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Impact of PD1 blockade added to neoadjuvant chemoradiotherapy on rectal cancer surgery: post-hoc analysis of the randomized POLARSTAR trial.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf057
Kai Pang, Xinzhi Liu, Hongwei Yao, Guole Lin, Yuanyuan Kong, Ang Li, Jiagang Han, Guoju Wu, Xin Wang, Yingjiang Ye, Jie Zhang, Guangyong Chen, Aiwen Wu, Yi Xiao, Yingchi Yang, Zhongtao Zhang

Background: The addition of PD1 blockade to neoadjuvant chemoradiotherapy (CRT) has been shown to significantly increase pCR rates in locally advanced rectal cancer (LARC). Yet, its impact on total mesorectal excision (TME) remains unknown.

Methods: A post-hoc analysis of the randomized POLARSTAR trial, which enrolled patients with LARC at eight major colorectal cancer centres in Beijing to compare neoadjuvant CRT plus PD1 blockade with CRT alone, was undertaken. Patients received one of three combinations of neoadjuvant treatments before TME surgery: CRT plus concurrent PD1 blockade (concurrent group), CRT plus sequential PD1 blockade (sequential group), and CRT alone (control group). Several parameters related to TME surgery were studied.

Results: For the concurrent group, the sequential group, and the control group, 52, 46, and 45 patients respectively were included in this analysis. The proportion of patients undergoing sphincter-saving plus one-stage anastomosis surgery was 92% (48 of 52), 96% (44 of 46), and 87% (39 of 45) respectively. The proportion of patients without a stoma was 21% (11 of 52), 17% (8 of 46), and 11% (5 of 45) respectively. The grade 3/4 surgical complication rate was 4% (2 of 52), 7% (3 of 46), and 4% (2 of 45) respectively. Significant differences were observed between the sequential group and the control group with respect to the proportion of patients with TRG0 (37% versus 18% respectively; P = 0.040), ypT0/is ypN0 (39% versus 20% respectively; P = 0.046), and a low neoadjuvant rectal (NAR) score (54% versus 31% respectively; P = 0.025).

Conclusions: Neoadjuvant CRT plus PD1 blockade enhances pathological tumour regression and is beneficial to the successful implementation of TME in patients with LARC. Validations with larger sample sizes are warranted.

