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Oncoplastic surgery in the treatment of breast cancer: a review of evolution and surgical training. 肿瘤整形外科在乳腺癌治疗中的应用:发展和外科训练的回顾。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-24-140
Francisco Pimentel Cavalcante, Felipe Pereira Zerwes, Eduardo Camargo Millen, André Mattar, Marcelo Antonini, Fabrício Palermo Brenelli, Antonio Luiz Frasson, René Aloisio da Costa Vieira

Oncoplastic breast surgery (OBS) has undergone significant advancement in recent decades, transforming breast cancer (BC) treatment by facilitating increased rates of breast-conserving surgery (BCS) through volume displacement techniques and enabling immediate reconstruction via volume replacement following mastectomy. This approach has demonstrably improved cosmetic outcomes and health-related quality of life metrics for patients undergoing oncological intervention. The progression of surgical methodology from Halsted's radical mastectomy to contemporary oncoplastic techniques constitutes a fundamental paradigm shift in surgical approach. Meta-analyses and prospective cohort studies have established that oncoplastic techniques maintain oncological safety when compared with conventional BCS and mastectomy, demonstrating comparable local recurrence (LR) rates and disease-free survival (DFS) outcomes. Multiple classification systems for oncoplastic procedures have been established based on quantifiable metrics including percentage of breast volume resected, surgical complexity indices, and technical approach parameters, providing evidence-based frameworks for clinical decision-making. The breast surgeon currently functions as the critical nexus in multidisciplinary treatment of BC, integrating optimized surgical techniques with multimodal treatment protocols, particularly systemic therapeutic agents. The implementation of neoadjuvant chemotherapy (NCT) regimens has expanded the indications for breast conservation in cases previously requiring mastectomy, leading to the development of the "extreme oncoplasty" concept for selected patients. Nevertheless, significant implementation barriers persist globally, predominantly related to educational infrastructure limitations and the absence of standardized oncoplastic surgical training curricula for breast surgeons. Diverse training methodologies have emerged internationally, including simulation-based learning, subspecialty fellowships, and curricular integration in surgical residency programs, though outcome-based standardization remains elusive. This non-systematic review analyzes the developmental trajectory of breast cancer surgery, examining the evolution and validation of oncoplastic techniques, standardized classification systems, applications in challenging clinical scenarios, and the current status of surgical education, emphasizing the pivotal role of professional societies in developing evidence-based educational initiatives to broaden access to these advanced surgical techniques.

近几十年来,乳腺肿瘤整形手术(OBS)取得了重大进展,通过容积置换技术促进保乳手术(BCS)的增加,并在乳房切除术后通过容积置换实现立即重建,从而改变了乳腺癌(BC)的治疗。这种方法明显改善了接受肿瘤干预的患者的美容结果和与健康相关的生活质量指标。从霍尔斯特德的根治性乳房切除术到当代肿瘤整形技术,手术方法的进展构成了手术方法的基本范式转变。荟萃分析和前瞻性队列研究表明,与传统BCS和乳房切除术相比,肿瘤整形技术保持肿瘤安全性,显示出相当的局部复发率和无病生存(DFS)结果。肿瘤整形手术的多种分类系统已经建立在可量化指标的基础上,包括乳房体积切除百分比、手术复杂性指数和技术方法参数,为临床决策提供了基于证据的框架。乳房外科医生目前是乳腺癌多学科治疗的关键纽带,将优化的手术技术与多模式治疗方案结合起来,特别是全身治疗药物。新辅助化疗(NCT)方案的实施扩大了以前需要乳房切除术的病例的保乳指征,导致对选定患者的“极端肿瘤成形术”概念的发展。然而,全球范围内仍存在重大的实施障碍,主要与教育基础设施的限制和乳腺外科医生缺乏标准化的肿瘤整形外科培训课程有关。国际上出现了多种培训方法,包括基于模拟的学习、亚专业奖学金和外科住院医师项目的课程整合,尽管基于结果的标准化仍然难以捉摸。这篇非系统综述分析了乳腺癌手术的发展轨迹,检查了肿瘤整形技术的发展和验证,标准化分类系统,在具有挑战性的临床场景中的应用,以及外科教育的现状,强调了专业协会在发展循证教育计划以扩大这些先进外科技术的获取方面的关键作用。
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引用次数: 0
Is preoperative immunotherapy promising for patients with proficient mismatch repair or microsatellite stable locally advanced rectal cancer?-a commentary on TORCH randomized phase 2 trial. 术前免疫治疗对熟练错配修复或微卫星稳定的局部晚期直肠癌患者有希望吗?-对TORCH随机2期试验的评论
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-25-16
Yuichiro Tsukada, Masaaki Ito
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引用次数: 0
Clinical significance of tumor infiltration length along the bile duct mucosa and submucosa in hilar cholangiocarcinoma. 肝门部胆管癌肿瘤沿胆管粘膜及粘膜下层浸润长度的临床意义。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-24-123
Taifeng Zhu, Zhijuan Li, Qibin Tang, Xianhuan Yu, Guangzi Shi, Hong Zeng, Xinting Sang, Chao Liu, Xiangde Shi

