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Clinical Studies

Comparison of the ADNEX and ROMA risk prediction models for the diagnosis of ovarian cancer: a multicentre external validation in patients who underwent surgery

British Journal of Cancer volume 130, pages 934–940 (2024)Cite this article

Subjects

Abstract

Background

Several diagnostic prediction models to help clinicians discriminate between benign and malignant adnexal masses are available. This study is a head-to-head comparison of the performance of the Assessment of Different NEoplasias in the adneXa (ADNEX) model with that of the Risk of Ovarian Malignancy Algorithm (ROMA).

Methods

This is a retrospective study based on prospectively included consecutive women with an adnexal tumour scheduled for surgery at five oncology centres and one non-oncology centre in four countries between 2015 and 2019. The reference standard was histology. Model performance for ADNEX and ROMA was evaluated regarding discrimination, calibration, and clinical utility.

Results

The primary analysis included 894 patients, of whom 434 (49%) had a malignant tumour. The area under the receiver operating characteristic curve (AUC) was 0.92 (95% CI 0.88–0.95) for ADNEX with CA125, 0.90 (0.84–0.94) for ADNEX without CA125, and 0.85 (0.80–0.89) for ROMA. ROMA, and to a lesser extent ADNEX, underestimated the risk of malignancy. Clinical utility was highest for ADNEX. ROMA had no clinical utility at decision thresholds <27%.

Conclusions

ADNEX had better ability to discriminate between benign and malignant adnexal tumours and higher clinical utility than ROMA.

Clinical trial registration

clinicaltrials.gov NCT01698632 and NCT02847832.

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Fig. 1
Fig. 2: Summary forest plot of the area under the receiver operating characteristic curve (AUC) after Bayesian meta-analysis of centre-specific results (n = 894).
Fig. 3: Overall calibration curves for the estimated risk of malignancy.
Fig. 4: Overall decision curves.

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Data availability

The dataset generated and analysed during the current study is available in the KU Leuven Research Data Repository (RDR), https://doi.org/10.48804/TXL95Z. The dataset is not publicly available because this was not part of the informed consent. However, the dataset may be obtained following permission of AC and DT and after fulfilling all data transfer requirements.

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Acknowledgements

We thank Gitte Thirion, Julie Oosterlynck, Katja Vandenbrande for processing the serum samples. We thank all medical specialists, data and case managers, secretaries, and all other people who collected data necessary for completing the database.

Funding

This research was funded by Kom Op Tegen Kanker (Stand up to Cancer), the Flemish cancer society (2016/10728/2603). The IOTA5 study is supported by the Research Foundation-Flanders (FWO) (projects G049312N, G0B4716N, 12F3114N, G097322N), and Internal Funds KU Leuven (projects C24/15/037 and C24M/20/064). DT is senior clinical investigator of FWO. TVG is a Senior Clinical Investigator of FWO (18B2921N). TBo is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Imperial College Healthcare UK National Health Service (NHS) Trust and Imperial College London. CL is supported by Linbury Trust Grant LIN 2600. The views expressed in this article are those of the authors and not necessarily those of the NHS, NIHR, or UK Department of Health. LV is supported by the Swedish Research Council (grant K2014-99X-22475-01-3, Dnr 2013-02282), funds administered by Malmö University Hospital and Skåne University Hospital, Allmänna Sjukhusets i Malmö Stiftelse for bekmäpande av cancer (the Malmö General Hospital Foundation for fighting against cancer), and two Swedish Governmental grants (Avtal om läkarutbildning och forskning (ALF)-medel and Landstingsfinansierad Regional Forskning).TBo

Author information

Author notes

  1. These authors contributed equally: Chiara Landolfo, Jolien Ceusters.

  2. These authors jointly supervised this work: An Coosemans, Dirk Timmerman, Ben Van Calster.

Authors and Affiliations

  1. Department of Oncology, Laboratory of Tumour Immunology and Immunotherapy, Leuven Cancer Institute, KU Leuven, Leuven, Belgium

    Chiara Landolfo, Jolien Ceusters, Roxanne Wouters, Ann Vankerckhoven & An Coosemans