{"title":"Impact of PD1 blockade added to neoadjuvant chemoradiotherapy on rectal cancer surgery: post-hoc analysis of the randomized POLARSTAR trial.","authors":"Kai Pang, Xinzhi Liu, Hongwei Yao, Guole Lin, Yuanyuan Kong, Ang Li, Jiagang Han, Guoju Wu, Xin Wang, Yingjiang Ye, Jie Zhang, Guangyong Chen, Aiwen Wu, Yi Xiao, Yingchi Yang, Zhongtao Zhang","doi":"10.1093/bjs/znaf057","DOIUrl":"https://doi.org/10.1093/bjs/znaf057","url":null,"abstract":"<p><strong>Background: </strong>The addition of PD1 blockade to neoadjuvant chemoradiotherapy (CRT) has been shown to significantly increase pCR rates in locally advanced rectal cancer (LARC). Yet, its impact on total mesorectal excision (TME) remains unknown.</p><p><strong>Methods: </strong>A post-hoc analysis of the randomized POLARSTAR trial, which enrolled patients with LARC at eight major colorectal cancer centres in Beijing to compare neoadjuvant CRT plus PD1 blockade with CRT alone, was undertaken. Patients received one of three combinations of neoadjuvant treatments before TME surgery: CRT plus concurrent PD1 blockade (concurrent group), CRT plus sequential PD1 blockade (sequential group), and CRT alone (control group). Several parameters related to TME surgery were studied.</p><p><strong>Results: </strong>For the concurrent group, the sequential group, and the control group, 52, 46, and 45 patients respectively were included in this analysis. The proportion of patients undergoing sphincter-saving plus one-stage anastomosis surgery was 92% (48 of 52), 96% (44 of 46), and 87% (39 of 45) respectively. The proportion of patients without a stoma was 21% (11 of 52), 17% (8 of 46), and 11% (5 of 45) respectively. The grade 3/4 surgical complication rate was 4% (2 of 52), 7% (3 of 46), and 4% (2 of 45) respectively. Significant differences were observed between the sequential group and the control group with respect to the proportion of patients with TRG0 (37% versus 18% respectively; P = 0.040), ypT0/is ypN0 (39% versus 20% respectively; P = 0.046), and a low neoadjuvant rectal (NAR) score (54% versus 31% respectively; P = 0.025).</p><p><strong>Conclusions: </strong>Neoadjuvant CRT plus PD1 blockade enhances pathological tumour regression and is beneficial to the successful implementation of TME in patients with LARC. Validations with larger sample sizes are warranted.</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Laparoscopic total pelvic exenteration: a simplified procedure using the fascial space priority approach.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znae316
Hongjie Yang, Yuanda Zhou, Peishi Jiang, Jiafei Liu, Zhichun Zhang, Qingsheng Zeng, Peng Li, Yu Long, Xipeng Zhang, Yi Sun
{"title":"Laparoscopic total pelvic exenteration: a simplified procedure using the fascial space priority approach.","authors":"Hongjie Yang, Yuanda Zhou, Peishi Jiang, Jiafei Liu, Zhichun Zhang, Qingsheng Zeng, Peng Li, Yu Long, Xipeng Zhang, Yi Sun","doi":"10.1093/bjs/znae316","DOIUrl":"https://doi.org/10.1093/bjs/znae316","url":null,"abstract":"","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143661653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Urinary retention after laparoscopic low rectal cancer resection: post-hoc analysis of predictive factors in the GRECCAR 10 trial.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znae315
Jean-Luc Faucheron, Fatah Tidadini, Antoine Vilotitch, Alison Foote, Bertrand Trilling
{"title":"Urinary retention after laparoscopic low rectal cancer resection: post-hoc analysis of predictive factors in the GRECCAR 10 trial.","authors":"Jean-Luc Faucheron, Fatah Tidadini, Antoine Vilotitch, Alison Foote, Bertrand Trilling","doi":"10.1093/bjs/znae315","DOIUrl":"https://doi.org/10.1093/bjs/znae315","url":null,"abstract":"","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143655707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Three-year follow-up of antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis: a secondary analysis of the APPAC III randomized clinical trial.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf016
Sami Sula, Suvi Sippola, Jussi Haijanen, Saija Hurme, Pia Nordström, Tero Rautio, Ville Sallinen, Paulina Salminen
{"title":"Three-year follow-up of antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis: a secondary analysis of the APPAC III randomized clinical trial.","authors":"Sami Sula, Suvi Sippola, Jussi Haijanen, Saija Hurme, Pia Nordström, Tero Rautio, Ville Sallinen, Paulina Salminen","doi":"10.1093/bjs/znaf016","DOIUrl":"https://doi.org/10.1093/bjs/znaf016","url":null,"abstract":"","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
International multicentre validation of the left pancreatectomy pancreatic fistula prediction models and development and validation of the combined DISPAIR-FRS prediction model. 左侧胰腺切除术胰瘘预测模型的国际多中心验证以及 DISPAIR-FRS 组合预测模型的开发和验证。
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znae313
Akseli Bonsdorff, Trond Kjeseth, Jakob Kirkegård, Charles de Ponthaud, Poya Ghorbani, Johanna Wennerblom, Caroline Williamson, Alexandra W Acher, Manoj Thillai, Timo Tarvainen, Ilkka Helanterä, Aki Uutela, Jukka Sirén, Arto Kokkola, Mushegh Sahakyan, Dyre Kleive, Rolf Hagen, Andrea Lund, Mette F Nielsen, Jean-Christophe Vaillant, Richard Fristedt, Christina Biörserud, Svein O Bratlie, Bobby Tingstedt, Knut J Labori, Sébastien Gaujoux, Stephen J Wigmore, Julie Hallet, Ernesto Sparrelid, Ville Sallinen

Background: Every fifth patient undergoing left pancreatectomy develops a postoperative pancreatic fistula (POPF). Accurate POPF risk prediction could help. Two independent preoperative prediction models have been developed and externally validated: DISPAIR and D-FRS. The aim of this study was to validate, compare, and possibly update the models.

Methods: Patients from nine high-volume pancreatic surgery centres (8 in Europe and 1 in North America) were included in this retrospective cohort study. Inclusion criteria were age over 18 years and open or minimally invasive left pancreatectomy since 2010. Model performance was assessed with discrimination (receiver operating characteristic (ROC) curves) and calibration (calibration plots). The updated model was developed with logistic regression and internally-externally validated.