Background: Radical resection remains the mainstay of treatment for patients with hilar cholangiocarcinoma (HCCA), however, the scope of resection remains controversial. This study investigates the influence of tumor infiltration length along the mucosa and submucosa of the bile duct on curative resection.

Methods: The clinical and pathological data of 31 HCCA patients who underwent en bloc and extended liver resection in the Department of Biliary-Pancreatic Surgery of Sun Yat-sen Memorial Hospital from January 2020 to December 2021 were retrospectively analyzed. First, the gross tumor boundary and bile duct resection margin were marked with ink before the specimen was fixed in formalin solution. Subsequently, the specimens were embedded and sectioned longitudinally along the bile duct. Finally, the length of tumor invasion was calculated according to the marked macroscopic and microscopic boundaries. SPSS statistical software was used for statistical analysis.

Results: The average infiltration length in the proximal bile duct mucosa and submucosa were 8.5±5.2 and 8.6±4.9 mm, while the average infiltration length in the distal bile duct mucosa and submucosa were 12.8±7.5 and 11.5±7.2 mm, respectively. The accuracy of the Bismuth-Corlette classification for type III lesions was 68.4% (13/19).

Conclusions: Imaging examinations may underestimate the extent of HCCA growth along the bile duct. The R0 resection rate can be increased by extended hepatectomy including more than half of the liver volume.

背景:根治性切除术仍然是肝门胆管癌(HCCA)患者的主要治疗方法,然而,切除的范围仍然存在争议。本研究探讨肿瘤沿胆管粘膜及粘膜下层浸润长度对根治性切除的影响。方法:回顾性分析中山纪念医院胆胰外科2020年1月至2021年12月行肝整体及扩大切除的31例HCCA患者的临床及病理资料。首先用墨水标记大体肿瘤边界和胆管切除边缘,然后将标本固定在福尔马林溶液中。随后,标本沿胆管纵向埋置和切片。最后根据明确的宏观和微观边界计算肿瘤的侵袭长度。采用SPSS统计软件进行统计分析。结果:近端胆管黏膜和粘膜下层的平均浸润长度分别为8.5±5.2和8.6±4.9 mm,远端胆管黏膜和粘膜下层的平均浸润长度分别为12.8±7.5和11.5±7.2 mm。Bismuth-Corlette分级对III型病变的准确率为68.4%(13/19)。结论:影像学检查可能低估HCCA沿胆管生长的程度。R0切除率可通过扩大肝切除术,包括肝体积的一半以上来提高。
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引用次数: 0
The role of perioperative immunotherapy with chemotherapy in muscle-invasive bladder cancer (MIBC). 围手术期免疫治疗联合化疗在肌肉浸润性膀胱癌(MIBC)中的作用。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-25-8
Min Woo Hwang, Jeanny B Aragon-Ching
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引用次数: 0
Risk factors for bone metastasis in patients with prostate cancer: a retrospective study based on single-center data and SEER database. 前列腺癌患者骨转移的危险因素:基于单中心数据和SEER数据库的回顾性研究
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-24-78
Xuechun Hu, Tao Zhou, Zongpan Ke, Ping Xiang, Jun Xiao, Changming Wang, Yixun Liu

Background: Bone metastasis in prostate cancer (PCa) has been considered a significant determinant of both patient survival and quality of life. However, the factors contributing to the incidence of bone metastasis remain unidentified. This study primarily aims to elucidate the risk factors associated with bone metastasis in individuals diagnosed with PCa.

