Safety of Boron Neutron Capture Therapy with Borofalan( 10 B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance
This study was conducted to evaluate the real-world safety and efficacy of boron neutron capture therapy (BNCT) with borofalan( B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA/LR-HNC). This prospective, multicenter observational study was initiated in Japa...
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| Veröffentlicht in: | Cancers 2024-02, Vol.16 (5), p.869 |
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| creator | Sato, Mariko Hirose, Katsumi Takeno, Satoshi Aihara, Teruhito Nihei, Keiji Takai, Yoshihiro Hayashi, Toshimitsu Bando, Kosuke Kimura, Hitomi Tsurumi, Keisuke Ono, Koji |
| description | This study was conducted to evaluate the real-world safety and efficacy of boron neutron capture therapy (BNCT) with borofalan(
B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA/LR-HNC).
This prospective, multicenter observational study was initiated in Japan in May 2020 and enrolled all patients who received borofalan(
B) as directed by regulatory authorities. Patient enrollment continued until at least 150 patients were enrolled, and adverse events attributable to drugs, treatment devices, and BNCT were evaluated. The patients with LA/LR-HNC were systematically evaluated to determine efficacy.
The 162 patients enrolled included 144 patients with squamous cell carcinoma of the head and neck (SCCHN), 17 patients with non-SCCHN (NSCCHN), and 1 patient with glioblastoma. Treatment-related adverse events (TRAEs) were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%) as acute TRAEs and dysphagia (4.5%), thirst (2.6%), and skin disorder (1.9%) as more common late TRAEs. One- and two-year OS rates in patients with recurrent SCCHN were 78.8% and 60.7%, respectively.
This post-marketing surveillance confirmed the safety and efficacy of BNCT with borofalan(
B) in patients with LA/LR-HNC in a real-world setting. |
| doi_str_mv | 10.3390/cancers16050869 |
| format | Article |
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B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA/LR-HNC).
This prospective, multicenter observational study was initiated in Japan in May 2020 and enrolled all patients who received borofalan(
B) as directed by regulatory authorities. Patient enrollment continued until at least 150 patients were enrolled, and adverse events attributable to drugs, treatment devices, and BNCT were evaluated. The patients with LA/LR-HNC were systematically evaluated to determine efficacy.
The 162 patients enrolled included 144 patients with squamous cell carcinoma of the head and neck (SCCHN), 17 patients with non-SCCHN (NSCCHN), and 1 patient with glioblastoma. Treatment-related adverse events (TRAEs) were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%) as acute TRAEs and dysphagia (4.5%), thirst (2.6%), and skin disorder (1.9%) as more common late TRAEs. One- and two-year OS rates in patients with recurrent SCCHN were 78.8% and 60.7%, respectively.
This post-marketing surveillance confirmed the safety and efficacy of BNCT with borofalan(
B) in patients with LA/LR-HNC in a real-world setting.</description><identifier>ISSN: 2072-6694</identifier><identifier>EISSN: 2072-6694</identifier><identifier>DOI: 10.3390/cancers16050869</identifier><identifier>PMID: 38473231</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Adverse events ; Boron ; Boron-neutron capture therapy ; Cancer ; Cancer therapies ; Case reports ; Chemotherapy ; Clinical trials ; Data collection ; Drug dosages ; Drug therapy ; Dysphagia ; Glioblastoma ; Head & neck cancer ; Head and neck cancer ; Head and neck carcinoma ; Hospitals ; Industrial equipment and supplies industry ; Laboratories ; Marketing ; Medical equipment ; Medical prognosis ; National health insurance ; Neutrons ; Patients ; Radiation therapy ; Safety ; Sialoadenitis ; Skin diseases ; Squamous cell carcinoma ; Stomatitis ; Surveillance ; Thirst ; Toxicity ; Tumors</subject><ispartof>Cancers, 2024-02, Vol.16 (5), p.869</ispartof><rights>COPYRIGHT 2024 MDPI AG</rights><rights>2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2024 by the authors. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489t-e00400565174250bbc513838e9f695bdfe8a6238b6d17c59bc4b950226273eb03</citedby><cites>FETCH-LOGICAL-c489t-e00400565174250bbc513838e9f695bdfe8a6238b6d17c59bc4b950226273eb03</cites><orcidid>0000-0003-0478-6971 ; 0000-0002-7582-8537 ; 0000-0002-9603-0567</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10931064/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10931064/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38473231$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sato, Mariko</creatorcontrib><creatorcontrib>Hirose, Katsumi</creatorcontrib><creatorcontrib>Takeno, Satoshi</creatorcontrib><creatorcontrib>Aihara, Teruhito</creatorcontrib><creatorcontrib>Nihei, Keiji</creatorcontrib><creatorcontrib>Takai, Yoshihiro</creatorcontrib><creatorcontrib>Hayashi, Toshimitsu</creatorcontrib><creatorcontrib>Bando, Kosuke</creatorcontrib><creatorcontrib>Kimura, Hitomi</creatorcontrib><creatorcontrib>Tsurumi, Keisuke</creatorcontrib><creatorcontrib>Ono, Koji</creatorcontrib><title>Safety of Boron Neutron Capture Therapy with Borofalan( 10 B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance</title><title>Cancers</title><addtitle>Cancers (Basel)</addtitle><description>This study was conducted to evaluate the real-world safety and efficacy of boron neutron capture therapy (BNCT) with borofalan(
B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA/LR-HNC).
