Efficacy results from clinical studies of TTFields therapy in adult patients with ndGBM.
| Study name; registration Region (enrollment years) . | Study type . | Therapy . | N . | Median OS . | OS HR (95% CI) P value . | 2-year OS rate . | 5-year OS rate . | Median PFS . | PFS6 . | Reference . |
|---|---|---|---|---|---|---|---|---|---|---|
| EF-07 Czech Republic | Prospective pilot | TTFields + TMZ | 10 | >39 mo | — | — | — | 155 weeks | — | 43 |
| EF-14; NCT00916409 Global (2009-2014)a | Pivotal (phase III) randomized controlled | TTFields + TMZ vs TMZ | 466 229 | 20.9 mo 16.0 mo | 0.63 (0.53-0.76) P < .001 | 43% 31% | 13% 5% | 6.7 mo 4.0 mo | 56% 37% | 42 |
| Elderly patients (≥ 65 years) | Subgroup analysis | 89 45 | 17.4 mo 13.7 mo | 0.51 (0.33-0.77) P = .02 | 39% 27% | 15% 0% | 6.5 mo 3.9 mo | 53% 26% | 44 | |
| Korean patients | Subgroup analysis | 24 15 | 27.2 mo 15.2 mo | 0.27 (0.10-0.75) P = .01 | 60% 30% | — | 6.2 mo 4.2 mo | — | 45 | |
| Usage (> 90% use vs ≤90% use) | Subgroup analysis | 43 229 | 24.9 mo 16.0 mo | 0.52 (0.35-0.79) P < .001 | 55% 31% | 29% 5% | 8.2 mo 4.0 mo | — | 46 | |
| United States (2014-2017) | Retrospective | TTFields + TMZ vs TMZ | 37 67 | — | 0.93 (0.58-1.47) P = .74 | — | — | — | — | 47 |
| United States (2014-2017) | Retrospective | TTFields + CTb vs CT | 55 57 | 25.5 mo 18.8 mo | 0.54 (0.31-0.94) P = .03 | — | — | 15.8 mo 6.9 mo | — | 48 |
| United Kingdom (2017-2019) | Prospective observational pilotc | TTFields + CT vs CT | 9 9 | 14.9 mo 11.6 mo | Log-rank test; P = .39 | — | — | 5.5 mo 3.3 mo | — | 49 |
| EF-29 Japan (2016-2020) | Retrospective | TTFields + CT | 40 | NR | — | 54% | — | 15.8 mo | 78% | 50 |
| China (2018-2021) | Retrospective | TTFields + TMZ vs TMZ | 63 204 | 21.8 mo 15 mod | 0.43 (0.38-0.67) P < .001 | — | — | 16 mo 11 mo | - | 51 |
| Austria (2016-2021) | Retrospective | TTFields + TMZ | 48d | 22.6 mo | — | — | — | — | - | 52 |
| United States (2015-2021) | Retrospective | TTFields + TMZ vs TMZ | 59 32 | 20.7 mo 15 mo | P = .04 | 33% | — | — | - | 53 |
| Czech Republic (2004-2021) | Retrospectivef | TTFields + TMZ vs TMZ | 55 54 | 31.7 mo 24.8 mo | 0.61 P = .03 | 61% 53% | 24% 12% | 19.8 mo 12.5 mo | - | 54 |
| China (2013-2021) | Retrospective | TTFields + TMZ vs TMZ | 13 39 | 24.8 mo 18.6 mo | P = .368 | — | — | 15.3 mo 10.6 mo | 55 | |
| Global (2004-2020)g | Meta-analysis | TTFields + CT | 512 | 21.7 mo | — | 45% | — | 7.2 moh | 56% | 56 |
| Germany (2012-2020) | Retrospective | TTFields + lomustine/TMZ vs lomustine/TMZi | 22 48 | NR 26.7 mo | 2.55 (1.25-5.20) P = .01 | — | — | 21.5 mo 11.2 mo | — | 57 |
| 2-THE-TOP; NCT03405792 United States (2018f-2022) | Prospective pilot (phase II) | TTFields + pembrolizumab/TMZ vs TTFields + TMZj | 26 26 | 24.8mo 14.7mo | 0.39 (0.19-0.78) P = .039 | 52% 12% | — | 12.0 mo 5.8 mo | — | 58 |
| NCT03780569 Israel (Apr-Dec 2017) | Prospective pilot | TTFields + RT + TMZ | 10 | NR | — | — | — | 8.9 mo | 58% | 59 |
| SPARE; NCT03477110 United States (2018-2021) | Prospective pilot | TTFields + scalp preserving RT/TMZ | 30 | 15.8 mo | — | — | — | 9.3 mo | — | 60 |
