{"id":1852,"date":"2019-12-06T17:57:00","date_gmt":"2019-12-06T22:57:00","guid":{"rendered":"https:\/\/nanobiotix.com\/resource\/rsna-treatment-of-locally-advanced-hnscc-by-nbtxr3\/"},"modified":"2024-10-29T08:50:20","modified_gmt":"2024-10-29T12:50:20","slug":"rsna-treatment-of-locally-advanced-hnscc-by-nbtxr3","status":"publish","type":"resource","link":"https:\/\/nanobiotix.com\/fr\/resource\/rsna-treatment-of-locally-advanced-hnscc-by-nbtxr3\/","title":{"rendered":"RSNA &#8211; Treatment of locally advanced HNSCC by NBTXR3"},"content":{"rendered":"<p>[vc_row padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; section_container_layout=&#8221;full-width&#8221; remove_horizontal_padding=&#8221;yes&#8221; module_type=&#8221;bg-color&#8221; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;#28282e&#8221;][vc_column][vc_row_inner padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221;][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; column_min_height=&#8221;700&#8243; column_min_height_sm=&#8221;400&#8243; column_min_height_xs=&#8221;350&#8243; module_type=&#8221;bg-image&#8221; bg_image=&#8221;99&#8243; mask_fx=&#8221;yes-mask&#8221; mask_color_mode=&#8221;palette&#8221; mask_bg_color_palette=&#8221;main-mask&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;200&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Authors&#8221; box_icon_color_mode=&#8221;on-the-fly&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;fa fa-edit&#8221; icon_color_mode=&#8221;on-the-fly&#8221; icon_size=&#8221;50&#8243; box_icon_color=&#8221;#ffffff&#8221; icon_color=&#8221;#ffffff&#8221;]Christophe Le Tourneau<span class=\"notes up\">1<\/span>, Valentin Calugaru<span class=\"notes up\">1<\/span>, Victor Moreno Garcia<span class=\"notes up\">2<\/span>, Xavier Mirabel<span class=\"notes up\">3<\/span>, Bernard Doger<span class=\"notes up\">2<\/span>, Emiliano Calvo<span class=\"notes up\">2<\/span>, Jacek Fijuth<span class=\"notes up\">4<\/span>, Tomasz Rutkowski<span class=\"notes up\">5<\/span>, Nicolas Magn\u00e9<span class=\"notes up\">6<\/span>, Miren Sanz Taberna<span class=\"notes up\">7<\/span>, Jorge Contreras<span class=\"notes up\">8<\/span>, Irene Brana<span class=\"notes up\">9<\/span>, Zsuzsanna Papai<span class=\"notes up\">10<\/span>, Zolt\u00e1n Takacsi-Nagy<span class=\"notes up\">11<\/span>, Xavier Liem<span class=\"notes up\">3<\/span>, S\u00e9bastien Salas<span class=\"notes up\">12<\/span>, St\u00e9phanie Wong<span class=\"notes up\">12<\/span>, Carmen Florescu<span class=\"notes up\">13<\/span>, Juliette Thariat<span class=\"notes up\">13<\/span>, Caroline Hoffmann<span class=\"notes up\">1<\/span> <span class=\"notes\"> 1 &#8211; Institut Curie, Paris, France 2 &#8211; START Madrid, Madrid, Spain 3 &#8211; Centre Oscar Lambret, Lille, France 4 &#8211; Provita Prolife, Tomasz\u00f3w Mazowiecki, Poland 5 &#8211; Maria Sk\u0142odowska-Curie Institute of Oncology, Gliwice, Poland 6 &#8211; Institut de Canc\u00e9rologie Lucien Neuwirt, Saint-Priest-en-Jarez, France 7 &#8211; Institut Catala d\u2019Oncologia, Barcelona, Spain 8 &#8211; University Regional Hospital of Malaga, Malaga, Spain 9 &#8211; Vall d&#8217;Hebron University Hospital, Bacelona, Spain 10 &#8211; Hungarian Defense Forces Military Hospital, Budapest, Hungary 11 &#8211; National Institute of Oncology, Budapest, Hungary 12 &#8211; H\u00f4pital Timone, APHM, Marseille 13 &#8211; Unicancer &#8211; Fran\u00e7ois Baclesse Center, Caen, France <\/span>[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/vc_column_inner][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; module_type=&#8221;bg-color&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;300&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; bg_color=&#8221;#ffffff&#8221; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Summary&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;az-icon