Efficacy
Overall survival
After a median follow up of 11.9 years, patients who received sequential radiation therapy followed by PCV chemotherapy had a significantly longer median overall survival of 13.3 years (95% CI, 10.6 to not reached) versus 7.8 years (95% CI, 6.1 to 9.8) in the radiation therapy alone arm (HR=0.59, P=0.003).
Five- and ten-year overall survival rates for radiation therapy plus PCV vs. radiation therapy alone were 72% vs. 63% and 60% vs 40%, respectively.r
Kaplan-Meier analysis of (A) Overall survival, (B,C,D) Overall survival according to individual histologic sub type
© New Engl J Med 2016
There did not appear to be any significant difference in OS between the two groups during the first 2 years after randomisation. However, the difference became more apparent over time, with OS curves separating significantly, favouring patients treated with radiation therapy + PCV.r
Progression-free survival
|
Radiation therapy + PCV chemotherapy |
Radiation therapy alone |
Hazard ratio |
Median PFS |
10.4 years
(95% CI, 6.1 to not reached) |
4.0 years
(95% CI, 3.1 to 5.5 years) |
HR 0.50
P<0.001 |
PFS at 5 years |
61%
(95% CI, 53 to 70) |
44%
(95% CI, 35 to 53) |
- |
PFS at 10 years |
51%
(95% CI, 42 to 59) |
21%
(95% CI, 14 to 28) |
- |
Kaplan-Meier analysis of progression-free survival
© New Engl J Med 2016
There did not appear to be any significant difference in PFS between the two groups during the first 2 years after randomisation. However, the difference became more apparent over time, with PFS curves separating significantly after 2 to 3 years, favouring radiation therapy + PCV.r