </strong>A multicentre cohort study examining the effectiveness of 1 mg, twice daily, budesonide orodispersible tablet induction therapy for the treatment of eosinophilic oesophagitis.</p><p><strong>Methods: </strong>Ethics approval was obtained through the Western Australia Health: Governance, Evidence, Knowledge, Outcomes system for assessment of Audit and Quality Activities. The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines.</p><p><strong>Results: </strong>A total of 43 patients (29 males, 14 females; median age 39) were recruited. Forty-one patients were included in the analysis. After induction therapy, 30 patients (73%) achieved histologic remission, and 35 patients (85%) demonstrated histologic response. Thirty-nine patients (95%) achieved clinical response, and 28 patients (68%) achieved clinical remission. An endoscopic response was seen in 37 patients (90%), and 16 patients (39%) achieved endoscopic remission. No significant adverse events were identified.</p><p><strong>Conclusion: </strong>Budesonide orodispersible tablet is an effective induction therapy for eosinophilic oesophagitis, as evidenced by its high histologic remission rate and favourable safety profile.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prescribed cumulative dosage of corticosteroids to patients with inflammatory bowel disease diagnosed between 2006 and 2020: a retrospective observational study.","authors":"Johannes Iiristo, Pontus Karling","doi":"10.1177/17562848241288851","DOIUrl":"https://doi.org/10.1177/17562848241288851","url":null,"abstract":"<p><strong>Background: </strong>Treatments and strategies for inflammatory bowel disease (IBD) have gradually evolved in the 2000s.</p><p><strong>Objectives: </strong>We investigated whether the prescription of corticosteroids (prednisolone and budesonide) in patients with IBD in the first 5 years after diagnosis changed in patients diagnosed between 2006 and 2018.</p><p><strong>Design: </strong>Retrospective observational study.</p><p><strong>Methods: </strong>The cumulative prescribed dosage of corticosteroids for the first 5 years after diagnosis was registered in all patients with IBD (<i>n</i> = 386) at our clinic for those diagnosed between 2006 and 2018.</p><p><strong>Results: </strong>The proportion of patients with IBD who were prescribed at least one prescription of corticosteroids in year 1-5 after diagnosis was 55.3%, 27.9%, 22.7%, 14.1%, and 14.6%, respectively. The proportion of patients who had a cumulative dose of prednisolone >1 g in the first 5 years after diagnosis was 40.1% for ulcerative colitis and 34.9% for Crohn's disease (CD). The cumulative prescribed dosage (within 3 years after diagnosis) of prednisolone had declined (rs = -0.164, <i>p</i> = 001), but had increased for budesonide (rs = 0.202, <i>p</i> < 0.001) between 2006 and 2020. The prescription of any immunomodulator for IBD in the first 5 years from diagnosis was stable between 2006 and 2018 (rs = 0.056, <i>p</i> = 0.257), but there was a minor increase in the prescription of Tumor Necrosis Factor (TNF)-inhibitors (rs = 0.119, <i>p</i> = 0.020). The use of five-acetyl salicylic acid (5-ASA) decreased in patients with CD (rs = -201, <i>p</i> = 0.012).</p><p><strong>Conclusion: </strong>There was a decrease in the prescription of prednisolone and an increase in the prescription of budesonide treatment from 2006 to 2023; however, the cumulative exposure to corticosteroids in patients with IBD remains at a relatively high level.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mette Mejlby Hansen, Nina Rågård, Pia Winther Andreasen, Sara Ellegaard Paaske, Jens Frederik Dahlerup, Susan Mikkelsen, Christian Erikstrup, Simon Mark Dahl Baunwall, Christian Lodberg Hvas
{"title":"Encapsulated donor faeces for faecal microbiota transplantation: the Glyprotect protocol.","authors":"Mette Mejlby Hansen, Nina Rågård, Pia Winther Andreasen, Sara Ellegaard Paaske, Jens Frederik Dahlerup, Susan Mikkelsen, Christian Erikstrup, Simon Mark Dahl Baunwall, Christian Lodberg Hvas","doi":"10.1177/17562848241289065","DOIUrl":"https://doi.org/10.1177/17562848241289065","url":null,"abstract":"<p><strong>Background: </strong>Faecal microbiota transplantation (FMT) is a highly effective treatment for <i>Clostridioides difficile</i> infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application.</p><p><strong>Objectives: </strong>We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.