1. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial
- Author
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Yong Kil Hong, Jong Hee Chang, Chae-Yong Kim, Do-Hyun Nam, Oh Lyong Kim, Jeong Hoon Kim, Sun Ha Paek, and Se-Hyuk Kim
- Subjects
Adult ,Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Population ,Cancer therapy ,Electric Stimulation Therapy ,Newly diagnosed ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Asian People ,Internal medicine ,Republic of Korea ,Temozolomide ,medicine ,Humans ,Adverse effect ,education ,Antineoplastic Agents, Alkylating ,Aged ,education.field_of_study ,Brain Neoplasms ,business.industry ,Incidence (epidemiology) ,Middle Aged ,medicine.disease ,Progression-Free Survival ,Neurology ,030220 oncology & carcinogenesis ,Population study ,Female ,Neurology (clinical) ,Glioblastoma ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Tumor treating fields (TTFields) are anti-mitotic, non-invasive loco-regional cancer therapy comprising low intensity, intermediate frequency alternating electric fields. TTFields plus Temozolomide (TTFields/TMZ) extended survival versus TMZ alone in newly diagnosed glioblastoma (GBM) patients in the EF-14 trial. We report on Korean newly diagnosed GBM patients who participated in the EF-14 trial. Thirty-nine participants of the EF-14 trial were enrolled at 8 sites in South Korea. Patients (24 TTFields/TMZ; 14 TMZ alone) received: TTFields (200 kHz) for > 18 h/day; TMZ at 120–150 mg for 5 days per a 28 day cycle. Safety and efficacy were assessed. Patient baseline characteristics were balanced in the 2 arms and the mean age was 52.1 years, 66.7% were male with a mean KPS of 90. Safety incidence was comparable between the 2 arms. In the TTFields/TMZ arm, 30% suffered from skin irritation versus 52% in the entire study population. No TTFields-related serious adverse events were reported. The median progression-free survival (PFS) in the TTFields/TMZ arm was 6.2 months (95% CI 4.2–12.2) versus 4.2 (95% CI 1.9–11.2) with TMZ alone (p = 0.67). Median overall survival was 27.2 months (95% CI 21-NA) with TTFields/TMZ versus 15.2 months (95% CI 7.5–24.1; HR 0.27, p = 0.01) with TMZ alone. Median OS and 1- and 2-year survival rates were higher with TTFields/TMZ and similar to the entire EF-14 population. About 30% of patients reported skin irritation, a lower rate than seen in the entire EF-14 population. These results demonstrate the efficacy and safety of TTFields in Korean newly diagnosed glioblastoma patients. Clinicaltrials.gov Identifier: NCT00916409.
- Published
- 2020
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