Table 3. Studies of IORT in locally advanced colorectal cancer after gross total resection.
| Author/Year | Sample size | Study design | T4 % | IORT type | IORT dose (Gy) | EBRT % | Median F/U | LC 5 year (%) | OS 5 year (%) | Toxicity grade 3 or > |
|---|---|---|---|---|---|---|---|---|---|---|
| Ratto et al. [52] 2003 | 43 IORT-19 No IORT-24 |
NRC | 93 | IOERT | 10–15 | 100 | 74 | Sx + IORT: 91 Sx − 57 p = 0.035 |
61 | NR for IORT patients |
| Sadahiro et al. [53] 2004 | IORT-99 No IORT-68 |
NRC | 12 | IOERT | 15–25 | 100 (20 Gy only) | 67 83 |
Sx + IORT-98 Sx- 84 p = 0.002 |
Sx + IORT- 79 Sx- 58 p = 0.002 |
NR for IORT patients |
| Ferenschild et al. [54] 2006 | 123 IORT-30 No IORT-93 |
NRC | 25 | HDR-IORT | 10 | 100 | 25 | R0+IORT:72 R0:71 (N.S diff) R(+) + IORT:58 R (+):0 (p = 0.016) |
R0+IORT:56 R0:66 (N.s diff) R+ ( + ) IORT:38 R+:0 (p= 0.026) |
NR for IORT patients |
| Roeder et al. [55] 2007 | 243 | RC | 20 | IOERT | 10–15 | 86 | 59 | R0 + IORT- 94 R(+) + IORT-72 |
NR | Total-10% Proctitis-8 Fistula-7 Bowel stenosis-8 |
| Mathis et al. [50] 2008 | 146 | PC | 64 | IOERT | 7.5–25 | 100 | 44 | 86 | 52 | Total- 22% Neuropathy-3* GI/GU-23* |
| Masaki et al. [56] 2008 | 44 IORT-19 No IORT-25 |
RCT | 0 | IOERT | 18–20 | No | 34 | Sx+IORT-94.7 Sx-95.5% |
p = 0.344 N.s diff |
Urinary catheter indwelling 29% vs. 3%, Rest- N.s diff |
| Valentini et al. [57] 2009 | 100 IORT-29 No IORT-71 |
NRC | 100 | IOERT | 10–15 | 100 | 31 | R0+IORT:100 R0:81 p = 0.014 |
NR | NR for IORT patients |
| Dubois et al [58] 2008 | 142 IORT-73 No IORT-69 |
RCT | 100 | IOERT | 15–18 | 100 | 60 | Sx + IORT- 91.8 Sx- 92.8 p = 0.6018 |
Sx + IORT - 69.8 Sx- 74.8 p=0.25 |
No difference in toxicity p=0.15 |
| Kusters et al [59] 2010 | 605 | PC Pooled analysis |
29 | IOERT | 10–12.5 | 100 | R0+IORT- 90.5 R(+) + IORT-55 p < 0.001 |
67 | NR | |
| Sole et al. [60] 2014 | 335 | PC | 16 | IOERT | 10–15 | 100 | 72.6 | 92 | 75 | Total-10% GI-19* GU-8* Neuropathy-7* |
| Holman et al [61] 2016 | 417 | PC Pooled analysis |
100% T4 |
IOERT | 10–12.5 | 97 | 52 |
R0 + IORT- 87 R1 + IORT- 60 R2 + IORT- 57 p < 0.001 |
R0 + IORT-65 R1 + IORT- 34 R2 + IORT- 14 p < 0.001 |
NR |
NRC: non randomised comparison, RCT: randomised controlled trial, PC: prospective cohort, RC: retrospective cohort, F/U: follow-up, Sx: surgery, R(+): residual after surgery, LC:-local control, OS:-overall Survival, NR: not reported,
*
Number of patients,
N.s diff: Non significant difference.