170021-176

Performance characteristics and stage distribution of invasive epithelial ovarian/tubal/peritoneal cancers in UKCTOCS.

Subcategory: 
Category: 
Gynecologic Cancer
Session Type and Session Title: 
Oral Abstract Session, Gynecologic Cancer
Abstract Number: 

5507

Citation: 
J Clin Oncol 34, 2016 (suppl; abstr 5507)
Author(s): 
Usha Menon, Andy Ryan, Matthew Burnell, Aleksandra Gentry-Maharaj, Jatinderpal K Kalsi, Steven J Skates, Mahesh K B Parmar, Ian J Jacobs, UKCTOCS trialists; University College London, Institute for Women's Health, London, United Kingdom; University College London, Institute for Womens Health, London, United Kingdom; University College London/Institute for Womens Health, London, United Kingdom; University College London/Institute for Women's Health, London, United Kingdom; Massachusetts General Hospital, Boston, MA; Medical Research Council, Clinical Trials Unit at University College London, London, United Kingdom; University of New South Wales, Sydney, Australia

Abstract Disclosures

Abstract: 

Background: We report on the overall performance of the screening strategies and stage distribution of invasive epithelial ovarian/tubal/peritoneal (iEO/T/PP) cancers Methods: Postmenopausal women aged 50-74 were randomised (1:1:2 ratio) to annual multimodal (MMS) using the Risk of Ovarian Cancer Algorithm (ROCA) or ultrasound (USS) screening, or no screening (control, C). Women with abnormal screens had repeat tests and those with persistent abnormality underwent clinical evaluation and, where appropriate, surgery. Results: Of 202,638 women randomised, 50,624 MMS, 50,623 USS and 101,299 C were eligible for analysis. At median follow-up 11.1 years, 299 MMS, 259 USS and 574 C women developed iEO/T/PP cancers. In the C group, 26% (149/574; 95% CI 22.4, 29.7) were stage I/II/IIIA (low volume disease, LVD). In the subgroup of screen detected cancers, in both MMS (44.2%; 80/181; 95% CI 36.8, 51.8; p<0.0001) and USS (42.9%; 45/105; 95% CI 33.2, 52.9; p=0.00042) group, there was significantly more LVD compared to C. However, across all iEO/T/PP cancers, while proportions of women with LVD remained significantly higher in the MMS (40.1%; 120/299; 95% CI 34.5, 45.9; p<0.0001) versus C comparison, there was no evidence of a difference between the USS (23.9%; 62/259; 95% CI 18.9, 29.6; p= 0.57) and C. Conclusions: While LVD was significantly more frequent in women with screen detected iEO/T/PP cancers in both screen arms compared to C, when all iEO/T/PP cancers were analysed, the difference only persisted in the MMS arm. The latter is a reflection of the high sensitivity of multimodal screening. The findings are in keeping with the emerging mortality reduction observed in the MMS arm in UKCTOCS. Clinical trial information: ISRCTN22488978.

Performance characteristics for iEO/T/PP cancers diagnosed <1 year of screen.

MMSUSS
No. of women randomised5064050639
No. of women eligible for screening5062450623
No. of women screen years345570327775
No. of surgeries7361825
Total cancers <1 year of screen210166
Screen positives181105
Screen negatives2961
Sensitivity (%, 95% CI)86.2 (80.8, 90.6)63.3 (55.4, 70.6)
Specificity (%, 95% CI)99.8 (99.8, 99.9)99.5 (99.4, 99.5)
PPV (%, 95% CI)24.6 (21.5, 27.9)5.8 (4.7, 6.9)
Surgery per screen positive4.117.4