Table 1.
Trials 13-93 and 14-93 SERM Treatment Adherence for Premenopausal (Trial 13-93) and Postmenopausal (Trial 14-93) Patients with ER-Positive Disease
| Tr 13-93 Randomized Tam | Tr 14-93 Assigned Tam | Tr 14-93 Randomized Tam | Tr 14-93 Randomized Tor | Total SERMs | |
|---|---|---|---|---|---|
| Total patients | 364 | 199 | 194 | 199 | 956 |
| N (%) | N (%) | N (%) | N (%) | N (%) | |
| Patients recurring prior to starting SERM | 5 (1) | 1 (0.5) | 2 (1) | 2 (1) | 10 (1) |
| Patients not starting SERM | 16 (4) | 3 (2) | 3 (2) | 10 (5) | 32 (3) |
| Reasons for not starting assigned SERM | |||||
| Refusal | 12 (3) | 1 (0.5) | 1 (0.5) | - | 14 (1) |
| Medical decision | 1 (0.3) | - | 1 (0.1) | ||
| Received wrong arm | 2 (1) | 1 (0.5) | 1 (0.5) | 10 (5) | 14 (1) |
| Lost to follow up | - | - | 1 (0.5) | - | 1 (0.1) |
| Unknown | 1 (0.3) | 1 (0.5) | - | 2 (0.1) | |
| Patients starting SERM | 343 (94) | 195 (98) | 189 (97) | 187 (94) | 914 (96) |
| Patients with recurrence or unrelated death prior to completion of 4 yrs of SERM | 71 (20) | 36 (18) | 47 (24) | 45 (23) | 199 (21) |
| Patients discontinuing SERM prior to 4 yrs | 43 (12) | 17 (9) | 19 (10) | 27 (14) | 106 (11) |
| Reasons for discontinuation | |||||
| Toxicity | 21 (6) | 9 (5) | 13 (7) | 14 (7) | 57 (6) |
| Refusal | 8 (2 ) | 2 (1) | 4 (2) | 6 (3) | 20 (2) |
| Pregnancy desire | 5 (1) | - | - | 5 (1) | |
| Medical decision | - | 1 (1) | - | - | 1 (0.1) |
| Medical error | 2 (1) | - | - | 2 (0.2) | |
| Lost to follow up | 6 (2) | 4 (2) | 1 (1) | 6 (3) | 17 (2) |
| Unknown | 1 (0.3) | 1 (1) | 1 (1) | 1 (1) | 4 (0.4) |
| Landmark analysis cohort: Pts alive and disease free 4 years after SERM start | 263 (72) | 155 (78) | 139 (72) | 133 (67) | 690 (72) |
| Pts with 4+ yrs SERM | 229 (63) | 142 (71) | 123 (63) | 115 (58) | 609 (64) |
| Pts with < 4 yrs SERM | 34 (9) | 13 (7) | 16 (8) | 18 (9) | 81 (8) |
Percentages are of total N in each of the 4 treatment categories and total SERMs. Abbreviations: SERM: selective estrogen receptor modulator