Table 1.
Baseline patient demographics and disease characteristics, study drug exposure and post-progression anti-cancer therapy by treatment and primary tumour location in PRIME and PEAK
PRIME | PEAK | |||||||
---|---|---|---|---|---|---|---|---|
Panitumumab + FOLFOX4 | FOLFOX4 | Panitumumab + mFOLFOX6 | Bevacizumab + mFOLFOX6 | |||||
Left (n = 169) | Right (n = 39) | Left (n = 159) | Right (n = 49) | Left (n = 53) | Right (n = 22) | Left (n = 54) | Right (n = 14) | |
Baseline demographics/disease characteristics | ||||||||
Median age (range), years | 61 (27–81) | 62 (42–80) | 62 (27–82) | 61 (24–78) | 60 (23–77) | 64 (43–82) | 60 (39–82) | 66 (50–78) |
Sex, n (%) | ||||||||
Male | 120 (71) | 21 (54) | 103 (65) | 25 (51) | 34 (64) | 15 (68) | 38 (70) | 10 (71) |
Female | 49 (29) | 18 (46) | 56 (35) | 24 (49) | 19 (36) | 7 (32) | 16 (30) | 4 (29) |
BRAF statusa,b, n (%) | ||||||||
Mutant | 7 (4) | 13 (33) | 8 (5) | 16 (33) | 1 (2) | 9 (41) | 1 (2) | 1 (7) |
Wild-type | 156 (92) | 26 (67) | 148 (93) | 32 (65) | 52 (98) | 13 (59) | 53 (98) | 13 (93) |
Site of metastases, n (%) | ||||||||
Liver + other | 119 (70) | 21 (54) | 108 (68) | 35 (71) | 21 (40) | 13 (59) | 21 (39) | 9 (64) |
Liver only | 33 (20) | 6 (15) | 31 (19) | 5 (10) | 18 (34) | 4 (18) | 15 (28) | 4 (29) |
Other only | 17 (10) | 12 (31) | 20 (13) | 9 (18) | 14 (26) | 5 (23) | 18 (33) | 1 (7) |
ECOG performance statusa, n (%) | ||||||||
0 | 106 (63) | 22 (56) | 88 (55) | 27 (55) | 37 (70) | 10 (45) | 35 (65) | 9 (64) |
1 | 56 (33) | 15 (38) | 61 (38) | 19 (39) | 16 (30) | 12 (55) | 19 (35) | 5 (36) |
2 | 7 (4) | 2 (5) | 9 (6) | 3 (6) | 0 | 0 | 0 | 0 |
Stage IV disease at diagnosis, n (%) | 101 (60) | 21 (54) | 90 (57) | 23 (47) | 28 (53) | 14 (64) | 27 (50) | 10 (71) |
Prior adjuvant chemotherapy, n (%) | 29 (17) | 10 (26) | 26 (16) | 10 (20) | 8 (15) | 4 (18) | 13 (24) | 4 (29) |
Study drug exposure and post-progression anti-cancer therapy | ||||||||
First-line study drug exposure, n (%) | ||||||||
<3 months | 20 (12) | 9 (23) | 23 (14) | 12 (24) | 5 (9) | 3 (14) | 11 (20) | 5 (36) |
≥3 to <6 months | 45 (27) | 13 (33) | 48 (30) | 16 (33) | 13 (25) | 7 (32) | 13 (24) | 1 (7) |
≥6 to <9 months | 33 (20) | 5 (13) | 44 (28) | 11 (22) | 10 (19) | 6 (27) | 11 (20) | 3 (21) |
≥9 months | 71 (42) | 12 (31) | 44 (28) | 10 (20) | 25 (47) | 6 (27) | 19 (35) | 5 (36) |
Any post-PD anti-cancer therapyc, n (%) | 126 (75) | 21 (54) | 120 (75) | 32 (65) | 39 (74) | 14 (64) | 44 (81) | 9 (64) |
Any post-PD anti-EGFR mAb | 31 (18) | 3 (8) | 42 (26) | 13 (27) | 18 (34) | 5 (23) | 27 (50) | 7 (50) |
Small molecule EGFRi | 1 (1) | 0 | 4 (3) | 0 | 0 | 1 (5) | 0 | 0 |
Any post-PD anti-VEGF therapy | 35 (21) | 7 (18) | 32 (20) | 10 (20) | 28 (53) | 10 (45) | 23 (43) | 4 (29) |
Fluoropyrimidine | 97 (57) | 17 (44) | 89 (56) | 22 (45) | 37 (70) | 13 (59) | 34 (63) | 4 (29) |
Irinotecan | 94 (56) | 17 (44) | 97 (61) | 29 (59) | 34 (64) | 10 (45) | 36 (67) | 7 (50) |
Oxaliplatin | 35 (21) | 6 (15) | 25 (16) | 6 (12) | 13 (25) | 1 (5) | 13 (24) | 3 (21) |
Other/unknown | 74 (44) | 12 (31) | 62 (39) | 17 (35) | 31 (58) | 10 (45) | 41 (76) | 4 (29) |
ECOG Eastern Cooperative Oncology Group, EGFR(i) epidermal growth factor receptor (inhibitor), mAb monoclonal antibody, mFOLFOX6 modified FOLFOX6, PD progressive disease, VEGF vascular endothelial growth factor.
aUnknown for some patients.
bPatients were characterised as having BRAF mutations if mutations in BRAF exon 15 (at codon 600) were found.
cPatients could have ≥1 post-PD therapy