CTNI-77. Phase 1 study of tumor treating fields concurrent with 5 day hypofractionated stereotactic radiosurgery with concurrent and adjuvant temozolomide in patients with newly diagnosed glioblastoma..
Year: 2025
Type: conference-abstract
Abstract: BACKGROUND Preclinical data suggest greater efficacy of radiotherapy when combined with Tumor Treating Fields (TTFs). Building upon our previous phase I trial of 5-fraction stereotactic radiosurgery (SRS), we sought to determine the safety of adding TTFs concurrent with 5-day SRS with concurrent and adjuvant Temozolomide (TMZ). METHODS Adult patients with newly diagnosed glioblastoma (GBM) were enrolled and treated with TTFs (on Day 1) and TMZ (75 mg/m2/day on Days 1-8) concurrent with hypofractionated SRS (35 Gy in 5 fractions starting on Day 2). TTFs were taken off each day during SRS. Adjuvant TMZ was not protocol defined and was per standard of care. Acute (within 1 month) and late (from 1 to 5 months) dose limiting toxicity (DLT) was defined as any treatment-related G3-5 adverse event (AE) (except reversible G3 hematologic), including device-related dermatologic AEs and brain necrosis/edema. Secondary endpoints included progression-free survival (PFS) per RANO and overall survival (OS). RESULTS From 2021 to 2024, twelve patients were enrolled. The median age was 71 years (range, 47-77 y). No patients had acute DLT. Late DLT occurred in 1 patient (G3 insomnia). The highest-level device-related dermatologic AEs were G1 in 7 patients, G2 in 5 patients. Late radiation necrosis occurred in 3 patients (all G1-2; none with G3-5). Median PFS was 10.5 months (95% CI: 10.3-10.6), median OS was 15.1 months (95% CI: 14.9-15.4). OS was 15.2 months if MGMT positive for hypermethylation (n=2 patients),15.0 months if MGMT negative (n=10 patients). CONCLUSION TTFs concurrent with 5-day hypofractionated SRS and TMZ were well tolerated, with no G3+ late radiation necrosis nor G3+ device-related dermatologic toxicity.
Source: Neuro-Oncology
Authors: Scott Soltys, Bernice Kwong, Chirag Patel, Katherine Jin, Camellia Djebroun, Elham Rahimy, Erqi Pollom, Kate Therkelsen, Seema Nagpal
Institution: Stanford University
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4416140946
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