早期宫颈癌患者术前肿瘤大小评估：SENTIX研究的最终结果

IF 4.5 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Gynecologic oncology Pub Date : 2025-04-11 DOI:10.1016/j.ygyno.2025.04.005

Martina Borčinová , Christhardt Köhler , Kristýna Němejcová , Ignacio Zapardiel , Jaroslav Klát , Filip Frühauf , Vladimír Kalist , Wiktor Szatkowski , Dariusz Wydra , Roman Kocián , Rene Laky , Róbert Tóth , Marcin Misiek , Mikuláš Redecha , Isabel Martin , Frederic Kridelka , Andrea Burgetová , F. Javier Santiago Garcia , Toon Van Gorp , Grzegorz Szewczyk , David Cibula

{"title":"早期宫颈癌患者术前肿瘤大小评估：SENTIX研究的最终结果","authors":"Martina Borčinová , Christhardt Köhler , Kristýna Němejcová , Ignacio Zapardiel , Jaroslav Klát , Filip Frühauf , Vladimír Kalist , Wiktor Szatkowski , Dariusz Wydra , Roman Kocián , Rene Laky , Róbert Tóth , Marcin Misiek , Mikuláš Redecha , Isabel Martin , Frederic Kridelka , Andrea Burgetová , F. Javier Santiago Garcia , Toon Van Gorp , Grzegorz Szewczyk , David Cibula","doi":"10.1016/j.ygyno.2025.04.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Preoperative tumour size is a key prognostic marker in tailoring surgical treatment in early-stage cervical cancer. This post-hoc analysis assessed the accuracy of preoperative tumour size evaluation via imaging, utilizing data from the prospective, international, multicentre SENTIX study that evaluated safety of sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer.</div></div><div><h3>Methods</h3><div>Between 05/2016–09/2020, forty-seven sites across 18 countries enrolled cervical cancer patients (FIGO2018 stages 1A1/lymphovascular-space-invasion-positive to 1B2). Preoperative staging included pelvic MRI or ultrasound as mandatory imaging modalities. All patients underwent primary surgical treatment. Pathological assessment of surgical specimens served as reference standard for evaluating the accuracy of preoperative assessments.</div></div><div><h3>Results</h3><div>Among the 680 included patients, although the mean tumour size discrepancy between preoperative/pathological assessments was only 1.24 ± 8.891 mm, postoperative pT stage was upgraded in 187 (27.5 %) and downgraded in 74 (10.9 %) patients. Discrepancy of ≥10 mm was observed among 155 (22.8 %) patients across all stages, with underestimation in 105 (15.4 %), overestimation in 50 (7.4 %), and a positive correlation (<em>P</em> < 0.0001) between the pathological tumour size and the discrepancy in size assessment. If a maximum 2 cm tumour size threshold were applied to guide the decision between simple and radical hysterectomy, underestimation would result in inadequate surgical management for 9.0 % of patients, whereas overestimation would lead to unnecessarily radical procedures in 5.1 % of cases.</div></div><div><h3>Conclusions</h3><div>The study highlights, that even with the use of modern imaging in preoperative staging, inaccuracies in tumour size assessment remain a common cause of up−/down-staging after surgery resulting in potential inappropriate planning of surgery, and thus in procedure that is either excessively or insufficiently radical.</div><div>Trial registration: ClinicalTrials.gov: NCT02494063.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"196 ","pages":"Pages 160-167"},"PeriodicalIF":4.5000,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Preoperative tumour size assessment in patients with early-stage cervical cancer: Final results of the SENTIX study\",\"authors\":\"Martina Borčinová , Christhardt Köhler , Kristýna Němejcová , Ignacio Zapardiel , Jaroslav Klát , Filip Frühauf , Vladimír Kalist , Wiktor Szatkowski , Dariusz Wydra , Roman Kocián , Rene Laky , Róbert Tóth , Marcin Misiek , Mikuláš Redecha , Isabel Martin , Frederic Kridelka , Andrea Burgetová , F. Javier Santiago Garcia , Toon Van Gorp , Grzegorz Szewczyk , David Cibula\",\"doi\":\"10.1016/j.ygyno.2025.04.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Preoperative tumour size is a key prognostic marker in tailoring surgical treatment in early-stage cervical cancer. This post-hoc analysis assessed the accuracy of preoperative tumour size evaluation via imaging, utilizing data from the prospective, international, multicentre SENTIX study that evaluated safety of sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer.</div></div><div><h3>Methods</h3><div>Between 05/2016–09/2020, forty-seven sites across 18 countries enrolled cervical cancer patients (FIGO2018 stages 1A1/lymphovascular-space-invasion-positive to 1B2). Preoperative staging included pelvic MRI or ultrasound as mandatory imaging modalities. All patients underwent primary surgical treatment. Pathological assessment of surgical specimens served as reference standard for evaluating the accuracy of preoperative assessments.</div></div><div><h3>Results</h3><div>Among the 680 included patients, although the mean tumour size discrepancy between preoperative/pathological assessments was only 1.24 ± 8.891 mm, postoperative pT stage was upgraded in 187 (27.5 %) and downgraded in 74 (10.9 %) patients. Discrepancy of ≥10 mm was observed among 155 (22.8 %) patients across all stages, with underestimation in 105 (15.4 %), overestimation in 50 (7.4 %), and a positive correlation (<em>P</em> < 0.0001) between the pathological tumour size and the discrepancy in size assessment. If a maximum 2 cm tumour size threshold were applied to guide the decision between simple and radical hysterectomy, underestimation would result in inadequate surgical management for 9.0 % of patients, whereas overestimation would lead to unnecessarily radical procedures in 5.1 % of cases.</div></div><div><h3>Conclusions</h3><div>The study highlights, that even with the use of modern imaging in preoperative staging, inaccuracies in tumour size assessment remain a common cause of up−/down-staging after surgery resulting in potential inappropriate planning of surgery, and thus in procedure that is either excessively or insufficiently radical.</div><div>Trial registration: ClinicalTrials.gov: NCT02494063.</div></div>\",\"PeriodicalId\":12853,\"journal\":{\"name\":\"Gynecologic oncology\",\"volume\":\"196 \",\"pages\":\"Pages 160-167\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2025-04-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gynecologic oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0090825825001635\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gynecologic oncology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0090825825001635","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景：术前肿瘤大小是早期宫颈癌手术治疗的关键预后指标。这项事后分析评估了通过影像学评估术前肿瘤大小的准确性，利用了前瞻性、国际、多中心SENTIX研究的数据，该研究评估了早期宫颈癌患者前哨淋巴结（SLN）活检而不进行盆腔淋巴结清扫的安全性。方法2016年5月至2020年9月，在18个国家的47个地点招募了宫颈癌患者（FIGO2018期1A1/淋巴血管空间浸润阳性至1B2）。术前分期包括盆腔MRI或超声作为强制性成像方式。所有患者均接受初步手术治疗。手术标本病理评估作为术前评估准确性的参考标准。结果在680例纳入的患者中，尽管术前/病理评估的平均肿瘤大小差异仅为1.24±8.891 mm，但术后pT分期升级的患者187例（27.5%），降级的患者74例（10.9%）。所有分期155例（22.8%）患者的差异≥10 mm，其中低估105例（15.4%），高估50例（7.4%），呈正相关(P <；0.0001)，病理肿瘤大小与大小评估差异。如果使用最大2cm肿瘤大小阈值来指导简单和根治性子宫切除术之间的决定，则9.0%的患者低估会导致手术治疗不充分，而高估会导致5.1%的病例不必要的根治性手术。结论：该研究强调，即使在术前分期中使用现代影像学，肿瘤大小评估的不准确性仍然是术后分期上升/下降的常见原因，导致潜在的不适当的手术计划，从而导致手术过度或不够彻底。试验注册：ClinicalTrials.gov: NCT02494063。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Preoperative tumour size assessment in patients with early-stage cervical cancer: Final results of the SENTIX study

