Table 4 Hypofractionated IMRT/IGRT trials
Reference | Study design | Number of patients | Fractionation (total dose/ singel dose/fractions) | EQD for tumor α/β-ratio 1.4Gy | EQD for normal tussues α/β-ratio 3Gy | IGRT | Follow-up | Acute GU toxicitiy | Late GU toxicity | Acute GI toxicity | Late GI toxicity | Therapeutic outcomes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arcangeli, G. [14] | Phase III prospective | 168 pat. | Arm I: 80Gy/2Gy/40 fractions, ArmII: 62Gy/3.1Gy/20 fractions, 4x/week. | 82.1Gy | 74.2Gy | daily portal imaging | 70 months | - | Arm I: 16% ≥ II° GI, Arm II: 11% ≥ II° GI., at 3 years. | - | Arm I: 17% ≥ II° GI, Arm II: 14% ≥ II° GI, at 3 years. | Hypofraction-RT is not inferior to conventional RT. |
Dearnaley, D. [15] | Phase III prospective | Arm I: 153 pat. 74Gy; Arm II 153 pat. 60Gy and 151 pat. 57Gy. | Arm I: 74Gy/2Gy/37 fx; Arm II: 57-60Gy/3Gy/19-20 fx. | Arm II: 73.8/77.6Gy | Arm II: 68.4/72Gy | no | 50.5 months | - | At 2 years, 3 pat. (2 · 2%) in 74Gy group, 3 (2 · 2%) in 60Gy group, and 0 in 57Gy group ≥ II° GU. | - | At 2 years, 6 pat. (4 · 3%) in Arm I ≥ II° RTOG, 5 pat. (3 · 6%) in 60Gy group, 2 (1 · 4%) in 57Gy group. | - |
Pollack, A. [16] | Phase III prospective | 307 (ASTRO Update 2011) | Arm I: 76Gy/2Gy/28 fx; Arm II: 70.2Gy/2.7Gy/26 fx. | Arm II: 84.7Gy | Arm II: 80Gy. | no | 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°; Arm II: 18% ≥ II° | 4.5% ≥ II° GI. | biochem. recurrence 21.5% vs. 21.9% at 5 years |
McDonald, A.M. [31] | Retrospective | 57 PORT and 31 WPRT | 70Gy/2.5Gy/ 28 fractions | 80.3Gy | 77Gy | CBCT daily | 41 months | 18/31(58%) in PORT, 28/57(49%) in WPRT ≥ II° | 4/57(7%)in WPRT, 0% in PORT ≥ III° GU | 7/31(23%) in PORT, 23/57 (40%) in WPRT ≥ II° GI | 0% in PORT, 10/57(18%) in WPRT ≥ II° GI | - |
Adkinson, J.B. [29] | Phase I prospective | 53 pat. | 70Gy/2.5Gy/28 fractions | 80.3Gy | 77Gy | yes | 25.4 months | 20/53(38%) ≥ II° GU | 14/53(27%) ≥ II° GU | 17/53(32%) ≥ II° GI | 4/53(8%) ≥ II° GI | biochem. control (nadir +2) 81.2 ± 6.6%. |
Jereczek-Fossa, B.A. [51] | Prospective longitudinal follow-up | 337 pat. cT1-2, 40.9% low-risk; 43.3% intermed-risk; 14.2% high-risk. | 70.2Gy/2.7Gy/26 frations | 84.7Gy | 80Gy | BAT 72%, stereo X-ray 16.4%, CBCT 11.9% pat. | 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. | - |
Kupelian, P. A. [18] | Retrospective | 770 pat, 34% low-risk, 28% intermed.-risk, 38% high-risk D'Amico criterien. | 70Gy/2.5Gy/28 fractions, but mean target dose was 75.3Gy at 2.7Gy! | 80.3Gy with 1.4Gy α/β-ratio (83.8Gy with 3.5Gy α/β-ratio in publication) | 77Gy | IGRT with BAT tranabdominal ultrasound | 45 months | 33% Pat. 0°, 48% I°, 18% II°, 1% III° RTOG | 90.5% pat. 0°, 4.3% I°, 5.1% II°, 0.1%(1 pat.) III° RTOG | 51% pat. 0°, 40% I°, 9% II° RTOG | 89.6% pat. 0°, 5.9% I°, 3.1% II°, 1.4% ≥ III° RTOG | At 5 years 94%, 83%, 72% for low-/intermed./high-risk respectively (Nadir + 2 ng/ml) |
Quon, H. [33] | Prospective phase I-II | 97 pat. High-risk | 67.5Gy/2.7Gy/25 fractions | 81.4Gy | 77Gy | IGRT with gold marker | 39 months median | 8% pat. 0°, 50% I°, 39% II°, 4% III° CTCAE | 82% pat. 0°, 9% I°, 5% II°, 3% III°, 1% IV°. | 4% pat. 0°, 59% I°, 37% II° | 54% pat. 0°, 40% I°, and 7% II° | 4 year bFFS 90.5%. |
Martin, J. [40] | Prospective phase I-II | 92 pat., mainly intermed./low risk | 60Gy/3Gy/20 fractions | 77.6Gy | 72Gy | IGRT with gold marker | 38 months median | 32% pat. 0°, 43% I°, 25% II° RTOG | 90% pat. 0°, 7% I°, 3% II° RTOG | 66% pat. 0°, 22% I°, 11% II°, 1% IV° RTOG | 93% pat. 0°, 2% I°, 4% II° RTOG | 3 year biochemical control 76%. |