Table 1.
Characteristics of patients at baseline
| Standard-of-care group (n=130) | Trametinib group (n=130) | ||
|---|---|---|---|
| Age, years | 55·3 (42·4–65·6) | 56·6 (44·6–63·3) | |
| Country | |||
| USA | 102 (79%) | 103 (79%) | |
| UK | 28 (21%) | 27 (21%) | |
| Race | |||
| White | 114 (88%) | 115 (89%) | |
| Black or African American | 5 (4%) | 4 (3%) | |
| Asian | 4 (3%) | 3 (2%) | |
| Native Hawaiian or Pacific Islander | 0 (0%) | 1 (1%) | |
| Patient refused to specify or unknown | 7 (5%) | 7 (5%) | |
| Ethnicity | |||
| Hispanic | 7 (5%) | 8 (6%) | |
| Non-Hispanic | 118 (91%) | 118 (91%) | |
| Refused to specify | 5 (4%) | 4 (3%) | |
| Disease site | |||
| Ovary | 117 (90%) | 119 (92%) | |
| Peritoneum | 13 (10%) | 11 (8%) | |
| Stage | |||
| I | 8 (6%) | 11 (8%) | |
| II | 11 (8%) | 11 (8%) | |
| III | 93 (72%) | 96 (74%) | |
| IV | 18 (14%) | 12 (9%) | |
| Mutational status* | |||
| KRAS, BRAF, or NRAS mutation | 22 (17%) | 22 (17%) | |
| KRAS mutation | 14 (11%) | 16 (12%) | |
| BRAF mutation | 1 (1%) | 2 (2%) | |
| NRAS mutation | 7 (5%) | 4 (3%) | |
| No mutation | 42 (32%) | 48 (37%) | |
| Missing (no tissue) | 66 (51%) | 60 (46%) | |
| Performance status | |||
| 0 | 93 (72%) | 93 (72%) | |
| 1 | 37 (28%) | 37 (28%) | |
| Previous lines of systemic therapy† | |||
| 1 | 30 (23%) | 29 (22%) | |
| 2 | 37 (28%) | 39 (30%) | |
| ≥3 | 63 (49%) | 62 (48%) | |
| Mean number | 2·9 (1·7) | 2·9 (1·9) | |
| Range | 1–10 | 1–10 | |
| Previous lines of chemotherapy‡ | |||
| 1 | 55 (42%) | 62 (48%) | |
| 2 | 39 (30%) | 32 (25%) | |
| ≥3 | 36 (28%) | 36 (28%) | |
| Previous lines of hormonal therapy‡ | |||
| 0 | 56 (43%) | 54 (42%) | |
| 1 | 68 (52%) | 76 (58%) | |
| 2 | 6 (5%) | 0 (0%) | |
| Planned treatment§ | |||
| Letrozole | 44 (34%) | 43 (33%) | |
| Tamoxifen | 27 (21%) | 27 (21%) | |
| Paclitaxel | 11 (8%) | 14 (11%) | |
| Pegylated liposomal doxorubicin | 40 (31%) | 37 (28%) | |
| Topotecan | 8 (6%) | 9 (7%) | |
| Current status¶ | |||
| Alive | 69 (53%) | 78 (60%) | |
| Dead | 61 (47%) | 52 (40%) | |
Data are median (IQR), n (%), or mean (SD), unless otherwise indicated.
*
No patient had more than one type of mutation.
†
As reported by study site for stratification before randomisation; includes both chemotherapy and hormonal therapy.
‡
As reported on study case report form.
§
Of the 44 patients who received letrozole and 27 patients who received tamoxifen in the standard-of-care group, only one patient received previous hormonal therapy; they received letrozole and tamoxifen sequentially and then received tamoxifen on the standard-of-care group.
¶
As of July 16, 2019.