Table 3 Activity, efficacy and effectiveness of FIr-B/FOx regimen according to KRAS genotype
c.35 G>A KRASmutant | other KRASmutant | KRASwild-type | ||||
|---|---|---|---|---|---|---|
Intent-to-treat analysis | Intent-to-treat analysis | Intent-to-treat analysis | ||||
Number | % | Number | % | Number | % | |
Enrolled pts | 15 | 100 | 13 | 100 | 31 | 100 |
Evaluable pts | 14 | 93 | 13 | 100 | 30 | 97 |
Objective response | 10 | 71 (CI ± 26) | 8 | 61 (CI ± 26) | 27 | 90 (CI ± 11) |
partial response | 9 | 64 | 8 | 61 | 23 | 76 |
complete response | 1 | 7 | - | - | 4 | 13 |
Stable disease | 3 | 21 | 2 | 15 | 2 | 7 |
Progressive disease | 1 | 7 | 3 | 23 | 1 | 3 |
Median PFS, months | 9 | 12 | 14 | |||
range | 1+-60+ | 3-37 | 1+-69+ | |||
progression events | 10 | 67 | 12 | 92 | 25 | 81 |
Median OS, months | 14 | 39 | 38 | |||
range | 1+-60+ | 8-59+ | 1+-69+ | |||
deaths | 10 | 67 | 8 | 61.5 | 17 | 55 |
Liver metastasectomies | 2 | 5 | 11 | |||
number/overall pts | 2/15 | 13 | 5/13 | 38 | 11/31 | 35 |
number/Pts with liver metastases | 2/12 | 17 | 5/8 | 62.5 | 11/19 | 58 |
number/Pts with L-L metastases | 2/6 | 33 | 5/7 | 71 | 10/12 | 83 |
Pathologic complete responses | - | - | 2 | 40 | - | - |