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Risk of Complications in Patients with Conservatively Managed Ovarian Tumours (IOTA5): a 2-Year Interim Analysis of a Multicentre, Prospective, Cohort Study

2019-03Journal article Open access
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dc.contributor.authorFroyman, W
dc.contributor.authorLandolfo, C
dc.contributor.authorCock, B
dc.contributor.authorWynants, L
dc.contributor.authorSladkevicius, P
dc.contributor.authorTesta, A
dc.contributor.authorVan Holsbeke, C
dc.contributor.authorDomali, E
dc.contributor.authorFruscio, R
dc.contributor.authorEpstein, E
dc.contributor.authorSantos Bernardo, MJ
dc.contributor.authorFranchi, D
dc.contributor.authorKudla, M
dc.contributor.authorChiappa, V
dc.contributor.authorAlcazar, JL
dc.contributor.authorLeone, F
dc.contributor.authorBuonomo, F
dc.contributor.authorHochberg, L
dc.contributor.authorCoccia, ME
dc.contributor.authorGuerriero, S
dc.contributor.authorDeo, N
dc.contributor.authorJokubkiene, L
dc.contributor.authorKaijser, J
dc.contributor.authorCoosemans, A
dc.contributor.authorVergote, I
dc.contributor.authorVerbakel, J
dc.contributor.authorBourne, T
dc.contributor.authorVan Calster, B
dc.contributor.authorValentin, L
dc.contributor.authorTimmerman, D
dc.date.accessioned2023-07-26T14:21:29Z
dc.date.available2023-07-26T14:21:29Z
dc.date.issued2019-03
dc.description.abstractBackground: 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. Methods: 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. Findings: 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. Interpretation: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationLancet Oncol. 2019 Mar;20(3):448-458.pt_PT
dc.identifier.doi10.1016/S1470-2045(18)30837-4pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4614
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherElsevierpt_PT
dc.subjectCHLC GINpt_PT
dc.subjectAdultpt_PT
dc.subjectAgedpt_PT
dc.subjectAdolescentpt_PT
dc.subjectAdnexal Diseases / diagnosispt_PT
dc.subjectFemalept_PT
dc.subjectYoung Adultpt_PT
dc.subjectMiddle Agedpt_PT
dc.subjectAdnexal Diseases / drug therapy*pt_PT
dc.subjectAdnexal Diseases / pathologypt_PT
dc.subjectAdnexal Diseases / surgerypt_PT
dc.subjectCohort Studiespt_PT
dc.subjectDiagnosis, Differential*pt_PT
dc.subjectNeoplasms / diagnosispt_PT
dc.subjectNeoplasms / drug therapy*pt_PT
dc.subjectNeoplasms / pathologypt_PT
dc.subjectNeoplasms / surgerypt_PT
dc.subjectOvarian Neoplasms / diagnosispt_PT
dc.subjectOvarian Neoplasms / pathologypt_PT
dc.subjectOvarian Neoplasms / surgerypt_PT
dc.subjectOvarian Neoplasms / drug therapy*pt_PT
dc.subjectProspective Studiespt_PT
dc.subjectRisk Factorspt_PT
dc.subjectUltrasonographypt_PT
dc.titleRisk of Complications in Patients with Conservatively Managed Ovarian Tumours (IOTA5): a 2-Year Interim Analysis of a Multicentre, Prospective, Cohort Studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage458pt_PT
oaire.citation.issue3pt_PT
oaire.citation.startPage448pt_PT
oaire.citation.titleThe Lancet Oncologypt_PT
oaire.citation.volume20pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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