Elderly Patients
In newly diagnosed GBM,
A post hoc analysis of the EF-14* study demonstrated that Optune Gio + TMZ was associated with increased survival benefit in elderly patients1
Overall survival (OS) in patients 65 years and older1
- This post hoc subgroup analysis included data from all 134 patients 65 years of age and older in the intent-to-treat population, and compared OS, PFS, and safety between the 2 treatment arms: Optune Gio + TMZ (n=89) vs TMZ alone (n=45)
- Patient baseline characteristics and known prognostic factors were balanced between the 2 treatment groups
- Median patient age and KPS were 69 years and 90, respectively
- Survival rates for patients 65 years of age and older were consistent with the overall trial population
*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.2
Survival with Optune Gio + TMZ vs TMZ alone was higher at the 2-year landmark analysis1
In a post hoc analysis,
Optune Gio + TMZ was also associated with improved progression-free survival (PFS) vs TMZ alone in elderly patients1
- Median PFS: 6.5 months vs 3.9 months (HR: 0.47 [95% CI, 0.30-0.74])
Optune Gio + TMZ in elderly patients showed no significant increase in adverse events (AEs)1
- No significant increase in systemic AEs in patients treated with Optune Gio + TMZ (46%) vs TMZ alone (40%)
- Serious adverse events (SAEs) were reported in 39% of patients treated with Optune Gio + TMZ and in 33% of patients treated with TMZ alone. None were considered related to treatment with Optune Gio
- The rate of grade 1 or 2 medical device site reaction was 51% for Optune Gio + TMZ compared with 0% for TMZ alone, and severe (grade 3) skin involvement occurred in 2% of patients treated with Optune Gio + TMZ
Many elderly patients were able to use Optune Gio effectively, with more than half (57%) achieving average time on treatment of ≥75% (≥18 hours/day)1
AEs, adverse events; GBM, glioblastoma; KPS, Karnofsky Performance Score; PFS, progression-free survival; SAEs, serious adverse events; TMZ, temozolomide.
References: 1. Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and safety of Tumor Treating Fields (TTFields) in elderly patients with newly diagnosed glioblastoma: subgroup analysis of the phase 3 EF-14 clinical trial. Front Oncol. 2021;11:671972. doi:10.3389/fonc.2021.671972 2. 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.