Table 1 Baseline characteristics—ITT analysis set.
Carboplatin/PLD N = 304 | Trabectedin/PLD N = 307 | Overall N = 611 | |
|---|---|---|---|
Age, years—median (Q1–Q3) | 64.0 (55.0–70.0) | 63.0 (55.0–71.0) | 64.0 (55.0–71.0) |
ECOG performance status—n (%) | |||
0 | 216 (74.2) | 208 (68.9) | 424 (71.5) |
1 | 70 (24.1) | 86 (28.5) | 156 (26.3) |
2 | 5 (1.7) | 8 (2.6) | 13 (2.2) |
Missing | 13 | 5 | 18 |
Primary site of disease—n (%) | |||
Ovary | 277 (91.1) | 266 (86.6) | 543 (88.9) |
Peritoneal | 16 (5.3) | 25 (8.1) | 41 (6.7) |
Fallopian | 10 (3.3) | 16 (5.2) | 26 (4.3) |
Unknown | 1 (0.3) | 0 (0.0) | 1 (0.2) |
Initial FIGO stage—n (%) | |||
I | 10 (3.3) | 9 (2.9) | 19 (3.1) |
II | 9 (3.0) | 4 (1.3) | 13 (2.1) |
IIIA/B | 17 (5.6) | 26 (8.5) | 43 (7.0) |
IIIC | 190 (62.5) | 178 (58.0) | 368 (60.2) |
IV | 67 (22.0) | 72 (23.5) | 139 (22.7) |
Unknown | 11 (3.6) | 18 (5.9) | 29 (4.7) |
Histological grade—n (%) | |||
1 | 9 (3.0) | 6 (2.0) | 15 (2.5) |
2 | 25 (8.2) | 35 (11.4) | 60 (9.8) |
3 | 219 (72.0) | 219 (71.3) | 438 (71.7) |
Unknown | 51 (16.8) | 47 (15.3) | 98 (16.0) |
Histological type—n (%) | |||
Serous | 253 (83.2) | 264 (86.0) | 517 (84.6) |
Endometroid | 10 (3.3) | 11 (3.6) | 21 (3.4) |
Other | 34 (11.2) | 18 (5.9) | 52 (8.5) |
Unknown | 7 (2.3) | 14 (4.6) | 21 (3.4) |
Presence of measurable disease at study entry—n (%) | 217 (71.4) | 221 (72.0) | 438 (71.7) |
Size of residual disease after initial surgery—n (%) | |||
≤1 cm | 154 (50.7) | 162 (52.8) | 316 (51.7) |
>1 cm | 77 (25.3) | 69 (22.5) | 146 (23.9) |
No primary sugery | 4 (1.3) | 4 (1.3) | 8 (1.3) |
Unknown | 69 (22.7) | 72 (23.5) | 141 (23.1) |
Germline BRCA1 mutational status—n (%) | |||
Mutated | 18 (6.0) | 29 (9.5) | 47 (7.7) |
Unknown | 115 (38.1) | 129 (42.2) | 244 (40.1) |
Wild-type | 169 (56.0) | 148 (48.4) | 317 (52.1) |
Missing | 2 | 1 | 3 |
Germline BRCA 2 mutational status—n (%) | |||
Mutated | 13 (4.3) | 13 (4.2) | 26 (4.3) |
Unknown | 119 (39.4) | 131 (42.8) | 250 (41.1) |
Wild-type | 170 (56.3) | 162 (52.9) | 332 (54.6) |
Missing | 2 | 1 | 3 |
Germline BRCA mutational status—n (%) | |||
Mutated | 30 (9.9) | 41 (13.4) | 71 (11.7) |
Unknown | 116 (38.4) | 131 (42.8) | 247 (40.6) |
Wild-type | 156 (51.7) | 134 (43.8) | 290 (47.7) |
Missing | 2 | 1 | 3 |
Number of prior lines—n (%) | |||
0 | 1 (0.3) | 0 (0.0) | 1 (0.2) |
1 | 212 (69.7) | 213 (69.4) | 425 (69.6) |
2 | 91 (29.9) | 94 (30.6) | 185 (30.3) |
Previous anthracycline-based chemotherapy—n (%) | 27 (8.9) | 28 (9.1) | 55 (9.0) |
Last prior chemotherapy—type—n (%) | |||
Combination with platinum | 216 (71.3) | 216 (70.4) | 432 (70.8) |
Combination with platinum and bevacizumab | 74 (24.4) | 81 (26.4) | 155 (25.4) |
Monotherapy with platinum | 12 (4.0) | 9 (2.9) | 21 (3.4) |
Other without platinum | 1 (0.3) | 1 (0.3) | 2 (0.3) |
Maintenance therapy following last prior chemotherapy—n (%) | 110 (36.7) | 122 (39.9) | 232 (38.3) |
Maintenance therapy—n (%) | |||
Bevacizumab | 99 (90.0) | 106 (86.9) | 205 (88.4) |
Olaparib | 6 (5.5) | 10 (8.2) | 16 (6.9) |
Other | 5 (4.5) | 6 (4.9) | 11 (4.7) |
Last treatment-free interval from platinum, months—median (Q1–Q3) | 8.4 (6.9–9.9) | 8.3 (7.0–9.9) | 8.3 (7.0–9.9) |
Surgery after last progression—n (%) | 18 (5.9) | 26 (8.5) | 44 (7.2) |
For patients who underwent surgery after last progression: all macroscopic disease debulked—n (%) | 10 (55.6) | 18 (69.2) | 28 (63.6) |
