Abstract 4703
Background
BNCT is a unique cancer treatment technique in which tumor cells are irradiated from the inside with heavy particles produced by 10B(n,α)7Li nuclear transmutation reaction of boron atom and neutron. A next-generation AB-BNCT system that does not require a nuclear reactor has been developed, and it has become possible to perform BNCT in urban hospitals along with stable supply of borofalan (10B) supported by high 10B concentration technology.
Methods
In this world-first, open-label phase II trial of AB-BNCT, patients (pts) with previously irradiated, platinum-resistant R-SCC-HN or with R/LA-nSCC-HN were administered with borofalan(10B) at 200 mg/kg/h intravenously for 2 hours, followed by neutron irradiation with continuous infusion at 100 mg/kg/h. The irradiated dose for tumor was determined passively as a mucosal maximum dose was given 12 Gy-Eq. Primary endpoint was objective response rate (ORR) by central review. Updated efficacy and safety analysis are presented here (data cut off: 5 April 2019).
Results
Eight R-SCC-HN and thirteen R/LA-nSCC-HN pts were enrolled. All R-SCC-HN pts had prior radiotherapy with a dose of 65.5 Gy (range, 59.4–76.0). The tumor minimum dose was 31.0 Gy-Eq (range, 16.1–42.6). ORR for all pts were 71.4%, and CR/PR were 50.0%/25.0% in R-SCC-HN and 7.7%/61.5% in R/LA-nSCC-HN. With a median follow up of 21.3 months (range 9.2–30.6), 1-year PFS by investigator review were 70.6%. Other ecacy data are shown in the table. For adverse event, nausea (81%), dysgeusia (71%), acute parotitis (67%) were observed frequently.Table: 1135P
All (N = 21) | R-SCC-HN (N = 8) | R/LA-nSCC-HN (N = 13) | |
---|---|---|---|
Overall response rate, n (%) (95% CI) | 15 (71.4) (47.8–88.8) | 6 (75) (34.9–96.8) | 9 (69.2) (38.6–90.9) |
Disease control rate, n (%) (95% CI) | 20 (95.2) (76.2–99.9) | 7 (87.5) (47.3–99.7) | 13 (100) (79.4–100) |
Median progression-free survival, months | NR | 10.4 | NR |
1-y / 2-y progression-free survival rate, % | 70.6 / 65.5 | 30.0 / 15.0 | 92.3 / 92.3 |
1-y / 2-y overall survival rate, % | 94.7 / 85.3 | 83.3 / 55.6 | 100 / 100 |
NR, Not reached.
Conclusions
These data suggest that AB-BNCT with borofalan(10B) emerges as a promising treatment option for pts with R –SCC- HN or R/LA-nSCC-HN with no other treatment option.
Clinical trial identification
JapicCTI-194640.
Editorial acknowledgement
Legal entity responsible for the study
Sumitomo Heavy Industries, Ltd, Stella Pharma Corporation.
Funding
Fukushima prefectural subsidy for development and testing of global cutting-edge medical devices.
Disclosure
K. Hirose: Research grant / Funding (self), Travel / Accommodation / Expenses: Sumitomo Heavy Industries, Ltd; Travel / Accommodation / Expenses: Stella Pharma Corporation. K. Ono: Advisory / Consultancy: Stella Pharma Corporation; Advisory / Consultancy: Sumitomo Heavy Industries, Ltd. Y. Takai: Travel / Accommodation / Expenses: Stella Pharma Corporation; Travel / Accommodation / Expenses: Sumitomo Heavy Industries, Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
2881 - Impact of corticosteroids and antibiotics on efficacy of immune-checkpoint inhibitors in advanced non-small cell lung cancer
Presenter: Joaquin Mosquera Martinez
Session: Poster Display session 3
Resources:
Abstract
3186 - The landscape of immuno-oncology clinical trials in China
Presenter: Dawei Wu
Session: Poster Display session 3
Resources:
Abstract
3468 - Clinical Significance of Immune-related Creatine Phosphokinase Increase Associated with Anti PD1/PD-L1 immunotherapies.
Presenter: Samia Hajem
Session: Poster Display session 3
Resources:
Abstract
3836 - Thyroid toxicity and anti-thyroid antibodies as predictive markers for patients treated with anti-PD1 checkpoint therapy
Presenter: Wim Meer
Session: Poster Display session 3
Resources:
Abstract
1343 - Treatment-related adverse events and tolerability in patients with advanced renal cell carcinoma treated with first-line combination therapy with checkpoint inhibitors
Presenter: Thura Win Htut
Session: Poster Display session 3
Resources:
Abstract
5783 - Immune-related adverse events (irAEs) with single-agent PD-1 vs PD-L1 inhibitors: a meta-analysis of 8,730 patients from clinical trials
Presenter: Guru Sonpavde
Session: Poster Display session 3
Resources:
Abstract
5422 - EULAR recommendations for the diagnosis and the management of rheumatic immune-related adverse events due to cancer immunotherapy
Presenter: Marie Kostine
Session: Poster Display session 3
Resources:
Abstract
1202 - Radiographic characteristics and poor prognostic factors of interstitial lung disease (ILD) in nivolumab-treated patients with non-small cell lung cancer (NSCLC)
Presenter: Shinichi Sasaki
Session: Poster Display session 3
Resources:
Abstract
2749 - Use of Checkpoint Inhibitors (CPI) in Allogeneic Stem Cell Transplant Recipients: An Institutional Experience and A Systemic Review of the Literature
Presenter: Chantal Saberian
Session: Poster Display session 3
Resources:
Abstract
3256 - Deep Learning Radiomics distinguishes intrapulmonary Disease from Metastases in Immunotherapy-treated Melanoma Patients
Presenter: Thi Dan Linh Nguyen-Kim
Session: Poster Display session 3
Resources:
Abstract