Results: Of 2284 patients included, 497 (21.8%) developed POPF. Both DISPAIR (area under the ROC curve (AUC) 0.62) and D-FRS (AUC 0.62) performed suboptimally, both in the pooled validation cohort combining every centre's data and centre-wise. An updated model, named DISPAIR-FRS, was constructed by combining the most stable predictors from the existing models and incorporating other readily available patient demographics, such as age, sex, transection site, pancreatic thickness at the transection site, and main pancreatic duct diameter at the transection site. Internal-external validation demonstrated an AUC of 0.72, a calibration slope of 0.93, and an intercept of -0.02 for the updated model.

Conclusion: The combined updated model of DISPAIR and D-FRS named DISPAIR-FRS demonstrated better performance and can be accessed at www.tinyurl.com/the-dispair-frs.

{"title":"International multicentre validation of the left pancreatectomy pancreatic fistula prediction models and development and validation of the combined DISPAIR-FRS prediction model.","authors":"Akseli Bonsdorff, Trond Kjeseth, Jakob Kirkegård, Charles de Ponthaud, Poya Ghorbani, Johanna Wennerblom, Caroline Williamson, Alexandra W Acher, Manoj Thillai, Timo Tarvainen, Ilkka Helanterä, Aki Uutela, Jukka Sirén, Arto Kokkola, Mushegh Sahakyan, Dyre Kleive, Rolf Hagen, Andrea Lund, Mette F Nielsen, Jean-Christophe Vaillant, Richard Fristedt, Christina Biörserud, Svein O Bratlie, Bobby Tingstedt, Knut J Labori, Sébastien Gaujoux, Stephen J Wigmore, Julie Hallet, Ernesto Sparrelid, Ville Sallinen","doi":"10.1093/bjs/znae313","DOIUrl":"10.1093/bjs/znae313","url":null,"abstract":"<p><strong>Background: </strong>Every fifth patient undergoing left pancreatectomy develops a postoperative pancreatic fistula (POPF). Accurate POPF risk prediction could help. Two independent preoperative prediction models have been developed and externally validated: DISPAIR and D-FRS. The aim of this study was to validate, compare, and possibly update the models.</p><p><strong>Methods: </strong>Patients from nine high-volume pancreatic surgery centres (8 in Europe and 1 in North America) were included in this retrospective cohort study. Inclusion criteria were age over 18 years and open or minimally invasive left pancreatectomy since 2010. Model performance was assessed with discrimination (receiver operating characteristic (ROC) curves) and calibration (calibration plots). The updated model was developed with logistic regression and internally-externally validated.</p><p><strong>Results: </strong>Of 2284 patients included, 497 (21.8%) developed POPF. Both DISPAIR (area under the ROC curve (AUC) 0.62) and D-FRS (AUC 0.62) performed suboptimally, both in the pooled validation cohort combining every centre's data and centre-wise. An updated model, named DISPAIR-FRS, was constructed by combining the most stable predictors from the existing models and incorporating other readily available patient demographics, such as age, sex, transection site, pancreatic thickness at the transection site, and main pancreatic duct diameter at the transection site. Internal-external validation demonstrated an AUC of 0.72, a calibration slope of 0.93, and an intercept of -0.02 for the updated model.</p><p><strong>Conclusion: </strong>The combined updated model of DISPAIR and D-FRS named DISPAIR-FRS demonstrated better performance and can be accessed at www.tinyurl.com/the-dispair-frs.</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient and tumour factors influencing length of sarcoma diagnostic trajectory intervals: first results from the international QUEST study.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf021
{"title":"Patient and tumour factors influencing length of sarcoma diagnostic trajectory intervals: first results from the international QUEST study.","authors":"","doi":"10.1093/bjs/znaf021","DOIUrl":"https://doi.org/10.1093/bjs/znaf021","url":null,"abstract":"","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143727202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Colorectal cancer staging-time for a re-think on TNM?
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf047
Jenny F Seligmann
{"title":"Colorectal cancer staging-time for a re-think on TNM?","authors":"Jenny F Seligmann","doi":"10.1093/bjs/znaf047","DOIUrl":"https://doi.org/10.1093/bjs/znaf047","url":null,"abstract":"","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preoperative educational briefings: systematic review and novel evidence-based framework.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf001
Joel Norton, Olivia Ambler, Heather Lillemoe, Andrew Tambyraja, Steven Yule

Background: The preoperative educational briefing is a focused discussion encompassing trainee goal setting and operative strategy. How to effectively deliver the educational briefing and the associated benefits to surgical learning and performance remain unclear. The aim of this study was to extract common themes from briefing templates, examine the impact on surgical education and performance metrics, and propose an evidence-based, structured framework for future implementation.

