Table 2.
Summary table of recent adjuvant chemotherapy trials in stage II and III resected colon cancer.
| Trial | Study patients | Treatment | Disease-free survival | Overall survival |
|---|---|---|---|---|
| IMPACT30 | Duke B + C | 5FU 370–400 mg/m2 + folinic acid 200 mg/m2 daily days 1–5 | 3 year | 3 year |
| n = 1493 | q28 days × 6 months | 71% | 83% | |
| (p < 0.001) | (p = 0.029) | |||
| vs. observation | 62% | 78% | ||
| MOSAIC31 | Stage II + III | FOLFOX4 × 6 months | 5 year | 6 yeara |
| n = 2246 | 73.3% | 78.5% | ||
| (p = 0.003) | (p = 0.046) | |||
| vs. FU5LV × 6 months | 67.4% | 76% | ||
| NSABP C-0732 | Stage II + III | FULV + oxaliplatin 85 mg/m2 weeks 1, 3, and 5 q8 weeks × 3 cycles | 8 year | 8 year |
| n = 2409 | 69.4% | 80.2% | ||
| (p = 0.002) | (p = 0.08) | |||
| vs. FULV × 3 cycles | 64.2% | 78.4% | ||
| QUASAR33 | Surgically resected | 5FU 370 mg/m2 + LV 25 or 175 mg/m2 days 1–5 q28 days or | NA | 5.5 year |
| (90% stage II) | weekly × 30 5FU treatments | HR = 0.82 | ||
| n = 3239 | vs. observation | (p = 0.008) | ||
| X-ACT34 | Stage III | Capecitabine 1250 mg/m2 PO BID days 1–14 q21 days × 8 cycles | 3 year | 3 year |
| n = 1987 | 64.2% | 81.3% | ||
| (p = 0.12) | (p = 0.05) | |||
| vs. 5FU 425 mg/m2 + LV 20 mg/m2 bolus days 1–5 | 60.6% | 77.6% | ||
| q28 days × 6 cyclesb | ||||
| XELOXA35 | Stage III | XELOX × 8 cycles | 3 year | 5 year |
| n = 1886 | 70.9% | 77.6% | ||
| (p = 0.0045) | (p = NS) | |||
| vs. FULV or Mayo | 66.5% | 74.2% | ||
| ACCORD-0236 | Stage III | FU5LV + irinotecan 180 mg/m2 day 1 q14 days × 6 months | 3 year | 5 year |
| n = 400 | 51% | 61% | ||
| (p = 0.22) | (p = 0.26) | |||
| vs. FU5LV × 6 months | 60% | 67% | ||
| CALGB 8980337 | Stage III | LV 20 mg/m2 + 5FU 500 mg/m2 + irinotecan 125 mg/m2 weekly | 5 year | 5 year |
| n = 1264 | for 4 weeks q6 weeks × 5 cycles | 59% | 68% | |
| (p = 0.85) | (p = 0.74) | |||
| vs. FULV × 4 cycles | 61% | 71% | ||
| PETACC 338 | Stage II + III | FU5LV + irinotecan 180 mg/m2 day 1 q14 days × 6 months | 5 yearc | 5 yearc |
| n = 3278 | (or LV 500 mg/m2 + 5FU 2000 mg/m2over 24 h + irinotecan | 56.7% | 73.6% | |
| 80 mg/m2 weekly for 6 weeks q8 weeks × 4 cycles) | (p = 0.106) | (p = 0.094) | ||
| vs. FU5LV or alternative | 54.3% | 71.3% | ||
| NSABP C-0839 | Stage II + III | mFOLFOX6 × 6 months | 3 year | NA |
| n = 2672 | vs. mFOLFOX6 × 6 months + bevacizumab 5 mg/kg q2 weeks × 1 year | HR = 0.89 | ||
| (p = 0.15) | ||||
| AVANT40 | Stage II + III | FOLFOX4 × 6 months | NSd | NA |
| vs. FOLFOX4 + bevacizumab 5 mg/kg q2 weeks × 6 months followed | ||||
| by bevacizumab 7.5 mg/kg q3 weeks alone × 6 months | ||||
| vs. XELOX + bevacizumab 7.5 mg/kg q3 weeks × 6 months followed by | ||||
| bevacizumab 7.5 mg/kg q3 weeks × 6 months | ||||
| Intergroup N014741 | Stage III | mFOLFOX6 + cetuximab 250 mg/m2 (initial dose 400 mg/m2) | NS | NA |
| q2 weeks × 6 months | ||||
| vs. mFOLFOX6 × 6 months |
5FU, 5-fluorouracil; LV, leucovorin; NS, not significant; NA, not applicable or not reported.
FULV = 5FU 500 mg/m2 + LV 500 mg/m2 bolus weekly for 6 weeks q8 weeks.
FU5LV = LV 200 mg/m2 + 5FU 400 mg/m2 bolus, followed by 5FU 600 mg/m2 22 h infusion day 1 and day 2 q14 days. FOLFOX4 = FU5LV + oxaliplatin 85 mg/m2 day 1 q14 days × 6 months.
mFOLFOX6 = LV 400 mg/m2 + 5FU 400 mg/m2 + oxaliplatin 85 mg/m2 day 1 followed by 5FU 2400 mg/m2 over 46 h q2 weeks. Mayo = 5FU 500 mg/m2 + LV 20 mg/m2 bolus weekly × 30 treatments.
XELOX = capecitabine and oxaliplatin.
Includes stage II and III patients. Stage II patients: no overall survival advantage, stage III patients 72.9% vs. 68.7%; p = 0.023.
Non-inferiority trial design.
For stage III only. Stage II 5-year disease-free survival and overall survival are NS, but pooled stage II + III patients disease-free survival is significant (p = 0.045).
No disease-free survival benefit for the addition of bevacizumab.