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

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift


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.


  • Wouter Froyman
  • Chiara Landolfo
  • Bavo De Cock
  • Laure Wynants
  • 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 Guerriero
  • Nandita Deo
  • Ligita Jokubkiene
  • Jeroen Kaijser
  • An Coosemans
  • Ignace Vergote
  • Jan Yvan Verbakel
  • Tom Bourne
  • Ben Van Calster
  • Dirk Timmerman
Enheter & grupper
Externa organisationer
  • Catholic University of Leuven
  • University Hospitals Leuven
  • Queen Charlotte's and Chelsea Hospital
  • Skåne University Hospital
  • Policlinico Universitario Agostino Gemelli
  • Ziekenhuis Oost-Limburg
  • National and Kapodistrian University of Athens
  • San Gerardo Hospital
  • Södersjukhuset
  • European Institute of Oncology
  • Medical University of Silesia
  • Istituto Nazionale dei Tumori
  • Luigi Sacco University Hospital
  • Burlo Garofolo Pediatric Institute
  • University of South Florida
  • University of Florence
  • University of Cagliari
  • Whipps Cross University Hospital
  • Ikazia Hospital
  • University of Oxford
  • Leiden University Medical Centre
  • Catholic University of the Sacred Heart
  • Alexandra Hospital, Athens
  • University of Milano-Bicocca
  • Karolinska Institute
  • EPE
  • University Clinic of Navarra
  • University of Milan
  • Azienda Ospedaliero Universitaria-Policlinico Duilio Casula

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Cancer och onkologi
  • Reproduktionsmedicin och gynekologi
Sidor (från-till)448-458
Antal sidor11
TidskriftThe Lancet Oncology
Utgåva nummer3
StatusPublished - 2019
Peer review utfördJa