Table 2.
Baseline characteristics of cohort groups of cetuximab for meta‐analysis
| Study | Study design | Enrollment | Neoadjuvant therapy | Median age, year | Stage at enrollment | Distance from anal verge, cm | KRAS status | Preoperative Grade3/4 toxicity | pCR |
|---|---|---|---|---|---|---|---|---|---|
| Bengala 2009 | Prospective Phase II | 40 | 5‐FU + cetuximab + RT | 61 | uT3N0: 12; uT3N1: 25; uT4N1: 3 | NR | Wild‐type: 30; Mutated: 9 | NR | 7.7% (3/39) |
| Horisberger 2009 | Prospective Phase II | 50 | Capecitabine+Irinotecan+cetuximab+RT | 57 | cT2: 5; T3: 42; cT4: 2; Local relapse: 1; cN0: 13; cN+: 37 | 7.5 (Median) (1–13, Range) | NR | NR | 8% (4/50) |
| Kim 2011 | Prospective Phase II | 40 | CapIri + cetuximab + RT | 56.5 | cT3N0: 6; cT3N+: 30; cT4N0: 2; cT4N+: 2 | ≤5: 19 > 5: 21 5.5 (Median) (0–8.0, Range) | Wild‐type: 33; Mutated: 5 | 17.9% (7/39) | 23.1% (9/39) |
| Machiels 2007 | Prospective Phase I/II | 40 | Capecitabine + cetuximab + RT | 61 | cT2N+: 2; cT3N0: 18; cT3N+: 13; cT4N0: 5; cT4N+: 2 | <6 cm: 25 6–10 cm: 10 > 10 cm: 5 | NR | NR | 5% (2/40) |
| Rodel 2008 | Prospective Phase I/II | 60 | Capox + cetuximab + RT | 61.5 | cT2N1‐2: 1; cT3N0: 7; cT3N1‐2: 43; cT4N0: 2; cT4N1‐2: 7 | 7 ± 3.5 (Mean ± SD) 0–14 (Range) Lower third (≤6 cm): 27 Middle third (6–12 cm): 27 Upper third (≥12 cm): 6 | NR | NR | 8.9% (4/45) |
| Sun 2012 | Prospective Phase II | 63 | Capecitabine + cetuximab + RT | 64 | cT3N0: 8; cT3N1: 21; cT3N2: 26; cT4N0: 2; cT4N1: 2; cT4N2: 4 | 5 (Median) (1–9, Range) | Wild‐type: 44; Mutated: 19 | NR | 12.7% (8/63) |
| Velenik 2012 | Prospective Phase II | 47 | Capecitabine + cetuximab + RT | 55 | cT3N0: 3; cT2N1: 1; cT3N1: 13; cT2N2: 1; cT3N2: 15; cT4N2: 4 | 6 (Median) (1–11, Range) | Wild‐type: 30; Mutated: 7 | NR | 8.1% (3/37) |
| Dewdney 2012 | Prospective Phase II | 83 | Capecitabine + cetuximab + RT | 61 | cT3c‐ T3d: 47; T4: 21 | NR | aWild‐type: 46; Mutated: 37 | NR | 18% (15/83) |
pCR, pathologic complete response; RT, radiotherapy; 5‐FU, fluorouracil; CapIri, capecitabine plus irinotecan; Capox, capecitabine plus oxaliplatin; NR, not reported.
a
KRAS/BRAF status.