Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Ultrasound Obstet Gynecol. 2023 Feb;61(2):231-242. doi: 10.1002/uog.26080. Epub 2023 Jan 12.
Previous work has suggested that the ultrasound-based benign simple descriptors (BDs) can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. This study aimed to validate a modified version of the BDs and to validate a two-step strategy to estimate the risk of malignancy, in which the modified BDs are followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model if modified BDs do not apply.
This was a retrospective analysis using data from the 2-year interim analysis of the International Ovarian Tumor Analysis (IOTA) Phase-5 study, in which consecutive patients with at least one adnexal mass were recruited irrespective of subsequent management (conservative or surgery). The main outcome was classification of tumors as benign or malignant, based on histology or on clinical and ultrasound information during 1 year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria.
A total of 8519 patients were recruited at 36 centers between 2012 and 2015. We excluded patients who were already in follow-up at recruitment and all patients from 19 centers that did not fulfil our criteria for good-quality surgical and follow-up data, leaving 4905 patients across 17 centers for statistical analysis. Overall, 3441 (70%) tumors were benign, 978 (20%) malignant and 486 (10%) uncertain. The modified BDs were applicable in 1798/4905 (37%) tumors, of which 1786 (99.3%) were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver-operating-characteristics curve (AUC) of 0.94 (95% CI, 0.92-0.96). The risk of malignancy was slightly underestimated, but calibration varied between centers. A sensitivity analysis in which we expanded the definition of uncertain outcome resulted in 1419 (29%) tumors with uncertain outcome and an AUC of the two-step strategy without CA125 of 0.93 (95% CI, 0.91-0.95).
A large proportion of adnexal masses can be classified as benign by the modified BDs. For the remaining masses, the ADNEX model can be used to estimate the risk of malignancy. This two-step strategy is convenient for clinical use. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
之前的研究表明，基于超声的良性单纯性描述符（BDs）可以在很大一部分患有附件肿块的女性中可靠地排除恶性肿瘤。本研究旨在验证 BDs 的改良版本，并验证一种两步策略来估计恶性肿瘤的风险，如果改良 BDs 不适用，则可以采用改良 BDs 后进行评估不同附件肿瘤的方法（ADNEX）模型。
这是一项回顾性分析，使用了 2012 年至 2015 年期间国际卵巢肿瘤分析（IOTA）第 5 阶段研究的 2 年中期分析数据，其中连续招募了至少有一个附件肿块的患者，无论随后的管理（保守或手术）如何。主要结局是根据组织学或 1 年随访期间的临床和超声信息，将肿瘤分类为良性或恶性。根据预设标准，当基于随访的结果不确定时，采用多重插补法。
在 36 个中心共招募了 8519 名患者。我们排除了招募时已经在随访的患者和来自 19 个中心的所有不符合我们高质量手术和随访数据标准的患者，在 17 个中心留下了 4905 名患者进行统计分析。总体而言，3441 个（70%）肿瘤为良性，978 个（20%）为恶性，486 个（10%）为不确定。改良 BDs 适用于 1798/4905（37%）个肿瘤，其中 1786 个（99.3%）为良性。不使用 CA125 的基于 ADNEX 的两步策略的受试者工作特征曲线（ROC）下面积（AUC）为 0.94（95%CI，0.92-0.96）。恶性肿瘤的风险略有低估，但校准因中心而异。在我们扩大不确定结果定义的敏感性分析中，有 1419 个（29%）肿瘤的结果不确定，不使用 CA125 的两步策略的 AUC 为 0.93（95%CI，0.91-0.95）。
很大一部分附件肿块可以通过改良 BDs 分类为良性。对于剩余的肿块，可以使用 ADNEX 模型来估计恶性肿瘤的风险。这种两步策略方便临床使用。
Zotero 插件
