Table 5.
Cumulative incidence of late RTOG grade ≥2 toxicity in five randomized trials
| Trial (ref.[s]) |
|||||
|---|---|---|---|---|---|
| Toxicity | M. D. Anderson (1) | NKI (2, 3) | PROG 9509 (4) | RMH pilot (5) | MRC RT01 (6, 7) |
| RT dose Gy | 70 vs. 78 | 68 vs. 78 | 70.2 vs 79.2 | 64 vs. 74 | 64 vs. 74 |
| Setting | US | The Netherlands | US | UK | UK, Australia, New Zealand |
| Sites | Single site | Multisite | Single site | Single site | Multisite |
| RT technique | CFRT photon | CFRT photon | CFRT photon | CFRT photon | CFRT photon |
| CFRT boost | CFRT boost | Proton boost | CFRT boost | CFRT boost | |
| No. of patients randomized | 301 | 669 | 393 | 126 | 843 |
| Toxicity scale | RTOG-LENT modified∗ | RTOG/EORTC | RTOG | RTOG original | RTOG original |
| Median follow-up (years) | 8.7 | 5.8 | 5.5 | 6.2 | 5.3 |
| Grade ≥2 64 Gy vs. 74 Gy | 13% vs. 26% (p = 0.013) | 25% vs. 35% (p = 0.04) | 9% vs. 18% (p = 0.005) | 11% vs. 23% (p = 0.02) | 24% vs. 33% (p = 0.005) |
| Analysis time point and type | By 10 years cumulative | By 7 years cumulative | “Late” snapshot | By 2 years cumulative | By 5 years cumulative |
∗
Composite score including rectal bleeding.