Table 3.
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.