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Perioperative hypersensitivity reactions to Patent Blue V in sentinel lymph node biopsy for breast cancer and melanoma 乳腺癌和黑色素瘤前哨淋巴结活检中Blue V专利的围手术期超敏反应。
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-03 DOI: 10.1016/j.ejso.2026.111459
Hayan El-Hallak , Lene Heise Garvey , Tove Filtenborg Tvedskov , Lisbet Rosenkrantz Hölmich , Lene Russell

Background

Patent Blue V (PBV) is widely used for sentinel lymph node biopsy (SLNB) in breast cancer and melanoma, but can rarely cause life-threatening perioperative hypersensitivity reactions (POH).

Methods

We conducted a retrospective analysis of POH to PBV in SLNBs for breast cancer and melanoma between February 2016 and May 2024, alongside a prospective survey of PBV administration techniques in 60 SLNB procedures for breast cancer and melanoma. The clinical characteristics of five patients with confirmed POH to PBV are also described.

Results

Eight of 2515 breast cancer patients and six of 1621 melanoma patients were referred to the Danish Anaesthesia Allergy Center (DAAC) for suspected POH. POH to PBV was confirmed in five patients with breast cancer (0.2%) and none in patients with melanoma (p = 0.16). Breast surgeons used deeper, higher-volume injections, while plastic surgeons favoured lower-volume intradermal techniques. All confirmed reactions occurred in otherwise healthy women, with onset of symptoms 20–70 min post-injection, predominantly as cutaneous signs and hypotension. Two patients required postoperative transfer to the Intensive Care Unit (ICU).

Discussion

POH to PBV is rare but clinically significant, with a rate of 0.2% in breast cancer SLNBs and 0% in melanoma SLNBs, though this difference was not statistically significant in our study. Variations in PBV administration techniques between breast and plastic surgeons may contribute to the different rates. In five patients with confirmed POH to PBV symptoms consisted mainly of mucocutaneous signs and hypotension. Awareness of these rare but potentially life-threatening reactions, along with prompt management, is essential for both surgeons and anaesthesiologists. This study further underscores the importance of vigilant perioperative monitoring and formal allergy evaluation to guide future care.
背景:专利蓝V (PBV)广泛用于乳腺癌和黑色素瘤的前哨淋巴结活检(SLNB),但很少会引起危及生命的围手术期过敏反应(POH)。方法:我们回顾性分析了2016年2月至2024年5月期间乳腺癌和黑色素瘤SLNB中POH对PBV的影响,同时对60例乳腺癌和黑色素瘤SLNB手术中PBV给药技术进行了前瞻性调查。本文还描述了5例确诊为POH - PBV的患者的临床特征。结果:2515例乳腺癌患者中有8例,1621例黑色素瘤患者中有6例因疑似POH被转至丹麦麻醉过敏中心(DAAC)。在5例乳腺癌患者(0.2%)中证实了POH到PBV,在黑色素瘤患者中没有(p = 0.16)。乳房外科医生使用更深、更大剂量的注射,而整形外科医生更喜欢小剂量的皮内注射技术。所有确认的反应均发生在健康女性中,注射后20-70分钟出现症状,主要表现为皮肤体征和低血压。2例患者术后需转重症监护病房(ICU)。讨论:POH致PBV罕见,但具有临床意义,乳腺癌slnb的发生率为0.2%,黑色素瘤slnb的发生率为0%,尽管在我们的研究中这一差异无统计学意义。乳房外科医生和整形外科医生不同的PBV给药技术可能导致不同的发生率。在5例确诊为POH到PBV的患者中,症状主要包括皮肤粘膜体征和低血压。意识到这些罕见但可能危及生命的反应,并及时处理,对外科医生和麻醉师都是至关重要的。本研究进一步强调了围手术期警惕监测和正式过敏评估对指导未来护理的重要性。
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引用次数: 0
Understanding the low adherence to fertility preservation program in women treated for borderline ovarian tumors 了解边缘性卵巢肿瘤患者对保留生育能力方案的依从性较低。
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-01-28 DOI: 10.1016/j.ejso.2026.111451
Adrien Cohen , Yohann Dabi , Clément Ferrier , Meryl Dahan , Nathalie Chabbert-Buffet , Kamila Kolanska , Isabelle Thomassin-Naggara , Nathalie Sermondade , Jean-Pierre Lotz , Cyril Touboul , Emile Daraï

Objective

Borderline ovarian tumors (BOT) account for 10–20 % of malignant ovarian tumors affecting up to one third of young patients. Therefore, fertility sparing surgery (FSS) has gained attention followed by fertility preservation program (FPP) mainly using controlled ovarian stimulation (COS). However, the determinants to accept or to refuse fertility FPP remain unclear raising the issue on shared decision making.

Methods

From January 2021 to November 2024, a retrospective analysis from a prospective database of patients with BOT eligible for FPP (patients between 18-, and 43-years-old) were identified and interviewed to evaluate the determinants to refuse FPP. For patients accepting FPP, results of COS were analyzed.

Results

Among which 66 patients with BOT undergoing FSS, 29 were eligible for FPP, among them 18 refused the procedure. The main determinants to refuse the FPP were an age >35-years-old, the futility of FPP in 50 % of case, the renouncement to future pregnancy in one-third of cases, and the stress of recurrence (two patients). One patient refused to answer. Among the 18 patients refusing FPP, five became pregnant spontaneously. For the 11 accepting the FPP with COS, the median delay between FSS and COS was 6 months (3–13 months), nine underwent 1 COS cycle and the two patients underwent 2 COS cycles. The median number of retrieved oocytes per COS cycle was 11 (5–39) and the median number of cryopreserved oocytes was 7 (0–35). None of the patients undergoing FPP demand to use their cryopreserved oocytes at the time of the study completion.