This prospective, multicenter observational study was initiated in Japan in May 2020 and enrolled all patients who received borofalan(
B) as directed by regulatory authorities. Patient enrollment continued until at least 150 patients were enrolled, and adverse events attributable to drugs, treatment devices, and BNCT were evaluated. The patients with LA/LR-HNC were systematically evaluated to determine efficacy.
The 162 patients enrolled included 144 patients with squamous cell carcinoma of the head and neck (SCCHN), 17 patients with non-SCCHN (NSCCHN), and 1 patient with glioblastoma. Treatment-related adverse events (TRAEs) were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%) as acute TRAEs and dysphagia (4.5%), thirst (2.6%), and skin disorder (1.9%) as more common late TRAEs. One- and two-year OS rates in patients with recurrent SCCHN were 78.8% and 60.7%, respectively.
This post-marketing surveillance confirmed the safety and efficacy of BNCT with borofalan(
B) in patients with LA/LR-HNC in a real-world setting.</description><subject>Adverse events</subject><subject>Boron</subject><subject>Boron-neutron capture therapy</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Case reports</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Data collection</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Dysphagia</subject><subject>Glioblastoma</subject><subject>Head & neck cancer</subject><subject>Head and neck cancer</subject><subject>Head and neck carcinoma</subject><subject>Hospitals</subject><subject>Industrial equipment and supplies industry</subject><subject>Laboratories</subject><subject>Marketing</subject><subject>Medical equipment</subject><subject>Medical prognosis</subject><subject>National health insurance</subject><subject>Neutrons</subject><subject>Patients</subject><subject>Radiation therapy</subject><subject>Safety</subject><subject>Sialoadenitis</subject><subject>Skin diseases</subject><subject>Squamous cell carcinoma</subject><subject>Stomatitis</subject><subject>Surveillance</subject><subject>Thirst</subject><subject>Toxicity</subject><subject>Tumors</subject><issn>2072-6694</issn><issn>2072-6694</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptksFO3DAQhqOqqCDg3FtlqRd6CNhx4sS9VLCiBYkuVaHq0XKc8a4hsbe2A9rH6hvWAUoB1T7Y8nzzz_zWZNlbgvcp5fhASavAB8JwhRvGX2VbBa6LnDFevn5y38x2Q7jCaVFKala_yTZpU9a0oGQr-30hNcQ1chodOe8smsMYp3MmV3H0gC6X4OVqjW5NXN4hWvbS7iGC0dEHJG2HTmNAx1obJVXSseg7qNF7sBGdgOzukDmo66Q4tfsxxWWf_3S-79D5GJUbICDt3YDmMhpnb00H6JsLMf8q_TVEYxfoYvQ3YPp-UtjJNlILAXYfzu3sx-fjy9lJfnb-5XR2eJarsuExB4xLjCtWkbosKty2qiK0oQ1wzXjVdhoayQratKwjtap4q8qWV7goWFFTaDHdzj7d667GdoBOJUNe9mLlzSD9WjhpxPOINUuxcDeCYE4JZmVS2HtQ8O7XCCGKwQQFkw1wYxAFrxhrSI1JQt-_QK_c6G3yN1FVSXHD8T9qIXsQxmqXCqtJVBzWTapYEMITtf8fKu0OBqOcBW3S-7OEg_sE5V0IHvSjSYLFNGnixaSljHdP_-aR_ztX9A_W8c8W</recordid><startdate>20240221</startdate><enddate>20240221</enddate><creator>Sato, Mariko</creator><creator>Hirose, Katsumi</creator><creator>Takeno, Satoshi</creator><creator>Aihara, Teruhito</creator><creator>Nihei, Keiji</creator><creator>Takai, Yoshihiro</creator><creator>Hayashi, Toshimitsu</creator><creator>Bando, Kosuke</creator><creator>Kimura, Hitomi</creator><creator>Tsurumi, Keisuke</creator><creator>Ono, Koji</creator><general>MDPI AG</general><general>MDPI</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TO</scope><scope>7XB</scope><scope>8FE</scope><scope>8FH</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M2O</scope><scope>M7P</scope><scope>MBDVC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-0478-6971</orcidid><orcidid>https://orcid.org/0000-0002-7582-8537</orcidid><orcidid>https://orcid.org/0000-0002-9603-0567</orcidid></search><sort><creationdate>20240221</creationdate><title>Safety of Boron Neutron Capture Therapy with Borofalan( 10 B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance</title><author>Sato, Mariko ; Hirose, Katsumi ; Takeno, Satoshi ; Aihara, Teruhito ; Nihei, Keiji ; Takai, Yoshihiro ; Hayashi, Toshimitsu ; Bando, Kosuke ; Kimura, Hitomi ; Tsurumi, Keisuke ; Ono, Koji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c489t-e00400565174250bbc513838e9f695bdfe8a6238b6d17c59bc4b950226273eb03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adverse events</topic><topic>Boron</topic><topic>Boron-neutron capture therapy</topic><topic>Cancer</topic><topic>Cancer therapies</topic><topic>Case reports</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Data collection</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Dysphagia</topic><topic>Glioblastoma</topic><topic>Head & neck cancer</topic><topic>Head