Accelerator-based BNCT in rescue treatment of patients with recurrent GBM: A multicenter phase II study.

Authors

null

Shin-Ichi Miyatake

Osaka Medical College, Takatsuki, Japan

Shin-Ichi Miyatake , Shinji Kawabata , Hiromi Goto , Yoshitaka Narita , Minoru Suzuki , Katsumi Hirose , Yoshihiro Takai , Koji Ono , Takanori Ohnishi , Hiroki Tanaka , Takahiro Kato

Organizations

Osaka Medical College, Takatsuki, Japan, Department of Neurosurgery,Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan, Research Center Research Reactor Institute, Kyoto University, Kumatori, Japan, Southern Tohoku BNCT Research Center, Koriyama, Japan, Osaka Medical College, Kansai BNCT Medical Center, Takatsuki, Japan, Department of Neurosurgery, Washoukai Sadamoto Hospital, Matsuyama, Japan, Institute for Integrated Radiation and Nuclear Science, Kyoto University, Kumatori, Japan

Research Funding

Pharmaceutical/Biotech Company
Stella Pharma Corporation

Background: Boron neutron capture therapy (BNCT) is tumor-selective particle radiation and theoretically efficacious especially for tumors with infiltrative nature, such as glioblastoma (GBM). The aim of this study is to assess safety and efficacy of accelerator-based BNCT (AB-BNCT) using cyclotron-based neutron generator, BNCT30, and 10B-boronophenylalanine (borofalan(10B)) agent, SPM-011, in patients with recurrent malignant gliomas, chiefly GBM. Methods: The multi-institutional open-label, phase II clinical trial for recurrent 27 cases of malignant gliomas (MG) (24 cases were GBM) was conducted with above mentioned AB-BNCT system, using 500mg/kg of SPM-011 (study code, JG002). The patients were enrolled from February 2016 to June 2018. The inclusion criteria are bevacizumab-naïve MG, recurrent after standard treatment composed of XRT and chemotherapy with TMZ. Neutron-irradiation time were determined not to exceed to 8.5 Gy-Eq for scalp dose which was decided by preceding phase I trial. Primary endpoint was 1-year survival rate and secondary ones were median overall survival (mOS), median progression free survival (mPFS) and so on. The results were compared to previous Japanese domestic bevacizumab trial for recurrent GBM (JO22506) which had the similar inclusion criteria with JG002. Results: 1-year survival rate and mOS of recurrent GBM cases in JG002 was 79.2% (95% CI:57.0-90.8) and 18.7 months (95% CI:12.9-23.4) (data cutoff = 20 Jun 2019) respectively, while those of JO22506 was 34.5% (90% CI:20.0-49.0) and 10.5 months (95% CI:8.2-12.4), respectively. Median PFS of JG002 and JO22506 were 0.9 and 3.3 months, respectively. Most important adverse event in JG002 was brain edema. 21 out of 27 cases were treated with bevacizumab after progress disease. Conclusions: AB-BNCT demonstrated acceptable safety and prolonged survival for recurrent MG chiefly GBM. AB-BNCT might produce brain edema somewhat after the treatment, which might be the unavoidable adverse event of re-irradiation for recurrent MG, however that seemed to be controlled with bevacizumab. Clinical trial information: JapicCTI-194742.

ParameterJG002(BNCT)
GBM (N = 24)
JO22506 (bevacizumab)
GBM (N = 29)
1-year survival rate,% (95% CI)79.2 (57.0-90.8)34.5 (90%CI, 20.0-49.0)
Median OS, mo (95% CI)18.7 (12.9-23.4)10.5 (8.2-12.4)
Median PFS, mo (95% CI)0.9 (0.8-1.0)3.3 (2.8-6.0)

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Central Nervous System Tumors

Track

Central Nervous System Tumors

Sub Track

Central Nervous System Tumors

Clinical Trial Registration Number

JapicCTI-194742

Citation

J Clin Oncol 38: 2020 (suppl; abstr 2536)

DOI

10.1200/JCO.2020.38.15_suppl.2536

Abstract #

2536

Poster Bd #

27

Abstract Disclosures

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