Risk of complications in patients with conservatively managed ovarian tumours (IOTA5): a 2-year interim analysis of a multicentre, prospective, cohort study

Wouter Froyman, Chiara Landolfo, Bavo De Cock, Laure Wynants, Povilas Sladkevicius, Antonia Carla Testa, Caroline Van Holsbeke, Ekaterini Domali, Robert Fruscio, Elisabeth Epstein, Maria José Dos Santos Bernardo, Dorella Franchi, Marek Jerzy Kudla, Valentina Chiappa, Juan Luis Alcazar, Francesco Paolo Giuseppe Leone, Francesca Buonomo, Lauri Hochberg, Maria Elisabetta Coccia, Stefano GuerrieroNandita Deo, Ligita Jokubkiene, Jeroen Kaijser, An Coosemans, Ignace Vergote, Jan Yvan Verbakel, Tom Bourne, Ben Van Calster, Lil Valentin, Dirk Timmerman

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Abstract

BACKGROUND: 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% (
Original languageEnglish
Pages (from-to)448-458
Number of pages11
JournalThe Lancet. Oncology
Volume20
Issue number3
DOIs
Publication statusPublished - Mar 2019

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Froyman, W., Landolfo, C., De Cock, B., Wynants, L., Sladkevicius, P., Testa, A. C., Van Holsbeke, C., Domali, E., Fruscio, R., Epstein, E., Dos Santos Bernardo, M. J., Franchi, D., Kudla, M. J., Chiappa, V., Alcazar, J. L., Leone, F. P. G., Buonomo, F., Hochberg, L., Coccia, M. E., ... Timmerman, D. (2019). Risk of complications in patients with conservatively managed ovarian tumours (IOTA5): a 2-year interim analysis of a multicentre, prospective, cohort study. The Lancet. Oncology, 20(3), 448-458. https://doi.org/10.1016/S1470-2045(18)30837-4