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Table 3 Primary and secondary endpoints of the RNOP-09 study as compared to the EORTC26981/NCIC-CE.3 trial.

From: RNOP-09: Pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma - a phase II study

  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
  1. * Numbers in parenthesis are 95 percent confidence intervals
  2. † Primary endpoint
  3. ‡ Obtained from the Cox model after adjustment of RNOP-09 treatment effect for extent of surgery (B/PR/CR), Age (< = 50,51-60,>60), Performance Status (0,1,2), administration of corticosteroids (No/Yes)
  4. ** Wald's test