A New Method to Improve the Pre-Operative Diagnosis of Ovarian Cancer Based on Ultrasound

A simple algorithm for the assessment of adnexal masses with ultrasound allows quantification of the risk of malignancy, reports the American Journal of Obstetrics and Gynecology

Philadelphia, PA, January 19, 2016

In a landmark study, investigators from Europe propose a new and simple method to assess the risk of malignancy of women with an adnexal mass. The method identified between 89-99% of patients with ovarian cancer using the results of ultrasound examination, which can be obtained in referral and non-referral centers. The work is based on the “Simple Rules”, criteria developed by the International Ovarian Tumor Analysis (IOTA) group to improve accurate diagnosis of ovarian cancer before surgery. Published in the American Journal of Obstetrics and Gynecology, this new approach has the potential to level and raise the playing field and put expert interpretation and improved diagnostic capability within reach of all practitioners.

While ovarian cancer is a common and potentially lethal disease, early detection and treatment improve survival. However, adnexal masses, ovarian masses or cysts that persist and become enlarged, often pose a diagnostic dilemma because preoperative tests to determine if they are benign or malignant are often inconclusive. The IOTA group developed a set of “Simple Rules” based on ultrasound images of the adnexal masses, which allows them to be classified as either benign or malignant.

Although the Simple Rules have been well-received by clinicians, an important question from patients and physicians has been whether it is possible to calculate the individual risk of malignancy for a particular patient. In this study published today, the IOTA group led by Professor Dirk Timmerman, MD, PhD, of the Department of Obstetrics and Gynecology, University Hospitals Leuven, Belgium, sought to develop and validate a model to predict the risk of malignancy in adnexal masses using the ultrasound features derived from the Simple Rules. This study represents the culmination of multiple consecutive multicenter studies involving 22 centers in 10 countries over 13 years (1999 to 2012) and approximately 5,000 patients with adnexal masses.

“The Simple Rules are intuitively attractive because of their ease of use, however, when used as originally suggested, they allow only a categorization of tumors into three groups: benign, malignant, or inconclusive,” explained Dr. Timmerman. “In this study we show that the Simple Rules can now be used to estimate the risk of malignancy in every adnexal mass and so can be used for individualized patient management.”

In this study, the IOTA investigators examined patients before surgery, using a standardized examination technique and standardized terms and definitions to describe ultrasound findings. The predictions based on ultrasounds were subsequently compared with the histological findings after the tumor was examined by pathologists (gold standard to define if a tumor is benign or malignant). The risk of malignancy was calculated.

“We conclude that individual risk estimates can be derived from the five ultrasound features in the Simple Rules with performance similar to the best previously published algorithms,” stated Dr. Timmerman. “A simple classification based on these risk estimates may form the basis of a clinical management approach. This will hopefully facilitate choosing optimal treatment for all patients presenting with adnexal masses.”

Roberto Romero, MD, DMedSci, Editor-in-Chief for Obstetrics of the American Journal of Obstetrics and Gynecology, stated that “this is a major breakthrough and the culmination of a major effort by multiple investigators in Europe over more than 10 years. The investigators have addressed an important clinical challenge and provided a method that was validated rigorously and urgently needed by patients and physicians.”

Beryl Benacerraf, MD, President of the American Institute of Ultrasound in Medicine (AIUM) and Clinical Professor of Radiology and OB GYN at Brigham and Women’s Hospital, Harvard Medical School, Boston, commented in an editorial that “Although an earlier systematic review indicated that magnetic resonance imaging (MRI) gives better results than ultrasound, Dr Timmerman and his colleagues have shown that the IOTA Simple Rules provide better results than ever before and support the notion that ultrasound is at least as accurate and likely better than MRI in distinguishing  benign from malignant masses. The investigators publishing in AJOG have shown here that if we use the Simple Rules with the scoring instrument developed by the IOTA group, we will make the correct diagnosis more readily than ever before and this offers the advantage that most practitioners could adopt this approach successfully.”

“I applaud this group for grappling with the challenging problem of the variability of ultrasound diagnoses of adnexal masses depending on the expertise of acquisition and interpretation, and succeeding in developing a simple, standardized, and scalable solution. By at once leveling and elevating the playing field, application of this method places expert interpretation and improved diagnostic ability within reach of all practitioners.”