Conclusion

While this represents a moderate cohort of patients, our results demonstrate the low adherence to FPP after FSS for BOT underlining the need of an objective and personalized information for shared decision making to accept FPP.
目的:交界性卵巢肿瘤(BOT)占恶性卵巢肿瘤的10- 20%,影响多达三分之一的年轻患者。因此,生育保留手术(FSS)和以控制卵巢刺激(COS)为主要手段的生育保留计划(FPP)逐渐受到重视。然而,接受或拒绝生育FPP的决定因素仍然不清楚,这引发了共同决策的问题。方法:从2021年1月至2024年11月,对符合FPP条件的BOT患者(患者年龄在18岁至43岁之间)的前瞻性数据库进行回顾性分析,并进行访谈,以评估拒绝FPP的决定因素。对接受FPP的患者进行COS结果分析。结果:66例BOT行FSS患者中,29例符合FPP条件,18例拒绝FPP。拒绝FPP的主要决定因素是年龄在50 - 35岁之间,50%的病例FPP无效,三分之一的病例放弃未来怀孕,以及复发的压力(2例)。一位病人拒绝回答。在拒绝FPP的18例患者中,5例自然怀孕。在接受FPP合并COS的11例患者中,FSS和COS之间的中位延迟时间为6个月(3-13个月),9例为1个COS周期,2例为2个COS周期。每个COS周期取出的卵母细胞中位数为11(5-39),冷冻保存的卵母细胞中位数为7(0-35)。在研究完成时,没有接受FPP的患者需要使用冷冻保存的卵母细胞。结论:虽然这代表了一个适度的患者队列,但我们的结果表明,在BOT的FSS后,FPP的依从性较低,这强调了共同决策接受FPP的客观和个性化信息的必要性。
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引用次数: 0
Logic, reason, and freethought: The case against axillary dissection after neoadjuvant therapy 逻辑、理性与自由思想:新辅助治疗后腋窝夹层的案例
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-09 DOI: 10.1016/j.ejso.2026.111467
Michael Alvarado
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引用次数: 0
Incidence and impact on survival outcomes of postoperative radiological evidence of residual disease in women with advanced stage ovarian cancer undergoing debulking surgery: a meta-analysis 接受减瘤手术的晚期卵巢癌患者残留疾病的放射学证据的发生率及其对生存结果的影响:一项荟萃分析
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-05 DOI: 10.1016/j.ejso.2026.111462
Vasilios Pergialiotis , Nikolaos Thomakos , Maria Fanaki , Vasilios Lygizos , Pantelis Antonakis , Konstantinos Bramis , Nikolaos Alexakis , Dimitrios Haidopoulos

Objective

The present systematic review and meta-analysis aims to assess the proportion of patients with radiological findings of residual disease following debulking surgery and determine its impact on survival outcomes.

Methods

We systematically searched the international literature using the Medline, Scopus, Clinicaltrials.gov, Cochrane Central Register of Controlled Trials CENTRAL and Google Scholar until July 2025 for studies that evaluated the proportion of patients with radiological evidence of residual disease following debulking surgery. The review was registered in PROSPERO prior to its conduct (CRD420251065596).

Results

Eleven studies were found eligible for inclusion in the present systematic review. Proportion meta-analysis indicated that 40% of patients had radiologic evidence of residual disease postoperatively (Generalized Mixed Linear Model 40%, 95% CI 33%, 48%). Differences in progression free survival were significantly worse among patients with residual disease (HR 2.08, 95% CI 1.42, 3.05). Similar findings were observed in the overall survival of patients (HR 1.93, 95% CI 1.49, 2.52).

Conclusion

The proportion of patients with radiological criteria of residual disease following debulking surgery appears to be significant. There seem to be evidence that indicate a negative impact on survival outcomes of patients with epithelial ovarian cancer, although these should be interpreted cautiously given the heterogeneity and limitations of the available evidence, but may be relevant during preoperative patient counseling to help establish realistic expectations.
目的:本系统综述和荟萃分析旨在评估减体积手术后残留病变的患者比例,并确定其对生存结果的影响。方法:我们使用Medline、Scopus、Clinicaltrials.gov、Cochrane Central Register of Controlled Trials Central和谷歌Scholar系统地检索国际文献,直到2025年7月,以评估减积手术后残留疾病的放射证据患者比例的研究。该审查在进行之前已在PROSPERO注册(CRD420251065596)。结果:11项研究被纳入本系统评价。比例荟萃分析显示,40%的患者术后有残留疾病的放射学证据(广义混合线性模型40%,95% CI 33%, 48%)。残留疾病患者的无进展生存期差异明显更大(HR 2.08, 95% CI 1.42, 3.05)。在患者的总生存率中也观察到类似的结果(HR 1.93, 95% CI 1.49, 2.52)。结论:减积术后符合残留病变放射学标准的患者比例显著。似乎有证据表明对上皮性卵巢癌患者的生存结果有负面影响,尽管鉴于现有证据的异质性和局限性,这些应谨慎解释,但可能与术前患者咨询有关,有助于建立切合实际的期望。
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引用次数: 0
Development and validation of prediction models for health-related quality of life outcomes after breast cancer surgery and reconstruction 乳腺癌手术和重建后健康相关生活质量预测模型的开发和验证
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-10 DOI: 10.1016/j.ejso.2026.111466
Elfi M. Verheul , Maria Margarete Karsten , Pimrapat Gebert , Lea Doppelbauer , Simona Borstnar , Sabine Siesling , Hester F. Lingsma , Noëlle J.M.C. Vrancken-Peeters , Anne M. Stiggelbout , Marc A.M. Mureau , Linetta B. Koppert , David van Klaveren

Background

Predictions of Health-Related Quality of Life (HRQoL) outcomes could support realistic recovery expectations after breast cancer (BC) surgery. We aimed to develop and validate prediction models for HRQoL outcomes after BC surgery.

