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. 2018 Oct 12;105(12):1553–1572. doi: 10.1002/bjs.10993

Table 3.

Summary of phase II trials of epidermal growth factor receptor inhibitors

Results (%)*
Reference Phase Disease stage Test drug Single/combination Cohort size pCR rate cCR rate Other endpoints Toxicity
66 II T3–4 N–/+ Panitumumab Single 19 0 Downstaging 41
Negative CRM 76
LRC 90
DFS 79
GI disturbance 89
Grade 4 toxicity 21
67 II T3–4 N–/+ Cetuximab Cetuximab + capecitabine 31 0 Downstaging 42 GI disturbance 13
Grade 4 toxicity 3
68 II T3–4 N–/+ Panitumumab Panitumumab + oxaliplatin +5‐FU 60 21 Downstaging 58 GI disturbance 39
1 death
69 II T3–4 N–/+ Panitumumab Panitumumab + capecitabine versus capecitabine alone 68 10 (18) R0 resection 85 (93)
Sphincter salvage 69 (70)
Downstaging 87 (85)
GI disturbance 10 (4)
70 II T3–4 Cetuximab Cetuximab + capecitabine + oxaliplatin versus capecitabine + oxaliplatin 165 11 (9) 11 (7) Radiological response 71 (51) GI disturbance 8 (9)
71 II T2–4 N–/+ Cetuximab Cetuximab + capecitabine + irinotecin 82 17 5 R0 resection 82 GI disturbance 25
Grade 4 toxicity 10
72 II T3–4 N–/+ Cetuximab Cetuximab + capecitabine 47 8 3‐year DFS 72
3‐year RFS 74
3‐year OS 68
2 of 32 unable to complete treatment owing to GI disturbance and leucopenia
73 I–II T3–4 N–/+ Cetuximab Cetuximab + capecitabine + oxaliplatin 60 8 5‐year OS 76
3‐year DFS 88
5 ‐year CSS 78
Grade 2 toxicity 5
*

Results for control group are shown in parentheses. pCR, pathological complete response; cCR, clinical complete response; CRM, circumferential resection margin; LRC, locoregional control; DFS, disease‐free survival; GI, gastrointestinal; 5‐FU, 5‐fluorouracil; RFS, relapse‐free survival; OS, overall survival; CSS, cancer‐specific survival.