</p><p><strong>Design: </strong>Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.</p><p><strong>Methods: </strong>We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.</p><p><strong>Results: </strong>The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 10<sup>8</sup> non-specified bacteria.</p><p><strong>Conclusion: </strong>The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.</p><p><strong>Trial registration: </strong>Not applicable.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483698/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparison of clinical and endoscopic efficacy between vedolizumab and infliximab in bio-naïve patients with ulcerative colitis: a multicenter, real-world study.","authors":"Zhaopeng Huang, Jian Tang, Ruibin Wu, Shunhua Long, Wenke Chen, Tingna Lu, Qiuyue Xia, Yanhui Wu, Hongsheng Yang, Qingfan Yang, Zicheng Huang, Qin Guo, Miao Li, Xiang Gao, Kang Chao","doi":"10.1177/17562848241281218","DOIUrl":"https://doi.org/10.1177/17562848241281218","url":null,"abstract":"<p><strong>Background: </strong>No head-to-head trial directly compares the effectiveness of vedolizumab (VDZ) and infliximab (IFX) in patients with ulcerative colitis (UC) who were naïve to biologic therapy.</p><p><strong>Objectives: </strong>We aimed to compare the clinical and endoscopic effectiveness of VDZ and IFX in biologic-naïve patients with UC in real-world settings.</p><p><strong>Design: </strong>It was a multicenter, observational, real-world cohort study conducted at five centers.</p><p><strong>Methods: </strong>Patients diagnosed with UC and treated with either IFX or VDZ as their first-line biologic therapy were retrospectively enrolled. Steroid-free remission, clinical response, clinical remission, and endoscopic healing at week 14 and week 52 were compared between the two groups after propensity score weighting.</p><p><strong>Results: </strong>A total of 199 patients (117 VDZ and 82 IFX) were included in the study. There were no significant differences in steroid-free remission (64.6% vs 56.1%, <i>p</i> = 0.224), clinical response (83.4% vs 73.4%, <i>p</i> = 0.086), or clinical remission (69.4% vs 60.1%, <i>p</i> = 0.174) at week 14. However, VDZ showed better results in steroid-free remission (67.5% vs 44.4%, <i>p</i> = 0.004), clinical response (69.7% vs 47.1%, <i>p</i> = 0.005), and clinical remission (67.5% vs 44.4%, <i>p</i> = 0.004) at week 52. In terms of endoscopic healing, VDZ was similar to IFX at week 14 (25.7% vs 17.4%, <i>p</i> = 0.185), but VDZ had a significantly higher rate at week 52 (29.5% vs 11.8%, <i>p</i> = 0.027). VDZ was found to be superior to IFX in therapeutic continuation (hazard ratio = 0.339, 95% CI: 0.187-0.614, <i>p</i> < 0.001). The rate of adverse events was similar between the two groups (6.8% vs 8.5%, <i>p</i> = 0.655).</p><p><strong>Conclusion: </strong>VDZ demonstrated similar clinical and endoscopic effectiveness to IFX at week 14 in biologic-naïve patients with UC, but appeared to be superior at week 52. The safety outcomes were comparable between the groups.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483708/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Panagiotis Paraskevopoulos, Mahmoud Obeidat, Dániel Bednárik, Petrana Martinekova, Dániel Sándor Veres, Nándor Faluhelyi, Alexandra Mikó, Péter Mátrai, Péter Hegyi, Bálint Erőss
{"title":"Hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting for malignant biliary obstruction: a systematic review and meta-analysis.","authors":"Panagiotis Paraskevopoulos, Mahmoud Obeidat, Dániel Bednárik, Petrana Martinekova, Dániel Sándor Veres, Nándor Faluhelyi, Alexandra Mikó, Péter Mátrai, Péter Hegyi, Bálint Erőss","doi":"10.1177/17562848241273085","DOIUrl":"https://doi.org/10.1177/17562848241273085","url":null,"abstract":"<p><strong>Background: </strong>Combining antegrade stenting (AGS) and hepaticogastrostomy (HGS) is an increasingly used endoscopic ultrasound-guided intervention when stenting by endoscopic retrograde cholangiopancreatography is impossible.</p><p><strong>Objectives: </strong>We comprehensively assessed the benefits and downsides of combined AGS and HGS (HGS procedure with AGS, HGAS).</p><p><strong>Data sources and methods: </strong>From 788 HGS and 295 HGAS cases, a random-effects meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol. Five electronic databases were searched for studies on HGS with or without AGS from inception until May 2024. The odds ratio (OR) and pooled rates were used for single and two-arm comparisons with 95% confidence intervals (CI).