Table 3.
Survival and response rates (COI)
| Parameter | All GBM | mEHT±SAT | Combination treatment | ddTMZ+mEHT | LD-mEHT | HD-mEHT | HD-mEHT <50 years |
|||||||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | ||||||||
| Value | % | Value | % | Value | % | Value | % | Value | % | Value | % | Value | % | |
| Response | ||||||||||||||
| NOP estimated | 22 | 29% | 7 | 39% | 15 | 26% | 15 | 28% | 9 | 38% | 13 | 25% | 7 | 30% |
| CR | 1 | 5% | 0 | 0% | 1 | 7% | 1 | 7% | 1 | 11% | 0 | 0% | 0 | 0% |
| PR | 2 | 9% | 0 | 0% | 2 | 13% | 2 | 13% | 0 | 0% | 2 | 15% | 2 | 29% |
| OR | 3 | 14% | 0 | 0% | 3 | 20% | 3 | 20% | 1 | 11% | 2 | 15% | 2 | 29% |
| SD | 9 | 41% | 4 | 57% | 5 | 33% | 5 | 33% | 2 | 22% | 7 | 54% | 4 | 57% |
| BRR | 12 | 55% | 4 | 57% | 8 | 53% | 8 | 53% | 3 | 33% | 9 | 69% | 6 | 86% |
| PD | 10 | 45% | 3 | 43% | 7 | 47% | 7 | 47% | 6 | 67% | 4 | 31% | 1 | 14% |
| p Value (χ2) | 0.77 | 0.003 | 0.007* | |||||||||||
| Exitus | 49 | 64% | 12 | 67% | 37 | 64% | 36 | 67% | 18 | 75% | 31 | 60% | 11 | 48% |
| Censored | 27 | 36% | 6 | 33% | 21 | 36% | 18 | 33% | 6 | 25% | 21 | 40% | 12 | 52% |
| Lost | 2 | 3% | 0 | 0% | 2 | 3% | 2 | 4% | 1 | 4% | 1 | 2% | 1 | 4% |
| Right-censored | 25 | 33% | 6 | 33% | 19 | 33% | 16 | 30% | 5 | 21% | 20 | 38% | 11 | 48% |
| Overall survival (since diagnosis)† | ||||||||||||||
| MST (months) | 20.0 | 14.8 | 20.7 | 20.8 | 18.5 | 20.4 | 23.9 | |||||||
| (95% CI)† | (14.7 to 23.6) | (12.2 to 28.3) | (15.0 to 25.0) | (15.2 to 25.1) | (11.8 to 23.0) | (14.6 to 25.7) | (13.0 to NR) | |||||||
| Range | 1.4–141.5 | 4.4–48.9 | 1.4–141.5 | 1.4–141.5 | 3.2–53.8 | 1.4–141.5 | 2.4–141.5 | |||||||
| 5-Year survival (%) | 13.5 | 0.0 | 13.3 | 13.5 | 0.0 | 16.1 | 31.0 | |||||||
| (95% CI) | (2.8 to 24.2) | (0.0 to 0.0) | (1.0 to 25.6) | (1.0 to 26.0) | (0.0 to 0.0) | (2.0 to 30.1) | (5.1 to 56.8) | |||||||
| p Value (log-rank) | 0.436 | 0.350 | 0.32* | |||||||||||
| Survival since first mEHT (months)† | ||||||||||||||
| MST (months) | 7.6 | 6.4 | 7.7 | 7.7 | 4.4 | 8.3 | 12.8 | |||||||
| (95% CI)† | (5.8 to 9.3) | (3.1 to 9.9) | (5.8 to 9.5) | (5.7 to 9.4) | (2.2 to 8.8) | (6.7 to 12.3) | (8.2 to 48.1) | |||||||
| Range | 0.3–47.3 | 0.3–13.6 | 0.7–47.3 | 0.7–47.3 | 0.3–14.9 | 1.0–47.3 | 1.0–47.3 | |||||||
| 1-Year survival (%) | 28.8 | 22.6 | 30.2 | 29.5 | 8.7 | 36.6 | 56.9 | |||||||
| (95% CI) | (16.5 to 41.0) | (0.0 to 47.9) | (16.1 to 44.2) | (15.5 to 43.6) | (0.0 to 24.5) | (21.3 to 51.9) | (33.3 to 80.5) | |||||||
| 2-Year survival (%) | 16.8 | 0.0 | 19.2 | 18.8 | 0.0 | 23.3 | 32.5 | |||||||
| (95% CI) | (6.0 to 27.5) | (0.0 to 0.0) | (6.8 to 31.6) | (6.5 to 31.1) | (0.0 to 0.0) | (9.0 to 37.5) | (7.7 to 57.4) | |||||||
| p Value (log-rank) | 0.403 | 0.007 | 0.047* | |||||||||||
| Survival time after the last mEHT (follow-up) (months) | ||||||||||||||
| Mean | 5.0±0.8 | 3.8±0.8 | 5.3±1.0 | 5.6±1.1 | 3.9±0.7 | 5.5±1.1 | 7.4±2.4 | |||||||
| Median | 3.3 | 2.9 | 3.4 | 3.5 | 2.4 | 3.4 | 3.3 | |||||||
| Range | 0.0–46.4 | 0.0–12.1 | 0.1–46.4 | 0.1–46.4 | 0.0–14.3 | 0.1–46.4 | 0.2–46.4 | |||||||
| 95% CI | 2.2 to 4.6 | 0.8 to 5.5 | 2.2 to 5.0 | 2.2 to 5.3 | 1.5 to 5.3 | 2.5 to 5.0 | 1.3 to 7.3 | |||||||
*Versus all GBM sample.
†Kaplan-Meier estimation.
CR, complete response; ddTMZ, dose-dense temozolomide; GBM, glioblastoma; HD, high dose; LD, low dose; mEHT, modulated electrohyperthermia; MST, median survival time; NOP, no. of patients; NR, not reached; PD, progressive disease; PR, partial response; SAT, supportive and alternative treatments; SD, stable disease.