Methods: The MEDLINE, Embase, PubMed, and Web of Science databases were systematically searched for relevant studies that were published between database inception and 15 May 2024. Eligible studies involved surgical trainees and implemented educational briefing in the operating room environment. Results were thematically analysed, identifying 12 outcome measures, organized within Kirkpatrick's model of learning evaluation.

Results: Some 7174 studies were screened, of which 20 met the inclusion criteria. A total of 17 studies compared pre- and post-educational briefing implementation participant surveys focusing on surgical education and performance metrics. A total of 95 statistically significant results were identified, of which 93 demonstrated improvement after the introduction of educational briefing. Benefit was identified in 7 of 7 studies investigating reaction (for example briefing impact), 11 of 13 studies examining learning (for example intraoperative teaching), 12 of 14 studies investigating behaviour (for example goal setting), and 6 of 9 studies examining surgical results (for example trainee autonomy). Thematic analysis of briefing templates demonstrated four key themes, forming the proposed 'Goals, Autonomy, Preparation, and Strategy' ('GAPS') framework for standardized preoperative educational briefing.

Conclusion: The implementation of structured preoperative educational briefing significantly improves surgical education and performance outcomes. The 'Goals, Autonomy, Preparation, and Strategy' framework facilitates a deliberate, evidence-based approach to educational briefing for implementation across surgical specialties and healthcare systems.

{"title":"Preoperative educational briefings: systematic review and novel evidence-based framework.","authors":"Joel Norton, Olivia Ambler, Heather Lillemoe, Andrew Tambyraja, Steven Yule","doi":"10.1093/bjs/znaf001","DOIUrl":"https://doi.org/10.1093/bjs/znaf001","url":null,"abstract":"<p><strong>Background: </strong>The preoperative educational briefing is a focused discussion encompassing trainee goal setting and operative strategy. How to effectively deliver the educational briefing and the associated benefits to surgical learning and performance remain unclear. The aim of this study was to extract common themes from briefing templates, examine the impact on surgical education and performance metrics, and propose an evidence-based, structured framework for future implementation.</p><p><strong>Methods: </strong>The MEDLINE, Embase, PubMed, and Web of Science databases were systematically searched for relevant studies that were published between database inception and 15 May 2024. Eligible studies involved surgical trainees and implemented educational briefing in the operating room environment. Results were thematically analysed, identifying 12 outcome measures, organized within Kirkpatrick's model of learning evaluation.</p><p><strong>Results: </strong>Some 7174 studies were screened, of which 20 met the inclusion criteria. A total of 17 studies compared pre- and post-educational briefing implementation participant surveys focusing on surgical education and performance metrics. A total of 95 statistically significant results were identified, of which 93 demonstrated improvement after the introduction of educational briefing. Benefit was identified in 7 of 7 studies investigating reaction (for example briefing impact), 11 of 13 studies examining learning (for example intraoperative teaching), 12 of 14 studies investigating behaviour (for example goal setting), and 6 of 9 studies examining surgical results (for example trainee autonomy). Thematic analysis of briefing templates demonstrated four key themes, forming the proposed 'Goals, Autonomy, Preparation, and Strategy' ('GAPS') framework for standardized preoperative educational briefing.</p><p><strong>Conclusion: </strong>The implementation of structured preoperative educational briefing significantly improves surgical education and performance outcomes. The 'Goals, Autonomy, Preparation, and Strategy' framework facilitates a deliberate, evidence-based approach to educational briefing for implementation across surgical specialties and healthcare systems.</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Extended pharmacological thromboprophylaxis and clinically relevant venous thromboembolism after major abdominal and pelvic surgery: international, prospective, propensity score-weighted cohort study.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znaf005

Background: There is low-certainty evidence on the impact of extended pharmacological prophylaxis on venous thromboembolism-associated morbidity and mortality. The aim of this study was to determine the efficacy and safety of extended prophylaxis after major abdominopelvic surgery for the prevention of clinically relevant venous thromboembolism after hospital discharge.