| PriCoTTF Germany (2018-ongoing) | Prospective pilot/ (phase I/II) | TTFields + RT/TMZ | 33 | NR | — | — | — | — | — | 61 |
| Global (2020-2023) | Meta-analysis of real-world evidence | TTFields + CT vs CT | 282 453 | 22.6 mo 17.4 mo | 0.66 0.54-0.82 P < .001 | 47% 32% | 62 |
| Study name; registration Region (enrollment years) . | Study type . | Therapy . | N . | Median OS . | OS HR (95% CI) P value . | 2-year OS rate . | 5-year OS rate . | Median PFS . | PFS6 . | Reference . |
|---|---|---|---|---|---|---|---|---|---|---|
| EF-07 Czech Republic | Prospective pilot | TTFields + TMZ | 10 | >39 mo | — | — | — | 155 weeks | — | 43 |
| EF-14; NCT00916409 Global (2009-2014)a | Pivotal (phase III) randomized controlled | TTFields + TMZ vs TMZ | 466 229 | 20.9 mo 16.0 mo | 0.63 (0.53-0.76) P < .001 | 43% 31% | 13% 5% | 6.7 mo 4.0 mo | 56% 37% | 42 |
| Elderly patients (≥ 65 years) | Subgroup analysis | 89 45 | 17.4 mo 13.7 mo | 0.51 (0.33-0.77) P = .02 | 39% 27% | 15% 0% | 6.5 mo 3.9 mo | 53% 26% | 44 | |
| Korean patients | Subgroup analysis | 24 15 | 27.2 mo 15.2 mo | 0.27 (0.10-0.75) P = .01 | 60% 30% | — | 6.2 mo 4.2 mo | — | 45 | |
| Usage (> 90% use vs ≤90% use) | Subgroup analysis | 43 229 | 24.9 mo 16.0 mo | 0.52 (0.35-0.79) P < .001 | 55% 31% | 29% 5% | 8.2 mo 4.0 mo | — | 46 | |
| United States (2014-2017) | Retrospective | TTFields + TMZ vs TMZ | 37 67 | — | 0.93 (0.58-1.47) P = .74 | — | — | — | — | 47 |
| United States (2014-2017) | Retrospective | TTFields + CTb vs CT | 55 57 | 25.5 mo 18.8 mo | 0.54 (0.31-0.94) P = .03 | — | — | 15.8 mo 6.9 mo | — | 48 |
| United Kingdom (2017-2019) | Prospective observational pilotc | TTFields + CT vs CT | 9 9 | 14.9 mo 11.6 mo | Log-rank test; P = .39 | — | — | 5.5 mo 3.3 mo | — | 49 |
| EF-29 Japan (2016-2020) | Retrospective | TTFields + CT | 40 | NR | — | 54% | — | 15.8 mo | 78% | 50 |
| China (2018-2021) | Retrospective | TTFields + TMZ vs TMZ | 63 204 | 21.8 mo 15 mod | 0.43 (0.38-0.67) P < .001 | — | — | 16 mo 11 mo | - | 51 |
| Austria (2016-2021) | Retrospective | TTFields + TMZ | 48d | 22.6 mo | — | — | — | — | - | 52 |
| United States (2015-2021) | Retrospective | TTFields + TMZ vs TMZ | 59 32 | 20.7 mo 15 mo | P = .04 | 33% | — | — | - | 53 |
| Czech Republic (2004-2021) | Retrospectivef | TTFields + TMZ vs TMZ | 55 54 | 31.7 mo 24.8 mo | 0.61 P = .03 | 61% 53% | 24% 12% | 19.8 mo 12.5 mo | - | 54 |
| China (2013-2021) | Retrospective | TTFields + TMZ vs TMZ | 13 39 | 24.8 mo 18.6 mo | P = .368 | — | — | 15.3 mo 10.6 mo | 55 | |
| Global (2004-2020)g | Meta-analysis | TTFields + CT | 512 | 21.7 mo | — | 45% | — | 7.2 moh | 56% | 56 |
| Germany (2012-2020) | Retrospective | TTFields + lomustine/TMZ vs lomustine/TMZi | 22 48 | NR 26.7 mo | 2.55 (1.25-5.20) P = .01 | — | — | 21.5 mo 11.2 mo | — | 57 |
| 2-THE-TOP; NCT03405792 United States (2018f-2022) | Prospective pilot (phase II) | TTFields + pembrolizumab/TMZ vs TTFields + TMZj | 26 26 | 24.8mo 14.7mo | 0.39 (0.19-0.78) P = .039 | 52% 12% | — | 12.0 mo 5.8 mo | — | 58 |
| NCT03780569 Israel (Apr-Dec 2017) | Prospective pilot | TTFields + RT + TMZ | 10 | NR | — | — | — | 8.9 mo | 58% | 59 |