Notes for Editors
“Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis (IOTA) group,” by Dirk Timmerman, MD, PhD, Ben Van Calster, MSc, PhD, Antonia Testa, MD, PhD, Luca Savelli, MD, PhD, Daniela Fischerova, MD, PhD, Wouter Froyman, MD, Laure Wynants, MSc, Caroline Van Holsbeke, MD, PhD, Elisabeth Epstein, MD, PhD, Dorella Franchi, MD, Jeroen Kaijser, MD, PhD, Artur Czekierdowksi, MD, PhD, Stefano Guerriero, MD, PhD, Robert Fruscio, MD, PhD, Francesco PG Leone, MD, Alberto Rossi, MD, Chiara Landolfo, MD, Ignace Vergote, MD, PhD, Tom Bourne, MD, PhD, and Lil Valentin, MD, PhD, DOI: http://dx.doi.org/10.1016/j.ajog.2016.01.007.

“Ultrasonic diagnosis of ovarian masses: Can the playing field be leveled and raised at the same time?” by Beryl Benacerraf, MD, DOI: http://dx.doi.org/10.1016/j.ajog.2015.12.045.

Published online in advance of Volume 214, Issue 4 (April 2016) of the American Journal of Obstetrics and Gynecology, published by Elsevier.

Full text of this article and editorial is available to credentialed journalists upon request. Contact Eileen Leahy at +1 732 238 3628 or ajogmedia@elsevier.com to obtain copies. Journalists wishing to interview the authors should contact:

Members of the IOTA Steering Committee
Dirk Timmerman, MD, PhD
Department of Obstetrics and Gynecology, University Hospitals KU Leuven
+ 32 16 344201, dirk.timmerman@uz.kuleuven.ac.be

Lil Valentin, MD, PhD
Department of Obstetrics and Gynecology, Malmö University Hospital
+46 40 332149 or 332094, lil.valentin@med.lu.se

Antonia Carla Testa, MD, PhD
Unità Operativa di Ginecologia Oncologica Dipartimento Tutela della Salute della Donna e della Vita Nascente Università Cattolica di Sacro Cuore
+39 06 30154979, +39 339 7044256 (cell), atesta@rm.unicatt.it

Tom Bourne, MD, PhD
Queen Charlotte’s & Chelsea Hospital, Imperial College London
Early Pregnancy and Acute Gynaecology Unit, Queen Charlotte's & Chelsea Hospital
+44 20 3313 5131, womensultrasound@btinternet.com

Beryl Benacerraf, MD
Lori J. Schroth, Manager, Media Relations, Communication & Public Affairs
Brigham and Women's Hospital
+1 617 525 6374 or +1 617 459 2111 (cell), ljschroth@partners.org

Peter Magnuson, CAE, Director of Communications and Member Services
American Institute of Ultrasound in Medicine
+1 301 498 4100 or +1 800 638 5352, pmagnuson@aium.org

About the American Journal of Obstetrics and Gynecology
The American Journal of Obstetrics and Gynecology, known as “The Gray Journal,” presents coverage of the entire spectrum of the field, from the newest diagnostic procedures to leading-edge research. The Journal provides comprehensive coverage of the specialty, including maternal-fetal medicine, reproductive endocrinology/infertility, and gynecologic oncology. It also publishes the annual meeting papers of several of its eight sponsoring societies, including the Society for Maternal-Fetal Medicine and the Society of Gynecologic Surgeons.

The American Journal of Obstetrics and Gynecology's 2014 Impact Factor is 4.704. The journal ranks third in Eigenfactor score, continues to be first in total citations, and is the number 3 journal in the Obstetrics & Gynecology category according to the 2014 Journal Citation Reports®, published by Thomson Reuters, 2015. The journal has also been recognized as one of the 100 most influential journals in Biology & Medicine over the last 100 years, as determined by the BioMedical & Life Sciences Division of the Special Libraries Association (2009).

About Elsevier
Elsevier is a global information analytics business that helps scientists and clinicians to find new answers, reshape human knowledge, and tackle the most urgent human crises. For 140 years, we have partnered with the research world to curate and verify scientific knowledge. Today, we’re committed to bringing that rigor to a new generation of platforms. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, 39,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. www.elsevier.com

Media contact
Eileen Leahy
+1 732 238 3628