Study | Dose (Gy)/fx | EQD2 (Gy) | OTT (weeks) | No. of patients | Median FU | Risk group (%) (ADT) | RT methods | BCFFS/DFS (%) | Grade ≥ 2 toxicity (%) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acute | Late | |||||||||||||||||||
a/b = 1.5 Gy | a/b = 3 Gy | a/b = 4 Gy | Low | Intermediate | High | Low | Intermediate | High | All | P= | GI | GU | GI | GU | ||||||
Randomized controlled trials: MHF vs. conventional fractionation | ||||||||||||||||||||
Pollack et al. [13] | 76.0/38 70.2/26 | 76.0 84.4 | 76.0 80.0 | 76.0 78.4 | 7.6 5.2 | 152 152 | 68 mo | 0 | 66 (20%, 4 mo) | 34 (100%, 24 mo) | IMRT | at 5-years | 80.5/85.0 82.2/73.8 (no ADT/ADT) | 73.9 67.9 | 78.6 76.7 | .268 | 22.5 18.1 | 14.6 15.3 | Not reported | 13.4 21.5 |
RTOG 0415 [14] | 73.8/41 70.0/28 | 69.6 80.0 | 70.8 77.0 | 71.3 75.8 | 8.2 5.6 | 542 550 | 70 mo | 100 (no ADT) | 0 | 0 | 3D-CRT/ IMRT | 85.3 86.3 | NI a | 10.3 10.7 | 27.2 27.0 | 13.9 22.2 | 22.5 29.5 | |||
HYPRO [15] | 78.0/39 64.6/19 | 78.0 90.4 | 78.0 82.7 | 78.0 79.7 | 7.8 6.5 | 397 407 | 60 mo | 0 | 27 (67%, 34 mo) | 73 | IMRT | 77.1 80.5 | .36 | 31.2 42.0 | 57.8 60.5 | 17.7 21.9 | 19.0 12.9 | |||
CHHiP [16] | 74.0/37 60.0/20 57.0/19 | 74.0 77.1 73.3 | 74.0 72.0 68.4 | 74.0 70.0 66.5 | 7.4 4.0 3.8 | 1065 1074 1077 | 62 mo | 15 | 73 (97%, 3–6 mo) | 12 | IMRT | 96.7 96.6 90.9 | 86.8 90.2 86.0 | 86.5 84.2 78.3 | 88.3 90.6 85.9 | NI a | 25 38 38 | 46 49 46 | 13.7 11.9 11.3 | 9.1 11.7 6.6 |
PROFIT [17] | 78.0/39 60.0/20 | 78.0 77.1 | 78.0 72.0 | 78.0 70.0 | 7.8 4.0 | 598 608 | 72 mo | 0 | 100 (no ADT) | 0 | 3D-CRT/ IMRT | 85.0 85.0 | .16 | 10.4 16.3 | 30.6 30.4 | 13.9 9.9 | 22.4 22.0 | |||
EHF single arm studies | ||||||||||||||||||||
Katz and Kang [22] | 35.0–36.25/5 | 85.0–90.6 | 70.0–74.3 | 64.2–68.0 | 1.0 given daily | 515 | 72 mo | 63 (8%) | 30 (16%) | 7 (55%) | SBRT | at 7-years 95.6 | 89.6 | 68.5 | 4 | 4 | 4 | 9.1 | ||
King et al. [19] | 35.0–36.25/5 | 85.0–90.6 | 70.0–74.3 | 64.2–68.0 | 1.0–1.5 | 1100 | 36 mo | 58 (8%, 3mo) | 30 (15%, 4 mo) | 11 (38%, 4mo) | SBRT | at 5-years 95 | 84 | 81 | Not assessed | |||||
Loblaw et al. [18] | 35.0/5b | 85.0 | 70.0 | 64.2 | 4.0 | 84 | 55 mo | 100 (no ADT) | 0 | 0 | SBRT | 98 | – | – | 10 | 20 | 8 | 5 | ||
Current trial: prospective phase II study comparing MHF vs. EHF | ||||||||||||||||||||
Current trial | MHF | 77.1–83.3 | 71.3–72.4 | 68.2–70.0 | 4.4–4.7 | 52 | 90 mo | 34 | 45 (no ADT) | 21 | PBT | at 7-years 90.5 | 83.5 | 41.7 | 76.2 | .005 | 0 | 4 | 19 | 12 |
EHF | 85.0 | 70.0 | 64.2 | 2.0–4.0 | 30 | 57.1 | 42.9 | 40.0 | 46.2 | 0 | 7 | 13 | 7 |