Overall survival
Four trials, START A, START B, Spooner 2012, and the Canadian trial, reported on overall survival. START B reported that the 10 year all-cause mortality rate was significantly lower in the hypofractionated radiotherapy arm than the standard radiotherapy arm; HR=0.80 (95% CI 0.65-0.99), p=0.042.10. The three other trials reported similar overall survival rates between hypofractionated radiotherapy and standard radiotherapy with no statistically significant differences.6,10,11
Disease-free survival
Both START A and START B reported disease-free survival (DFS). START B reported a significantly higher rate of DFS in patients receiving hypofractionated radiotherapy compared to standard radiotherapy; HR=0.79 (95% CI 0.65-0.97), p=0.022.10 Whereas START A reported no significant difference in DFS between the hypofractionated radiotherapy schedules and standard radiotherapy.10
Relapse-free survival
The trial by Spooner et al (2012) reported no significant difference between short- and long-course radiotherapy for relapse-free survival estimates at 2, 5, 10 and 15 years; HR=0.98; (95% CI 0.75-1.29), p-value not reported.11
Table 4: Survival outcomes of RCTs comparing hypofractionated radiotherapy and standard radiotherapy.
| Key outcomes | START A | START B | Spooner 2012 | Canadian trial | RMH/GOC trial |
|---|---|---|---|---|---|
|
Overall survival |
Equivalent 41.6 Gy HR=0.96, p=0.74; 39 Gy HR=1.05, p=0.69 |
Superior for hypofractionated radiotherapy HR=0.80, p=0.042 |
Equivalent HR=1.02, p-value NR, 95% CI NS |
Equivalent 10yr survival 84.6% hypofractionated vs. 84.4% control p=0.79 |
NR |
|
Disease-free survival |
Equivalent 41.6 Gy HR=0.94, p=0.57; 39 Gy HR=1.08, p=0.48 |
Superior for hypofractionated radiotherapy HR=0.79, p=0.022 |
NR |
NR |
NR |
|
Relapse-free survival |
NR |
NR |
Equivalent HR=0.98, p-value NR, 95% CI NS |
NR |
NR |