Table 1.
Demographic profile of patients in the four studies of PDS versus NACT-IDS.
| Study | EORTC55971 | CHORUS | JCOG0602 | SCOPION |
|---|---|---|---|---|
| Year of publication | 2010 | 2015 | 2016† | 2016† |
| Countries | Belgium, Canada, UK, Netherlands, Italy, Norway, and Spain | UK and New Zealand | Japan | Italy |
| No. of patients | 336 vs 334 | 276 vs 274 | 149 vs 152 | 84 vs 87 |
| Age (years) | 62 vs 63 | 66 vs 65 | 59 vs 60.5 | 54.8 vs 56.2 |
| PS | ||||
| 0-1 | 294 (88) vs 290 (87) | 221 (80) vs 221 (81) | 130 (87) vs 131 (86) | 51 (93) vs 50 (91) |
| 2-3 | 40 (12) vs 44 (13) | 54 (20) vs 53 (19) | 19 (13) vs 21 (14) | 4 (7) vs 5 (9) |
| Unknown | 2 (0.6) vs 0 | 1 vs 0 | 0 | 0 |
| CA125 (U/ml) | 1130 vs 1180 | Not specified | Not specified | 2653 vs. 2100 |
| Initial tumor size (cm) | ||||
| Up to 2 cm | 4(1.2) vs 10(3) | 13(5) vs 15(5) | 32(22) vs 42(28) | Not specified |
| >2-5 cm | 90(27) vs 85(25) | 59(21) vs 60(22) | 42(28) vs 51(34) | |
| >5-10 cm | 90(27) vs88(26) | 111(40) vs 110(40) | 40(27) vs 35(23) | |
| >10cm | 131(39) vs 137(41) | 86(32) vs 86(32) | 35(24) vs 24(16) | |
| Unknown | 21(6.3) vs 14(4.2) | 7(3) vs 5(2) | 0 vs 0 | |
| FIGO Stage | ||||
| II | 0 vs. 0 | 12 (5) vs. 7 (3) | 0 vs 0 | 0 vs 0 |
| III | 257 (77) vs. 253 (76) | 190 (78) vs.165 (80) | 100 (67) vs 105 (69) | 71 (85) vs 79 (91) |
| IV | 77 (23) vs. 81 (24) | 41 (17) vs. 31 (15) | 49 (33) vs 47 (31) | 13 (16) vs 8 (9) |
| Others | 2 (0.6) vs 0 | 12 vs 16 | 0 | 0 |
| Histology | ** | |||
| Serous | 220 (66) vs 194 (58) | 219 (86) vs 185 (85) | 116 (78) vs 110 (72) | 82 (98) vs 87 (100) |
| Clear cell | 6(2) vs 4 (1.2) | 4 (2) vs 13 (6) | 12(8) vs 4 (3) | 1 (1.2) vs 0 |
| Endometrioid | 11 (3) vs 5 (1.5) | 11 (4) vs 5 (2) | 6 (4) vs 4 (3) | 0 vs 0 |
| Mucinous | 8 (2) vs 11 (3) | 2 (1) vs 4 (2) | 2 (1.4) vs 2 (1.5) | 0 vs 0 |
| Others | 91 (27) vs 120 (36) | 19 (7) vs 12 (5) | 12 (8) vs 18 (13) | 1 (1.2) vs 0 |
| Surgery | ||||
| Operating time (min) | 165 vs 180 | 120 vs 120 | 341 vs 273 | 461 vs 253 |
| Blood loss (ml) | Not specified | Not specified | 3447 vs 620 | Not specified |
| Lymphadenectomy* | 26(8) vs 49(15) | 3(1) vs 1(0.5) | 29(20) vs 64(49) | 21(38) vs 7(14) |
| Abdominal organs resected | 48(16) vs 28(9) | 27(12) vs 18(8) | 51(35) vs 33(25) | 83(99) vs 33(38) |
| Complete surgery | 61(19) vs 151(51) | 39(17) vs 79(39) | 45(31) vs 83(64) | 40(48) vs 57(77) |
| Optimal surgery | 131(42) vs 238(81) | 96(41) vs147(73) | 92(63) vs107(82) | 78(93) vs 74(100) |
| Complications | ||||
| G3-4 postoperative AEs | 68 (22) vs 21 (6.5) | 74 (29) vs 31 (14) | 24 (16) vs 7 (4.6) | 39 (46) vs 7 (9.5) |
| G3-4 thromboembolism | 8 (3) vs 0 | 5 (2) vs 0 | 7 (5) vs 5 (3) | Not specified |
| G3-4 infection | 25 (8.1) vs 5(2) | 16 (6) vs 8 (3) | 1 (0.7) vs 1 (0.8) | Not specified |
| Postoperative death | 8 (2.5) vs 2(0.7) | 14 (6) vs1 (0.5) | 1 (0.7) vs 0 | 3 (3.6) vs 0 |
| Chemotherapy | ||||
| Carboplatin plus taxane | 243 (78) vs 283 (88) | 138 (61) vs 178 (70) | 148 (100) vs150 (100) | 50 (98) vs 52 (100) |
| Platinum only | 25 (8) vs 20 (6) | 89 (39) vs 75 (30) | 0 vs 0 | 1(2) vs 0 |
| Others | 21 (7) vs 19 (6) | 1(0.1) vs 1(0.1) | 0 vs 0 | 0 vs 0 |
| Cycles | Not specified | |||
| 0 | 21 (7) vs 0 | 1 (1) vs 0 | 11 (7) vs 2 (1) | |
| 1-3 | 25 (8) vs 39 (12) | 24 (11) vs 36 (17) | 6 (4) vs 17 (12) | |
| 4-5 | 11 (4) vs 7 (2) | 16 (5) vs 17 (7) | 9 (6) vs 10 (7) | |
| >6 | 253 (82) vs 276 (86) | 188 (82) vs 201 (79) | 123 (83) vs 123 (81) | |
| PFS (months) | 12 vs 12 | 11 vs 12 | 15.1 vs 16.4 | Not specified |
| OS (months) | 29 vs 30 | 23 vs 24 | 49 vs 44.3 | Not specified |
The number (%) or median is shown for PDS versus NACT-IDS.
*
Lymphadenectomy includes the pelvic and paraaortic lymph nodes.
**
For operated patients, histology was diagnosed from surgical specimens in the JCOG 0602 trial.
†
Both study including latest data presented at ASCO 2018.
Abbreviations: PDS, primary debulking surgery; NACT-IDS, neoadjuvant chemotherapy followed by interval debulking surgery; No., number; AE, adverse event; PFS, progression-free survival; and OS, overall survival.