Methods

We used three datasets of BC patients from Berlin, Germany; Ljubljana, Slovenia; and Rotterdam; Netherlands. We included non-metastasised patients who were surgically treated for an initial diagnosis of BC and completed pre- and postoperative validated questionnaires. We used linear mixed models to analyse 15 domains of the EORTC QLQ-C30 and EORTC QLQ-BR23 over a two-year horizon. Baseline domain score (measured pre-operatively), age, BMI, smoking, TN stage, receptor status, neoadjuvant chemotherapy, axillary surgery and surgery type (breast-conserving, mastectomy, and immediate implant-based reconstruction) were included as predictors. Predictive performance at validation was assessed by the proportion of variance explained (marginal R2; mR2).

Results

We included N = 795 patients from Germany for development and N = 623 from Slovenia and N = 417 from Netherlands for validation. The largest proportion of variance was explained by the prediction models for sexual functioning (SF, mR2 35%), physical functioning (PF, mR2 29%), body image (BI, mR2 26%), and cognitive functioning (CF, mR2 25%). The models captured meaningfully different trends over time for different outcomes and surgery types. The predictive performance of the models was largely driven by the baseline domain score. Performance was reasonable at external validation, with r2 values of 19–33% for PF, 10–17% for CF, 15–18% for BI, and 22–28% for SF, although some other outcomes (e.g. breast symptoms and role functioning) showed miscalibration, indicating a need for recalibration.

Conclusion

HRQoL after breast cancer surgery can be predicted using simple models with baseline domain scores and surgery type, demonstrating a new opportunity for Patient-Reported Outcome Measures (PROMs) in personalized care.
背景:与健康相关的生活质量(HRQoL)结果的预测可以支持乳腺癌(BC)手术后现实的康复预期。我们的目的是建立和验证BC手术后HRQoL结果的预测模型。方法我们使用来自德国柏林的三个BC患者数据集;斯洛文尼亚卢布尔雅那;和鹿特丹;荷兰。我们纳入了未转移的患者,他们接受了手术治疗,初步诊断为BC,并完成了术前和术后有效的问卷调查。我们使用线性混合模型对EORTC QLQ-C30和EORTC QLQ-BR23的15个域进行了为期两年的分析。基线域评分(术前测量)、年龄、BMI、吸烟、TN分期、受体状态、新辅助化疗、腋窝手术和手术类型(保乳、乳房切除术和立即植体重建)作为预测因素。验证时的预测性能通过解释方差的比例来评估(边际R2; mR2)。结果我们纳入了来自德国的N = 795例患者进行开发,来自斯洛文尼亚的N = 623例,来自荷兰的N = 417例进行验证。最大比例的方差被性功能(SF, mR2 35%)、身体功能(PF, mR2 29%)、身体形象(BI, mR2 26%)和认知功能(CF, mR2 25%)的预测模型所解释。这些模型捕捉到了不同结果和手术类型的不同趋势。模型的预测性能很大程度上是由基线域得分驱动的。在外部验证时,表现是合理的,PF的r2值为19-33%,CF为10-17%,BI为15-18%,SF为22-28%,尽管一些其他结果(如乳房症状和角色功能)显示校准错误,表明需要重新校准。结论基于基线域评分和手术类型的简单模型可以预测乳腺癌手术后的hrqol,为患者报告结果测量(PROMs)在个性化护理中的应用提供了新的机会。
{"title":"Development and validation of prediction models for health-related quality of life outcomes after breast cancer surgery and reconstruction","authors":"Elfi M. Verheul ,&nbsp;Maria Margarete Karsten ,&nbsp;Pimrapat Gebert ,&nbsp;Lea Doppelbauer ,&nbsp;Simona Borstnar ,&nbsp;Sabine Siesling ,&nbsp;Hester F. Lingsma ,&nbsp;Noëlle J.M.C. Vrancken-Peeters ,&nbsp;Anne M. Stiggelbout ,&nbsp;Marc A.M. Mureau ,&nbsp;Linetta B. Koppert ,&nbsp;David van Klaveren","doi":"10.1016/j.ejso.2026.111466","DOIUrl":"10.1016/j.ejso.2026.111466","url":null,"abstract":"<div><h3>Background</h3><div>Predictions of Health-Related Quality of Life (HRQoL) outcomes could support realistic recovery expectations after breast cancer (BC) surgery. We aimed to develop and validate prediction models for HRQoL outcomes after BC surgery.</div></div><div><h3>Methods</h3><div>We used three datasets of BC patients from Berlin, Germany; Ljubljana, Slovenia; and Rotterdam; Netherlands. We included non-metastasised patients who were surgically treated for an initial diagnosis of BC and completed pre- and postoperative validated questionnaires. We used linear mixed models to analyse 15 domains of the EORTC QLQ-C30 and EORTC QLQ-BR23 over a two-year horizon. Baseline domain score (measured pre-operatively), age, BMI, smoking, TN stage, receptor status, neoadjuvant chemotherapy, axillary surgery and surgery type (breast-conserving, mastectomy, and immediate implant-based reconstruction) were included as predictors. Predictive performance at validation was assessed by the proportion of variance explained (marginal R<sup>2</sup>; mR<sup>2</sup>).</div></div><div><h3>Results</h3><div>We included N = 795 patients from Germany for development and N = 623 from Slovenia and N = 417 from Netherlands for validation. The largest proportion of variance was explained by the prediction models for sexual functioning (SF, mR<sup>2</sup> 35%), physical functioning (PF, mR<sup>2</sup> 29%), body image (BI, mR<sup>2</sup> 26%), and cognitive functioning (CF, mR<sup>2</sup> 25%). The models captured meaningfully different trends over time for different outcomes and surgery types. The predictive performance of the models was largely driven by the baseline domain score. Performance was reasonable at external validation, with r<sup>2</sup> values of 19–33% for PF, 10–17% for CF, 15–18% for BI, and 22–28% for SF, although some other outcomes (e.g. breast symptoms and role functioning) showed miscalibration, indicating a need for recalibration.</div></div><div><h3>Conclusion</h3><div>HRQoL after breast cancer surgery can be predicted using simple models with baseline domain scores and surgery type, demonstrating a new opportunity for Patient-Reported Outcome Measures (PROMs) in personalized care.</div></div>","PeriodicalId":11522,"journal":{"name":"Ejso","volume":"52 4","pages":"Article 111466"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Metastatic response and short-term survival outcomes in patients with stage IV rectal cancer treated with curative intent in the era of Total Neoadjuvant Therapy 在全新辅助治疗时代以治愈为目的的IV期直肠癌患者的转移反应和短期生存结局
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-07 DOI: 10.1016/j.ejso.2026.111464
T.R. Fitzsimmons , Z. Bunjo , E.L. Neo , A. Badiei , M. Penniment , S. Selva-Nayagam , T. Sammour