</p><p><strong>Results: </strong>From 26 eligible studies. The pooled technical and clinical success was 94% (CI: 92%-96%) and 88% (CI: 84%-91%) for HGS and 89% (CI: 83%-93%) and 94% (CI: 89%-97%) for HGAS, respectively. Pooled OR of HGAS and HGS showed an OR = 0.38 (CI: 0.07-2.00) for technical success and an OR = 1.02 (CI: 0.50-2.06) for clinical success. The pooled adverse event rates were 20% (CI: 16%-25%) for HGS and 14% (CI: 9%-20%) for HGAS, whereas pooled OR showed an OR = 1.09 (CI: 0.30-3.94). For re-intervention, an OR = 0.37 (CI: 0.27-0.52) was found. Time to stent dysfunction increased, HGAS 333 (CI: 280-Not reached) and HGS 209 (CI: 120-325) with no change in overall survival HGS 117 (CI: 94-147) and 140 (CI: 105-170).</p><p><strong>Conclusion: </strong>The use of HGAS appears to increase clinical success and reduce the need for re-intervention. Overall adverse event rates were similar but bile leakage prevalence was decreased. Time to stent dysfunction seems to increase with no change in overall survival.</p><p><strong>Trial registration: </strong>Our protocol was prospectively registered with PROSPERO (CRD42024509412).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiao-Xuan Wang, Yu-Wen Zhou, Bo Wang, Peng Cao, De-Yun Luo, Chun-Hong Li, Kai Wang, Meng Qiu
{"title":"A nomogram construction and multicenter validation for predicting overall survival after fruquintinib application in patients with metastatic colorectal cancer: a multicenter retrospective study.","authors":"Xiao-Xuan Wang, Yu-Wen Zhou, Bo Wang, Peng Cao, De-Yun Luo, Chun-Hong Li, Kai Wang, Meng Qiu","doi":"10.1177/17562848241284229","DOIUrl":"10.1177/17562848241284229","url":null,"abstract":"<p><strong>Background: </strong>Fruquintinib is a third-line and subsequent targeted therapy for patients with metastatic colorectal cancer (mCRC). Identifying survival predictors after fruquintinib is crucial for optimizing the clinical use of this medication.</p><p><strong>Objectives: </strong>We aimed to identify factors influencing the prognosis of patients with mCRC treated with fruquintinib and to leverage these insights to develop a nomogram model for estimating survival rates in this patient population.</p><p><strong>Design: </strong>Multicenter retrospective observational study.</p><p><strong>Methods: </strong>We collected patient data from January 2019 to October 2023, with one healthcare institution's data serving as the training cohort and the other three hospitals' data serving as the multicenter validation cohort. The nomogram for overall survival was calculated from Cox regression models, and variable selection was screened using the univariate Cox regression analysis with additional variables based on clinical experience. Model performance was measured by the concordance index (C-index), calibration curves, decision curve analyses (DCA), and utility (patient stratification into low-risk vs high-risk groups).</p><p><strong>Results: </strong>Data were ultimately collected on 240 patients, with 144 patients included in the training cohort and 96 included in the multicenter validation cohort. Predictors included in the nomogram were CA199, body mass index, T stage, the primary site of the tumor, and other metastatic and pathological differentiation. The C-index of the nomogram in the training set and multicenter validation was 0.714 and 0.729, respectively. The models were fully calibrated and their predictions aligned closely with the observed data. DCA curves indicated the promising clinical benefits of the predictive model. Finally, the reliability of the model was also verified through the risk classification using the nomogram.</p><p><strong>Conclusions: </strong>We constructed a nomogram for mCRC treated with fruquintinib based on six variables that may be used to assist in personalizing the use of the drug.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11462570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142394383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The impact of periampullary diverticula on cannulation and adverse events in endoscopic retrograde cholangiopancreatography.","authors":"Arvid Gustafsson, Bobby Tingstedt, Greger Olsson","doi":"10.1177/17562848241279105","DOIUrl":"https://doi.org/10.1177/17562848241279105","url":null,"abstract":"<p><strong>Background: </strong>Periampullary diverticulum (PAD) is commonly encountered in endoscopic retrograde cholangiopancreatography (ERCP) procedures.