Table 2.
Two phase III studies investigating the role of adding oxaliplatin to preoperative chemoradiotherapy in rectal cancer
| Study | Schema | N | Grade 3/4 toxicities (%) |
LAR | pCR | Pathological metastatic disease (%) |
|---|---|---|---|---|---|---|
|
STAR-01 |
Radiotherapy (59.4 Gy) and 5-fluorouracil |
379 |
8% |
72% |
16% |
3% |
| (primary objective: | ||||||
| overall survival) |
Radiotherapy, 5-fluorouracil and oxaliplatin |
368 |
24% (p < 0.0001) |
73% |
16% |
0.5% |
|
ACCORD 12/0405 |
Radiotherapy (45 Gy) and capecitabine |
299 |
11% |
73% |
14% |
4% |
| PRODIGE 2 (primary | ||||||
| objective: pCR) |
Radiotherapy, capecitabine and oxaliplatin |
299 |
25% (p < 0.0001) |
76% |
19% |
3% |
N: patient number; LAR: low anterior resection; pCR: pathological complete response