Table 3 Primary and secondary endpoints of the RNOP-09 study as compared to the EORTC26981/NCIC-CE.3 trial.
EORTC/NCI-C (N = 287) | RNOP-09 (N = 63) | |
|---|---|---|
All patients | ||
Progression Free Survival | ||
Median duration (mo) | 6.9 (5.8-8.2) | 6.5 (6.0-8.3) |
Rate at 1 yr (%) † | 26.9 (21.9-32.2) | 30.2 (19.4-41.6) |
Rate at 2 yrs (%) | 11.2 (7.9-15.1) | 11.0 (4.4-20.9) |
Hazard Ratio ‡ | 1.00 | 0.91 (0.67-1.26) |
p-value ** | P = 0.58 | |
Overall Survival | ||
Median duration (mo) | 14.6 (13.2-16.8) | 17.6 (12.2-22.7) |
Rate at 1 yr (%) | 61.2 (55.3-66.6) | 60.3 (47.2-71.2) |
Rate at 2 yrs (%) | 27.2 (22.2-32.5) | 35.3 (22.1-48.7) |
Hazard Ratio ‡ | 1.00 | 0.79 (0.55-1.14) |
p-value ** | P = 0.21 | |
MGMT methylation status | (N = 106) (46 meth., 60 unmeth.) | (N = 33) (16 meth., 17 unmeth.) |
Methylated MGMT Promoter | ||
Progression Free Survival | ||
Rate at 1 yr (%) | 40.0 (25.8-53.8) | 31.3 (11.4-53.7) |
Hazard Ratio ‡ | 1.00 | 0.79 (0.39-1.61) |
p-value ** | P = 0.52 | |
Overall Survival | ||
Rate at 1 yr (%) | 77.8 (62.6-87.4) | 68.8 (40.5-85.6) |
Rate at 2 yrs (%) | 48.9 (33.7-62.4) | 37.5 (15.4-59.8) |
Hazard Ratio ‡ | 1.00 | 0.98 (0.46-2.11) |
p-value ** | P = 0.97 | |
Unmethylated MGMT Promoter | ||
Progression Free Survival | ||
Rate at 1 yr (%) | 13.3 (6.2-23.2) | 25.5 (7.3-44.9) |
Hazard Ratio ‡ | 1.00 | 1.03 (0.47-2.26) |
p-value ** | P = 0.94 | |
Overall Survival | ||
Rate at 1 yr (%) | 56.7 (43.2-68.1) | 41.2 (18.6-62.6) |
Rate at 2 yrs (%) | 14.8 (7.2-25.0) | 16.5 (2.9-39.9) |
Hazard Ratio ‡ | 1.00 | 0.93 (0.44-1.95) |
p-value ** | P = 0.84 | |