Table 3.
Analysis endpoints and side effects during first year of protocol therapy according to treatment assignment
| Treatment | ||||
|---|---|---|---|---|
| Overall | Exemestane + OFS | Tamoxifen + OFS | ||
| (n = 1967a) | (n = 987) | (n = 980) | ||
| Analysis endpoint | ||||
| Early-onset hot flashes/sweating, grade ≥2 | 848 (43) | 411 (42) | 437 (45) | |
| Early-onset musculoskeletal symptoms, grade ≥2 | 516 (26) | 331 (34) | 185 (19) | |
| Side effect and time point | Grade | |||
| Hot flashes | ||||
| Baseline | Unk | 2 (0) | 2 (0) | 0 (0) |
| Gr0 | 1812 (92) | 924 (94) | 888 (91) | |
| Gr1 | 134 (7) | 51 (5) | 83 (8) | |
| Gr2 | 19 (1) | 10 (1) | 9 (1) | |
| 3 months | Unk | 8 (0) | 3 (0) | 5 (1) |
| Gr0 | 637 (32) | 325 (33) | 312 (32) | |
| Gr1 | 766 (39) | 386 (39) | 380 (39) | |
| Gr2 | 500 (25) | 248 (25) | 252 (26) | |
| Gr3 | 56 (3) | 25 (3) | 31 (3) | |
| 6 months | Unk | 20 (1) | 9 (1) | 11 (1) |
| Gr0 | 525 (27) | 294 (30) | 231 (24) | |
| Gr1 | 797 (41) | 401 (41) | 396 (40) | |
| Gr2 | 573 (29) | 260 (26) | 313 (32) | |
| Gr3 | 52 (3) | 23 (2) | 29 (3) | |
| Sweating | ||||
| Baseline | Unk | 3 (0) | 3 (0) | 0 (0) |
| Gr0 | 1832 (93) | 920 (93) | 912 (93) | |
| Gr1 | 119 (6) | 56 (6) | 63 (6) | |
| Gr2 | 13 (1) | 8 (1) | 5 (1) | |
| 3 months | Unk | 9 (0) | 4 (0) | 5 (1) |
| Gr0 | 1332 (68) | 675 (68) | 657 (67) | |
| Gr1 | 444 (23) | 219 (22) | 225 (23) | |
| Gr2 | 182 (9) | 89 (9) | 93 (9) | |
| 6 months | Unk | 22 (1) | 9 (1) | 13 (1) |
| Gr0 | 1285 (65) | 688 (70) | 597 (61) | |
| Gr1 | 447 (23) | 206 (21) | 241 (25) | |
| Gr2 | 213 (11) | 84 (9) | 129 (13) | |
| Musculoskeletal symptoms | ||||
| Baseline | Unk | 3 (0) | 3 (0) | 0 (0) |
| Gr0 | 1669 (85) | 837 (85) | 832 (85) | |
| Gr1 | 248 (13) | 125 (13) | 123 (13) | |
| Gr2 | 47 (2) | 22 (2) | 25 (3) | |
| Gr3 | 0 (0) | 0 (0) | 0 (0) | |
| 3 months | Unk | 9 (0) | 5 (1) | 4 (0) |
| Gr0 | 1360 (69) | 670 (68) | 690 (70) | |
| Gr1 | 467 (24) | 231 (23) | 236 (24) | |
| Gr2 | 118 (6) | 74 (7) | 44 (4) | |
| Gr3 | 13 (1) | 7 (1) | 6 (1) | |
| 6 months | Unk | 21 (1) | 9 (1) | 12 (1) |
| Gr0 | 1070 (54) | 463 (47) | 607 (62) | |
| Gr1 | 648 (33) | 366 (37) | 282 (29) | |
| Gr2 | 198 (10) | 128 (13) | 70 (7) | |
| Gr3 | 30 (2) | 21 (2) | 9 (1) | |
| 9 months | Unk | 41 (2) | 24 (2) | 17 (2) |
| Gr0 | 995 (51) | 386 (39) | 609 (62) | |
| Gr1 | 670 (34) | 392 (40) | 278 (28) | |
| Gr2 | 228 (12) | 159 (16) | 69 (7) | |
| Gr3 | 33 (2) | 26 (3) | 7 (1) | |
| 12 months | Unk | 37 (2) | 23 (2) | 14 (1) |
| Gr0 | 965 (49) | 388 (39) | 577 (59) | |
| Gr1 | 708 (36) | 400 (41) | 308 (31) | |
| Gr2 | 235 (12) | 158 (16) | 77 (8) | |
| Gr3 | 22 (1) | 18 (2) | 4 (0) | |
Reports of hot flashes and sweating side effects and of musculoskeletal symptoms according to common terminology criteria for adverse events (CTCAE) v3.0 at time points during the first year of protocol therapy. All data are summarized as number (%) of patients. aPatients without any adverse event data (two patients without hot flashes/sweating and one without musculoskeletal symptoms) were excluded from summary. Unk unknown, Gr grade OFS ovarian function suppression