Background

While patients with stage IV rectal cancer treated with curative intent have a high risk of distant failure, the benefits of delivering systemic treatment within a TNT setting remain unexplored. We describe the short-term outcomes of stage IV rectal cancer patients treated with curative intent using a personalised TNT (pTNT) approach.

Methods

All rectal cancer patients with resectable metastases were treated with pTNT over a 5-year period and included in a prospective database. The primary outcome of this cohort analysis was grade of metastatic response to pTNT. A subset analysis was performed for patients with a minimum of 36 months follow-up and 3-year progression free and overall survival rates were determined.

Results

Of 141 patients diagnosed with stage IV rectal cancer during the study period, 62 were treated with curative intent using a pTNT protocol. On initial restaging, 38.7% demonstrated a complete metastatic response and 33.9% exhibiting partial response. The remaining 27.4% progressed on treatment. A complete clinical response (cCR) in the primary rectal tumour was seen in 32.3% of patients. In the subset analysis of 39 patients with a minimum follow-up of 36 months, the 3-year progression free survival rate was 30.8% (median 20.19 months, 95%CI 12.924-27.456) and 3-year overall survival rate of 61.5% (median 44.52 months, 95%CI 31.527-57.513).

Conclusion

A pTNT approach to stage IV rectal cancer with curative intent resulted in favourable metastatic and primary tumour response in most patients. These results provide support for pTNT to be given consideration as a primary treatment option for these patients, pending longer term survival data.
虽然以治愈目的治疗的IV期直肠癌患者存在远处失败的高风险,但在TNT环境下进行全身治疗的益处仍未被探索。我们描述了IV期直肠癌患者使用个性化TNT (pTNT)方法治疗的短期结果。方法所有可切除转移的直肠癌患者在5年内接受pTNT治疗,并纳入前瞻性数据库。该队列分析的主要结果是pTNT转移反应的分级。对至少36个月随访和3年无进展的患者进行亚组分析,并确定总生存率。结果在研究期间,141例诊断为IV期直肠癌的患者中,62例采用pTNT方案进行治疗。初次再分期时,38.7%表现为完全转移缓解,33.9%表现为部分缓解。剩余的27.4%在治疗中取得进展。32.3%的原发直肠肿瘤患者有完全临床缓解(cCR)。在39例患者的亚组分析中,至少随访36个月,3年无进展生存率为30.8%(中位20.19个月,95%CI 12.924-27.456), 3年总生存率为61.5%(中位44.52个月,95%CI 31.527-57.513)。结论pTNT入路治疗IV期直肠癌具有良好的转移性和原发性肿瘤反应。这些结果支持将pTNT作为这些患者的主要治疗选择,等待更长期的生存数据。
{"title":"Metastatic response and short-term survival outcomes in patients with stage IV rectal cancer treated with curative intent in the era of Total Neoadjuvant Therapy","authors":"T.R. Fitzsimmons ,&nbsp;Z. Bunjo ,&nbsp;E.L. Neo ,&nbsp;A. Badiei ,&nbsp;M. Penniment ,&nbsp;S. Selva-Nayagam ,&nbsp;T. Sammour","doi":"10.1016/j.ejso.2026.111464","DOIUrl":"10.1016/j.ejso.2026.111464","url":null,"abstract":"<div><h3>Background</h3><div>While patients with stage IV rectal cancer treated with curative intent have a high risk of distant failure, the benefits of delivering systemic treatment within a TNT setting remain unexplored. We describe the short-term outcomes of stage IV rectal cancer patients treated with curative intent using a personalised TNT (pTNT) approach.</div></div><div><h3>Methods</h3><div>All rectal cancer patients with resectable metastases were treated with pTNT over a 5-year period and included in a prospective database. The primary outcome of this cohort analysis was grade of metastatic response to pTNT. A subset analysis was performed for patients with a minimum of 36 months follow-up and 3-year progression free and overall survival rates were determined.</div></div><div><h3>Results</h3><div>Of 141 patients diagnosed with stage IV rectal cancer during the study period, 62 were treated with curative intent using a pTNT protocol. On initial restaging, 38.7% demonstrated a complete metastatic response and 33.9% exhibiting partial response. The remaining 27.4% progressed on treatment. A complete clinical response (cCR) in the primary rectal tumour was seen in 32.3% of patients. In the subset analysis of 39 patients with a minimum follow-up of 36 months, the 3-year progression free survival rate was 30.8% (median 20.19 months, 95%CI 12.924-27.456) and 3-year overall survival rate of 61.5% (median 44.52 months, 95%CI 31.527-57.513).</div></div><div><h3>Conclusion</h3><div>A pTNT approach to stage IV rectal cancer with curative intent resulted in favourable metastatic and primary tumour response in most patients. These results provide support for pTNT to be given consideration as a primary treatment option for these patients, pending longer term survival data.</div></div>","PeriodicalId":11522,"journal":{"name":"Ejso","volume":"52 4","pages":"Article 111464"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Clinicopathologic characteristics and lymph node status in the NAUTILUS clinical trial:KBCSG-21 NAUTILUS临床试验的临床病理特征和淋巴结状态:KBCSG-21
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-02 DOI: 10.1016/j.ejso.2026.111458
Jai Min Ryu , Han-Byoel Lee , Wonshik Han , Il-Yong Chung , Se Hyun Ahn , Seeyoun Lee , Seho Park , Joon Jeong , Woosung Lim , Jeong Eon Lee , Eunhye Kang , Ji Hyun Chang , Kyung Hwan Shin , Jung Min Chang , Woo Kyung Moon , Eun-Kyu Kim , for the NAUTILUS Investigators

