Table 1.
Patients characteristics and main study results according to the 2 study groups (unfavourable and favourable)
| Whole group | Unfavourable | Favourable | p value | |
|---|---|---|---|---|
| (n = 46) | (n = 29) | (n = 17) | ||
| Age (range) | 67 (36–81) | 66 (36–79) | 67 (38–81) | ns |
| Sex | ||||
| Males | 30 (65%) | 21 (72%) | 9 (53%) | ns |
| Females | 16 (35%) | 8 (28%) | 7 (47%) | ns |
| ECOG PS | ||||
| 0-1 | 29 (63%) | 18 (62%) | 11 (65%) | ns |
| 2-3 | 17 (47%) | 11 (38%) | 6 (35%) | ns |
| Metastatic sites | ||||
| 1 | 7 (15%) | 5 (17%) | 2 (12%) | ns |
| ≥ 2 | 39 (85%) | 24 (83%) | 15 (88%) | ns |
| Previous lines of treatment | ||||
| 1 | 10 (22%) | 6 (21%) | 4 (9%) | ns |
| ≥ 2 | 36 (78%) | 23 (89%) | 15 (88%) | ns |
| Treatment | ||||
| FOLFIRI/Cet | 9 (19%) | 6 (21%) | 3 (23%) | ns |
| Irinotecan/Cet | 37 (81%) | 23 (79%) | 14 (77%) | ns |
| Response rate | ||||
| PR | 13 (26%) | 2 (7%) | 11 (65%) | 0.007 |
| SD | 6 (16%) | 3 (10%) | 3 (18%) | 0.8 |
| DCR (PR + SD) | 19 (41%) | 5 (17%) | 14 (82%) | 0.0001 |
| PD | 27 (59%) | 24 (83%) | 3 (18%) | 0.0001 |
| Survival | ||||
| PFS(months) | 3.3 | 3 | 8 | < 0.0001 |
| OS (months) | 11 | 6 | 15 | < 0.0001 |
ECOG PS = Eastern Cooperative Oncology Group Performance Status.
FOLFIRI = Fluorouracil, leucovorin, Irinotecan.
Cet = Cetuximab.
PR = Partial Response.
SD = Stable Disease.
DCR = Disease Control Rate.
PD = Progressive Disease.