Table 3.
Summary of efficacy measures
| Outcome | Controls (N = 52) | Mut-positive (N = 26) | P-value |
|---|---|---|---|
| Overall survival (mo) | 0.0467 | ||
| Median | 18.8 | 24.6 | – |
| Real-world progression free survival (mo) | 0.0068 | ||
| Median | 6.9 | 10.1 | – |
| Overall response rate—no. (%)a | 8 (21) | 14 (58) | 0.0022 |
| Complete response | 1 | 0 | – |
| Partial response | 7 | 14 | – |
| Stable disease | 24 | 5 | – |
| Progressive disease | 7 | 5 | – |
| Disease control rate—no. (%)b | 42 (81) | 21 (81) | > 0.99 |
| Overall response rate by regimen - no. with response/no. evaluable (%)a | – | ||
| FOLFIRINOX | 8/29 (28) | 6/10 (60) | – |
| FOLFOX | 0 (0) | 4/8 (50) | – |
| Gemcitabine cisplatin | 0 (0) | 4/6 (67) | – |
Response criteria according to RECIST (response evaluation criteria in solid tumours) v1.1
Patients in the control group (n = 13) and mut-positive group (n = 2) without measurable disease at baseline were excluded from overall response rate analysis. The two patients in the mut-positive group without measurable were treated with FOLFOX and were thus excluded from the subset analysis of overall response to FOLFOX
aThe overall response rate was defined as the percentage of patients that achieved complete response or partial response
bThe disease control rate was defined as the percentage of patients that achieved complete response, partial response or stable disease. Patients without measurable disease at baseline were included in the DCR analysis. Patients were defined as having SD or PD based on evaluation of non-target lesions