| SPARE; NCT03477110 United States (2018-2021) | Prospective pilot | TTFields + scalp preserving RT/TMZ | 30 | 15.8 mo | — | — | — | 9.3 mo | — | 60 |
| PriCoTTF Germany (2018-ongoing) | Prospective pilot/ (phase I/II) | TTFields + RT/TMZ | 33 | NR | — | — | — | — | — | 61 |
| Global (2020-2023) | Meta-analysis of real-world evidence | TTFields + CT vs CT | 282 453 | 22.6 mo 17.4 mo | 0.66 0.54-0.82 P < .001 | 47% 32% | 62 |
The table shows studies that report outcomes from at least 10 patients. CT refers to treatment regimens where the study publication did not specify the type of chemotherapy or allow more than one CT regimen.
aIn EF-14, PFS was the primary endpoint and OS was a secondary endpoint.
bThe majority of patients received TMZ.
cEnrolled patients with poor prognostic markers who lacked promising treatment options.
dThe control arm reports patients treated between 2016 and 2017.
eOne patient had rGBM.
fEleven patients were part of EF-07 and 8 were part of EF-14.
gTime period estimated from studies included in the analysis.
hPooled PFS was calculated from 522 patients.
iControl arm includes patients who received TTFields for 0-8 weeks.
jCase controls from the EF-14 study.
Abbreviations: CT, chemotherapy; HR, hazard ratio; mo, months; ndGBM; newly diagnosed glioblastoma; NR, not reached; OS, overall survival; PFS, progression-free survival; PFS6, 6-month PFS rate; RT, radiotherapy; TMZ, temozolomide; TTFields, Tumor Treating Fields.
Efficacy results from clinical studies of TTFields therapy in adult patients with ndGBM.
| Study name; registration Region (enrollment years) . | Study type . | Therapy . | N . | Median OS . | OS HR (95% CI) P value . | 2-year OS rate . | 5-year OS rate . | Median PFS . | PFS6 . | Reference . |
|---|---|---|---|---|---|---|---|---|---|---|
| EF-07 Czech Republic | Prospective pilot | TTFields + TMZ | 10 | >39 mo | — | — | — | 155 weeks | — | 43 |
| EF-14; NCT00916409 Global (2009-2014)a | Pivotal (phase III) randomized controlled | TTFields + TMZ vs TMZ | 466 229 | 20.9 mo 16.0 mo | 0.63 (0.53-0.76) P < .001 | 43% 31% | 13% 5% | 6.7 mo 4.0 mo | 56% 37% | 42 |
| Elderly patients (≥ 65 years) | Subgroup analysis | 89 45 | 17.4 mo 13.7 mo | 0.51 (0.33-0.77) P = .02 | 39% 27% | 15% 0% | 6.5 mo 3.9 mo | 53% 26% | 44 | |
| Korean patients | Subgroup analysis | 24 15 | 27.2 mo 15.2 mo | 0.27 (0.10-0.75) P = .01 | 60% 30% | — | 6.2 mo 4.2 mo | — | 45 | |
| Usage (> 90% use vs ≤90% use) | Subgroup analysis | 43 229 | 24.9 mo 16.0 mo | 0.52 (0.35-0.79) P < .001 | 55% 31% | 29% 5% | 8.2 mo 4.0 mo | — | 46 | |
| United States (2014-2017) | Retrospective | TTFields + TMZ vs TMZ | 37 67 | — | 0.93 (0.58-1.47) P = .74 | — | — | — | — | 47 |
| United States (2014-2017) | Retrospective | TTFields + CTb vs CT | 55 57 | 25.5 mo 18.8 mo | 0.54 (0.31-0.94) P = .03 | — | — | 15.8 mo 6.9 mo | — | 48 |
| United Kingdom (2017-2019) | Prospective observational pilotc | TTFields + CT vs CT | 9 9 | 14.9 mo 11.6 mo | Log-rank test; P = .39 | — | — | 5.5 mo 3.3 mo | — | 49 |
