Wouter Froyman1, Chiara Landolfo2, Bavo De Cock3, Laure Wynants3, Povilas Sladkevicius4, Antonia Carla Testa5, Caroline Van Holsbeke6, Ekaterini Domali7, Robert Fruscio8, Elisabeth Epstein9, Maria José Dos Santos Bernardo10, Dorella Franchi11, Marek Jerzy Kudla12, Valentina Chiappa13, Juan Luis Alcazar14, Francesco Paolo Giuseppe Leone15, Francesca Buonomo16, Lauri Hochberg17, Maria Elisabetta Coccia18, Stefano Guerriero19, Nandita Deo20, Ligita Jokubkiene4, Jeroen Kaijser21, An Coosemans22, Ignace Vergote22, Jan Yvan Verbakel23, Tom Bourne24, Ben Van Calster25, Lil Valentin4, Dirk Timmerman26. 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. Electronic address: dirk.timmerman@uzleuven.be.
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% (<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.
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.
Authors: Julio Vara; Nabil Manzour; Enrique Chacón; Ana López-Picazo; Marta Linares; Maria Ángela Pascual; Stefano Guerriero; Juan Luis Alcázar Journal: Cancers (Basel) Date: 2022-06-27 Impact factor: 6.575
Authors: Dirk Timmerman; François Planchamp; Tom Bourne; Chiara Landolfo; Andreas du Bois; Luis Chiva; David Cibula; Nicole Concin; Daniela Fischerova; Wouter Froyman; Guillermo Gallardo Madueño; Birthe Lemley; Annika Loft; Liliana Mereu; Philippe Morice; Denis Querleu; Antonia Carla Testa; Ignace Vergote; Vincent Vandecaveye; Giovanni Scambia; Christina Fotopoulou Journal: Int J Gynecol Cancer Date: 2021-06-10 Impact factor: 3.437
Authors: T Bourne; M Leonardi; C Kyriacou; M Al-Memar; C Landolfo; D Cibula; G Condous; U Metzger; D Fischerova; D Timmerman; T van den Bosch Journal: Ultrasound Obstet Gynecol Date: 2020-06 Impact factor: 8.678
Authors: Ben Van Calster; Lil Valentin; Wouter Froyman; Chiara Landolfo; Jolien Ceusters; Antonia C Testa; Laure Wynants; Povilas Sladkevicius; Caroline Van Holsbeke; Ekaterini Domali; Robert Fruscio; Elisabeth Epstein; Dorella Franchi; Marek J Kudla; Valentina Chiappa; Juan L Alcazar; Francesco P G Leone; Francesca Buonomo; Maria Elisabetta Coccia; Stefano Guerriero; Nandita Deo; Ligita Jokubkiene; Luca Savelli; Daniela Fischerová; Artur Czekierdowski; Jeroen Kaijser; An Coosemans; Giovanni Scambia; Ignace Vergote; Tom Bourne; Dirk Timmerman Journal: BMJ Date: 2020-07-30
Authors: Isabelle Thomassin-Naggara; Edouard Poncelet; Aurelie Jalaguier-Coudray; Adalgisa Guerra; Laure S Fournier; Sanja Stojanovic; Ingrid Millet; Nishat Bharwani; Valerie Juhan; Teresa M Cunha; Gabriele Masselli; Corinne Balleyguier; Caroline Malhaire; Nicolas F Perrot; Elizabeth A Sadowski; Marc Bazot; Patrice Taourel; Raphaël Porcher; Emile Darai; Caroline Reinhold; Andrea G Rockall Journal: JAMA Netw Open Date: 2020-01-03