Background

The NAUTILUS trial randomized cT1-2/N0 breast cancer patients to evaluate the non-inferiority of omitting SLNB. We report the clinicopathologic characteristics and axillary lymph node (ALN) status of the patients enrolled in the NAUTILUS trial and suggest expectations based on the results of this trial, which are relevant in the context of the SOUND and INSEMA trials, where the majority of participants were aged 50 years or older.

Methods

The NAUTILUS trial randomized 1734 subjects into SLNB or no-SLNB arms. Axillary ultrasonography was mandatory to determine clinical N0. Clinicopathologic variables and ALN status in the SLNB arm were analyzed to determine expectations for the NAUTILUS trial results compared to other clinical trials.

Results

Among 1734 patients, 1664 subjects were available for clinicopathologic analysis; 50.4% were in the SLNB arm and 49.6% were in the no-SLNB arm. Median age was 55 (range, 29–92) years, and 40.1% were premenopausal. Overall, 1.7%, 83.9%, and 14.0% subjects were pTmic, pT1, and pT2, respectively, with a median tumor size of 1.3 cm (range, 0.1–6.0). In the SLNB arm, 11.2% had ALN metastasis, comprising 1.1%, 9.4%, and 0.6% with pN1mic, pN1, and pN2-3, respectively. ALN metastasis rates according to tumor size were 7.0%, 12.8%, and 17.2% for sizes ≤1.0 cm, >1.0 cm & ≤ 2.0 cm, and >2.0 cm & ≤ 5.0 cm, respectively.

Conclusions

The NAUTILUS trial completed enrollment, with included 14.0% pT2 and 40.1% premenopausal subjects and is expected to show the impact of SLNB omission in these subgroups.