| EF-29 Japan (2016-2020) | Retrospective | TTFields + CT | 40 | NR | — | 54% | — | 15.8 mo | 78% | 50 |
| China (2018-2021) | Retrospective | TTFields + TMZ vs TMZ | 63 204 | 21.8 mo 15 mod | 0.43 (0.38-0.67) P < .001 | — | — | 16 mo 11 mo | - | 51 |
| Austria (2016-2021) | Retrospective | TTFields + TMZ | 48d | 22.6 mo | — | — | — | — | - | 52 |
| United States (2015-2021) | Retrospective | TTFields + TMZ vs TMZ | 59 32 | 20.7 mo 15 mo | P = .04 | 33% | — | — | - | 53 |
| Czech Republic (2004-2021) | Retrospectivef | TTFields + TMZ vs TMZ | 55 54 | 31.7 mo 24.8 mo | 0.61 P = .03 | 61% 53% | 24% 12% | 19.8 mo 12.5 mo | - | 54 |
| China (2013-2021) | Retrospective | TTFields + TMZ vs TMZ | 13 39 | 24.8 mo 18.6 mo | P = .368 | — | — | 15.3 mo 10.6 mo | 55 | |
| Global (2004-2020)g | Meta-analysis | TTFields + CT | 512 | 21.7 mo | — | 45% | — | 7.2 moh | 56% | 56 |
| Germany (2012-2020) | Retrospective | TTFields + lomustine/TMZ vs lomustine/TMZi | 22 48 | NR 26.7 mo | 2.55 (1.25-5.20) P = .01 | — | — | 21.5 mo 11.2 mo | — | 57 |
| 2-THE-TOP; NCT03405792 United States (2018f-2022) | Prospective pilot (phase II) | TTFields + pembrolizumab/TMZ vs TTFields + TMZj | 26 26 | 24.8mo 14.7mo | 0.39 (0.19-0.78) P = .039 | 52% 12% | — | 12.0 mo 5.8 mo | — | 58 |
| NCT03780569 Israel (Apr-Dec 2017) | Prospective pilot | TTFields + RT + TMZ | 10 | NR | — | — | — | 8.9 mo | 58% | 59 |
| SPARE; NCT03477110 United States (2018-2021) | Prospective pilot | TTFields + scalp preserving RT/TMZ | 30 | 15.8 mo | — | — | — | 9.3 mo | — | 60 |
| PriCoTTF Germany (2018-ongoing) | Prospective pilot/ (phase I/II) | TTFields + RT/TMZ | 33 | NR | — | — | — | — | — | 61 |
| Global (2020-2023) | Meta-analysis of real-world evidence | TTFields + CT vs CT | 282 453 | 22.6 mo 17.4 mo | 0.66 0.54-0.82 P < .001 | 47% 32% | 62 |
| Study name; registration Region (enrollment years) . | Study type . | Therapy . | N . | Median OS . | OS HR (95% CI) P value . | 2-year OS rate . | 5-year OS rate . | Median PFS . | PFS6 . | Reference . |
|---|---|---|---|---|---|---|---|---|---|---|
| EF-07 Czech Republic | Prospective pilot | TTFields + TMZ | 10 | >39 mo | — | — | — | 155 weeks | — | 43 |
| EF-14; NCT00916409 Global (2009-2014)a | Pivotal (phase III) randomized controlled | TTFields + TMZ vs TMZ | 466 229 | 20.9 mo 16.0 mo | 0.63 (0.53-0.76) P < .001 | 43% 31% | 13% 5% | 6.7 mo 4.0 mo | 56% 37% | 42 |
| Elderly patients (≥ 65 years) | Subgroup analysis | 89 45 | 17.4 mo 13.7 mo | 0.51 (0.33-0.77) P = .02 | 39% 27% | 15% 0% | 6.5 mo 3.9 mo | 53% 26% | 44 | |
| Korean patients | Subgroup analysis | 24 15 | 27.2 mo 15.2 mo | 0.27 (0.10-0.75) P = .01 | 60% 30% | — | 6.2 mo 4.2 mo | — | 45 | |
| Usage (> 90% use vs ≤90% use) | Subgroup analysis | 43 229 | 24.9 mo 16.0 mo | 0.52 (0.35-0.79) P < .001 | 55% 31% | 29% 5% | 8.2 mo 4.0 mo | — | 46 | |
| United States (2014-2017) | Retrospective | TTFields + TMZ vs TMZ | 37 67 | — | 0.93 (0.58-1.47) P = .74 | — | — | — | — | 47 |
| United States (2014-2017) | Retrospective | TTFields + CTb vs CT | 55 57 | 25.5 mo 18.8 mo | 0.54 (0.31-0.94) P = .03 | — | — | 15.8 mo 6.9 mo | — | 48 |
