Table 1. Characteristics of Patients in the Recurrence Score of 26 to 100 Cohort Assigned to Chemotherapy Stratified by Chemotherapy Regimen in the Intention-to-Treat Population.
| Study Arm | No. (%) | ||||||
|---|---|---|---|---|---|---|---|
| Total | Taxane and Cyclophosphamide | Anthracycline Without Taxane | Anthracycline Plus Taxane | CMF | Other | No Chemotherapy | |
| No. | 1389 | 589 | 334 | 244 | 52 | 81 | 89 |
| Age, y | |||||||
| Median (range) | 56 (23-75) | 57 (23-74) | 57 (31-75) | 53.5 (30-75) | 61.5 (40-75) | 54 (36-75) | 56 (36-75) |
| IQR | (49-63) | (50-63) | (50-63) | (46-60) | (53-67.5) | (49-62) | (50-63) |
| Mean (SD) | 55.8 (9.4) | 56.2 (9.3) | 56.3 (8.8) | 53.3 (9.8) | 60.0 (9.7) | 55.4 (8.9) | 55.9 (9.4) |
| ≤40 | 79 (6) | 33 (6) | 13 (4) | 26 (11) | 1 (2) | 1 (1) | 5 (6) |
| 41-50 | 330 (24) | 127 (22) | 76 (23) | 65 (27) | 10 (19) | 29 (36) | 23 (26) |
| 51-60 | 512 (37) | 217 (37) | 137 (41) | 92 (38) | 12 (23) | 21 (26) | 33 (37) |
| 61-70 | 395 (28) | 185 (31) | 93 (28) | 52 (21) | 20 (38) | 26 (32) | 19 (21) |
| 71-75 | 73 (5) | 27 (5) | 15 (4) | 9 (4) | 9 (17) | 4 (5) | 9 (10) |
| Premenopausal | 407 (29) | 158 (27) | 91 (27) | 99 (41) | 10 (19) | 25 (31) | 24 (27) |
| Postmenopausal | 982 (71) | 431 (73) | 243 (73) | 145 (59) | 42 (81) | 56 (69) | 65 (73) |
| Tumor size, cm | |||||||
| Median (range) | 1.7 (0.2-21.4) | 1.7 (0.5-8.4) | 1.6 (0.2-21.4) | 1.95 (0.6-7.0) | 1.5 (0.6-3.7) | 1.6 (0.5-3.8) | 1.7 (0.6-3.8) |
| IQR | (1.3-2.3) | (1.3-2.3) | (1.2-2.2) | (1.4-2.5) | (1.1-3.7) | (0.5-2.1) | (1.3-2.2) |
| Mean (SD) | 1.88 (0.99) | 1.8 (0.8) | 1.9 (1.4) | 2.1 (1.0) | 1.6 (0.7) | 1.8 (0.8) | 1.8 (0.7) |
| Distribution | |||||||
| ≤1.0 | 188 (14) | 73 (12) | 51 (15) | 31 (13) | 11 (21) | 14 (17) | 8 (9) |
| 1.1-2.0 | 741 (53) | 324 (55) | 180 (54) | 109 (45) | 30 (58) | 44 (54) | 54 (61) |
| 2.1-3.0 | 348 (25) | 153 (26) | 75 (22) | 74 (30) | 9 (17) | 15 (19) | 22 (25) |
| 3.1-4.0 | 91 (7) | 33 (6) | 22 (7) | 21 (9) | 2 (4) | 8 (10) | 5 (6) |
| ≥4.1 | 20 (1) | 5 (1) | 6 (2) | 9 (4) | 0 | 0 | 0 |
| Unknown | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Histologic grade | |||||||
| Low | 89 (7) | 34 (6) | 22 (7) | 17 (7) | 1 (2) | 5 (6) | 10 (11) |
| Intermediate | 590 (43) | 269 (46) | 146 (45) | 90 (38) | 26 (55) | 26 (33) | 33 (38) |
| High | 681 (50) | 277 (48) | 160 (49) | 132 (55) | 20 (43) | 48 (61) | 44 (51) |
| Unknown | 29 | 9 | 6 | 5 | 5 | 2 | 2 |
| ER expression | |||||||
| Negative | 40 (3) | 17 (3) | 10 (3) | 10 (4) | 1 (2) | 2 (2) | 0 |
| Positive | 1349 (97) | 572 (97) | 324 (97) | 234 (96) | 51 (98) | 79 (98) | 89 (100) |
