Table 4.
Prognostic value of mutation status
|
Standard-of-care group |
Trametinib group |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| KRAS, BRAF, or NRAS mutation present (n=22) | KRAS, BRAF, and NRAS mutation absent (n=42) | HR or OR (95% CI) | Nominal prognostic p value | Adjusted prognostic p value* | KRAS, BRAF, or NRAS mutation present (n=22) | KRAS, BRAF, and NRAS mutation absent (n=48) | HR or OR (95% CI) | ||
| Progression-free survival | .. | .. | .. | 0·093 | 0·19 | .. | .. | .. | |
| Number of events | 20 | 38 | .. | .. | .. | 20 | 37 | .. | |
| Median progression-free survival, months (95% CI) | 11·4 (3·7–13·3) | 6·3 (3·7–9·9) | HR 0·58 (0·30–1·10) | .. | .. | 13·2 (9·4–20·8) | 7·3 (5·6–12·7) | HR 0·41 (0·21–0·80) | |
| Clinical response | .. | .. | .. | 0·39 | 0·39 | .. | .. | .. | |
| Number of participants with a complete or partial response | 2 | 3 | .. | .. | .. | 11 | 4 | .. | |
| Overall response rate (95% CI) | 9·1% (1·9–26·1) | 7·1% (2·1–17·9) | OR 1·67 (0·30–9·28) | .. | .. | 50·0% (30·2–69·8) | 8·3% (2·9–18·6) | OR 15·07 (3·33–68·22) | |
HR=hazard ratio. OR=odds ratio.
*
Adjusted for multiple comparisons. p values are provided for the standard-of-care group only because the prognostic value of mutational status was formally assessed in this group alone. Trametinib group statistics are provided for information only.