Table 3.
Outcome parameters according to early tumor shirnkage and deepness of response of FOLFOXIRI plus biologics, FIRE-3 and PEAK trials
| Study | TRIBE | GONO retrospective analysis RAS/BRAF wild-type |
FIRE3 (N=330) RAS wild-type |
PEAK (N=169) RAS wild-type |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regimen | FOLFOXIRI +bev (N=225) |
FOLFIRI +bev (N=216) |
P-value | FOLFOXIRI +bev (N=62) |
FOLFOXIRI +anti-EGFR (N=101) |
P-value | FOLFIRI +bev (N=173) |
FOLFIRI +cet (N=157) |
P-value | FOLFOX +bev (N=216) |
FOLFOX +pani (N=) |
P-value | ||
| Response rate ETS | 71.6% | 62.0% | 0.043* | 71% | 82% | 0.12* | 56.1% | 72.0% | 0.003* | 61.7% | 64.8% | |||
| Median | 31.2% | 23.5% | <0.001** | 26.4% | 40.8% | 0.003*** | ||||||||
| ETS>20% | 62.7% | 51.9% | 62% | 74% | 0.15* | 49.1% | 68.2% | 0.0005* | 62% | 75% | 0.12 | |||
| ETS<20% | 30.2% | 39.8% | 38% | 26% | 38% | 25% | ||||||||
| Not evaluated | 7.1% | 8.3% | ||||||||||||
| DpR | ||||||||||||||
| Median | 43.4% | 37.8% | 0.003** | 32.3% | 48.9% | <0.0001 | 46% | 65% | 0.0007 | |||||
| Median within 4 months | 37.8 | 48.6 | 0.0047*** | |||||||||||
| Evaluable population (n=407) |
||||||||||||||
| ETS>20% (n=253) |
ETS<20% (n=154) |
ETS (n=85) |
No ETS (n=88) |
ETS (n=107) |
No ETS (n=50) |
ETS>20% | ETS>20% | |||||||
| Median PFS (months) | 8.8† |
7.2† | 11.7 | 8.3 | 9.7 | 5.8 | 11.1 | 13.2 | ||||||
| HR 0.78, P=0.027 | HR 0.71, P=0.03 | HR 0.59, P=0.0037 | HR 0.69, P=0.13 | |||||||||||
| Medina PPS (months) | 17.1† | 11.5† | ||||||||||||
| HR 0.65, P=0.030 | ||||||||||||||
| Median OS (months) | 31.9† | 21.9† | 31.9 | 21.2 | 38.3 | 20.5 | ||||||||
| HR 0.63, P=0.001 | HR 0.48, P=0.0001 | HR 0.52, P=0.0023 | ||||||||||||
ETS was defined as the relative change in the sum of longest diameters of RECIST target lesions at week 8 in TRIBE and GONO studies, week 6 in FIRE3 study, compared to baseline.
DpR was defined as the relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, as compared to baseline.
Fisher’s exact test;
Kruskal Wallis test;
Mann-Whitney test
Not including the first 4 months after randomization
Abbreviation: bev, bevacizumab; cet, cetuximab; pani, panitumumab; NA, not applicable; NR, not reached; FIr-bev/FOx, 5-FU plus alternating irinotecan/bev or oxaliplatin; FN, febrile neutropenia; rDI, relative dose intensity; CI, continuous infusion; PPS, post progression survival