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
5056 - Phase 2 study of 2 dosing regimens of cemiplimab, a human monoclonal anti–PD-1, in metastatic cutaneous squamous cell carcinoma (mCSCC)
Presenter: Danny Rischin
Session: Poster Display session 3
Resources:
Abstract
5710 - Avelumab for advanced Merkel cell carcinoma in the Netherlands; a nationwide survey
Presenter: Sonja Levy
Session: Poster Display session 3
Resources:
Abstract
3152 - Health-related quality of life in patients with metastatic Merkel cell carcinoma receiving second-line or later avelumab treatment: 36-month follow-up data
Presenter: Sandra D'Angelo
Session: Poster Display session 3
Resources:
Abstract
5715 - A Phase 2, Randomized Study of Nivolumab (NIVO) and Ipilimumab (IPI) versus NIVO, IPI and Stereotactic Body Radiation Therapy (SBRT) for Metastatic Merkel Cell Carcinoma (MCC, NCT03071406) – a preliminary report.
Presenter: Sungjune Kim
Session: Poster Display session 3
Resources:
Abstract
2854 - Real-world impact of immune checkpoint inhibitors in metastatic uveal melanoma
Presenter: Kalijn Bol
Session: Poster Display session 3
Resources:
Abstract
2928 - Immune checkpoint inhibitors in a cohort of 206 metastatic uveal melanomas patients
Presenter: Mathilde Saint-Ghislain
Session: Poster Display session 3
Resources:
Abstract
1235 - Incidence and survival of Uveal Melanoma occurring as single cancer versus its occurrence as a first or second primary neoplasm
Presenter: Ahmad Alfaar
Session: Poster Display session 3
Resources:
Abstract
3615 - Validation of a Clinicopathological and Gene Expression Profile (CP-GEP) Model for Sentinel Lymph Node Metastasis in Primary Cutaneous Melanoma
Presenter: Evalyn Mulder
Session: Poster Display session 3
Resources:
Abstract
1793 - External validation of the 8th Edition Melanoma Staging System of the American Joint Committee on Cancer (AJCC) using the Surveillance, Epidemiology and End Results (SEER) Program
Presenter: Angelina Tjokrowidjaja
Session: Poster Display session 3
Resources:
Abstract
4278 - Clinical factors and overall survival (OS) associated with patterns of metastases (mets) in melanoma patients (pts).
Presenter: Ines Pires da Silva
Session: Poster Display session 3
Resources:
Abstract