Trial registration

ClinicalTrials.gov Identifier: NCT04303715.
NAUTILUS试验对cT1-2/N0乳腺癌患者进行随机分组,以评估省略SLNB的非劣效性。我们报告了参加NAUTILUS试验的患者的临床病理特征和腋窝淋巴结(ALN)状态,并根据该试验的结果提出了预期,这与SOUND和INSEMA试验的背景相关,其中大多数参与者年龄在50岁或以上。方法NAUTILUS试验将1734名受试者随机分为SLNB组和非SLNB组。腋窝超声检查是确定临床no的必要手段。对SLNB组的临床病理变量和ALN状态进行分析,以确定与其他临床试验相比,NAUTILUS试验结果的预期。结果1734例患者中有1664例可进行临床病理分析;SLNB组占50.4%,非SLNB组占49.6%。中位年龄为55岁(范围29-92岁),40.1%为绝经前。总体而言,pTmic、pT1和pT2患者分别为1.7%、83.9%和14.0%,中位肿瘤大小为1.3 cm(范围0.1-6.0)。在SLNB组中,11.2%的患者发生ALN转移,其中pN1mic、pN1和pN2-3分别占1.1%、9.4%和0.6%。大小≤1.0 cm、1.0 cm≤2.0 cm和2.0 cm≤5.0 cm的ALN转移率分别为7.0%、12.8%和17.2%。NAUTILUS试验完成了入组,包括14.0%的pT2和40.1%的绝经前受试者,预计将显示SLNB遗漏对这些亚组的影响。临床试验注册号:NCT04303715。
{"title":"Clinicopathologic characteristics and lymph node status in the NAUTILUS clinical trial:KBCSG-21","authors":"Jai Min Ryu ,&nbsp;Han-Byoel Lee ,&nbsp;Wonshik Han ,&nbsp;Il-Yong Chung ,&nbsp;Se Hyun Ahn ,&nbsp;Seeyoun Lee ,&nbsp;Seho Park ,&nbsp;Joon Jeong ,&nbsp;Woosung Lim ,&nbsp;Jeong Eon Lee ,&nbsp;Eunhye Kang ,&nbsp;Ji Hyun Chang ,&nbsp;Kyung Hwan Shin ,&nbsp;Jung Min Chang ,&nbsp;Woo Kyung Moon ,&nbsp;Eun-Kyu Kim ,&nbsp;for the NAUTILUS Investigators","doi":"10.1016/j.ejso.2026.111458","DOIUrl":"10.1016/j.ejso.2026.111458","url":null,"abstract":"<div><h3>Background</h3><div>The NAUTILUS trial randomized cT1-2/N0 breast cancer patients to evaluate the non-inferiority of omitting SLNB. We report the clinicopathologic characteristics and axillary lymph node (ALN) status of the patients enrolled in the NAUTILUS trial and suggest expectations based on the results of this trial, which are relevant in the context of the SOUND and INSEMA trials, where the majority of participants were aged 50 years or older.</div></div><div><h3>Methods</h3><div>The NAUTILUS trial randomized 1734 subjects into SLNB or no-SLNB arms. Axillary ultrasonography was mandatory to determine clinical N0. Clinicopathologic variables and ALN status in the SLNB arm were analyzed to determine expectations for the NAUTILUS trial results compared to other clinical trials.</div></div><div><h3>Results</h3><div>Among 1734 patients, 1664 subjects were available for clinicopathologic analysis; 50.4% were in the SLNB arm and 49.6% were in the no-SLNB arm. Median age was 55 (range, 29–92) years, and 40.1% were premenopausal. Overall, 1.7%, 83.9%, and 14.0% subjects were pTmic, pT1, and pT2, respectively, with a median tumor size of 1.3 cm (range, 0.1–6.0). In the SLNB arm, 11.2% had ALN metastasis, comprising 1.1%, 9.4%, and 0.6% with pN1mic, pN1, and pN2-3, respectively. ALN metastasis rates according to tumor size were 7.0%, 12.8%, and 17.2% for sizes ≤1.0 cm, &gt;1.0 cm &amp; ≤ 2.0 cm, and &gt;2.0 cm &amp; ≤ 5.0 cm, respectively.</div></div><div><h3>Conclusions</h3><div>The NAUTILUS trial completed enrollment, with included 14.0% pT2 and 40.1% premenopausal subjects and is expected to show the impact of SLNB omission in these subgroups.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov Identifier: NCT04303715.</div></div>","PeriodicalId":11522,"journal":{"name":"Ejso","volume":"52 4","pages":"Article 111458"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Neoadjuvant chemotherapy enables fertility preservation without compromising oncologic outcomes in early cervical cancer ≥2 cm: A systematic review and meta-analysis 新辅助化疗能够在不影响肿瘤预后的情况下保留生育能力≥2 cm的早期宫颈癌:一项系统回顾和荟萃分析
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-06 DOI: 10.1016/j.ejso.2026.111461
Ádám Vincze , Dávid Márai , Lőrinc Frivaldszky , Anett Rancz , Péter Hegyi , Nándor Ács , Ferenc Bánhidy , Márton Keszthelyi , Boglárka Lilla Szentes , Zoltán Sipos , Balázs Lintner

Introduction

Early-stage cervical cancer tumours ≥2 cm present a dilemma for fertility preservation, as guidelines generally discourage fertility-sparing surgery (FSS) due to oncologic risks. Neoadjuvant chemotherapy (NACT) followed by FSS has emerged as an alternative to downstage tumours. This study evaluated recurrence and pregnancy outcomes of NACT + FSS versus upfront FSS.

Methods

A PROSPERO-registered (CRD42024605906) meta-analysis was conducted using PubMed, EMBASE, and Cochrane (updated Feb 26, 2025). Eligible studies included women with early-stage cervical cancer (FIGO 2018 IB2–IIA1; ≥2 cm) undergoing upfront FSS or NACT + FSS. Pooled proportions with 95% confidence intervals (CIs) were calculated using a random effects model.

Results

Nineteen observational studies (n = 1453) were analysed. Indirect comparison indicated significantly higher pooled pregnancy rate for NACT + FSS (31%; 95% CI: 23–41%) compared to upfront FSS (8%; CI: 1–43%; p = 0.002). Pooled recurrence rate was statistically similar: 10% (CI: 5–20%) for upfront FSS and 13% (CI: 9–20%) for NACT + FSS (p = 0.415). Studies generally exhibited a moderate-to-high risk of bias.

