{"id":2163,"date":"2020-07-20T13:22:52","date_gmt":"2020-07-20T12:22:52","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=2163"},"modified":"2020-07-20T13:25:47","modified_gmt":"2020-07-20T12:25:47","slug":"2020-mhncs-nbtxr3-for-locally-advanced-hnscc","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2020-mhncs-nbtxr3-for-locally-advanced-hnscc\/","title":{"rendered":"2020 \u2013 MHNCS \u2013 NBTXR3 for locally advanced HNSCC"},"content":{"rendered":"

[vc_row padding_top=\u00a0\u00bb0″ padding_bottom=\u00a0\u00bb0″ section_container_layout=\u00a0\u00bbfull-width\u00a0\u00bb remove_horizontal_padding=\u00a0\u00bbyes\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb bg_color=\u00a0\u00bb#28282e\u00a0\u00bb][vc_column][vc_row_inner padding_top=\u00a0\u00bb0″ padding_bottom=\u00a0\u00bb0″ gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb][vc_column_inner column_paddings=\u00a0\u00bb105″ column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb column_min_height=\u00a0\u00bb700″ column_min_height_sm=\u00a0\u00bb400″ column_min_height_xs=\u00a0\u00bb350″ module_type=\u00a0\u00bbbg-image\u00a0\u00bb bg_image=\u00a0\u00bb102″ mask_fx=\u00a0\u00bbyes-mask\u00a0\u00bb mask_color_mode=\u00a0\u00bbpalette\u00a0\u00bb mask_bg_color_palette=\u00a0\u00bbmain-mask\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb200″ animation_offset_scroll_down=\u00a0\u00bb90″ width=\u00a0\u00bb1\/2″ animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbAuthors\u00a0\u00bb box_icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbfa fa-edit\u00a0\u00bb icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_size=\u00a0\u00bb50″ box_icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb]C. Le Tourneau1<\/span>, V. Calugaru1<\/span>, E. Borcoman1<\/span>, V. Moreno2<\/span>, E. Calvo3<\/span>, X. Liem4<\/span>, S. Salas5<\/span>, B. Doger3<\/span>, T. Jouffroy1<\/span>, X. Mirabel4<\/span>, J. Rodriguez1<\/span>, A. Chilles1<\/span>, K. Bernois6<\/span>, M. De Rink6<\/span>, E. Baskin-Bey6<\/span>, N. Fakhry7<\/span>,\u2028S. Wong Hee Kam8<\/span>, and C. Hoffmann1<\/span>
\n
\n1 \u2013 Institut Curie, Paris, France
\n2 \u2013 Hospital Fundacio\u00b4n Jimenez Diaz, Madrid, Spain
\n3 \u2013 START Madrid, Madrid, Spain
\n4 – Centre Oscar Lambret, Lille, France
\n5 \u2013 Assistance Publique H\u00f4pitaux de Marseille, Timone Hospital, Marseille, France
\n6 \u2013 Nanobiotix, Paris, France
\n7 \u2013 H\u00f4pital Timone, Marseille, France
\n8 \u2013 H\u00f4pital Timone, APHM, Marseille, France
\n<\/span>[\/az_box_icons][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][\/vc_column_inner][vc_column_inner column_paddings=\u00a0\u00bb105″ column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb300″ animation_offset_scroll_down=\u00a0\u00bb90″ width=\u00a0\u00bb1\/2″ bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbSummary\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbaz-icon az-icon-layers2″ icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_color=\u00a0\u00bb#28282e\u00a0\u00bb icon_size=\u00a0\u00bb50″]Purpose\/Objectives:<\/strong> Elderly and\/or frail patients (pts) with head and neck squamous cell carcinoma (HSNCC) remain a challenging to manage and neglected population regarding clinical trials and data generation to support treatment choices. Despite representing 20% of the HNSCC population no consensus exists on what is the optimal treatment for these pts with locally advanced (LA) disease, vulnerable to treatment-induced toxicities with the current standard of care. New approaches are needed to improve clinical outcomes without adding toxicity. NBTXR3 hafnium oxide nanoparticles injected intratumorally may represent such an option. Otherwise inert; this first-in-class radioenhancer, augments the radiotherapy (RT) dose within tumor cells when activated by RT, increasing tumor cell death compared to RT alone. The results presented here demonstrate the feasibility and safety of NBTXR3 activated by RT in elderly\/frail patients, a population with few therapeutic options.<\/p>\n

Material\/Methods:<\/strong> Elderly\/frail 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 theoretical tumor volume, followed by a dose expansion. Primary endpoints include Recommended Phase 2 Dose (RP2D) determination and early dose limiting toxicities (DLT). NBTXR3 presence in surrounding healthy tissues and anti-tumor activity (RECIST 1.1) were also evaluated.<\/p>\n

Results:<\/strong> Enrollment 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, asthenia, and injection site hemorrhage) related to injection were observed. RT-related toxicity was as expected with IMRT. The RP2D was determined to be 22%. CT-scan assessment demonstrated localization of NBTXR3 intratumorally without presence in surrounding healthy tissues. At a median follow-up of 231 days, 9\/13 (2 unconfirmed) evaluable pts receiving doses \u226510%, achieved a complete response of the treated tumors. The final dose escalation safety and efficacy results will be presented herein.<\/p>\n

Conclusion:<\/strong> NBTXR3 was well tolerated at all tested doses and demonstrated preliminary anti-tumor activity. A dose expansion phase at the RP2D is ongoing. These results highlight the potential of NBTXR3 as a novel treatment option for elderly\/frail pts with LA HNSCC and address an unmet medical need.<\/p>\n

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Elderly and\/or frail patients (pts) with head and neck squamous cell carcinoma (HSNCC) remain a challenging to manage and neglected population regarding clinical trials and data generation to support treatment choices. Despite representing 20% of the HNSCC population no consensus exists on what is the optimal treatment for these pts with locally advanced (LA) disease, vulnerable to treatment-induced toxicities with the current standard of care. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2168,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,668],"tags":[610,612],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2163"}],"collection":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/comments?post=2163"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2163\/revisions"}],"predecessor-version":[{"id":2173,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2163\/revisions\/2173"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2168"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=2163"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=2163"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=2163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}