Background

Preoperative tumour size is a key prognostic marker in tailoring surgical treatment in early-stage cervical cancer. This post-hoc analysis assessed the accuracy of preoperative tumour size evaluation via imaging, utilizing data from the prospective, international, multicentre SENTIX study that evaluated safety of sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer.

Methods

Between 05/2016–09/2020, forty-seven sites across 18 countries enrolled cervical cancer patients (FIGO2018 stages 1A1/lymphovascular-space-invasion-positive to 1B2). Preoperative staging included pelvic MRI or ultrasound as mandatory imaging modalities. All patients underwent primary surgical treatment. Pathological assessment of surgical specimens served as reference standard for evaluating the accuracy of preoperative assessments.

Results

Among the 680 included patients, although the mean tumour size discrepancy between preoperative/pathological assessments was only 1.24 ± 8.891 mm, postoperative pT stage was upgraded in 187 (27.5 %) and downgraded in 74 (10.9 %) patients. Discrepancy of ≥10 mm was observed among 155 (22.8 %) patients across all stages, with underestimation in 105 (15.4 %), overestimation in 50 (7.4 %), and a positive correlation (P < 0.0001) between the pathological tumour size and the discrepancy in size assessment. If a maximum 2 cm tumour size threshold were applied to guide the decision between simple and radical hysterectomy, underestimation would result in inadequate surgical management for 9.0 % of patients, whereas overestimation would lead to unnecessarily radical procedures in 5.1 % of cases.

Conclusions

The study highlights, that even with the use of modern imaging in preoperative staging, inaccuracies in tumour size assessment remain a common cause of up−/down-staging after surgery resulting in potential inappropriate planning of surgery, and thus in procedure that is either excessively or insufficiently radical.

Trial registration: ClinicalTrials.gov: NCT02494063.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Gynecologic oncology 医学-妇产科学

CiteScore

8.60

自引率

6.40%

发文量

1062

审稿时长

37 days

期刊介绍： Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy