Scientific publications
Risk of complications in patients with conservatively managed ovarian tumours (IOTA5): a 2-year interim analysis of a multicentre, prospective, cohort study
Froyman W (1), Landolfo C (2), De Cock B (3), Wynants L (3), Sladkevicius P (4), Testa AC (5), Van Holsbeke C (6), Domali E (7), Fruscio R (8), Epstein E (9), Dos Santos Bernardo MJ (10), Franchi D (11), Kudla MJ (12), Chiappa V (13), Alcazar JL (14), Leone FPG (15), Buonomo F (16), Hochberg L (17), Coccia ME (18), Guerriero S (19), Deo N (20), Jokubkiene L (4), Kaijser J (21), Coosemans A (22), Vergote I (22), Verbakel JY (23), Bourne T (24), Van Calster B (25), Valentin L (4), Timmerman D (26)
(1) Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
(2) Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
(3) Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
(4) Department of Obstetrics and Gynecology, Skåne University Hospital Malmö, Lund University, Sweden.
(5) Department of Woman and Child Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore Roma, Rome, Italy.
(6) Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium.
(7) First Department of Obstetrics and Gynecology, Alexandra Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
(8) Clinic of Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy.
(9) Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
(10) Department of Obstetrics and Gynecology, Centro Hospitalar Lisboa Central, Lisbon, Portugal.
(11) Preventive Gynecology Unit, Division of Gynecology, European Institute of Oncology IRCCS, Milan, Italy.
(12) Department of Perinatology and Oncological Gynecology, School of Health Sciences in Katowice, Medical University of Silesia, Katowice, Poland.
(13) Department of Gynecologic Oncology, National Cancer Institute of Milan, Milan, Italy.
(14) Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, School of Medicine, Pamplona, Spain.
(15) Department of Obstetrics and Gynecology, Biomedical and Clinical Sciences Institute L. Sacco, University of Milan, Milan, Italy.
(16) Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
(17) Imaged Based Gynecology Service, Department of Obstetrics and Gynecology, University of South Florida Morsani College, Tampa, FL, USA.
(18) Department of Obstetrics and Gynecology, University of Florence, Florence, Italy.
(19) Department of Obstetrics and Gynecology, University of Cagliari, Policlinico Universitario Duilio Casula, Monserrato, Cagliari, Italy.
(20) Department of Obstetrics and Gynaecology, Whipps Cross Hospital, London, UK.
(21) Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, Netherlands.
(22) Department of Oncology, Leuven Cancer Institute, Laboratory of Tumor Immunology and Immunotherapy, ImmunOvar Research Group, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
(23) Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
(24) Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
(25) Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, Netherlands.
(26) Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
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.
CITATION Lancet Oncol. 2019 Feb 5. pii: S1470-2045(18)30837-4. doi: 10.1016/S1470-2045(18)30837-4