Methods: A total of 177 patients who had undergone radical prostatectomy at our institution were included in the analysis. These patients were categorized into two groups based on the results of whole-body bone emission computed tomography (ECT) scanning: the bone metastasis group and the non-bone metastasis group. Univariate and multivariate logistic regression analyses were conducted to determine the independent risk factors for bone metastasis. Additionally, receiver operating characteristic (ROC) curves were employed to compare the diagnostic efficacy of the clinical variables. Additional data from the Surveillance, Epidemiology, and End Results (SEER) database, consisting of 96,497 patients, were analyzed for external validation.

Results: The findings indicated that among the diagnosed patients with PCa, 18.64% (33/177) exhibited bone metastasis. Through multivariate logistic regression analysis, it was determined that prostate-specific antigen (PSA), Gleason score, percentage of monocyte (M%), and N stage were identified as independent risk factors for bone metastasis in PCa. The study found that the sensitivities for PSA and Gleason score were 66.67% and 69.70%, respectively, while the specificities were 85.42% and 65.97%, respectively. Additionally, the analysis of data from the SEER database confirmed that both PSA, Gleason score and N stage were independent risk factors. Furthermore, the Chi-squared test revealed a positive correlation between the primary histological grade and the rate of bone metastasis.

Conclusions: The present study ascertained that PSA, Gleason score and N stage served as prognostic indicators for bone metastasis in PCa. The investigation of the significance of M% and the primary histological grade in the diagnosis of bone metastasis in PCa warranted further exploration.

背景:前列腺癌(PCa)骨转移被认为是患者生存和生活质量的重要决定因素。然而,导致骨转移发生的因素尚不清楚。本研究的主要目的是阐明前列腺癌患者骨转移的相关危险因素。方法:对我院行根治性前列腺切除术的177例患者进行分析。根据全身骨发射计算机断层扫描(ECT)结果将患者分为两组:骨转移组和非骨转移组。进行单因素和多因素logistic回归分析以确定骨转移的独立危险因素。此外,采用受试者工作特征(ROC)曲线比较临床变量的诊断效果。来自监测、流行病学和最终结果(SEER)数据库的其他数据,包括96,497名患者,进行分析以进行外部验证。结果:在确诊的前列腺癌患者中,18.64%(33/177)出现骨转移。通过多因素logistic回归分析,确定前列腺特异性抗原(PSA)、Gleason评分、单核细胞百分比(M%)和N分期是前列腺癌骨转移的独立危险因素。研究发现PSA和Gleason评分的敏感性分别为66.67%和69.70%,特异性分别为85.42%和65.97%。此外,对SEER数据库数据的分析证实,PSA、Gleason评分和N分期均为独立的危险因素。此外,卡方检验显示原发性组织学分级与骨转移率呈正相关。结论:PSA、Gleason评分和N分期可作为前列腺癌骨转移的预后指标。探讨m%及原发性组织学分级在前列腺癌骨转移诊断中的意义值得进一步探讨。
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引用次数: 0
Mucinous cystic neoplasia (MCN) of the pancreas: systematic review and meta-analysis of sex differences in prevalence and malignancy risk between males and females. 胰腺粘液囊性瘤变(MCN):男性和女性患病率和恶性风险性别差异的系统回顾和荟萃分析
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-04-01 DOI: 10.21037/cco-24-124
Marcus T T Roalsø, Daniel L Hughes, Patrik Larsson, Poya Ghorbani, Nikolaos Kartalis, Carlos Fernándes Moro, Kjetil Søreide

Background: Among the pancreatic cystic neoplasia, the mucinous cystic neoplasia (MCN) is less-well understood as these are a much rarer to come by and a poorly described cyst entity. Notably, the MCNs have previously been thought to almost exclusively develop in females, with few reports of MCN in males. Here we present a case of male MCN together with a systematic review of the disparities in sex-dependent prevalence and malignancy risk as found in the literature.