| PgR expression | |||||||
| Negative | 405 (30) | 177 (32) | 75 (23) | 81 (33) | 15 (29) | 30 (38) | 27 (30) |
| Positive | 948 (70) | 381 (68) | 257 (77) | 161 (67) | 37 (71) | 50 (62) | 62 (70) |
| Unknown | 36 | 31 | 2 | 2 | 0 | 1 | 0 |
| Clinical risk | |||||||
| Low | 589 (43) | 256 (44) | 149 (45) | 90 (38) | 26 (55) | 31 (39) | 37 (43) |
| High | 770 (57) | 323 (56) | 179 (55) | 149 (62) | 21 (45) | 48 (61) | 50 (57) |
| Unknown | 30 | 10 | 6 | 5 | 5 | 2 | 2 |
| Primary surgery | |||||||
| Breast conservation | 1021 (74) | 442 (75) | 249 (75) | 174 (71) | 38 (73) | 61 (75) | 57 (64) |
| Mastectomy | 368 (26) | 147 (25) | 85 (25) | 70 (29) | 14 (27) | 20 (25) | 32 (36) |
| Postoperative radiation therapy | |||||||
| Yes | 1300 (94) | 387 (66) | 213 (64) | 157 (64) | 31 (60) | 40 (49) | 28 (31) |
| No/unknown | 89 (6.4) | 202 (34) | 121 (36) | 87 (36) | 21 (40) | 41 (51) | 61 (69) |
| Recurrence score | |||||||
| Median (range) | 32 (26-87) | 32 (26-81) | 32 (26-72) | 36 (26-87) | 30 (26-64) | 32 (26-64) | 29 (26-77) |
| IQR | (28-40) | (28-39) | (28-37) | (30-48) | (28-35) | (28-40) | (27-35) |
| Mean (SD) | 35.2 (9.8) | 34.6 (9.4) | 33.9 (8.2) | 39.3 (11.8) | 32.7 (7.7) | 35.4 (9.4) | 33.5 (10.3) |
| 26-30 | 598 (43) | 267 (45) | 147 (44) | 70 (29) | 30 (58) | 32 (40) | 52 (58) |
| 31-35 | 315 (23) | 133 (23) | 86 (26) | 49 (20) | 10 (19) | 21 (26) | 16 (18) |
| 36-40 | 158 (11) | 59 (10) | 44 (13) | 35 (14) | 6 (12) | 8 (10) | 6 (7) |
| 41-50 | 202 (15) | 91 (15) | 40 (12) | 48 (20) | 4 (8) | 12 (15) | 7 (8) |
| 51-100 | 116 (8) | 39 (7) | 17 (5) | 42 (17) | 2 (4) | 8 (10) | 8 (9) |
| Endocrine Therapy | |||||||
| Premenopausal | |||||||
| AI | 41 (10) | 13 (8) | 7 (8) | 13 (13) | 0 | 5 (20) | 3 (12) |
| OFS | 21 (5) | 4 (3) | 7 (8) | 8 (8) | 0 | 1 (4) | 1 (4) |
| OFS and AI | 31 (8) | 13 (8) | 6 (7) | 10 (10) | 0 | 1 (4) | 1 (4) |
| Tam | 177 (43) | 77 (49) | 35 (38) | 39 (39) | 5 (50) | 10 (40) | 11 (46) |
| Tam and AI | 117 (29) | 48 (30) | 33 (36) | 21 (21) | 4 (40) | 7 (28) | 4 (17) |
| Other | 1 (<1) | 0 | 1 (1) | 0 | 0 | 0 | 0 |
| None reported | 19 (5) | 3 (2) | 2 (2) | 8 (8) | 1 (10) | 1 (4) | 4 (17) |
| Postmenopausal | |||||||
| AI | 695 (71) | 320 (74) | 165 (68) | 99 (68) | 30 (71) | 38 (68) | 43 (66) |
| Other | 256 (26) | 105 (24) | 73 (30) | 39 (27) | 10 (24) | 12 (21) | 17 (26) |
| None reported | 31 (3) | 6 (1) | 5 (2) | 7 (5) | 2 (5) | 6 (11) | 5 (8) |
Abbreviations: AI, aromatase inhibitor; ER, estrogen receptor; IQR, interquartile range; OFS, ovarian function suppression; PgR, progesterone receptor; tam, tamoxifen.