Conclusion

NACT followed by FSS appears to enhance fertility outcomes without increasing oncologic risk compared to upfront FSS in patients with tumours ≥2 cm. These findings support the personalized extension of fertility-sparing indications, though prospective validation remains necessary.
≥2cm的早期宫颈癌肿瘤在保留生育能力方面面临两难境地,因为由于肿瘤风险,指南通常不鼓励保留生育能力的手术(FSS)。新辅助化疗(NACT)之后的FSS已成为晚期肿瘤的替代方案。本研究评估了NACT + FSS与前期FSS的复发率和妊娠结局。方法使用PubMed、EMBASE和Cochrane(2025年2月26日更新)进行普洛斯普洛斯注册(CRD42024605906)荟萃分析。符合条件的研究包括接受前期FSS或NACT + FSS的早期宫颈癌妇女(FIGO 2018 IB2-IIA1;≥2 cm)。采用随机效应模型计算95%置信区间(ci)的合并比例。结果共分析了19项观察性研究(n = 1453)。间接比较显示,NACT + FSS的合并妊娠率(31%;95% CI: 23-41%)明显高于FSS前组(8%;CI: 1-43%; p = 0.002)。合并复发率在统计学上相似:术前FSS为10% (CI: 5-20%), NACT + FSS为13% (CI: 9-20%) (p = 0.415)。研究通常显示出中等到高度的偏倚风险。结论:与肿瘤≥2 cm的患者相比,nact后FSS似乎可以提高生育结果,而不会增加肿瘤风险。这些发现支持保留生育适应症的个性化扩展,尽管仍需要前瞻性验证。
{"title":"Neoadjuvant chemotherapy enables fertility preservation without compromising oncologic outcomes in early cervical cancer ≥2 cm: A systematic review and meta-analysis","authors":"Ádám Vincze ,&nbsp;Dávid Márai ,&nbsp;Lőrinc Frivaldszky ,&nbsp;Anett Rancz ,&nbsp;Péter Hegyi ,&nbsp;Nándor Ács ,&nbsp;Ferenc Bánhidy ,&nbsp;Márton Keszthelyi ,&nbsp;Boglárka Lilla Szentes ,&nbsp;Zoltán Sipos ,&nbsp;Balázs Lintner","doi":"10.1016/j.ejso.2026.111461","DOIUrl":"10.1016/j.ejso.2026.111461","url":null,"abstract":"<div><h3>Introduction</h3><div>Early-stage cervical cancer tumours ≥2 cm present a dilemma for fertility preservation, as guidelines generally discourage fertility-sparing surgery (FSS) due to oncologic risks. Neoadjuvant chemotherapy (NACT) followed by FSS has emerged as an alternative to downstage tumours. This study evaluated recurrence and pregnancy outcomes of NACT + FSS versus upfront FSS.</div></div><div><h3>Methods</h3><div>A PROSPERO-registered (CRD42024605906) meta-analysis was conducted using PubMed, EMBASE, and Cochrane (updated Feb 26, 2025). Eligible studies included women with early-stage cervical cancer (FIGO 2018 IB2–IIA1; ≥2 cm) undergoing upfront FSS or NACT + FSS. Pooled proportions with 95% confidence intervals (CIs) were calculated using a random effects model.</div></div><div><h3>Results</h3><div>Nineteen observational studies (n = 1453) were analysed. Indirect comparison indicated significantly higher pooled pregnancy rate for NACT + FSS (31%; 95% CI: 23–41%) compared to upfront FSS (8%; CI: 1–43%; p = 0.002). Pooled recurrence rate was statistically similar: 10% (CI: 5–20%) for upfront FSS and 13% (CI: 9–20%) for NACT + FSS (p = 0.415). Studies generally exhibited a moderate-to-high risk of bias.</div></div><div><h3>Conclusion</h3><div>NACT followed by FSS appears to enhance fertility outcomes without increasing oncologic risk compared to upfront FSS in patients with tumours ≥2 cm. These findings support the personalized extension of fertility-sparing indications, though prospective validation remains necessary.</div></div>","PeriodicalId":11522,"journal":{"name":"Ejso","volume":"52 4","pages":"Article 111461"},"PeriodicalIF":2.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Feasibility of ERAS guidelines for cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CRS-HIPEC): An international multicenter study ERAS指导细胞减少手术伴或不伴腹腔热化疗(CRS-HIPEC)的可行性:一项国际多中心研究。
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-01-31 DOI: 10.1016/j.ejso.2026.111452
Amaniel Kefleyesus , Vahan Képénékian , Naoual Bakrin , Laurent Villeneuve , Guillaume Passot , Eddy Cotte , Jennifer Mateshaytis , Prafull Ghatage , Lloyd Mack , Antoine Bouchard-Fortier , Melina Deban , Manuela Robella , Clarisse Eveno , Barbara Noiret , Cedric Cirenei , Virginie Sanders , Guillaume Piessen , Hugo Teixeira , Tino Münster , Pompiliu Piso , Martin Hübner

Background

Enhanced Recovery After Surgery (ERAS) protocols aim to optimize perioperative care and improve recovery after major surgery. While ERAS pathways are well established in several oncologic disciplines, their feasibility and consistency in the setting of cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy (CRS ± HIPEC), remain uncertain due to the complexity and heterogeneity of these procedures.

Methods

A prospective multicenter observational study was conducted across 10 expert CRS-HIPEC centers to assess the feasibility and real-world implementation of the ERAS Society guidelines for cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy. Perioperative practices were compared before (PRE-ERAS) and after (POST-ERAS) structured ERAS guideline implementation. ERAS adherence, clinical outcomes, and predictors of 90-day postoperative complications and prolonged length of stay were analyzed using multivariable logistic regression models. In addition, a predefined subgroup analysis compared outcomes between ovarian and non-ovarian primary tumors.

Results

Between 2021 and 2022, 497 patients were included (PRE-ERAS: 288; POST-ERAS: 209). Baseline characteristics were similar except for more ovarian primaries in POST-ERAS (26.4% vs 44%, p = 0.004). POST-ERAS patients showed higher adherence to anemia screening (60% vs 69%, p = 0.042), carbohydrate loading (4% vs 30%, p < 0.001), and NSAIDs use (26% vs 53%, p < 0.001). Overall ERAS adherence remained stable (median 67%). Complication rates were unchanged, but LOS decreased (13 vs 11 days, p < 0.001) while readmissions increased (11% vs 34%, p < 0.001). Carbohydrate loading (OR 0.29, 95% CI 0.08–0.98, p = 0.048), epidural analgesia (OR 0.39, 95% CI 0.16–0.87, p = 0.025), and >70% ERAS adherence (OR 0.19, 95% CI 0.06–0.54, p = 0.003) predicted fewer complications. Ovarian primary (OR 0.50, 95% CI 0.28–0.87, p = 0.016), >70% adherence (OR 0.33, 95% CI 0.12–0.82, p = 0.025), and POST-ERAS status (OR 0.61, 95% CI 0.37–0.99, p = 0.046) correlated with shorter LOS.

