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Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Clinical Trials

Clinicaltrials.gov Identifier: NCT00916409.

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Acknowledgements

The study was funded by Novocure Ltd. Novocure Ltd. had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data. David Christiansen PhD provided editorial assistance funded by Novocure.

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Authors and Affiliations

  1. Department of Neurosurgery, Seoul National University College of Medicine, Seoul, South Korea

    Chae-Yong Kim & Sun Ha Paek

  2. Department of Neurosurgery, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Do-hyun Nam

  3. Department of Neurosurgery, Yonsei University Health System Severance Hospital, Seoul, South Korea

    Jong-Hee Chang

  4. Department of Neurosurgery, The Catholic University of Korea, Seoul, South Korea

    Yong-Kil Hong

  5. Department of Neurosurgery, Asan Medical Center, Seoul, South Korea

    Jeong Hoon Kim

  6. Department of Neurosurgery, Yeungnam University Medical Center, Daegu, South Korea

    Oh Lyong Kim

  7. Department of Neurosurgery, Ajou University Hosptial, Suwon, South Korea

    Se-Hyuk Kim

  8. Neuro-Oncology Division of Department of Neurosurgery, SNU Bundang Comprehensive Cancer Hospital and Bundang Clinical Neuro-Science Institute, Seoul National University Bundang Hospital, Seongnam, South Korea

    Chae-Yong Kim

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Kim, CY., Paek, S.H., Nam, Dh. et al. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial. J Neurooncol 146, 399–406 (2020). https://doi.org/10.1007/s11060-019-03361-2

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