Table 4.
Summary of proton and carbon ion therapy studies
| Study | Nature of study and number of patients | Dose/fractionation | Concurrent chemotherapy | Outcomes | Acute toxicity (≥ Grade 3) | Late toxicity (≥ Grade 3) |
|---|---|---|---|---|---|---|
| Hong et al., 2014 (26) (Proton) | Prospective (Neoadjuvant), 50 | 25 Gy/5 fractions | Capecitabine | 11 patients did not have surgery | Colitis [1], chest wall pain [1] | |
| Out of 48 patients: PFS: 10.4 months; OS: 17.3 months; 2-year OS: 42%; | ||||||
| Out of 37 patients who had surgery: PFS: 14.5 months; OS: 27 months | ||||||
| Nichols et al., 2013 (27) (Proton) | Retrospective, 22 [5 resectable, 5 borderline resectable (BRPC), 12 LAPC] | 50.4–59.4 Gy/28–33 fractions | Capecitabine | Median survival: Resectable—11 months; BRPC—14 months; LAPC—8.8 months | None | |
| Sachsman et al., 2014 (28) (Proton) | Prospective (Definitive), 11 | 59.4 Gy/33 fractions | Capecitabine | 2-year PFS: 14%; OS: 18.4 months; 2-year OS: 31%; 2-year FFLP: 69% | None | |
| Terashima et al., 2012 (29) (Proton) | Prospective (Definitive), 50 | P1: 50 Gy/25 fractions [5]; P2: 70.2 Gy/26 fractions [5]; P3: 67.5 Gy/25 fractions [40] | Gemcitabine | Overall: 1-year PFS: 64.3%; 1-year OS: 76.8%; 1-year FFLP: 81.7%; | P1 and P2: acute GI bleeding [1] | P3: GI ulcer treated with medications [3]; death from GI bleed [1] |
| P3 patients: 1-year PFS: 60.8%; 1-year OS: 78.8%; 1-year FFLP: 79.9% | ||||||
| Ito et al., 2004(30) (Carbon) | Retrospective (Neoadjuvant), 4 | 48 GyE (covering pancreas, lymph nodes and nervous plexus) | Post-operative cholangitis [1] | None | ||
| Shinoto et al., 2016 (31) (Carbon) | Prospective (Definitive), 71 | 43.2–55.2 GyE/12 fractions | Gemcitabine | 1-year OS: 73%; 2-year OS: 35%; Median OS: 19.6 months | Anorexia [6], GI bleed [1] | |
| Okada et al., 2010 (32) (Carbon) | Prospective (Neoadjuvant), 22 | 16 fractions over 4 weeks | 1-year FFLP: 100%; 2-year FFLP: 87%; 2-year OS: 24% (7 patients did not proceed to surgery) | |||
| Prospective (Definitive), 31 | 38.4–48 GyE/12 fractions/3 weeks | 1-year FFLP: 81%; 1-year OS: 44% | None | None |
IMRT, intensity modulated radiation therapy; SBRT, stereotactic body radiotherapy; LAPC, locally advanced pancreatic cancer; BRPC, borderline resectable pancreatic cancer; OS, overall survival; GI, gastrointestinal; PFS, progression-free survival; BED, biological equivalent dose; FFLP, freedom from local progression.