Methods: A systematic review and meta-analysis were conducted on pre-existing literature to assess the incidence and malignancy rates of MCN in male and female patients. The study protocol was prospectively registered on PROSPERO (CRD42024606793). A comprehensive search of PubMed, Embase, MEDLINE and Web of Science was performed covering all studies published from January 2014 to August 2024.

Results: The study included 51 studies with a total of 3,519 patients. Prevalence rates show a marked predominance of MCN in female patients at 84.5% [95% confidence interval (CI): 80.5-87.9%], while malignancy rates are significantly higher in male patients with MCN 47.2% (95% CI: 26.1-69.3%) compared to females at 16.6% (95% CI: 6.4-36.6%).

Conclusions: Among all studies reporting on MCN, the systematic review of accumulated data found an overall prevalence of 14.2% in males, but with an almost 50% risk of malignancy rate in males compared to females.

背景:在胰腺囊性瘤变中,粘液囊性瘤变(MCN)是一种罕见且描述不佳的囊肿实体,人们对其了解较少。值得注意的是,以前认为MCN几乎只在女性中发育,很少有关于男性MCN的报道。在这里,我们提出了一个男性MCN病例,并对文献中发现的性别依赖性患病率和恶性肿瘤风险的差异进行了系统回顾。方法:对已有文献进行系统回顾和荟萃分析,评估男性和女性MCN患者的发病率和恶性肿瘤发生率。该研究方案在PROSPERO (CRD42024606793)进行前瞻性注册。全面检索PubMed、Embase、MEDLINE和Web of Science,涵盖2014年1月至2024年8月发表的所有研究。结果:该研究包括51项研究,共3,519例患者。患病率显示MCN在女性患者中占明显优势,为84.5%[95%可信区间(CI): 80.5-87.9%],而男性MCN患者的恶性肿瘤发生率为47.2% (95% CI: 26.1-69.3%),而女性为16.6% (95% CI: 6.4-36.6%)。结论:在所有报道MCN的研究中,对累积数据的系统回顾发现,男性的总体患病率为14.2%,但男性的恶性肿瘤发生率几乎是女性的50%。
{"title":"Mucinous cystic neoplasia (MCN) of the pancreas: systematic review and meta-analysis of sex differences in prevalence and malignancy risk between males and females.","authors":"Marcus T T Roalsø, Daniel L Hughes, Patrik Larsson, Poya Ghorbani, Nikolaos Kartalis, Carlos Fernándes Moro, Kjetil Søreide","doi":"10.21037/cco-24-124","DOIUrl":"10.21037/cco-24-124","url":null,"abstract":"<p><strong>Background: </strong>Among the pancreatic cystic neoplasia, the mucinous cystic neoplasia (MCN) is less-well understood as these are a much rarer to come by and a poorly described cyst entity. Notably, the MCNs have previously been thought to almost exclusively develop in females, with few reports of MCN in males. Here we present a case of male MCN together with a systematic review of the disparities in sex-dependent prevalence and malignancy risk as found in the literature.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted on pre-existing literature to assess the incidence and malignancy rates of MCN in male and female patients. The study protocol was prospectively registered on PROSPERO (CRD42024606793). A comprehensive search of PubMed, Embase, MEDLINE and Web of Science was performed covering all studies published from January 2014 to August 2024.</p><p><strong>Results: </strong>The study included 51 studies with a total of 3,519 patients. Prevalence rates show a marked predominance of MCN in female patients at 84.5% [95% confidence interval (CI): 80.5-87.9%], while malignancy rates are significantly higher in male patients with MCN 47.2% (95% CI: 26.1-69.3%) compared to females at 16.6% (95% CI: 6.4-36.6%).</p><p><strong>Conclusions: </strong>Among all studies reporting on MCN, the systematic review of accumulated data found an overall prevalence of 14.2% in males, but with an almost 50% risk of malignancy rate in males compared to females.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 2","pages":"19"},"PeriodicalIF":2.1,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Robotic-assisted trans-mesocolic side-to-side duodenojejunostomy for palliative management of malignant distal duodenal obstruction. 机器人辅助经肠系膜侧对侧十二指肠空肠吻合术对恶性十二指肠远端梗阻的姑息性治疗。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.21037/cco-24-87
Han Yin, Devesh Sharma, Jaeyun Jane Wang, Amir Ashraf Ganjouei, Abdul Kouanda, Kenzo Hirose, Eric Nakakura, Kimberly Kirkwood, Carlos Corvera, Adnan Alseidi, Mohamed Abdelgadir Adam