Methods: CArdiovaSCulAr outcomes after major abDominal surgEry (CASCADE) was a prospective, international, cohort study into which consecutive adult patients undergoing major abdominopelvic surgery were enrolled (January-May 2022). Extended prophylaxis was considered at least 28 days of anticoagulant prescription after surgery. The primary efficacy outcome was clinically relevant venous thromboembolism and the primary safety outcome was clinically relevant bleeding within 30 days after surgery (European Medicines Agency definitions). The independent association of these outcomes with extended prophylaxis was explored using mixed-effects logistic regression and propensity score weighting.

Results: A total of 11 571 patients (median age of 58.0 years; 6399 (55.3%) women) from 29 countries were included. The extended prophylaxis prescription rate was 31.7% (3670 patients). The post-discharge venous thromboembolism and bleeding rates were 0.1% (12 patients) and 0.7% (85 patients) respectively. After weighting, extended prophylaxis was not significantly associated with increased bleeding risk (OR 1.07 (95% c.i. 0.64 to 1.81); P = 0.792) or decreased venous thromboembolism incidence, both in the overall cohort (OR 1.13 (95% c.i. 0.33 to 3.90); P = 0.848) and in a subgroup analysis of patients undergoing complex major surgery and with active cancer (OR: 1.36 (95% c.i. 0.33 to 5.57); P = 0.669).

Conclusion: In modern practice, the incidence of postoperative venous thromboembolism is low. Extended prophylaxis appears safe, yet the clinical efficacy remains uncertain. Further work is required to define patients who stand to benefit.

{"title":"Extended pharmacological thromboprophylaxis and clinically relevant venous thromboembolism after major abdominal and pelvic surgery: international, prospective, propensity score-weighted cohort study.","authors":"","doi":"10.1093/bjs/znaf005","DOIUrl":"10.1093/bjs/znaf005","url":null,"abstract":"<p><strong>Background: </strong>There is low-certainty evidence on the impact of extended pharmacological prophylaxis on venous thromboembolism-associated morbidity and mortality. The aim of this study was to determine the efficacy and safety of extended prophylaxis after major abdominopelvic surgery for the prevention of clinically relevant venous thromboembolism after hospital discharge.</p><p><strong>Methods: </strong>CArdiovaSCulAr outcomes after major abDominal surgEry (CASCADE) was a prospective, international, cohort study into which consecutive adult patients undergoing major abdominopelvic surgery were enrolled (January-May 2022). Extended prophylaxis was considered at least 28 days of anticoagulant prescription after surgery. The primary efficacy outcome was clinically relevant venous thromboembolism and the primary safety outcome was clinically relevant bleeding within 30 days after surgery (European Medicines Agency definitions). The independent association of these outcomes with extended prophylaxis was explored using mixed-effects logistic regression and propensity score weighting.</p><p><strong>Results: </strong>A total of 11 571 patients (median age of 58.0 years; 6399 (55.3%) women) from 29 countries were included. The extended prophylaxis prescription rate was 31.7% (3670 patients). The post-discharge venous thromboembolism and bleeding rates were 0.1% (12 patients) and 0.7% (85 patients) respectively. After weighting, extended prophylaxis was not significantly associated with increased bleeding risk (OR 1.07 (95% c.i. 0.64 to 1.81); P = 0.792) or decreased venous thromboembolism incidence, both in the overall cohort (OR 1.13 (95% c.i. 0.33 to 3.90); P = 0.848) and in a subgroup analysis of patients undergoing complex major surgery and with active cancer (OR: 1.36 (95% c.i. 0.33 to 5.57); P = 0.669).</p><p><strong>Conclusion: </strong>In modern practice, the incidence of postoperative venous thromboembolism is low. Extended prophylaxis appears safe, yet the clinical efficacy remains uncertain. Further work is required to define patients who stand to benefit.</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial.
IF 8.6 1区 医学 Q1 SURGERY Pub Date : 2025-03-04 DOI: 10.1093/bjs/znae311
Roberto Agresti, Marco Sandri, Giuseppe Capri, Giulia Bianchi, Tiziana Triulzi, Laura Lozza, Giovanna Trecate, Anna Trapani, Cristina Ferraris, Biagio Paolini, Sylvie Menard, Marco Greco, Secondo Folli, Elda Tagliabue

Background: The role of axillary surgery in breast cancer has shifted over time from a therapeutic operation to a staging method for subsequent adjuvant therapies, through the introduction of sentinel lymph node biopsy. The discovery of molecular subtypes has since questioned the necessity of axillary staging in breast cancer.

