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
2108 - Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase 3 study.
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3090 - Comparison of Immuno-Oncology (IO) Biomarkers in Adenocarcinoma (ACB), Urothelial Carcinoma (UCB) and Squamous Cell Carcinoma (SCCB) of the Bladder, with interim results from PURE01
Presenter: Daniele Raggi
Session: Poster Display session 3
Resources:
Abstract
5211 - Potential role of a clinical, taxonomical classification and RNA expression integrated signature to predict response to neoadjuvant platinum-based chemotherapy in muscle-invasive bladder cancer (MIBC) patients
Presenter: Albert Font
Session: Poster Display session 3
Resources:
Abstract
3206 - Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Anti-tumor Activity Among Patients (Pts) with Advanced Urothelial Carcinoma (UC)
Presenter: Scott Tagawa
Session: Poster Display session 3
Resources:
Abstract
3110 - Prognostic role of FGFR Mutations and FGFR mRNA expression in metastatic urothelial cancer treated with anti-PD(L1) inhibitors in first and second line setting
Presenter: Florian Roghmann
Session: Poster Display session 3
Resources:
Abstract
3564 - Circulating tumour DNA (ctDNA) utility as a biomarker for metastatic urothelial carcinoma (mUC)
Presenter: Jean-Michel Lavoie
Session: Poster Display session 3
Resources:
Abstract
2760 - Comparative analysis of tumor mutational burden (TMB) prediction methods and its association with determinants of the tumor immune microenvironment of urothelial bladder cancer (UBC)
Presenter: Markus Eckstein
Session: Poster Display session 3
Resources:
Abstract
2513 - The Immunoscore in patients with urothelial carcinoma treated with neoadjuvant chemotherapy: clinical significance for pathological response and survival
Presenter: Elise Nassif
Session: Poster Display session 3
Resources:
Abstract
2835 - Genomic analysis of urothelial cancer and associations with treatment choice and outcome
Presenter: David Sarid
Session: Poster Display session 3
Resources:
Abstract
5763 - cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
Presenter: Sumanta Pal
Session: Poster Display session 3
Resources:
Abstract