Table 1.
Hypofractionated primary radiotherapy for prostate cancer
| Institution | Number of patients | Fractionation (total dose/singel dose/fractions) | EQD for tumor α/β-ratio 1.4Gy | EQD for normal tissue α/β-ratio 3Gy | Follow-up | Acute GU toxicitiy | Late GU toxicity | Acute GI toxicity | Late GI toxicity | Therapeutic outcomes |
|---|---|---|---|---|---|---|---|---|---|---|
| Rome, Italy [14] | 168 pat. | Arm I: 80Gy/2Gy/40 fractions; ArmII: 62Gy/3.1Gy/20 fractions, 4x/week. | 82.1Gy | 74.2Gy | 70 months | Arm I: 40% ≥ II° GI, Arm II: 47% ≥ II° GI. | Arm I: 16% ≥ II° GI, Arm II: 11% ≥ II° GI. | Arm I: 21% = II° GI, Arm II: 35% = II° GI. | Arm I: 17% ≥ II° GI, Arm II: 14% ≥ II° GI. | Hypofraction-RT is not inferior to conventional RT, potentially even better for high-risk pat. (iPSA > 20 ng/ml, GS > 7, cT > 2c). |
| 11 UK centres [15] | Arm I: 153 pat. 74Gy; Arm II 153 pat. 60Gy and 151 pat. 57Gy. | Arm I: 74Gy/2Gy/37 fractions; Arm II: 57-60Gy/3Gy/19-20 fractions | 73.8/77.6Gy | 68.4/72Gy | 50.5 months | - | 3 pat. (2 · 2%) in 74Gy group, 3 (2 · 2%) in 60Gy group, and 0 in 57Gy group ≥ II° GU. | - | 6 pat. (4 · 3%) in Arm I ≥ II° GI RTOG, 5 pat. (3 · 6%) in Arm II, 2 (1 · 4%) in 57Gy group. | - |
| Fox Chase, Philadelphia [16] | 307 pat. (ASTRO Update 2011) | Arm I: 76Gy/2Gy/28 fractions; Arm II: 70.2Gy/2.7Gy/26 fractions | 84.7Gy | 80Gy | 5 years | Arm I: 54% > II°; 2% > III°; Arm II: 40% > II°; 8% > III°. | Arm I: 8.3%; Arm II: 18.3% at 5 years. | Arm I: 8% > II° GI; Arm II: 18% > II° GI. | - | biochemical recurrence 21.5% vs. 21.9% at 5 years |
| MDACC [17] | 101 pat. in CIMRT, 102 pat. in HIMRT arm. For all pat. 28% low-risk, 71% intermed.-risk, 1% high-risk | CIMRT arm: 75.6 Gy/1.8Gy/42 fractions; HIMRT arm: 72Gy/2.4Gy/30 fractions | 85,5Gy | 81Gy | 6 years | - | At 5 years, CIMRT: 15% I°, 14% II°, 1% III°; HIMRT: 10% I°, 15% II°, 0% III°. | - | At 5 years, CIMRT: 17% I°, 4% II°, 1% III°;HIMRT: 26% I°, 9% II°, 2% III°. | - |
| Ontario, Canada [11] | Arm I: 470, Arm II: 436 pat. | Arm I: 66Gy/2Gy/33 fractions; Arm II: 52.5Gy/2.63Gy/20 fractions | 62.2Gy | 59.1Gy | 5.7 years | Arm I: 7% ≥ III° GU, Arm II: 11.4% ≥ III° GU. | Arm I: 1.9% ≥ III° GU, Arm II: 1.9% ≥ III° GU. | Arm I: 2.6% ≥ III° GI, Arm II: 4.1% ≥ III° GI. | Arm I: 1.3% ≥ III° GI, Arm II: 1.3% ≥ III° GI. | at 5 years, BCF in Arm I 53%, in Arm II 60%. |
| Adelaide, Australia [13] | Arm I: 108 pat.; Arm II: 109 pat. | Arm I: 64Gy/2Gy/32 fractions; Arm II: 55Gy/2.75Gy/20 fractions | 67.1Gy | 63.25Gy | 90 months | - | no signif. diff. between 2 groups at 5 years | - | no signif. diff. between 2 groups | biochemical relapse-free survival at 90 months 53% in hypofraction Arm vs. 34% in control Arm. |
| Vilnius, Lithuania [50] | 91 pat. low- and intermed.-risk | Arm I: 74Gy/2Gy/37 fractions; Arm II: 57Gy = 13×3Gy + 4×4.5Gy | 84.9Gy | 73.8Gy | 3 months | Arm I: 21 (47.7%) and Arm II: 9 (19.1%) = II° GU. | - | Arm I: 10 (22.7%) and Arm II: 8 (17%) = II° GI. | - | - |
| Milan, Italy [51] | 337 all cT1-2. 40.9% low-risk; 43.3% intermed-risk; 14.2% high-risk. | 70.2Gy/2.7Gy/26 frations | 84.7Gy | 80Gy | 19 months | 35% ≥ II° GU, 6.2% ≥ III° GU. | 10.4% ≥ II° GU, 1.6% ≥ III° GU. | 11.3% ≥ II° GI, 1.2% ≥ III° GI. | 7.5% ≥ II° GI, 1.3% ≥ III° GI. | - |
| Cleveland Ohio [18] | 770 pat, 34% low-risk, 28% intermed.-risk, 38% high-risk . | 70Gy/2.5Gy/28 fractions, but mean target dose was 75.3Gy at 2.7Gy. | 80.3Gy, 90.8Gy (mean target dose) | 77Gy | 45 months | 48% I°, 18% II°, 1% III° RTOG GU. | 4.3% I°, 5.1% II°, 0.1%(1 pat.) III° RTOG GU. | 40% I°, 9% II° RTOG GI. | 5.9% I°, 3.1% II°, 1.3% III°, 0.1%(1 pat.) IV° RTOG GI. | nadia + 2 ng/ml bRFS at 5 years 83%, and 94%, 83%, 72%. |