TABLE 1.
Patient and Tumor Characteristics by Chemotherapy Subgroup: OlympiA PRO Study
| Characteristic | Neoadjuvant Chemotherapy, No. (%) | Adjuvant Chemotherapy, No. (%) | ||||
|---|---|---|---|---|---|---|
| OL (n = 385) | PL (n = 361) | Total (N = 746) | OL (n = 385) | PL (n = 407) | Total (N = 792) | |
| Age groups at random assignment, years | ||||||
| <30 | 24 (6.2) | 21 (5.8) | 45 (6.0) | 16 (4.2) | 26 (6.4) | 42 (5.3) |
| 30-39 | 137 (35.6) | 141 (39.1) | 278 (37.3) | 145 (37.7) | 110 (27.0) | 255 (32.2) |
| 40-49 | 119 (30.9) | 114 (31.6) | 233 (31.2) | 142 (36.9) | 153 (37.6) | 295 (37.2) |
| 50-59 | 87 (22.6) | 62 (17.2) | 149 (20.0) | 52 (13.5) | 81 (19.9) | 133 (16.8) |
| 60-69 | 16 (4.2) | 21 (5.8) | 37 (5.0) | 25 (6.5) | 35 (8.6) | 60 (7.6) |
| ≥70 | 2 (0.5) | 2 (0.6) | 4 (0.5) | 5 (1.3) | 2 (0.5) | 7 (0.9) |
| Sex | ||||||
| Female | 384 (99.7) | 360 (99.7) | 744 (99.7) | 384 (99.7) | 404 (99.3) | 788 (99.5) |
| Male | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1 (0.3) | 3 (0.7) | 4 (0.5) |
| Race | ||||||
| American Indian or Alaska Native | 1 (0.3) | 1 (0.3) | 2 (0.3) | 2 (0.5) | 0 (0.0) | 2 (0.3) |
| Asian | 77 (20.0) | 85 (23.5) | 162 (21.7) | 159 (41.3) | 169 (41.5) | 328 (41.4) |
| Black or African American | 7 (1.8) | 10 (2.8) | 17 (2.3) | 4 (1.0) | 11 (2.7) | 15 (1.9) |
| Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 1 (0.1) |
| White | 297 (77.1) | 261 (72.3) | 558 (74.8) | 214 (55.6) | 221 (54.3) | 435 (54.9) |
| Other | 1 (0.3) | 2 (0.6) | 3 (0.4) | 1 (0.3) | 3 (0.7) | 4 (0.5) |
| Missing | 2 (0.5) | 2 (0.6) | 4 (0.5) | 4 (1.0) | 3 (0.7) | 7 (0.9) |
| Ethnic origin | ||||||
| Hispanic or Latino | 11 (2.9) | 8 (2.2) | 19 (2.5) | 15 (3.9) | 9 (2.2) | 24 (3.0) |
| Non-Hispanic or Latino | 342 (88.8) | 322 (89.2) | 664 (89.0) | 341 (88.6) | 365 (89.7) | 706 (89.1) |
| Not known, not recorded, or refused | 32 (8.3) | 31 (8.6) | 63 (8.4) | 29 (7.5) | 33 (8.1) | 62 (7.8) |
| Jewish/Ashkenazi descent | ||||||
| Yes, of Ashkenazi Jewish descent | 22 (5.7) | 14 (3.9) | 36 (4.8) | 11 (2.9) | 12 (2.9) | 23 (2.9) |
| No, not of Ashkenazi Jewish descent | 363 (94.3) | 346 (95.8) | 709 (95.0) | 374 (97.1) | 394 (96.8) | 768 (97.0) |
| Missing | 0 (0.0) | 1 (0.3) | 1 (0.1) | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Previous platinum therapy | ||||||
| Yes | 132 (34.3) | 138 (38.2) | 270 (36.2) | 68 (17.7) | 74 (18.2) | 142 (17.9) |
| No | 253 (65.7) | 223 (61.8) | 476 (63.8) | 317 (82.3) | 333 (81.8) | 650 (82.1) |
| Type of previous chemotherapy | ||||||
| Anthracycline | 2 (0.5) | 2 (0.6) | 4 (0.5) | 4 (1.0) | 8 (2.0) | 12 (1.5) |
| Taxane | 8 (2.1) | 8 (2.2) | 16 (2.1) | 13 (3.4) | 21 (5.2) | 34 (4.3) |
| Anthracycline and taxane | 375 (97.4) | 351 (97.2) | 726 (97.3) | 368 (95.6) | 377 (92.6) | 745 (94.1) |
| Missing | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Surgery type | ||||||
| Conservative surgery | 90 (23.4) | 99 (27.4) | 189 (25.3) | 176 (45.7) | 171 (42.0) | 347 (43.8) |
| Nonconservative surgery | 295 (76.6) | 262 (72.6) | 557 (74.7) | 209 (54.3) | 234 (57.5) | 443 (55.9) |
| Missing | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.5) | 2 (0.3) |
| Radiation | ||||||
| Yes | 288 (74.8) | 260 (72.0) | 548 (73.5) | 247 (64.2) | 273 (67.1) | 520 (65.7) |
| No | 97 (25.2) | 101 (28.0) | 198 (26.5) | 138 (35.8) | 134 (32.9) | 272 (34.3) |
| Hormone receptor status | ||||||
| ER-positive and/or PgR-positive/HER2-negative | 81 (21.0) | 69 (19.1) | 150 (20.1) | 45 (11.7) | 56 (13.8) | 101 (12.8) |
| TNBC | 304 (79.0) | 292 (80.9) | 596 (79.9) | 340 (88.3) | 351 (86.2) | 691 (87.2) |
| Centrally confirmed BRCA gene name | ||||||
| BRCA1 | 250 (64.9) | 237 (65.7) | 487 (65.3) | 227 (59.0) | 225 (55.3) | 452 (57.1) |
| BRCA2 | 110 (28.6) | 94 (26.0) | 204 (27.3) | 80 (20.8) | 86 (21.1) | 166 (21.0) |
| BRCA1 and BRCA2 | 6 (1.6) | 17 (4.7) | 23 (3.1) | 15 (3.9) | 14 (3.4) | 29 (3.7) |
| Missinga | 19 (4.9) | 13 (3.6) | 32 (4.3) | 63 (16.4) | 82 (20.1) | 145 (18.3) |
| Geographic region | ||||||
| North America | 51 (13.2) | 38 (10.5) | 89 (11.9) | 33 (8.6) | 51 (12.5) | 84 (10.6) |
| South America | 4 (1.0) | 2 (0.6) | 6 (0.8) | 9 (2.3) | 7 (1.7) | 16 (2.0) |
| Europe | 233 (60.5) | 217 (60.1) | 450 (60.3) | 162 (42.1) | 154 (37.8) | 316 (39.9) |
| Asia Pacific and South Africa | 97 (25.2) | 104 (28.8) | 201 (26.9) | 181 (47.0) | 195 (47.9) | 376 (47.5) |
Abbreviations: ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; OL, olaparib; PgR, progesterone receptor; PL, placebo; PRO, patient-reported outcomes; TNBC, triple-negative breast cancer.
a
Most missing are due to central Myriad testing not done/not available in China.