az-icon-layers2&#8243; icon_color_mode=&#8221;on-the-fly&#8221; icon_color=&#8221;#28282e&#8221; icon_size=&#8221;50&#8243;]<strong>Purpose:<\/strong> Elderly head and neck squamous cell carcinoma (HSNCC) patients (pts) ineligible for standard of care treatment require new therapeutic approaches. NBTXR3, hafnium oxide nanoparticles, may represent such an option. NBTXR3 is activated by radiotherapy, enhancing its effects, leading to physical destruction of cancer cells. A Phase I\/II trial [NCT01946867] is underway to evaluate NBTXR3 in elderly (\u226570 years) or frail pts with HNSCC of the oral cavity and oropharynx ineligible for cisplatin or intolerant to cetuximab.  <strong>Method &amp; Materials:<\/strong> Pts received a single intratumoral injection of NBTXR3 and intensity modulated radiation therapy (IMRT; 70 Gy\/35 fractions\/7 weeks). The study was a 3 + 3 dose escalation to test the NBTXR3 dose equivalent to 5, 10, 15, and 22% of baseline tumor volume, followed by a dose expansion. Primary endpoints include Recommended Phase 2 Dose (RP2D) determination and early dose limiting toxicities (DLT). Presence of NBTXR3 in surrounding healthy tissues and efficacy (RECIST 1.1 principles) were also evaluated.  <strong>Results:<\/strong> Enrollment for the dose escalation phase was completed at all dose levels: 5% (3 pts), 10% (3 pts), 15% (5 pts), and 22% (8 pts). No early DLT or SAE related to NBTXR3 or injection were observed. One G1 AE (asthenia; 22%) related to NBTXR3 and four AEs (G2 oral pain, G1 tumor hemorrhage, G1 asthenia, and G1 injection site hemorrhage) related to injection were reported. RT-related toxicity was as expected. The RP2D has been determined to be 22%. CT-scan assessment demonstrated absence of NBTXR3 in surrounding tissues. Among 13 evaluable pts treated at doses \u226510%, 9 achieved complete response of the injected lesion. The final dose escalation safety results will be presented herein.  <strong>Conclusion:<\/strong> NBTXR3 was well tolerated at all tested doses and demonstrated a good safety profile. A dose expansion phase has started with the identified RP2D. NBTXR3 is currently being evaluated in a phase II\/III trial in soft tissue sarcoma [NCT02379845] and phase I\/II trials in prostate [NCT02805894], liver [NCT02721056] and rectal [NCT02465593] cancers.  <strong>Clinical Relevance &amp; Application:<\/strong> The results of this study highlight the potential of NBTXR3 as a novel treatment option for elderly and\/or frail pts with locally advanced HNSCC and address an unmet medical need.[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"wds_primary_resource_type":0,"wds_primary_data_type":0,"wds_primary_indication":0,"wds_primary_platform_type":0,"footnotes":""},"resource_type":[31],"data_type":[25],"indication":[26],"platform_type":[36],"class_list":["post-1852","resource","type-resource","status-publish","hentry","resource_type-abstracts","data_type-clinical","indication-head-neck","platform_type-nbtxr3"],"acf":[],"_links":{"self":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource"}],"about":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/resource"}],"version-history":[{"count":0,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1852\/revisions"}],"wp:attachment":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1852"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource_type?post=1852"},{"taxonomy":"data_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/data_type?post=1852"},{"taxonomy":"indication","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/indication?post=1852"},{"taxonomy":"platform_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/platform_type?post=1852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}