and neck cancer</topic><topic>Head and neck carcinoma</topic><topic>Hospitals</topic><topic>Industrial equipment and supplies industry</topic><topic>Laboratories</topic><topic>Marketing</topic><topic>Medical equipment</topic><topic>Medical prognosis</topic><topic>National health insurance</topic><topic>Neutrons</topic><topic>Patients</topic><topic>Radiation therapy</topic><topic>Safety</topic><topic>Sialoadenitis</topic><topic>Skin diseases</topic><topic>Squamous cell carcinoma</topic><topic>Stomatitis</topic><topic>Surveillance</topic><topic>Thirst</topic><topic>Toxicity</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sato, Mariko</creatorcontrib><creatorcontrib>Hirose, Katsumi</creatorcontrib><creatorcontrib>Takeno, Satoshi</creatorcontrib><creatorcontrib>Aihara, Teruhito</creatorcontrib><creatorcontrib>Nihei, Keiji</creatorcontrib><creatorcontrib>Takai, Yoshihiro</creatorcontrib><creatorcontrib>Hayashi, Toshimitsu</creatorcontrib><creatorcontrib>Bando, Kosuke</creatorcontrib><creatorcontrib>Kimura, Hitomi</creatorcontrib><creatorcontrib>Tsurumi, Keisuke</creatorcontrib><creatorcontrib>Ono, Koji</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>ProQuest_Research Library</collection><collection>ProQuest Biological Science Journals</collection><collection>Research Library (Corporate)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancers</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sato, Mariko</au><au>Hirose, Katsumi</au><au>Takeno, Satoshi</au><au>Aihara, Teruhito</au><au>Nihei, Keiji</au><au>Takai, Yoshihiro</au><au>Hayashi, Toshimitsu</au><au>Bando, Kosuke</au><au>Kimura, Hitomi</au><au>Tsurumi, Keisuke</au><au>Ono, Koji</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of Boron Neutron Capture Therapy with Borofalan( 10 B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance</atitle><jtitle>Cancers</jtitle><addtitle>Cancers (Basel)</addtitle><date>2024-02-21</date><risdate>2024</risdate><volume>16</volume><issue>5</issue><spage>869</spage><pages>869-</pages><issn>2072-6694</issn><eissn>2072-6694</eissn><abstract>This study was conducted to evaluate the real-world safety and efficacy of boron neutron capture therapy (BNCT) with borofalan(
B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA/LR-HNC).
This prospective, multicenter observational study was initiated in Japan in May 2020 and enrolled all patients who received borofalan(
B) as directed by regulatory authorities. Patient enrollment continued until at least 150 patients were enrolled, and adverse events attributable to drugs, treatment devices, and BNCT were evaluated. The patients with LA/LR-HNC were systematically evaluated to determine efficacy.
The 162 patients enrolled included 144 patients with squamous cell carcinoma of the head and neck (SCCHN), 17 patients with non-SCCHN (NSCCHN), and 1 patient with glioblastoma. Treatment-related adverse events (TRAEs) were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%) as acute TRAEs and dysphagia (4.5%), thirst (2.6%), and skin disorder (1.9%) as more common late TRAEs. One- and two-year OS rates in patients with recurrent SCCHN were 78.8% and 60.7%, respectively.
This post-marketing surveillance confirmed the safety and efficacy of BNCT with borofalan(
B) in patients with LA/LR-HNC in a real-world setting.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>38473231</pmid><doi>10.3390/cancers16050869</doi><orcidid>https://orcid.org/0000-0003-0478-6971</orcidid><orcidid>https://orcid.org/0000-0002-7582-8537</orcidid><orcidid>https://orcid.org/0000-0002-9603-0567</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Cancers, 2024-02, Vol.16 (5), p.869 |
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| source | PubMed Central(OpenAccess); PubMed Central Open Access; MDPI - Multidisciplinary Digital Publishing Institute; EZB Electronic Journals Library |
| subjects | Adverse events Boron Boron-neutron capture therapy Cancer Cancer therapies Case reports Chemotherapy Clinical trials Data collection Drug dosages Drug therapy Dysphagia Glioblastoma Head & neck cancer Head and neck cancer Head and neck carcinoma Hospitals Industrial equipment and supplies industry Laboratories Marketing Medical equipment Medical prognosis National health insurance Neutrons Patients Radiation therapy Safety Sialoadenitis Skin diseases Squamous cell carcinoma Stomatitis Surveillance Thirst Toxicity Tumors |
| title | Safety of Boron Neutron Capture Therapy with Borofalan( 10 B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance |
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