Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2017 Jul;6(3):185-193.
doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.

Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial

Santosh Kesari  1   2   3 , Zvi Ram  4 ; EF-14 Trial Investigators
Affiliations
Clinical Trial

Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial

Santosh Kesari et al. CNS Oncol. 2017 Jul.

Abstract

Background: This post hoc analysis of the EF-14 trial (NCT00916409) of tumor-treating fields (TTFields) plus temozolomide versus temozolomide alone in newly diagnosed glioblastoma compared the efficacy of TTFields plus chemotherapy (physician's choice) versus chemotherapy alone after first recurrence.

Methods: Patients on TTFields plus temozolomide continued TTFields plus second-line chemotherapy after first recurrence. Some patients on temozolomide alone crossed over after approval of TTFields for recurrent GBM. The primary efficacy outcome was overall survival (OS).

Results: After disease progression, 131 patients received TTFields plus chemotherapy and 73 chemotherapy alone. Thirteen patients in the original temozolomide-alone group crossed over to receive TTFields plus chemotherapy after disease progression, resulting in 144 patients receiving TTFields plus chemotherapy and 60 chemotherapy alone. Median follow-up was 12.6 months. Bevacizumab, alone or with cytotoxic chemotherapy, was the most frequent treatment. Median OS in the TTFields plus chemotherapy group was significantly longer versus chemotherapy alone (11.8 vs 9.2 months; HR: 0.70; 95% CI, 0.48-1.00; p=0.049). TTFields showed a low toxicity safety profile, as previously reported, with no grade 3/4 device-related adverse events.

Conclusion: TTFields plus chemotherapy after first disease recurrence on TTFields plus temozolomide or temozolomide alone prolonged OS in patients in the EF-14 trial.

Keywords: TTFields; bevacizumab; disease recurrence; glioblastoma; overall survival; second-line chemotherapy.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure

The study was funded by NovoCure Ltd. S Kesari is a consultant with Novocure and has received research grants from the company. Z Ram is a consultant and shareholder with Novocure and has received research grants from the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Patient flow.
TMZ: Temozolomide; TTFields: Tumor-treating fields.
<b>Figure 2.</b>
Figure 2.. Overall survival from first disease recurrence.
(A) TTFields plus second-line chemotherapy versus second-line chemotherapy alone, or (B) TTFields plus bevacizumab alone or in combination with chemotherapy versus bevacizumab alone or in combination with chemotherapy. HR: Hazard ratio; OS: Overall survival; TTFields: Tumor-treating fields.
See this image and copyright information in PMC

References

    1. Ostrom QT, Gittleman H, Fulop J, et al. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2008–2012. Neuro Oncol. 2015;17(Suppl. 4):iv1–iv62. - PMC - PubMed
    1. Gallego O. Nonsurgical treatment of recurrent glioblastoma. Curr. Oncol. 2015;22:e273–e281. - PMC - PubMed
    1. Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised Phase III study: 5 year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459–466. - PubMed
    1. Gilbert MR, Wang M, Aldape KD, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized Phase III clinical trial. J. Clin. Oncol. 2013;31:4085–4091. - PMC - PubMed
    1. Gilbert MR, Dignam JJ, Armstrong TS, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N. Engl. J. Med. 2014;370:699–708. - PMC - PubMed

MeSH terms

Associated data