Table 2.
Long-term outcomes and short-term early endpoints.
| RAPIDO | PRODIGE 23 | STELLAR | ||||
|---|---|---|---|---|---|---|
| No of Patients | 920 Enrolled 912 Eligible | 461 Randomized | 599 Randomized (Non-Inferiority) | |||
| 462 | 450 | 231 | 300 | 300 | 293 | |
|
Novel arm
SCPRT + Capeox × 6 |
Standard LCCRT/+/− adjuvant |
Novel arm
FOLFOXIRI + LCCRT |
Standard LCCRT + adj |
Novel arm
SCPRT + Capeox × 4 |
Standard LCCRT+ adj | |
| Underwent surgery | 423 | 398 | 213 | 215 | 235 | 230 |
| Primary endpoint | 3 year DRTF 30.4% vs. 23.7% HR 0.75, p = 0.019 |
3 year DFS 75.5% vs. 68.5%) HR 0.69, p = 0.03 |
3 year DFS (non inferiority) 64.5 vs. 62.3% HR 0.88 p ≤ 0.001 |
|||
|
pCR rate resected
and ITT |
120/423 (28.4%) ITT 26% |
14.3% p ≤ 0.0001 ITT 12.6% |
59/212 (27.8%) ITT 25.5% |
26/215 (12%) p ≤ 0.0001 ITT 11.3% |
39/235 (16.6%) ITT 13% |
27/230 (11.8%) NS ITT 9.2% |
| Median NAR score | No data | No data | 8.4 | 15.0 | No data | No data |
| Mean NAR score | No data | No data | 11.2 | 16.1 | No data | No data |
| R0 resection rate | 90% | 90% | 95% | 94% | 91.5% | 87.8% |
| ypT2 | 82/423 (19%) | 96/398 (24%) | 57/212 (27%) | 62/215 (29%) | 73 (31.1%) | 64 (27.8%) |
| ypT3 | 157/423 (37%) | 190/398 (48%) | 77/212 (36%) | 103/215 (48%) | 106 (45.1%) | 113 (49.1%) |
| ypT4 | 36/423 (9%) | 25/398 (6%) | 4/212 (2%) | 4/215 (2%) | 7 (3.0%) | 10 (4.3%) |
| ypN+ | 106/423 (25%) | 125/398 (31.4%) | 37/212 (17.6%) | 69/215 (32%) | 67 (28.4%) | 70 (30.6%) |
| Acute G3/4 toxicity | 48% during NACT | 25% during LCCRT | 47% during NACT | 36% during LCCRT | 26.5% during NACT | 12.6% during LCCRT p < 0.001 |
| Treatment related death | 3% | 3% | 4% | 5% | No data? 1/298 (0.3%) | No data? 1/293 (0.3%) |
| Sphincter sparing procedures | 58.9% | 56.2% | 85.9% | 85.1% | 47.2% | 52.6% |
| APER rate | 149/426 (35%) | 160/400 (40%) | 30/213 (14.1%) | 30/215 (14.0%) | 106/235 (45.1%) | 95/230 (41.3%) |
| 3-year Locoregional failure | 8.3% | 6% NS | 4.8% | 5.6% NS | 8.5% | 11.1% NS |
| 3-year survival without mets | 78.8% | 71.7% | 80% | 73.2% | 76.8% | 75% |
| 3-year overall survival | 89% | 89% | 91% | 88% | 86.5% | 75.1% HR = 0.67 p = 0.038 |