Selected trials with hyper-fractionated regimes
Author, year [ref.] | Design | Patients n | Chemotherapy | Radiation dose/fractionation | Results | Oesophagitis grade 3–4 | ||
p-value# | p-value# | |||||||
Turrisi, 1999 [26] | Phase III | 417 | EP | 45 Gy/1.5 Gy twice daily | Median OS 23 months, 5-year OS 26% | 0.04 | 27% | <0.001 |
45 Gy/1.8 Gy once daily | Median OS 19 months, 5-year OS 16% | 11% | ||||||
Schild, 2004 [22] | Phase III | 261 | EP | 50.4 Gy/1.8 Gy once daily | Median OS 20.6 months, 5-year OS 21% | 0.68 | 5% | 0.05 |
48 Gy/1.5 Gy twice daily (with a 2.5 week break inbetween) | Median OS 20.6 months, 5-year OS 22% | 12% | ||||||
Komaki, 2012 [27] | Phase II | 71 | EP | 39.6 Gy/1.8 Gy once daily followed by 21.6 Gy/1.8 Gy | Median OS 19 months, 2-year OS 36.6% | N/A | 18% | N/A |
Gronberg, 2016 [28] | Phase II | 157 | EP | 42 Gy/2.8 Gy once daily | Median OS 18.8 months | 0.61 | 31% | 0.80 |
45 Gy/1.5 Gy twice daily | Median OS 25.1 months | 33% | ||||||
Faivre-Finn, 2016 [29] | Phase III | 547 | EP | 66 Gy/2 Gy once daily | Median OS 25 months, 2-year OS 51% | 0.15 | 19% | No statistical difference |
45 Gy/1.5 Gy twice daily | Median OS 30 months, 2-year OS 56% | 19% |
EP: etoposide and cisplatin-based chemotherapy; OS: overall survival. #: statistical significance p≤0.05.