Patients With Biopsy Only
In newly diagnosed GBM,
A post hoc analysis of the EF-14* study showed Optune Gio + TMZ was associated with increased median survival benefit vs TMZ alone in patients ineligible for surgical resection1
The pivotal EF-14* phase 3 trial included patients with newly diagnosed GBM who only 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
Overall survival (OS) in patients with biopsy only2
Patients with biopsy only using Optune Gio + TMZ had longer median OS (mOS) (16.5 months) vs those using TMZ alone (11.6 months)2
In the EF-14 trial
- 13% of patients in each study arm only had a biopsy1
- 3 patients treated with Optune Gio + TMZ and 1 patient in the TMZ alone group were included in the analysis at 48 months2
In a post hoc analysis of the EF-14* study,
Optune Gio + TMZ was associated with improved mOS vs TMZ alone regardless of extent of resection1,2
- In patients who had a partial resection, mOS was 21.4 months with Optune Gio + TMZ (n=157) compared with 15.1 months with TMZ alone (n=77) (HR: 0.56 [95% CI, 0.41-0.77])
- In patients who had a gross total resection, mOS was 22.6 months with Optune Gio + TMZ (n=249) compared with 18.5 months with TMZ alone (n=123) (HR: 0.70 [95% CI, 0.54-0.91])
*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 Optune Gio plus maintenance TMZ or TMZ alone.1
GBM, glioblastoma; ITT, intent to treat; 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.