Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

James Dilley; Aleksandra Gentry-Maharaj; Andy Ryan; Matthew Burnell; Ranjit Manchanda; Jatinderpal Kalsi; Naveena Singh; Robert Woolas; Aarti Sharma; Karin Williamson; Tim Mould; Lesley Fallowfield; Stuart Campbell; Steven J Skates; Alistair McGuire; Mahesh Parmar; Ian Jacobs; Usha Menon

doi:10.1016/j.ygyno.2023.11.005

Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

Gynecol Oncol. 2023 Dec:179:123-130. doi: 10.1016/j.ygyno.2023.11.005. Epub 2023 Nov 18.

Authors

James Dilley¹, Aleksandra Gentry-Maharaj², Andy Ryan³, Matthew Burnell³, Ranjit Manchanda⁴, Jatinderpal Kalsi⁵, Naveena Singh⁶, Robert Woolas⁷, Aarti Sharma⁸, Karin Williamson⁹, Tim Mould¹⁰, Lesley Fallowfield¹¹, Stuart Campbell¹², Steven J Skates¹³, Alistair McGuire¹⁴, Mahesh Parmar³, Ian Jacobs⁵, Usha Menon¹⁵

Affiliations

¹ Department of Gynaecological Oncology, Barts Health NHS Trust, London, UK.
² MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, London, UK; Department of Women's Cancer, Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.
³ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, London, UK.
⁴ Department of Gynaecological Oncology, Barts Health NHS Trust, London, UK; Wolfson Institute of Population Health, CRUK Barts Cancer Centre, Queen Mary University of London, London, UK.
⁵ Department of Women's Cancer, Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.
⁶ Department of Cellular Pathology, Barts Health NHS Trust, London, UK.
⁷ Department of Gynaecological Oncology, Queen Alexandra Hospital, Portsmouth, UK.
⁸ Department of Obstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK.
⁹ Department of Gynaecological Oncology, Nottingham University Hospitals, Nottingham, UK.
¹⁰ Department of Gynaecological Oncology, University College London Hospitals NHS Trust, London, UK.
¹¹ Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Sussex, UK.
¹² Create Health London, London, UK.
¹³ Massachusetts General Hospital and Harvard Medical School, Harvard, MA, USA.
¹⁴ London School of Economics, London, UK.
¹⁵ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, London, UK. Electronic address: [email protected].

Abstract

Objective: UKCTOCS provides an opportunity to explore symptoms in preclinical invasive epithelial ovarian cancer (iEOC). We report on symptoms in women with pre-clinical (screen-detected) cancers (PC) compared to clinically diagnosed (CD) cancers.

Methods: In UKCTOCS, 202638 postmenopausal women, aged 50-74 were randomly allocated (April 17, 2001-September 29, 2005) 2:1:1 to no screening or annual screening till Dec 31,2011, using a multimodal or ultrasound strategy. Follow-up was through national registries. An outcomes committee adjudicated on OC diagnosis, histotype, stage. Eligible women were those diagnosed with iEOC at primary censorship (Dec 31, 2014). Symptom details were extracted from trial clinical-assessment forms and medical records. Descriptive statistics were used to compare symptoms in PC versus CD women with early (I/II) and advanced (III/IV/unable to stage) stage high-grade-serous (HGSC) cancer. ISRCTN-22488978; ClinicalTrials.gov-NCT00058032.

Results: 1133 (286PC; 847CD) women developed iEOC. Median age (years) at diagnosis was earlier in PC compared to CD (66.8PC, 68.7CD, p = 0.0001) group. In the PC group, 48% (112/234; 90%, 660/730CD) reported symptoms when questioned. Half PC (50%, 13/26PC; 36%, 29/80CD; p = 0.213) women with symptomatic HGSC had >1symptom, with abdominal symptoms most common, both in early (62%, 16/26, PC; 53% 42/80, CD; p = 0.421) and advanced (57%, 49/86, PC; 74%, 431/580, CD; p = 0.001) stages. In symptomatic early-stage HGSC, compared to CD, PC women reported more gastrointestinal (change in bowel habits and dyspepsia) (35%, 9/26PC; 9%, 7/80CD; p = 0.001) and systemic (mostly lethargy/tiredness) (27%, 7/26PC; 9%, 7/80CD; p = 0.017) symptoms.

Conclusions: Our findings, add to the growing evidence, that we should reconsider what constitutes alert symptoms for early tubo-ovarian cancer. We need a more nuanced complex of key symptoms which is then evaluated and refined in a prospective trial.

Keywords: GOFF index; NICE; Ovarian cancer; Symptoms; UKCTOCS.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Ovarian Epithelial / diagnosis
Early Detection of Cancer*
Female
Humans
Ovarian Neoplasms* / diagnosis
Prospective Studies
United Kingdom / epidemiology

Associated data

ClinicalTrials.gov/NCT00058032

Abstract

Publication types

MeSH terms

Associated data

Grants and funding