Table 1. Summary of stage and treatment of women with high-grade serous tubo-ovarian cancer diagnosed between randomisation and Dec 31, 2014.
| No screening group (clinically diagnosed) | Multimodal screening group | Ultrasound screening group | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Screen detected | Clinically diagnosed | Total | p value* | Screen detected | Clinically diagnosed | Total | p value* | |||
| Randomly assigned and eligible women | 101314 | ·· | ·· | 50 625 | ·· | ·· | ·· | 50623 | ·· | |
| Randomly assigned women who developed high-grade serous cancer by intention to screen | 520/101314 (0-51%) | ·· | ·· | 259/50 625 (0·51%) | 1·00 | ·· | ·· | 250/50 623 (0·49%) | 0·60 | |
| Cancers by screening status | 520 | 153 | 106 | ·· | ·· | 81 | 169 | ·· | ·· | |
| Advanced stage by screening status † | 446/520 (86%) | 107/153 (70%) | 88/106 (83%) | ·· | ·· | 60/81 (74%) | 154/169 (91%) | ·· | ·· | |
| Advanced stage by intention to screen† | 446/520 (86%) | ·· | ·· | 195/259 (75%) | 0·0003 | 214/250 (86%) | 0·95 | |||
| Primary surgery by screening status | 219/520 (42%) | 119/153 (78%) | 39/106 (37%) | ·· | ·· | 54/81 (67%) | 50/169 (30%) | ·· | ·· | |
| Primary surgery by intention to screen | 219/520 (42%) | ·· | ·· | 158/259(61%) | <0·0001 | ·· | ·· | 104/250 (42%) | 1·00 | |
| Zero residual after surgery by screening status | 157/520 (30%) | 84/153 (55%) | 35/106 (33%) | ·· | ·· | 44/81 (54%) | 39/169(23%) | ·· | ·· | |
| Zero residual after surgery on intention to screen | 157/520 (30%) | 119/259 (46%) | <0·0001 | 83/250 (33%) | 0·40 | |||||
| Surgery and chemotherapy by screening status | 331/520 (64%) | 133/153 (87%) | 59/106 (56%) | ·· | ·· | 66/81 (81%) | 93/169 (55%) | ·· | ·· | |
| Surgery and chemotherapy by intention to screen | 331/520 (64%) | ·· | ·· | 192/259 (74%) | 0·003 | ·· | ·· | 159/250(64%) | 0·97 | |
| Combination chemotherapy by screening status‡ | 293/520 (56%) | 93/153 (61%) | 49/106 (46%) | ·· | ·· | 49/81 (60%) | 93/169 (55%) | ·· | ·· | |
| Combination chemotherapy by intention to screen‡ | 293/520 (56%) | ·· | ·· | 142/259 (55%) | 0·69 | ·· | ·· | 142/250 (57%) | 0·91 | |
| Subgroup analyses | ||||||||||
| Treatment in women with stage IA and IB | 14 | 11 | 3 | ·· | ·· | 4 | 1 | ·· | ·· | |
| Surgery and chemotherapy by screening status | 9/14 (64%) | 6/11 (55%) | 2/3 (66%) | ·· | ·· | 3/4 (75%) | 0 | ·· | ·· | |
| Surgery and chemotherapy by intention to screen | 9/14 (64%) | ·· | ·· | 8/14 (57%) | 0·71 | ·· | ·· | 3/5 (60%) | 0·88 | |
| Combination chemotherapy by screening status‡ | 3/14 (21%) | 1/11 (9%) | 1/3 (33%) | ·· | ·· | 0 | 0 | ·· | ·· | |
| Combination chemotherapy by intention to screen‡ | 3/14 (21%) | ·· | ·· | 2/14 (14%) | 0·64 | ·· | ·· | 0 | 0·28 | |
| Treatment in women with stage IC or higher | 506 | 142 | 103 | ·· | ·· | 77 | 168 | ·· | ·· | |
| Primary surgery by screening status | 206/506 (41%) | 108/142 (76%) | 36/103 (35%) | ·· | ·· | 50/77 (65%) | 49/168 (29%) | ·· | ·· | |
| Primary surgery by intention to screen | 206/506 (41%) | ·· | ·· | 144/245 (59%) | <0·0001 | ·· | ·· | 99/245 (40%) | 0·94 | |
| Zero residual after surgery by screening status | 144/506 (28%) | 73/142 (51%) | 33/103 (32%) | ·· | ·· | 40/77 (52%) | 38/168 (23%) | ·· | ·· | |
| Zero residual after surgery on intention to screen | 144/506 (28%) | ·· | ·· | 106/245 (43%) | <0·0001 | ·· | ·· | 78/245 (32%) | 0·26 | |
| Surgery and chemotherapy by screening status | 322/506 (64%) | 127/142 (89%) | 57/103 (55%) | ·· | ·· | 63/77(82%) | 93/168 (55%) | ·· | ·· | |
| Surgery and chemotherapy by intention to screen | 322/506 (64%) | ·· | ·· | 184/245 (74%) | 0·006 | ·· | 156/245 (64%) | 1·00 | ||
| Combination chemotherapy by screening status‡ | 290/506 (57%) | 92/142 (65%) | 48/103 (47%) | ·· | ·· | 49/77 (64%) | 93/168 (55%) | ·· | ·· | |
| Combination chemotherapy by intention to screen‡ | 290/506 (57%) | ·· | ·· | 140/245 (57%) | 1·00 | ·· | ·· | 142/245 (58%) | 0·80 | |
Data are n or n/N (%).
*
All comparisons are by intention to screen between the screening group (multimodal or ultrasound) and the no screening group.
†
FIGO 2014 cancer stages III, IV, or unable to stage.
‡
Combination chemotherapy includes trial drugs; majority of patients received platinum and taxol.