Table 1.
Summary of clinical data on TTFields treatment for malignant gliomas
| Phase III trial for newly diagnosed glioblastoma interim analysis | TTFields treatment + temozolomide | Temozolomide alone | Hazard ratio | P |
|---|---|---|---|---|
| Overall survival, mediana | 19.6 months | 16.6 months | 0.75 | 0.03 |
| Progression-free survivala | 7.1 months | 4.0 months | 0.63 | <0.01 |
| Phase III recurrent glioblastoma | TTFields treatment (n = 120) | Active chemotherapy (n = 117) | ||
| Overall survival, medianb | 6.6 months | 6.0 months | 0.86 (95 % CI 0.66–1.12) | 0.27 |
| 1-year survival | 20 % | 20 % | ||
| 2-year survival | 8 % | 4 | ||
| 3-year survival | 5 % | 1 % | ||
| Prognostic factors, median overall survivalc | ||||
| Prior bevacizumab failure | 6.0 months (n = 23) | 3.3 months (n = 21) | 0.43 (95 % CI 0.22–0.85) | 0.02 |
| Prior low-grade glioma | 25.3 months (n = 12) | 7.7 months (n = 9) | 0.31 (95 % CI 0.09–0.99) | 0.05 |
| Tumor size ≥18 cm2 | 5.6 months (n = 39) | 3.3 months (n = 41) | 0.53 (95 % CI 0.32–0.85) | <0.01 |
| Karnofsky performance status ≥80 | 7.9 months (n = 83) | 6.1 months (n = 77) | 0.71 (95 % CI 0.51–0.99) | 0.05 |
| TTFields treatment versus bevacizumab | 6.6 months (n = 120) | 4.9 months (n = 36) | 0.64 (95 % CI 0.41–0.99) | 0.05 |
| Progression-free survival, medianb | 2.2 months | 2.1 months | 0.81 (95 % CI 0.60–1.09) | 0.13 |
| PFS at 6 months | 21 % | 15 % | ||
| Respondersd | 14 | 7 | ||
| Response status, median overall survival | ||||
| Partial and complete response versus | 24.7 months (n = 14) | |||
| Stable disease | 7.6 months (n = 34) | 0.28 (95 % CI 0.14–0.58) | <0.01 | |
| Progressive disease | 5.5 months (n = 59) | 0.24 (95 % CI 0.14–0.42) | <0.01 | |
| Prognostic factor in TTFields treatment responderse | ||||
| Overall survival, median | ||||
| With prior low-grade glioma | 27.7 months | |||
| Without prior low-grade glioma | 16.6 months | 0.05 | ||
| Daily dexamethasone dose, median | ||||
| Responders | 1.0 mg | |||
| Nonresponders | 5.2 mg | <0.01 | ||
| Cumulative dexamethasone dose, median | ||||
| Responders | 7.1 mg | |||
| Nonresponders | 261.7 mg | <0.01 | ||
| Treatment-related adverse events, ≥grade 2b,f | ||||
| Hematological | 3 % | 17 % | ||
| Gastrointestinal | 4 % | 17 % | ||
| Dermatological | 2 % | 0 % | ||
| Nervous system disorders | 30 % | 28 % | ||
| Recurrent glioblastoma from patient registry data set (PRiDe) | PRiDe TTFields treatment (n = 457) | EF-11 TTFields treatment (n = 120) | ||
| Survivalg | ||||
| 1-year survival | 44 % | 20 % | ||
| 2-year survival | 30 % | 9 % | ||
| Prognostic factors, median overall survivalg | ||||
| Number of prior recurrences | ||||
| First recurrence versus | 20 months | |||
| Second recurrence | 8.5 months, HR = 0.6 (95 % CI 0.4–0.9), P = 0.03 | |||
| Third to fifth recurrence | 4.9 months, HR = 0.3 (95 % CI 0.2–0.5), P < 0.01 | |||
| Compliance | ||||
| <75 % versus | 4.0 months | |||
| ≥75 % | 13.5 months, HR = 0.4 (95 % CI 0.3–0.6), P < 0.01 | |||
| Karnofsky performance status | ||||
| 90–100 versus | 14.8 months | |||
| 70–90 | 7.7 months, HR = 0.6 (95 % CI 0.4–0.9), P < 0.01 | |||
| 10–60 | 6.1 months, HR = 0.4 (95 % CI 0.2–0.6), P < 0.01 | |||
| Prior bevacizumab use | ||||
| No versus | 13.4 months | |||
| Yes | 7.2 months, HR = 0.5 (95 % CI 0.4–0.7), P < 0.01 | |||
| Prior debulking surgery | ||||
| No versus | 8.9 months | |||
| Yes | 9.8 months, HR = 1.1 (95 % CI 0.8–1.5), P = 0.79 | |||
aStupp R, Wong E, Scott C, et al. Neuro-Oncol 2014;16(Suppl 5):v167
bStupp R, Wong ET, Kanner AA, et al. Eur J Cancer 2012;48:2192-2202
cKanner AA, Wong ET, Villano JL, et al. Semin Oncol 2014;41(Suppl 6):S25-S34
dVymazal J, Wong ET. Semin Oncol 2014;41(Suppl 6):S14-S24
eWong ET, Lok E, Swanson KD, et al. Cancer Med 2014;3:592-602
fLacouture ME, Davis ME, Elzinga G, et al. Semin Oncol 2014;41(Supple 4):S1-S14
gMrugala MM, Engelhard HH, Tran DD, et al. Semin Oncol 2014;41(Supple 6):S4-S13