Methods: The INT09/98 randomized trial explored the omission of axillary surgery in early-stage breast cancer in patients under 65 years of age. From June 1998 to June 2003, a total of 565 T1N0 breast cancer patients were enrolled. The trial tested the non-inferiority of quadrantectomy without axillary surgery (QU) compared to quadrantectomy with axillary dissection (QUAD). The primary endpoint was overall survival (OS). Secondary endpoints included disease-free survival (DFS) and incidence/timing of axillary lymph node metastasis in the QU arm.

Results: Follow-up at 20 years showed no significant differences between the QU versus the QUAD arm. The adjusted hazard ratio for OS was 1.18 (P = 0.326) and DFS was 1.27 (P = 0.280) respectively, both within the predetermined non-inferiority limit. Axillary relapse rates in the QU arm remained low, indicating that only a subset of metastatic nodes cause recurrences if not removed. In the QU arm, patients with favourable biological features but unknown axillary node involvement did not receive adjuvant chemotherapy, without significant differences in outcomes. The axillary relapse rate with distant metastases was similar in both arms and may reflect aggressive biology of the primary tumour.

Conclusion: Avoiding axillary surgery and reducing adjuvant treatments in early breast cancer does not increase distant metastases or affect long-term survival. Axillary relapsed patients with distant metastases in both QU and QUAD arms may represent cancers with genomically determined poorer prognosis, independent of surgical intervention and adjuvant therapies.

Registration number: NCT01508546 (http://www.clinicaltrials.gov).

{"title":"Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial.","authors":"Roberto Agresti, Marco Sandri, Giuseppe Capri, Giulia Bianchi, Tiziana Triulzi, Laura Lozza, Giovanna Trecate, Anna Trapani, Cristina Ferraris, Biagio Paolini, Sylvie Menard, Marco Greco, Secondo Folli, Elda Tagliabue","doi":"10.1093/bjs/znae311","DOIUrl":"https://doi.org/10.1093/bjs/znae311","url":null,"abstract":"<p><strong>Background: </strong>The role of axillary surgery in breast cancer has shifted over time from a therapeutic operation to a staging method for subsequent adjuvant therapies, through the introduction of sentinel lymph node biopsy. The discovery of molecular subtypes has since questioned the necessity of axillary staging in breast cancer.</p><p><strong>Methods: </strong>The INT09/98 randomized trial explored the omission of axillary surgery in early-stage breast cancer in patients under 65 years of age. From June 1998 to June 2003, a total of 565 T1N0 breast cancer patients were enrolled. The trial tested the non-inferiority of quadrantectomy without axillary surgery (QU) compared to quadrantectomy with axillary dissection (QUAD). The primary endpoint was overall survival (OS). Secondary endpoints included disease-free survival (DFS) and incidence/timing of axillary lymph node metastasis in the QU arm.</p><p><strong>Results: </strong>Follow-up at 20 years showed no significant differences between the QU versus the QUAD arm. The adjusted hazard ratio for OS was 1.18 (P = 0.326) and DFS was 1.27 (P = 0.280) respectively, both within the predetermined non-inferiority limit. Axillary relapse rates in the QU arm remained low, indicating that only a subset of metastatic nodes cause recurrences if not removed. In the QU arm, patients with favourable biological features but unknown axillary node involvement did not receive adjuvant chemotherapy, without significant differences in outcomes. The axillary relapse rate with distant metastases was similar in both arms and may reflect aggressive biology of the primary tumour.</p><p><strong>Conclusion: </strong>Avoiding axillary surgery and reducing adjuvant treatments in early breast cancer does not increase distant metastases or affect long-term survival. Axillary relapsed patients with distant metastases in both QU and QUAD arms may represent cancers with genomically determined poorer prognosis, independent of surgical intervention and adjuvant therapies.</p><p><strong>Registration number: </strong>NCT01508546 (http://www.clinicaltrials.gov).</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 3","pages":""},"PeriodicalIF":8.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143565553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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British Journal of Surgery
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