</p><p><strong>Objectives: </strong>We sought to determine whether PADs are associated with a lower success rate of cannulation and an increased risk of adverse events.</p><p><strong>Design: </strong>A retrospective cohort study was conducted using prospectively gathered nationwide registry data.</p><p><strong>Methods: </strong>Using the Swedish registry for gallstone surgery and ERCP, we analyzed a cohort of 66,974 prospectively registered ERCP procedures performed in 2006-2021. The presence of PAD was divided into two groups based on the PAD type: Boix type 1 (the papilla located inside the PAD) and Boix types 2-3 (the papilla located either at the edge of the PAD or immediately adjacent to the PAD). The primary outcomes were the success rate of cannulation and overall adverse events within 30 days.</p><p><strong>Results: </strong>PADs were registered in 8130 (12.1%) of ERCPs included in the study population. In total, 2114 (3.9%) patients had Boix type 1 PAD, while 5035 (8.2%) patients had Boix type 2 or 3 PAD. The chance of successful cannulation was lower in patients with type 1 PAD compared to no PAD (80.1% vs 88.7%; odds ratio: 0.42, 95% confidence interval: 0.38-0.46). No differences were seen in overall adverse events or post-ERCP pancreatitis. Adverse events occurred in 14.6% of patients with PAD type 1 and 16.0% of patients with PAD type 2 or 3, compared to 16.5% of patients without a PAD.</p><p><strong>Conclusion: </strong>Cannulation appears less successful during ERCP when the papilla is located in the PAD (i.e., type 1). Adverse events seem not to increase with the presence of a PAD, but they could theoretically be influenced by the inability to cannulate.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11470493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"TAS-102 with or without bevacizumab treatment for patients with metastatic colorectal cancer: a multi-country cost-effectiveness analysis.","authors":"Youwen Zhu, Kun Liu, Hong Zhu","doi":"10.1177/17562848241284998","DOIUrl":"10.1177/17562848241284998","url":null,"abstract":"<p><strong>Background: </strong>TAS-102 (trifluridine/tipiracil) plus bevacizumab demonstrated a significant survival benefit in patients with refractory metastatic colorectal cancer (mCRC). Physicians and patients are uncertain whether this treatment option is clinically acceptable in different countries, underscoring the need for analyses of the cost-effectiveness of this regimen.</p><p><strong>Objectives: </strong>To guide doctors and patients to choose TAS-102 plus bevacizumab or TAS-102 monotherapy in cancer treatment.</p><p><strong>Design: </strong>The cost-effective analysis.</p><p><strong>Methods: </strong>A comprehensive Markov model of the 10-year horizon for three health states was established using data from the SUNLIGHT trial to evaluate the cost and health effects of TAS-102 with or without bevacizumab at particular willingness-to-pay (WTP) thresholds, analyzing parameters including quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), incremental net monetary benefit, as well as incremental net-health benefit (INHB). Sensitivity and subgroup analyses were additionally conducted.</p><p><strong>Results: </strong>Treatment with TAS-102 plus bevacizumab versus TAS-102 monotherapy increased effectiveness (cost) by 0.39 ($151,474), 0.38 ($26,794), and 0.41 ($8596) QALYs, with an ICER of $388,171, $69,617, and $20,919 per QALY and an INHB of -0.62, -0.03, and 0.18 QALYs in the United States, United Kingdom, and China, respectively. The utility of progression-free survival was the most important factor in this model. At respective WTP thresholds of $150,000, $65,000, and $37,653 per QALY in the United States, United Kingdom, and China, the odds of TAS-102 plus bevacizumab being the dominant treatment were 0%, 49.6%, and 87.8%, respectively. In addition, mCRC patients with an Eastern Oncology Cooperative Group performance status ⩾ 1 may be the best candidates for treatment.</p><p><strong>Conclusion: </strong>TAS-102 plus bevacizumab treatment represents a cost-effective third-line treatment for refractory mCRC from a Chinese payers' perspective, although the same was not true in the United States or United Kingdom at current drug prices.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}