Malignant duodenal obstruction is a common issue affecting up to 20% of patients with advanced gastrointestinal malignancies. Distal duodenal obstruction (DDO) poses unique surgical challenges, such as the need to drain the stomach and the proximal portions of the duodenum. The traditional approach, gastrojejunostomy, may not be as effective for relieving DDO, as gastrojejunostomy does not necessarily drain the duodenum. In this situation, a duodenojejunostomy could be more advantageous due to its ability to provide dual (stomach and duodenal) drainage. Here we present a case of a 75-year-old female with distal (D4) duodenal obstruction due to metastatic duodenal adenocarcinoma. Despite being previously treated with a gastrojejunostomy stent at an outside hospital, the patient presented with recurrent malignant DDO for which a robotic-assisted trans-mesocolic duodenojejunostomy was performed. This approach leverages the duodenal drainage ability of duodenojejunal bypass and the advantages of the minimally invasive robotic approach, resulting in effective and efficient relief of the obstruction. The patient's postoperative course was characterized by minimal postoperative pain, rapid resumption of solid intake, and early re-initiation of chemotherapy, underscoring the potential of this technique. This innovative surgical technique has notable clinical implications for patients in need of palliation from distal duodenal or proximal jejunal obstruction.

恶性十二指肠梗阻是影响高达20%的晚期胃肠道恶性肿瘤患者的常见问题。远端十二指肠梗阻(DDO)提出了独特的手术挑战,如需要排出胃和十二指肠近端部分。传统的方法,胃空肠吻合术,可能不像缓解DDO那样有效,因为胃空肠吻合术不一定会排出十二指肠。在这种情况下,十二指肠空肠吻合术可能更有利,因为它能够提供双重(胃和十二指肠)引流。我们在此报告一位75岁女性,因转移性十二指肠腺癌导致远端(D4)十二指肠梗阻。尽管此前曾在外院接受胃空肠造口支架治疗,但患者出现复发性恶性DDO,因此进行了机器人辅助的经肠系膜十二指肠空肠造口术。该入路充分利用了十二指肠空肠旁路的十二指肠引流能力和微创机器人入路的优点,有效、高效地解除梗阻。患者术后过程的特点是术后疼痛最小,快速恢复固体摄入,早期重新开始化疗,强调了该技术的潜力。这种创新的手术技术对于需要缓解十二指肠远端或空肠近端梗阻的患者具有显著的临床意义。
{"title":"Robotic-assisted trans-mesocolic side-to-side duodenojejunostomy for palliative management of malignant distal duodenal obstruction.","authors":"Han Yin, Devesh Sharma, Jaeyun Jane Wang, Amir Ashraf Ganjouei, Abdul Kouanda, Kenzo Hirose, Eric Nakakura, Kimberly Kirkwood, Carlos Corvera, Adnan Alseidi, Mohamed Abdelgadir Adam","doi":"10.21037/cco-24-87","DOIUrl":"10.21037/cco-24-87","url":null,"abstract":"<p><p>Malignant duodenal obstruction is a common issue affecting up to 20% of patients with advanced gastrointestinal malignancies. Distal duodenal obstruction (DDO) poses unique surgical challenges, such as the need to drain the stomach and the proximal portions of the duodenum. The traditional approach, gastrojejunostomy, may not be as effective for relieving DDO, as gastrojejunostomy does not necessarily drain the duodenum. In this situation, a duodenojejunostomy could be more advantageous due to its ability to provide dual (stomach and duodenal) drainage. Here we present a case of a 75-year-old female with distal (D4) duodenal obstruction due to metastatic duodenal adenocarcinoma. Despite being previously treated with a gastrojejunostomy stent at an outside hospital, the patient presented with recurrent malignant DDO for which a robotic-assisted trans-mesocolic duodenojejunostomy was performed. This approach leverages the duodenal drainage ability of duodenojejunal bypass and the advantages of the minimally invasive robotic approach, resulting in effective and efficient relief of the obstruction. The patient's postoperative course was characterized by minimal postoperative pain, rapid resumption of solid intake, and early re-initiation of chemotherapy, underscoring the potential of this technique. This innovative surgical technique has notable clinical implications for patients in need of palliation from distal duodenal or proximal jejunal obstruction.