Conclusion

ERAS implementation for CRS ± HIPEC shortened hospital stay but remained incomplete and was associated with increased readmissions, without reducing complication rates. These findings highlight the need to focus on a pragmatic set of high-impact ERAS elements to improve feasibility in complex cytoreductive surgery.
背景:ERAS (Enhanced Recovery After Surgery)方案旨在优化围手术期护理,提高大手术后的康复。虽然ERAS途径在一些肿瘤学学科中已经得到了很好的建立,但由于这些手术的复杂性和异质性,它们在细胞减少手术(包括或不包括腹腔热化疗(CRS±HIPEC))中的可行性和一致性仍然不确定。方法:在10个CRS-HIPEC专家中心进行了一项前瞻性多中心观察性研究,以评估ERAS协会指南在有或没有腹腔热化疗的情况下进行细胞减少手术的可行性和实际实施情况。比较ERAS术前和ERAS后的围手术期实践。使用多变量logistic回归模型分析ERAS的依从性、临床结果以及90天术后并发症和延长住院时间的预测因素。此外,预定义的亚组分析比较了卵巢和非卵巢原发性肿瘤的结果。结果:在2021年至2022年期间,纳入497例患者(PRE-ERAS: 288例;POST-ERAS: 209例)。除了eras后更多的卵巢原发外,基线特征相似(26.4% vs 44%, p = 0.004)。ERAS后患者对贫血筛查的依从性更高(60%对69%,p = 0.042),碳水化合物负荷(4%对30%,p = 70%), ERAS依从性(OR 0.19, 95% CI 0.06-0.54, p = 0.003)预测并发症更少。卵巢原发(OR 0.50, 95% CI 0.28-0.87, p = 0.016)、>70%依从性(OR 0.33, 95% CI 0.12-0.82, p = 0.025)和eras后状态(OR 0.61, 95% CI 0.37-0.99, p = 0.046)与较短的LOS相关。结论:CRS±HIPEC的ERAS实施缩短了住院时间,但仍然不完整,并与再入院率增加相关,未降低并发症发生率。这些发现强调需要关注一套实用的高影响ERAS元素,以提高复杂细胞减少手术的可行性。
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引用次数: 0
Differential effects of preoperative cholangitis and biliary stenting in long-term survival of patients undergoing surgery for perihilar cholangiocarcinoma 术前胆管炎和胆道支架置入术对肝门周围胆管癌患者长期生存的不同影响。
IF 2.9 2区 医学 Q2 ONCOLOGY Pub Date : 2026-04-01 Epub Date: 2026-02-05 DOI: 10.1016/j.ejso.2026.111448
Eriselda Keshi , Florian Siemund , Sebastian Knitter , Nils Haep , Karl Herbert Hillebrandt , Philipp Haber , Thomas Malinka , Nathanael Raschzok , Igor M. Sauer , Wenzel Schöning , Johann Pratschke , Felix Krenzien

Background

Painless icterus, elevated cholestatic parameters and cholangitis are among the most common symptoms associated with patients with perihilar cholangiocarcinoma. Preoperative optimization of these conditions is crucial and usually done through preoperative biliary stenting. Cholangitis is a frequent complication of biliary obstruction through tumor, and of stenting, but its impact on surgical and oncologic outcomes remains controversial.

Methods

We analyzed patients undergoing curative-intent surgery for perihilar cholangiocarcinoma. Clinical, laboratory, operative and pathological data were collected. Propensity score matching was performed to minimize baseline differences. Outcomes of patients with and without preoperative cholangitis were compared, with particular focus on survival in relation to preoperative biliary stenting.

Result

Of 305 patients, 204 remained after prospective score matching for baseline characteristics, including 108 with cholangitis and 96 without. Severe complications (Clavien Dindo IV-V) were more common in patients with cholangitis (25 % vs. 13.8%, p = 0.028). Median overall survival was significantly shorter in patients with cholangitis (2.05 vs. 3.03 years, p = 0.014), as was disease-free survival (1.26 vs. 2.21 years, p = 0.0006). Patients with both stenting and cholangitis had the poorest overall survival, when compared to those with stenting only (3.63 years) or those without stenting and without cholangitis (2.31 years, p = 0.03).

Conclusion

Preoperative cholangitis, particularly when combined with biliary stenting, is associated with significantly worse perioperative outcomes and long-term survival in patients with perihilar cholangiocarcinoma. These results underscore the importance of prophylactic antibiotics in the preoperative phase and call for strategies aimed at reducing stent-associated cholangitis.
背景:无痛性黄疸、胆汁淤积参数升高和胆管炎是肝门周围胆管癌患者最常见的症状。术前优化这些条件是至关重要的,通常通过术前胆道支架置入来完成。胆管炎是肿瘤引起的胆道梗阻和支架置入术的常见并发症,但其对手术和肿瘤预后的影响仍存在争议。方法:我们分析了接受肝门周围胆管癌治疗目的手术的患者。收集临床、实验室、手术及病理资料。进行倾向评分匹配以最小化基线差异。比较术前胆管炎患者和术前无胆管炎患者的结果,特别关注术前胆道支架置入术的生存率。结果:305例患者中,有204例患者在基线特征的前瞻性评分匹配后仍然存在,其中胆管炎患者108例,无胆管炎患者96例。严重并发症(Clavien Dindo IV-V)在胆管炎患者中更为常见(25% vs. 13.8%, p = 0.028)。胆管炎患者的中位总生存期显著缩短(2.05年对3.03年,p = 0.014),无病生存期也显著缩短(1.26年对2.21年,p = 0.0006)。与仅行支架植入(3.63年)或不行支架植入且无胆管炎(2.31年,p = 0.03)的患者相比,同时行支架植入和胆管炎患者的总生存率最低。结论:术前胆管炎,特别是合并胆道支架置入术时,与肝门周围胆管癌患者围手术期预后和长期生存显著恶化相关。这些结果强调了术前预防性抗生素的重要性,并呼吁制定旨在减少支架相关性胆管炎的策略。
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引用次数: 0
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