Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
Lancet Oncol. 2019 Mar;20(3):448-458. doi: 10.1016/S1470-2045(18)30837-4. Epub 2019 Feb 5.
Ovarian tumours are usually surgically removed because of the presumed risk of complications. Few large prospective studies on long-term follow-up of adnexal masses exist. We aimed to estimate the cumulative incidence of cyst complications and malignancy during the first 2 years of follow-up after adnexal masses have been classified as benign by use of ultrasonography.
In the international, prospective, cohort International Ovarian Tumor Analysis Phase 5 (IOTA5) study, patients aged 18 years or older with at least one adnexal mass who had been selected for surgery or conservative management after ultrasound assessment were recruited consecutively from 36 cancer and non-cancer centres in 14 countries. Follow-up of patients managed conservatively is ongoing at present. In this 2-year interim analysis, we analysed patients who were selected for conservative management of an adnexal mass judged to be benign on ultrasound on the basis of subjective assessment of ultrasound images. Conservative management included ultrasound and clinical follow-up at intervals of 3 months and 6 months, and then every 12 months thereafter. The main outcomes of this 2-year interim analysis were cumulative incidence of spontaneous resolution of the mass, torsion or cyst rupture, or borderline or invasive malignancy confirmed surgically in patients with a newly diagnosed adnexal mass. IOTA5 is registered with ClinicalTrials.gov, number NCT01698632, and the central Ethics Committee and the Belgian Federal Agency for Medicines and Health Products, number S51375/B32220095331, and is ongoing.
Between Jan 1, 2012, and March 1, 2015, 8519 patients were recruited to IOTA5. 3144 (37%) patients selected for conservative management were eligible for inclusion in our analysis, of whom 221 (7%) had no follow-up data and 336 (11%) were operated on before a planned follow-up scan was done. Of 2587 (82%) patients with follow-up data, 668 (26%) had a mass that was already in follow-up at recruitment, and 1919 (74%) presented with a new mass at recruitment (ie, not already in follow-up in the centre before recruitment). Median follow-up of patients with new masses was 27 months (IQR 14-38). The cumulative incidence of spontaneous resolution within 2 years of follow-up among those with a new mass at recruitment (n=1919) was 20·2% (95% CI 18·4-22·1), and of finding invasive malignancy at surgery was 0·4% (95% CI 0·1-0·6), 0·3% (<0·1-0·5) for a borderline tumour, 0·4% (0·1-0·7) for torsion, and 0·2% (<0·1-0·4) for cyst rupture.
Our results suggest that the risk of malignancy and acute complications is low if adnexal masses with benign ultrasound morphology are managed conservatively, which could be of value when counselling patients, and supports conservative management of adnexal masses classified as benign by use of ultrasound.
Research Foundation Flanders, KU Leuven, Swedish Research Council.
由于卵巢肿瘤并发症的潜在风险，通常需要手术切除。目前很少有关于附件包块经超声检查诊断为良性后长期随访的大型前瞻性研究。我们旨在评估附件包块经超声检查诊断为良性后，在最初 2 年的随访期间，囊肿并发症和恶性肿瘤的累积发生率。
在国际、前瞻性、队列研究国际卵巢肿瘤分析第 5 期（IOTA5）中，从 14 个国家的 36 个癌症和非癌症中心连续招募了年龄在 18 岁及以上、经超声评估后选择手术或保守治疗的至少有一个附件包块的患者。目前正在对接受保守治疗的患者进行随访。在本 2 年中期分析中，我们根据超声图像的主观评估，分析了那些经超声判断为良性的附件包块选择保守治疗的患者。保守治疗包括超声和临床随访，间隔 3 个月和 6 个月，此后每 12 个月一次。本 2 年中期分析的主要结局是新诊断的附件包块患者中肿块自发消退、扭转或囊肿破裂，或经手术证实为交界性或浸润性恶性肿瘤的累积发生率。IOTA5 在 ClinicalTrials.gov 注册，编号为 NCT01698632，中央伦理委员会和比利时联邦药品和保健品管理局，编号为 S51375/B32220095331，正在进行中。
在 2012 年 1 月 1 日至 2015 年 3 月 1 日期间，IOTA5 招募了 8519 名患者。3144 名（37%）选择保守治疗的患者符合纳入本分析的条件，其中 221 名（7%）无随访数据，336 名（11%）在计划进行随访扫描前接受了手术。在 2587 名（82%）有随访数据的患者中，668 名（26%）在招募时已经在随访中，1919 名（74%）在招募时出现新的肿块（即在招募前中心尚未随访）。有新肿块患者的中位随访时间为 27 个月（IQR 14-38）。在招募时有新肿块的患者中，在 2 年内肿块自发消退的累积发生率为 20.2%（95%CI 18.4-22.1），手术时发现浸润性恶性肿瘤的累积发生率为 0.4%（95%CI 0.1-0.6），交界性肿瘤为 0.3%（<0.1-0.5），扭转为 0.4%（0.1-0.7），囊肿破裂为 0.2%（<0.1-0.4）。
如果附件包块具有良性的超声形态，采用保守治疗，其恶性肿瘤和急性并发症的风险较低，这在为患者提供咨询时可能具有重要价值，并支持使用超声将附件包块分类为良性后进行保守治疗。
佛兰德研究基金会、鲁汶大学、瑞典研究理事会。