  2. Department of Development and Regeneration, KU Leuven, Leuven, Belgium

    Chiara Landolfo, Jolien Ceusters, Wouter Froyman, Ruben Heremans, Tom Bourne, Dirk Timmerman & Ben Van Calster

  3. Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK

    Chiara Landolfo & Tom Bourne

  4. Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy

    Chiara Landolfo, Francesca Moro, Floriana Mascilini & Antonia Testa

  5. Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden

    Lil Valentin

  6. Department of Clinical Sciences Malmö, Lund University, Lund, Sweden

    Lil Valentin

  7. Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium

    Wouter Froyman, Toon Van Gorp, Ruben Heremans, Thaïs Baert & Dirk Timmerman

  8. Department of Oncology, Gynaecological Oncology, KU Leuven, Leuven Cancer Institute, Leuven, Belgium

    Toon Van Gorp & Thaïs Baert

  9. Oncoinvent AS, Oslo, Norway

    Roxanne Wouters

  10. Department of Pathology, UZ Leuven, Leuven, Belgium

    Anne-Sophie Van Rompuy

  11. Department of Laboratory Medicine, UZ Leuven, Leuven, Belgium

    Jaak Billen

  12. Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University, Prague, Czech Republic

    Adam Neumann & Daniela Fischerova

  13. General University Hospital, Prague, Czech Republic

    Adam Neumann & Daniela Fischerova

  14. Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium

    Caroline Van Holsbeke

  15. Department of Gynecologic Oncology, National Cancer Institute of Milan, Milan, Italy

    Valentina Chiappa

  16. Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands

    Ben Van Calster

  17. Leuven Unit for Health Technology Assessment Research (LUHTAR), KU Leuven, Leuven, Belgium

    Ben Van Calster

Authors
  1. Chiara Landolfo
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Contributions

DT, TBo, CL, WF, AC, AT, LV, and BVC conceived and designed the study. DT, TBo, CL, WF, TVG, RH, FMo, FMa, AN, CVH, VC, DF, AT, LV, TBa, and AC enrolled patients and acquired data. CL, RW, AV, JB, AN, Tba, and AC worked on the lab processes. DT, BVC, WF, CL, and JC did the data cleaning, with support from ASVR. DT, LV, TBo, BVC, JC, CL, and WF wrote the statistical analysis plan. BVC and JC analysed the data. DT, LV, TBo, BVC, JC, WF, CL, AC, and TVG interpreted the data. DT, LV, TBo, BVC, WF, CL, and JC wrote the first draft of the manuscript, which was then critically reviewed and revised by all the other authors. All authors approved the final version of the manuscript for submission. AC, DT, and BVC had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Ben Van Calster.

Ethics declarations

Competing interests

TBo reports grants, personal fees, and travel support from Samsung Medison; travel support from Roche Diagnostics; and personal fees from GE Healthcare; all outside the submitted work. RW is employed by Oncoinvent AS. AC is a contracted researcher for Oncoinvent AS and Novocure and a consultant for Sotio a.s. and Epics Therapeutics SA. BVC and DT report consultancy work done by KU Leuven to help implementing and testing the ADNEX model in ultrasound machines by Samsung Medison and GE Healthcare, outside the submitted work. Tba reports grants, personal fees, and travel support from Roche, Novartis, GSK, MSD, and AstraZeneca, all outside the submitted work. All other authors declare no competing interests.

Ethics approval and consent to participate

Trans-IOTA is a subproject of the IOTA phase 5 and phase 7 studies (clinicaltrials.gov NCT01698632 and NCT02847832). The trans-IOTA project was approved by the Research Ethics Committee of the University Hospitals KU Leuven (reference numbers S51375 and S59207), and by the ethics committees of all participating centres. All patients gave their informed consent before enrolment in the study. The study was performed in accordance with the Declaration of Helsinki.

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Landolfo, C., Ceusters, J., Valentin, L. et al. Comparison of the ADNEX and ROMA risk prediction models for the diagnosis of ovarian cancer: a multicentre external validation in patients who underwent surgery. Br J Cancer 130, 934–940 (2024). https://doi.org/10.1038/s41416-024-02578-x

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