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 1","pages":"5"},"PeriodicalIF":2.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Befotertinib: one more drug targeting EGFR-the more may be the merrier. 贝福替尼:又一种靶向表皮生长因子受体的药物--多多益善。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 Epub Date: 2024-08-13 DOI: 10.21037/cco-24-50
Guilherme Sacchi de Camargo Correia, Yanyan Lou, Rami Manochakian
{"title":"Befotertinib: one more drug targeting EGFR-the more may be the merrier.","authors":"Guilherme Sacchi de Camargo Correia, Yanyan Lou, Rami Manochakian","doi":"10.21037/cco-24-50","DOIUrl":"10.21037/cco-24-50","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"12"},"PeriodicalIF":2.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Challenges and considerations in non-inferiority trials: a narrative review from statisticians' perspectives. 非劣效性试验的挑战和考虑:从统计学家的角度叙述回顾。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.21037/cco-24-84
Ruizhe Chen, Qian Shi

Background and objective: Non-inferiority (NI) study is a popular randomized controlled trial design that aims to demonstrate whether a test treatment, considering its auxiliary benefits, is not unacceptably worse compared to a standard active control treatment. There is extensive work in the literature that discusses NI trials' merits, issues, and how certain clinical and statistical challenges can be addressed. Here, we are aimed to provide a narrative review of NI studies in terms of its design considerations, potential issues, and corresponding solutions from the perspectives of biostatisticians.

Methods: We conducted a wide literature search on clinical and statistical methodology papers related to NI trials.

Key content and findings: In the "Fundamentals of NI study" section, we start from the formulation of the margin and the NI hypothesis test and then focus on the underlying two fundamental assumptions (the constancy assumption and assay sensitivity). We present experts and regulatory agencies' opinions on how certain statistical issues of NI studies are caused and how they could be addressed. We focus on key aspects of NI studies, which include formulations of an NI hypothesis test, definition of NI margins, determining historical evidence of the active control drug, checking assay sensitivity and constancy assumption, etc. We also briefly touch on topics such as comparisons between the fixed-margin method and the synthesis method for NI evaluation, analysis principle in presence of treatment non-adherence, Bayesian design of NI studies, and restricted mean survival time (RMST) as a measure for designing NI studies. Figures and examples are given throughout the article to better illustrate ideas.

Conclusions: We believe that NI design, with its issues addressed by appropriate statistical and clinical considerations, still plays a pivotal role in clinical research by improving patients' experience and alleviating healthcare inequalities.

