Phase I/II studies on liver SBRT
| Study and Year | Type of Study | Histology | No. of patients (No. of tumors) | Tumor size (range) (mL) | Dose | Median FU (m) | Child-Pugh class | Local control | Overall survival | ≥ G3 acute toxicity (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Méndez Romero et al., 200685 | Phase I/II | met (n=34), HCC (n=11) | 25 (45) | 22.2 (1.1-322) | 10–12.5 Gy ×3ǂ | 12.9 | Child-PughA(n=5), Child-Pugh B (n=2); rest N/A | 1y 94%; 2y 82% | 1y 75%; 2y 40% | G3 (12%): 2 liver enzyme elevation; 1 asthenia; G5 (4%): liver failure |
| Tse et al., 200Ց88 | Phase I | HCC, IHC | 41 | 173 (9-1,913) | 24-54 Gy in 3 fx | 17.6 | Child-Pugh A | 1y 65% | Median 13.4 m | G3 (12%): 6 liver enzyme elevation |
| Cárdenes et al., 201083 | Phase I | HCC | 17(25) | 34 (8-95) | Dose esc to 48 Gy in 3 fx | 24 | Child-Pugh A (n=6), Child-Pugh B (n=11) | 1y 100% | 1y 75%; 2y 60% | Child-Pugh A: no DLT. Child-Pugh B: >G3 hepatic toxicity |
| Rusthoven et al., 200979 | Phase I/II | met (31.9% CRM) | 47 (63) | 14.9 (0.8-98.0) | Dose esc to 60 Gy in 3 fx | 16 | 1y 95%; 2y 92% | Median 20.5 m | G3 (2%): 1 soft tissue toxicity | |
| Lee et al., 200993 | Phase I | met (58.8% CRM) | 68 (143) | 75.2 (1.2-3,090) | 60 Gy in 6 fxǂ | 10.8 | Child-Pugh A | 1y71% | Median 17.6 m | G3 (6%): 2 gastritis, 2 nausea, 1 lethargy, 1 thrombocytopenia; G4 (1%): 1 thrombocytopenia |
| Goodman et al., 201094 | Phase I | met (n=10), HCC (n=2), IHC (n=5) | 26 (40) | 32.6 (0.8-146.6) | Dose esc to 18 Gy in 1 fx | 17.3 | Child-Pugh A | 1y 77% | Median 28.6 m | No acute G3 or higher acute toxicity |
| Kang et al., 201295 | Phase II | HCC | 50 (56) | 14.9 (2.4-213.8) | 42-60 Gy in 3 fx | 17 | Child-Pugh A (n=41), Child-Pugh B (n=6) | 2y 94.6% | 2y 68.7% | G3 (6%): 3 GI ulcers; G4 (4%): 2 gastric ulcer perforation |
| Scorsetti et al., 201396 | Phase II | met (47.5% CRM) | 61 (76) | 54.9 (1.8-134.3) | 75 Gy in 3 fxǂ | 12 | 1y 94% | Median 19 m | G3 (1.7%): 1 chronic chest wall pain | |
| Bujold et al., 201382 | Sequential phase I/II | HCC | 102 | 117 (1.3-1,913) | 24-54 Gy in 6 fx | 31.4 | Child-Pugh A | 1y 83% | Median 17 m | G3 (27%): increased AST/ ALT most common G4 (3%): 2 bilirubin increase ; 1 liver failure; G5 (7%): 5 liver failure , 1 GI bleed, 1 cholangitis |
ǂ, dose reduction if necessary for poor baseline liver function/to maintain constraints for organs at risk. SBRT, stereotactic body radiation therapy; CRM, colorectal metastases; CTV, clinical target volume; esc, escalation; DLT, dose limiting toxicity; met, metastatic liver tumors; fx, fractions; G3, grade 3; IHC, intrahepatic cholangiocarcinoma; m, months; n, number; N/A, not available.