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Page 6 of 23 Thonglert et al. Hepatoma Res 2023;9:40 https://dx.doi.org/10.20517/2394-5079.2023.47

Table 1. Summary of proton beam therapy (PBT) studies for patients with intrahepatic cholangiocarcinoma (iCCA)

Pt and tumor Median
Author yr Study type Country No.of Pts RT Details LC OS G3+ Toxicity
characteristic follow-up
[20]
Hong et al. 2016 Prospective USA 83 (iCCA: 37; Treatment volume Age: median 66.9 yr (range 19.5 mo 2-yr LC 94.1% Median OS 22.5 G3: 3 (7.7%): liver
phase II study cHCC/CCA 2) - GTV = gross tumor 29.9-87)* (range: 0.6- (Recurrence mo* failure, stomach ulcer,
- CTV = GTV + (0-10) mm Sex: male 35.9%* 55.9 mo)* beyond 2 years 1-yr 69.7%* elevated blirubin*
- PTV = CTV + (5-10) mm Solitary lesion: 87.2%* occurred)* 2-yr 46.5%*
Dose: peripheral: 67.5 Tumor size: median 6 cm
GyE/15 F; central: 58.05 (range 2.2-10.9)*
GyE/15 F Metastasis: 0%*
Cirrhosis: 97.4%*
Prior treatment: 61.5% (CT:
61.5%; Resection: 2.6%;
Ablation: 2.6%; TACE: 0;
Other 23.1%)*
[22]
Smart et al. 2020 Retrospective USA iCCA 66 Treatment volume Age: median 76 yr (range 14 mo from 2-yr LC 84% Median OS 25 RILD 1 (1.5%); G3+: 7
study - GTV = gross tumor 30-92) RT, 21 mo overall; 93% for mo (11%)
- CTV = GTV + (3-10) mm Sex: male 41% from curative intent 2-yr OS 58%
- PTV = CTV + (5-10) mm Solitary lesion: 70% diagnosis Curative intent:
Dose: median 58.05 Gy Tumor size: 5.6 cm (range Median OS 26
(range 37.5-67.5) in 15 F; 2.5-16 cm) mo
median BED of 80.52 Gy Metastasis: 23% 2-yr OS 62%
(range 46.9-97.9) Cirrhosis: 9%
Technique: - Proton (PS): Prior treatment: CT: 42%;
32 (48%) resection 8%
- Photon: 34 (52%) Definitive intent: 77%
[23]
Tao et al. 2016 Retrospective USA iCCA 79 Treatment volume Age: median 63 yr (range 33 mo (range 1-yr LC 81% Median OS 30 0 cases of RILD
study - GTV = gross tumor 31-87) 11-93 mo) 2-yr LC 45% mo
- CTV = GTV + (0-10) mm Sex: male 42% 3-yr LC 27% 1-yr OS 87%
- PTV = CTV + 5 mm) Solitary lesion: N/A (89% recur within 2-yr OS 61%
Dose: median 58.05 Gy Tumor diameter: median the high dose RT 3-yr OS 44%
(range 35-100 Gy) in 3-30 7.9 cm (range 2.2-17 cm) field) BED10 > 80.5 vs.
F; median BED 80.05 Gy Metastasis: 20% BED10 > 80.5 vs. ≤ ≤ 80.5 Gy: 3-yr
(range 43.75-180 Gy) Cirrhosis: N/A 80.5 Gy: 3-yr LC OS: 73% vs.
Technique: Prior treatment: 78% vs. 45% (P = 38% (P = 0.017)
- proton (PS): 25 (32%) chemotherapy 89% 0.04)
- photon: IMRT 41 (52%);
3D-CRT 13 (16%)
[35]
Makita et al. 2014 Retrospective Japan 28 (iCCA 6) Treatment volume Age: median: 71 (range 41- 12 mo (range, 1-yr LC 67.7% 1-yr OS 49% Acute G3: cholangitis 1
study - GTV = gross tumor 84) 3-29) BED10 > 70 vs. < 70 Late G3: cholangitis 2;
- CTV = GTV + (5-10) mm Sex: male: 61% GyE: 1-yr LC 83.1% common bile duct
- PTV = CTV + (5-7) mm Location: iCCA 21%; eCCA vs. 22.2% (P = stenosis;
Dose: median 68.2 GyE 32%; GB 10.7% 0.002) duodenal ulcer 1;
(range 50.6-80 GyE) of 2- Solitary lesion: N/A duodenal hemorrhage
3.2 Gy per F; median BED10 Tumor size: median: 5.2 cm 2;
75.8 GyE (range, 61.7-105.6 (range 2-17.5 cm) duodenal stenosis 1
GyE) Metastasis: 0% No G4+ toxicity