Table 3. Studies of neoadjuvant chemoradiation followed by chemotherapy.
| Study | Key inclusion criteria | # pts | Treatment | pCR rate | Outcomes |
|---|---|---|---|---|---|
| Zampino, et al. (54) | T3, T4 or N+ | 51 | ChemoRT with capecitabine → capecitabine ×6 weeks | 18% (9/50) | R0 resection—100% 5-year DFS—85.4% |
| Gao, et al. (55) | T4, bulky (>5 cm), <6 cm from anal verge, N+, elevated CEA | 36 | ChemoRT with CAPOX → CAPOX ×3 weeks | 36% | R0 resection—100% Downstaged—81% |
| van DijK, et al. (56) | Metastatic rectal cancer | 50 | Short course radiation → CAPOX + bevacizumab for up to 18 weeks | 26% (11/43) | R0 resection of primary—91% (39/43) 2-year OS—80% LR rate after R0 resection—6% (2/36) |
| Garcia-Aguilar, et al. (51) | T3, T4 or N+ | 144 | Chemoradiation with 5-FU | 18% | R0 resection—97% |
| Chemoradiation with 5-FU → FOLFOX ×4 weeks | 25% | R0 resection—96% |
pCR, pathologic complete response; DFS, disease free survival; CEA, carcino-embryonic antigen; LR, local recurrence.