TABLE 5.
Summary of response rates by treatment arm
| ARM A No. of patients | % | ARM B No. of patients | % | P | ||
|---|---|---|---|---|---|---|
| Response rate after induction chemotherapy-RECIST | CR | 0 | 0 | 0 | 0 | / |
| PR | 25 | 48.1 | 31 | 57.4 | 0.34 | |
| SD | 27 | 51.9 | 22 | 40.7 | 0.25 | |
| PD | 0 | 0 | 1 | 1.9 | 0.32 | |
| Response rate after induction chemotherapy-volumetric results | V (cm3) (median) before ChT | 145 | 124 | 0.55 | ||
| V (cm3) (median) after ChT | 40.9 | 28.2 | 0.26 | |||
| Reduction (median, %) | 62.6 | 64.7 | 0.41 | |||
| Response 5 months after completion of treatment | CR | 18 | 14 | 0.33 | ||
| PR | 14 | 19 | 0.36 | |||
| SD | 1 | 5 | 0.10 | |||
| PD | 5 | 6 | 0.80 | |||
| Median PFS (month) | 15.7 | 18.9 | 0.24 | |||
| Median OS (month) | 24.8 | 28.6 | 0.18 | |||
| 1-year OS (%) | 38 | 73.1 | 44 | 81.5 | 0.30 | |
| 2-year OS (%) | 27 | 51.9 | 30 | 55.6 | 0.71 | |
| 3-year OS (%) | 17 | 32.7 | 24 | 46.2 | 0.15 | |
| 4-year OS (%) | 11 | 24.2 | 17 | 38.0 | 0.43 | |
| 5-year OS (%) | 7 | 19.1 | 11 | 32.2 | 0.22 | |
| Site of the first relapse | No relapse | 11 | 21.2 | 11 | 20.4 | 0.74 |
| Locoregional | 18 | 48.6 | 21 | 53.9 | 0.51 | |
| Distant | 12 | 32.5 | 10 | 25.6 | 0.56 | |
| Both | 7 | 18.9 | 8 | 20.5 | 0.84 | |
| CNS as the first site of relapse | 9 | 24.3 | 8 | 20.5 | 0.73 |
ChT = chemotherapy; CNS = central nervous system; CR = complete response; No. = number; OS = overall survival; PD = progressive disease; PFS = progression-free survival; PR = partial response; RECIST = response evaluation criteria in solid tumor; SD = stable disease; V = volume