TY - JOUR
T1 - Risk of complications in patients with conservatively managed ovarian tumours (IOTA5)
T2 - a 2-year interim analysis of a multicentre, prospective, cohort study
AU - Froyman, Wouter
AU - Landolfo, Chiara
AU - De Cock, Bavo
AU - Wynants, Laure
AU - Sladkevicius, Povilas
AU - Testa, Antonia Carla
AU - Van Holsbeke, Caroline
AU - Domali, Ekaterini
AU - Fruscio, Robert
AU - Epstein, Elisabeth
AU - Dos Santos Bernardo, Maria José
AU - Franchi, Dorella
AU - Kudla, Marek Jerzy
AU - Chiappa, Valentina
AU - Alcazar, Juan Luis
AU - Leone, Francesco Paolo Giuseppe
AU - Buonomo, Francesca
AU - Hochberg, Lauri
AU - Coccia, Maria Elisabetta
AU - Guerriero, Stefano
AU - Deo, Nandita
AU - Jokubkiene, Ligita
AU - Kaijser, Jeroen
AU - Coosemans, An
AU - Vergote, Ignace
AU - Verbakel, Jan Yvan
AU - Bourne, Tom
AU - Van Calster, Ben
AU - Valentin, Lil
AU - Timmerman, Dirk
N1 - Copyright © 2019 Elsevier Ltd. All rights reserved.
PY - 2019/3
Y1 - 2019/3
N2 - 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% (<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.FUNDING: Research Foundation Flanders, KU Leuven, Swedish Research Council.
AB - 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% (<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.FUNDING: Research Foundation Flanders, KU Leuven, Swedish Research Council.
KW - BENIGN
KW - CANCER
KW - DERMOID CYSTS
KW - EXPECTANT MANAGEMENT
KW - FOLLOW-UP
KW - NATURAL-HISTORY
KW - POSTMENOPAUSAL WOMEN
KW - PREMENOPAUSAL
KW - SIMPLE ADNEXAL CYSTS
KW - ULTRASOUND
U2 - 10.1016/S1470-2045(18)30837-4
DO - 10.1016/S1470-2045(18)30837-4
M3 - Article
C2 - 30737137
SN - 1470-2045
VL - 20
SP - 448
EP - 458
JO - Lancet oncology
JF - Lancet oncology
IS - 3
ER -