| United Kingdom (2017-2019) | Prospective observational pilotc | TTFields + CT vs CT | 9 9 | 14.9 mo 11.6 mo | Log-rank test; P = .39 | — | — | 5.5 mo 3.3 mo | — | 49 |
| EF-29 Japan (2016-2020) | Retrospective | TTFields + CT | 40 | NR | — | 54% | — | 15.8 mo | 78% | 50 |
| China (2018-2021) | Retrospective | TTFields + TMZ vs TMZ | 63 204 | 21.8 mo 15 mod | 0.43 (0.38-0.67) P < .001 | — | — | 16 mo 11 mo | - | 51 |
| Austria (2016-2021) | Retrospective | TTFields + TMZ | 48d | 22.6 mo | — | — | — | — | - | 52 |
| United States (2015-2021) | Retrospective | TTFields + TMZ vs TMZ | 59 32 | 20.7 mo 15 mo | P = .04 | 33% | — | — | - | 53 |
| Czech Republic (2004-2021) | Retrospectivef | TTFields + TMZ vs TMZ | 55 54 | 31.7 mo 24.8 mo | 0.61 P = .03 | 61% 53% | 24% 12% | 19.8 mo 12.5 mo | - | 54 |
| China (2013-2021) | Retrospective | TTFields + TMZ vs TMZ | 13 39 | 24.8 mo 18.6 mo | P = .368 | — | — | 15.3 mo 10.6 mo | 55 | |
| Global (2004-2020)g | Meta-analysis | TTFields + CT | 512 | 21.7 mo | — | 45% | — | 7.2 moh | 56% | 56 |
| Germany (2012-2020) | Retrospective | TTFields + lomustine/TMZ vs lomustine/TMZi | 22 48 | NR 26.7 mo | 2.55 (1.25-5.20) P = .01 | — | — | 21.5 mo 11.2 mo | — | 57 |
| 2-THE-TOP; NCT03405792 United States (2018f-2022) | Prospective pilot (phase II) | TTFields + pembrolizumab/TMZ vs TTFields + TMZj | 26 26 | 24.8mo 14.7mo | 0.39 (0.19-0.78) P = .039 | 52% 12% | — | 12.0 mo 5.8 mo | — | 58 |
| NCT03780569 Israel (Apr-Dec 2017) | Prospective pilot | TTFields + RT + TMZ | 10 | NR | — | — | — | 8.9 mo | 58% | 59 |
| SPARE; NCT03477110 United States (2018-2021) | Prospective pilot | TTFields + scalp preserving RT/TMZ | 30 | 15.8 mo | — | — | — | 9.3 mo | — | 60 |
| PriCoTTF Germany (2018-ongoing) | Prospective pilot/ (phase I/II) | TTFields + RT/TMZ | 33 | NR | — | — | — | — | — | 61 |
| Global (2020-2023) | Meta-analysis of real-world evidence | TTFields + CT vs CT | 282 453 | 22.6 mo 17.4 mo | 0.66 0.54-0.82 P < .001 | 47% 32% | 62 |
The table shows studies that report outcomes from at least 10 patients. CT refers to treatment regimens where the study publication did not specify the type of chemotherapy or allow more than one CT regimen.
aIn EF-14, PFS was the primary endpoint and OS was a secondary endpoint.
bThe majority of patients received TMZ.
cEnrolled patients with poor prognostic markers who lacked promising treatment options.
dThe control arm reports patients treated between 2016 and 2017.
eOne patient had rGBM.
fEleven patients were part of EF-07 and 8 were part of EF-14.
gTime period estimated from studies included in the analysis.
hPooled PFS was calculated from 522 patients.
iControl arm includes patients who received TTFields for 0-8 weeks.
jCase controls from the EF-14 study.
Abbreviations: CT, chemotherapy; HR, hazard ratio; mo, months; ndGBM; newly diagnosed glioblastoma; NR, not reached; OS, overall survival; PFS, progression-free survival; PFS6, 6-month PFS rate; RT, radiotherapy; TMZ, temozolomide; TTFields, Tumor Treating Fields.
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