背景和目的:非劣效性(NI)研究是一种流行的随机对照试验设计,旨在证明考虑到其辅助益处,测试治疗是否比标准主动对照治疗差得不可接受。文献中有大量的工作讨论NI试验的优点、问题,以及如何解决某些临床和统计挑战。在这里,我们旨在从生物统计学家的角度,就NI研究的设计考虑、潜在问题和相应的解决方案,提供一个叙述性的回顾。方法:我们对与NI试验相关的临床和统计方法学论文进行了广泛的文献检索。关键内容和发现:在“NI研究的基础”部分,我们从边际和NI假设检验的公式开始,然后关注潜在的两个基本假设(恒常性假设和测定灵敏度)。我们就NI研究的某些统计问题是如何引起的以及如何解决这些问题提出了专家和监管机构的意见。我们专注于NI研究的关键方面,包括NI假设检验的公式,NI边际的定义,确定活性对照药物的历史证据,检查检测灵敏度和恒定假设等。我们还简要介绍了固定边际法与NI评估综合法的比较、治疗不依从的分析原则、NI研究的贝叶斯设计以及作为NI研究设计指标的限制平均生存时间(RMST)等主题。为了更好地说明观点,整篇文章都给出了图表和例子。结论:我们认为,通过适当的统计和临床考虑来解决NI设计问题,通过改善患者体验和减轻医疗不平等,仍然在临床研究中发挥关键作用。
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引用次数: 0
A periungual eccrine poroma masquerading as amelanotic melanoma: a case report. 伪装为无色素黑色素瘤的甲周内分泌囊肿1例报告。
IF 2.1 4区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 Epub Date: 2025-02-20 DOI: 10.21037/cco-24-94
Sha Yi, Shang-Shang Wang

Background: Eccrine poroma (EP) is a benign cutaneous neoplasm that originates from the acrosyringium of the eccrine sweat duct. EP can be found on any skin area with sweat glands and typically occurs on the palmoplantar areas. They usually present as solitary, asymptomatic, well-circumscribed, smooth or verrucous papules or nodules that range in color from skin-colored to red or brown. However, some cases may be difficult to diagnose clinically, especially when the distribution and morphology are not typical. The periungual region represents an uncommon localization for these neoplasms and can easily be misdiagnosed.

Case description: Here, we present a rare case of a 52-year-old man who presented with a 2-year history of a painless, slowly growing, erythematous nodule on the lateral nail fold of his right toe. The lesion was initially suspected to be an amelanotic melanoma, but histopathological revealed a tumor composed of broad anastomosing bands of cuboidal cells with eosinophilic cytoplasm and round nuclei within the dermis, confirmed to be an EP. After complete surgical excision of the lesion with 1 mm margins, the wound healed well and there was no recurrence or metastasis after 12 months of follow-up.

Conclusions: EPs in the periungual region are exceedingly rare. Their presentation and atypical appearance can lead to misdiagnosis and missed opportunities for early treatment. Clinicians should be aware of this possibility and perform biopsies of any suspicious periungual lesion to ensure timely and appropriate management.

背景:小汗腺脓肿(epp)是一种良性皮肤肿瘤,起源于小汗腺管的顶尖部。EP可以在任何有汗腺的皮肤区域发现,通常发生在掌足底区域。它们通常表现为孤立、无症状、边界清楚、光滑或疣状丘疹或结节,颜色从皮肤颜色到红色或棕色不等。然而,有些病例可能难以临床诊断,特别是当分布和形态不典型时。对于这些肿瘤来说,骨趾周围区域是一种罕见的定位,很容易被误诊。病例描述:在这里,我们报告一个罕见的病例,52岁的男性,他的右脚趾外侧甲襞有2年的无痛,缓慢生长的红斑结节病史。病变最初被怀疑为无色素黑色素瘤,但组织病理学显示肿瘤由具有嗜酸性细胞质的宽吻合带的立方体细胞和真皮内的圆形细胞核组成,证实为EP。手术切除病灶边缘1 mm后,伤口愈合良好,随访12个月无复发转移。结论:腹周区EPs极为罕见。他们的表现和不典型的外观可能导致误诊和错过早期治疗的机会。临床医生应该意识到这种可能性,并对任何可疑的口周病变进行活检,以确保及时和适当的治疗。
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引用次数: 0
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Chinese clinical oncology
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