The EF-14 pivotal phase 3 trial included patients with newly diagnosed GBM who only had a biopsy1
- Patients who did not have a resection had a biopsy1
Extent of Resection was consistent across both study arms1
The study protocol defined surgery as surgical resection to the extent safely feasible or biopsy.1
Biopsy-only patients using Optune + TMZ had longer median OS (16.5 months) vs those using TMZ alone (11.6 months)1
In the EF-14 trial1
- 13% of patients in each study arm only had a biopsy
- 3 patients treated with Optune + TMZ and 1 patient in the TMZ alone group were included in the analysis at 48 months2
In a post hoc analysis, extension of OS was observed with Optune + TMZ across all patient subgroups vs TMZ alone1*
- In patients who had a partial resection, median OS was 21.4 months with Optune + TMZ (n=157) compared with 15.1 months with TMZ alone (n=77)1
- In patients who had a gross total resection, median OS was 22.6 months with Optune + TMZ (n=249) compared with 18.5 months with TMZ alone (n=123)1
Optune + TMZ improved median survival vs TMZ alone regardless of extent of resection
*A randomized, open-label trial in 695 patients with newly diagnosed GBM whose tumor was resected or biopsied and had completed concomitant radiochemotherapy were randomized 2:1 to TTFields plus maintenance TMZ or TMZ alone.
GBM, glioblastoma; OS, overall survival; TMZ, temozolomide.
References: 1. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 2. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007.