Table 5.
Summary of phase II/III clinical trials examining radiation dose escalation with external beam radiotherapy in esophageal cancer.
| INT0123 Control arm | INT0123 High-dose arm | Li et al. (34) | Chen et al. (35) | Our study | |
|---|---|---|---|---|---|
| Patient No | 109 | 109 | 44 | 46 | 87 |
| SCC: AC | 84%: 16% | 87%: 13% | 100%: 0% | 52%: 48% | 100%: 0% |
| TNM stage | |||||
| T3-4 | 43% | 48% | 81% | 87% | 79.3% |
| N1 | 17% | 27% | 98% | 68% | 64.4% |
| M1 | - | - | - | 17% | 14.9% |
| Stage I-II | 13% | 22% | 33% | ||
| Stage III-IV | 87% | 78% | 67% | ||
| RT dose | |||||
| PTV-G | 50.4Gy/28F 1.8Gy/F |
64.8Gy/36F 1.8Gy/F |
59.92Gy/28F 2.14Gy/F | 63Gy/28F 2.25Gy/F |
66Gy/30F 2.2Gy/F |
| PTV-C | 50.4Gy/28F 1.8Gy/F |
64.8Gy/36F 1.8Gy/F |
50.4Gy/28F 1.8Gy/F |
50.4Gy/28F 1.8Gy/F |
54Gy/30F 1.8Gy/F |
| PTV-G BED2 | 61.74 Gy | 79.4 Gy | 76.0 Gy | 80.7 Gy | 84.2 Gy |
| Treatment time (weeks) | 5.6 | 7.2 | 5.6 | 5.6 | 6 |
| RT techniques | 2D | 2D | IMRT | IMRT | IMRT |
| Boost methods | NA | Sequential | SIB | SIB | SIB |
| Acute toxicities (Grade 3-5) |
G3: 43% G4: 26% G5: 2% |
G3: 46% G4: 21% G5: 9% |
G3: 53% G4: 4% G5: 0 |
G3: 22% G4: 0 G5: 0 |
G3: 20% G4: 8% G5: 0 |
| Late toxicities (Grade 3-5) |
G3: 24% G4: 13% G5: 0 |
G3: 34% G4: 11% G5: 1% |
G3: 0 G4: 0 G5: 2% |
G3: 7% G4: 0 G5: 0 |
G3: 15% G4: 0 G5: 5% |
| OS rates | 2-y: 40% | 2-y: 31% | 1-y: 76.9% | 1-y: 78% 2-y: 41% 3-y: 29% |
1-y: 83% 2-y: 67% 3-y: 62% 5-y: 58% |
| LC rates | 2-y: 48% | 2-y: 44% | 1-y: 78.8% | 1-y: 70% 2-y: 67% |
1-y: 87% 2-y: 82% 3-y: 82% 5-y: 80% |
| Reference | 5 | 5 | 26 | 28 | |
SCC, squamous-cell carcinoma; AC, adenocarcinoma; PTV-G, planning target volume for gross tumor; PTV-C, planning target volume for subclinical diseases; BED2, biologically equivalent dose for 2Gy conventional fractionated radiotherapy; 2D, two dimensional; IMRT, Intensity modulated radiotherapy; SIB, Simultaneous Integrated Boost; NA, not applicable; G, Grade; OS, Overall survival; LC, Local control; -y, -year.