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
1291 - PD-L1 expression in uncommon EGFR-mutant non-small cell lung cancer and its response to immunotherapy
Presenter: Yun Fan
Session: Poster Display session 3
Resources:
Abstract
2171 - CCND1 Amplification Contributes to Immunosuppression in Head and Neck Squamous Cell Carcinoma and the Association with a Poor Response to Immune Checkpoint Inhibitors
Presenter: Chloe Huang
Session: Poster Display session 3
Resources:
Abstract
2624 - Efficacy of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer patients with sensitive genes mutation
Presenter: Hui-Juan Cui
Session: Poster Display session 3
Resources:
Abstract
3494 - Neutrophil to Lymphocyte Ratio (NLR) kinetics as predictors of outcomes in metastatic renal cell carcinoma (mRCC) and non-small cell lung cancer (NSCLC) patients treated with nivolumab (N).
Presenter: Audrey Simonaggio
Session: Poster Display session 3
Resources:
Abstract
3964 - Predictive markers of checkpoint inhibitor activity in adult metastatic solid tumours
Presenter: Alexandra Pender
Session: Poster Display session 3
Resources:
Abstract
3041 - Blood-based TMB (bTMB) correlates with tissue-based TMB (tTMB) in a multi-cancer Phase I IO Cohort
Presenter: Daniel Araujo
Session: Poster Display session 3
Resources:
Abstract
3910 - Analysis of Molecular Profile Complexities for Immunotherapy Decision Support
Presenter: Robert Dóczi
Session: Poster Display session 3
Resources:
Abstract
4836 - The Role of Tumor Neoantigens in the Differential Response to Immunotherapy (IO) in EGFR and BRAF Mutated Lung Cancers - Quantity or Quality?
Presenter: Katrina Case
Session: Poster Display session 3
Resources:
Abstract
1929 - Impact of previous corticosteroid (CS) exposure on efficacy of Programmed Cell Death-(Ligand) 1 blockade in patients with advanced Non-Small-Cell Lung Cancer (NSCLC): a single Center retrospective analysis
Presenter: Fabrizio Nelli
Session: Poster Display session 3
Resources:
Abstract
2601 - Comparison 18F-FDG-PET/CT criteria for prediction of therapy response and clinical outcome in patients with metastatic melanoma treated with Ipilimumab and PD-1 inhibitors
Presenter: Sabrina Vari
Session: Poster Display session 3
Resources:
Abstract