Table 3. Treatment characteristics and response according to RECIST 1.1 depending on the KRAS/TP53 co–mutational status and for KRASG12C/TP53, respectively.
| Variable | KRASwt/TP53wt (n=27) | KRASmut/TP53wt (n=36) | KRASwt/TP53mut (n=30) | KRASmut/TP53mut (n=26) | P value | KRASG12C/TP53mut (n=12) | KRASG12C/TP53wt (n=20) | KRASother/TP53mut (n=14) | KRASother/TP53wt (n=16) | P value |
|---|---|---|---|---|---|---|---|---|---|---|
| Cycles administered, n [range] | 11 [1–45] | 15 [1–45] | 12 [1–43] | 10 [1–38] | 0.48 | 28 [2–37] | 13 [1–38] | 7 [1–38] | 16 [2–45] | 0.03* |
| Follow-up, months (median, 95% CI) | 25.6 (20.9–30.4) | 29.2 (24.7–33.7) | 21.3 (17.5–25.2) | 28.9 (19.3–38.4) | 0.02* | 26.9 (19.0–34.7) | 28.0 (23.7–32.2) | 29.3 (20.5–38.1) | 30.7 (24.3–37.1) | 0.33 |
| Duration of treatment, months (median, 95% CI) | 3.2 (1.2–5.3) | 12.4 (9.7–15.0) | 7.2 (4.6–9.7) | 6.8 (3.1–10.5) | 0.41 | 22.0 (16.7–26.4) | 12.4 (0.8–24.0) | 4.1 (0.1–11.8) | 12.3 (9.0–15.7) | 0.01* |
| Therapy ongoing, n (%) | 11 (17.7) | 4 (11.1) | 7 (23.3) | 7 (26.9) | 0.26 | 6 (50.0) | 3 (15.0) | 1 (7.1) | 1 (6.3) | 0.01* |
| RECIST-evaluation available, n (%) | 22 (81.5) | 33 (91.7) | 28 (93.8) | 22 (84.6) | 0.45 | 11 (91.7) | 19 (95.0) | 11 (78.6) | 14 (87.5) | 0.51 |
| ORR, % [95% CI] | 50.0 [32–73] | 42.4 [24–61] | 42.9 [25–61] | 63.6 [41–82] | 0.42 | 100.0 [100–100] | 42.1 [21–63] | 27.3 [9–55] | 42.9 [14–71] | 0.003* |
| DCR, % [95% CI] | 77.3 [59–96] | 84.8 [70–97] | 71.4 [54–86] | 81.8 [64–96] | 0.62 | 100.0 [100–100] | 78.9 [58–95] | 63.6 [36–91] | 92.9 [79–100] | 0.09 |
*, P<0.05. CI, confidence interval; RECIST, Response Evaluation Criteria in Solid Tumors; ORR, objective response rate; DCR, disease control rate; KRAS+, KRAS mutation; KRAS–, KRAS wildtype; KRASother, KRAS mutation other than KRASG12C; TP53+, TP53 mutation; TP53–, TP53 wildtype.