Table 5.
Comparison of different adjuvant chemoradiation studies
| First author (country, year) |
Type of study | No. of patients | Type of chemotherapy | T3-4 | N+ | Any Gr ≥ 3 tox. | Gr > 3 Hem. tox. | Gr > 3 Non- hem. tox. | Toxic deaths | Relapse rate | Median survival (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| MacDonald [4] (USA, 2001) |
Phase 3 | 556 | 5FU/LV1 | 66% | 85% | 41% | 54% | 63% | 1% | 43% | 36 |
| Park [18] (South-Korea,2003) |
Phase 2 | 290 | 5FU/LV | NA | 90% | NA | 30% | 38% | 0% | 39% | NA |
| Hughes [14] (Australia, 2004) |
Retrosp. | 452 | 5FU/LV | 85% | 81% | 42% | 18% | 20% | 0% | 68% | 22.8 |
| Kollmannsberger [20] (Germany, 2005) |
Phase 2 | 86 | DDP/5FU PAC/DDP/5FU/LV4 |
NA | NA | NA | 81% 89% | 56% 56% | 0% 0% |
19% 33% |
NA NA |
| Kim [9] (South Korea, 2005) |
Retrosp. | 990 | 5FU/LV | 48% | 93% | NA | 30% | 15% | 1% | 42% | 95 |
| Kassam [15] (Canada, 2006) |
Retrosp. | 822 | 5FU/LV3 DDP/5FU |
53% | 82% | 56% | 33% | 34% | 0% | 32% | NR |
| Lee [19] (South-Korea, 2006) |
Phase 2 | 31 | DDP/5FU | NA | 100% | NA | 66% | 12% | 0% | 13% | NA |
| Oechsle [8] (Germany,2007) |
Phase 2 | 157 | DDP/PAC/5FU/LV | NA | NA | NA | 100% | 58% | 0.6%5 | 51% | NA |
| DDP/5FU/LV | 93% | 59% | 52% | NA | |||||||
| CPT11/5FU/LV | 80% | 73% | 100% | NA | |||||||
| DOC/DDP/5FU | 100% | 30% | 30% | NA | |||||||
| Tsang13] (Hong Kong, 2008) |
Retrosp. | 632 | 5FU/LV | 52% | 86% | 30% | 24% | 14% | 1.5% | 52% | NR |
| Hofheinz [16] Germany, 2008) |
Extend. phase I | 322 | CAPE/OXALI | 44% | 97% | NA | 21% | 42% | 0% | 47% | NA |
| Di Costanzo [7] (Italy, 2008) |
Phase 3 | 258 | DDP/EPI/5FU/LV1 | 54% | 84% | NR | 27% | 75% | 0.8% | 48% | 57 |
| Leong [22] (Australia, 2009) |
Phase 2 | 54 | EPI/DDP/5FU | 57% | 98% | NA | 28% | 66% | 0% | 37% | NR |
| Aftimos [21] (Lebanon, 2010) |
Retrosp. | 24 | 5FU/LV DDP/5FU |
75% | 71% | NA | 20% | 36% | 0% | 22% | 75 |
| Chang [17] (Hong Kong, 2011) |
Retrosp. | 1202 | 5FU/LV | 45% | 93% | 66% | 61% | 15% | 0% | 41% | 64 |
| Current (Israel, 2011) |
Retrosp. | 166 | 5FU/LV | 77% | 85% | 46% | 32% | 25% | 1.8% | 30% | NR |
Tox. = toxicity, Hem. = hematological, Extend. = extended, Retrosp. = retrospective, DDP = cisplatin, PAC = paclitaxel, EPI = epirubicin, CAP = capecitabine, OX = oxaliplatin, DOC = docetaxel, 5FU = 5 fluorouracil, LV = Leucovorin. NR = not reached, NA = not available.
1The regimen used in the treatment arm. The control arm included surgery alone.
2These studies included also patients undergoing R1 resection; results of outcome represent patients undergoing R0 resection,
whenever reported separately.
3Combined analysis of more than one regimen.
4Combined report of consecutive phase II cohorts.
5Joint figure for all cohorts combined