{"id":2216,"date":"2020-12-18T12:19:04","date_gmt":"2020-12-18T12:19:04","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=2216"},"modified":"2020-12-18T12:35:03","modified_gmt":"2020-12-18T12:35:03","slug":"2020-astro-nbtxr3-in-hnscc","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2020-astro-nbtxr3-in-hnscc\/","title":{"rendered":"2020 \u2013 ASTRO \u2013 NBTXR3 in 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]Christophe Le Tourneau1<\/span>, Valentin Calugaru2<\/span>, Edith Borcoman1<\/span>, Victor Moreno3<\/span>, Emiliano Calvo4<\/span>, Xavier Liem5<\/span>, S\u00e9bastien Salas6<\/span>, Bernard Doger3<\/span>, Olivier Choussy7<\/span>, Maria Lesnik7<\/span>, Xavier Mirabel5<\/span>, Nathalie Badois8<\/span>, Samar Krihli2<\/span>, Josefin Blomkvist9<\/span>, Nicolas Fakhry6<\/span>, St\u00e9phanie Wong Hee Kam6<\/span>, Caroline Hoffmann8<\/span>
\n
\n1 \u2013 Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France
\n2 \u2013 Department of Radiation Therapy, Institut Curie, Paris, France
\n3 \u2013 START \u2013 Fundaci\u00f3n Jim\u00e9nez D\u00edaz, Madrid, Spain
\n4 \u2013 START \u2013 Hospital Sanchinarro, Madrid, Spain
\n5 \u2013 Oscar Lambret Center, Lille, France
\n6 \u2013 H\u00f4pital Timone, Marseille, France
\n7 \u2013 Department of Surgical Oncology, Institut Curie, Paris, France
\n8 \u2013 Department Medical Oncology, Institut Curie, Paris, France
\n9 \u2013 Nanobiotix, SA, 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> Concurrent chemoradiation (CRT) with high dose cisplatin or cetuximab in case of contra-indication to cisplatin is the standard of care non-surgical approach for patients (pts) with locally advanced head and neck squamous cell carcinoma (LA HNSCC). Older age is a contra-indication to cisplatin and survival in older pts might not improve with cetuximab. The development of new treatment options for elderly pts with LA HNSCC is therefore urgently needed. NBTXR3, hafnium oxide nanoparticles that enhance the efficacy of radiotherapy (RT) by locally increasing the deposited dose, may benefit this patient population. In this phase I clinical trial we aimed to evaluate the feasibility and safety of intratumoral (IT) NBTXR3 injection prior to RT in elderly pts with LA HNSCC.<\/p>\n

Materials\/Methods:<\/strong> Patients with stage III-IV LA HNSCC of the oropharynx or oral cavity ineligible for platinum-based CRT received a single IT injection of NBTXR3 into a selected primary tumor followed by intensity modulated RT (IMRT; 70 Gy\/35 fractions\/7 weeks) [NCT01946867]. The study used a 3+3 dose escalation design to test NBTXR3 dose levels of 5, 10, 15, and 22% of baseline tumor volume, followed by a dose expansion at the Recommended Phase 2 Dose (RP2D). Primary endpoints included RP2D determination, and early dose limiting toxicities (DLT). NBTXR3 intratumoral bioavailability and anti-tumor activity (RECIST 1.1) were also evaluated.<\/p>\n

Results:<\/strong> Enrollment at all dose levels has been completed: 5% (3 pts), 10% (3 pts), 15% (5 pts), and 22% (8 pts). There were no observed early DLT or SAE related to NBTXR3 or injection. Median follow-up from NBTXR3 administration is currently 7.6 months. One Grade 1 AE related to NBTXR3 at the 22% dose level and 4 Grade 1-2 AEs related to the injection at the 15% and 22% dose levels were observed. IMRT-related toxicity was as expected. NBTXR3 was well dispersed throughout the tumor and not in surrounding healthy tissues, as assessed by CT-scan. The RP2D was determined to be 22%. Preliminary efficacy was evaluated in pts who received the intended dose of NBTXR3 and RT. Among 13 evaluable pts at doses \u226510%, 9 pts (69%) achieved a complete response (2 unconfirmed) of the injected tumor and 5 pts (38%)achieved an overall complete response. Preliminary safety and efficacy data of the dose expansion cohort at the RP2D will also be presented.<\/p>\n

Conclusions:<\/strong> NBTXR3 was well tolerated at all tested doses and when activated by RT demonstrated promising preliminary anti-tumor activity. Recruitment in the dose expansion cohort is ongoing. These results highlight the potential of NBTXR3 activated by RT as a novel treatment option for elderly pts with LA HNSCC and address an unmet medical need.[\/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_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

Concurrent chemoradiation (CRT) with high dose cisplatin or cetuximab in case of contra-indication to cisplatin is the standard of care non-surgical approach for patients (pts) with locally advanced head and neck squamous cell carcinoma (LA HNSCC). Older age is a contra-indication to cisplatin and survival in older pts might not improve with cetuximab. The development of new treatment options for elderly pts with LA HNSCC is therefore urgently needed. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2222,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183],"tags":[610,612],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2216"}],"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=2216"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2216\/revisions"}],"predecessor-version":[{"id":2241,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2216\/revisions\/2241"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2222"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=2216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=2216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=2216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}