Table 2.
Study | Study design | No. of patients | Previous radiotherapy | Follow-up, mo | Tumor volume, median (range), cm3 | No. of fractions, median (range) | Total dose, median (range), Gy | Efficacy | Severe toxicity | References |
---|---|---|---|---|---|---|---|---|---|---|
David J Perry, 2010 | R | 34 |
Median time to previous irradiation: 16 mo (range, 1–337 mo); Median dose of prior irradiation: 63 Gy (range, 24–74 Gy) |
23 (6–54) | NA | 1 | 15 (10–20) |
1-year LPFS: 66%; 2-year LPFS: 56%; 1-year OS: 73%; 2-year OS: 55%; Median OS: 24 mo |
Cellulitis: 14%; Fistula or wound complications: 9%; Osteoradionecrosis: 3%; Radiation-induced trigeminal neuralgia: 3% |
[30] |
V Rudzianskas, 2012 | R | 30 |
Median interval to failure from prior irradiation: 12 mo (range, 3–43 mo); Median dose of prior irradiation: 66 Gy (range, 50–72 Gy) |
16 (4–32) | PTV: 36 (8–107) | 12, bid | 30 |
1-year LC: 73%; 2-year LC: 67%; 1-year DFS: 60%; 2-year DFS: 53%; 1-year OS: 63%; 2-year OS: 47% |
Acute toxicities: Grade 2 moderate fibrosis: 7%; Grade 3 delayed wound healing: 3%; Late toxicities: Grade 2 dysphagia: 3%; Grade 2 persistent hoarseness: 3%; Grade 4 osteonecrosis: 3% |
[28] |
L Matthew Scala, 2013 | R | 76 |
Median time to previous irradiation: 24 mo (range, 3–240 mo); Median dose of prior irradiation: NA (46.8–80 Gy) |
11 | Median IORT field size: 5 cm × 6 cm (range: 1 cm × 2 cm to 11 cm × 17 cm) | 1 | 12 (7.5–17.5) |
1-year in-field control rate: 66%; 2-year in-field control rate: 62%; Median DFS: 12 mo; 1-year OS: 64%; 2-year OS: 42%; Median OS: 19 mo |
Flaps revision: 4%; Nonfatal carotid hemorrhage: 1%; Vagal neuropathy: 1% |
[31] |
Susanne Wiegand, 2013 | R | 12 |
Median time to previous irradiation: 96 mo (range, 12 -180 mo); Median dose of prior irradiation: NA |
NA | NA | NA (2–3 Gy per fraction), bid | (20–33) | Median OS: 8.5 mo | None | [7] |
Viktoras Rudžianskas, 2014 | RCT | 32 |
Median time to previous irradiation: 14.9 mo (range, 3–26.1 mo); Median dose of prior irradiation: 66 Gy (range, 50–70 Gy) |
NA | PTV: 34.8 (8–107) | 12, bid | 30 |
1-year LC: 77%; 2-year LC: 63%; Median LC: 28.1 mo; 1-year OS: 74%; 2-year OS: 67%; Median OS: 33.4 mo |
Severe acute toxicities: 34.4%; Severe late toxicities: 3.1% |
[6] |
Luca Tagliaferri, 2015 | R | 9 |
Median interval to failure from prior irradiation: 28 mo (range, 11–60 mo); Dose of prior irradiation > 65 Gy |
21 | NA | 12, bid | 30 |
Median DFS: 12 mo; Median OS: 23 mo |
Grade 3 acute toxicities: 11.1%; Grade 2 late toxicities: 11.1% |
[24] |
John V Hegde, 2018 | R | 20 |
Median interval to failure from prior irradiation: 9.1 mo (range, 2.4–351.6 mo); Median dose of prior irradiation: NA |
11.3 (3.4–65.6) | CTV: 43.7 (7.6–155.6) | 8 (2–12), bid | 36.5 (16.25–48) |
1-year LC: 55%; 1-year regional control: 62%; 1-year LRC: 38%; 1-year DMFS: 94%; 1-year OS: 77% |
Acute grade 3 toxicities: Dysphagia: 25%; Soft tissue necrosis: 5%; Grade 3 to 4 late toxicities: 33% |
[29] |
R retrospective analysis, RCT randomized controlled trial, mo months, NA not available, bid twice daily, IORT intraoperative radiotherapy, PTV planning target volume, CTV clinical target volume, LPFS local progression-free survival, OS overall survival, LC local control, DFS disease-free survival, LRC locoregional control, DMFS distant metastasis-free survival