{"id":2834,"date":"2022-05-27T09:53:55","date_gmt":"2022-05-27T08:53:55","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=2834"},"modified":"2022-05-27T16:13:15","modified_gmt":"2022-05-27T15:13:15","slug":"2021-radiation-enhancing-hafnium-oxide-nanoparticles-nbtxr3-for-the-treatment-of-cisplatin-ineligible-locally-advanced-hnscc-patients-a-phase-i-dose-expansion-study","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2021-radiation-enhancing-hafnium-oxide-nanoparticles-nbtxr3-for-the-treatment-of-cisplatin-ineligible-locally-advanced-hnscc-patients-a-phase-i-dose-expansion-study\/","title":{"rendered":"2021 \u2013 Radiation enhancing NBTXR3 for the treatment of cisplatin-ineligible locally advanced HNSCC patients"},"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\u00bb99″ 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 Calugaru1<\/span>, Victor Moreno2<\/span>, Emiliano Calvo3<\/span>, Xavier Liem4<\/span>, S\u00e9bastien Salas5<\/span>, Bernard Doger2<\/span>, Thomas Jouffroy1<\/span>, Xavier Mirabel4<\/span>, Jose Rodriguez1<\/span>, Anne Chilles1 Katell Bernois6<\/span>, Nicolas Fakhry5<\/span>, St\u00e9phanie Wong Hee Kam5<\/span>, CarolineHoffmann1<\/span>
\n
\n1 \u2013 Institut Curie, France
\n2 \u2013 START \u2013 Fundaci\u00f3n Jim\u00e9nez D\u00edaz, Spain
\n3 \u2013 START \u2013 Hospital Sanchinarro, Spain
\n4 \u2013 Oscar Lambret Cancer Center, France
\n5 \u2013 H\u00f4pital Timone, France
\n6 \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″]Introduction:<\/b> The non-surgical standard of care (SOC) for the treatment of locally advanced head and neck squamous cell carcinoma(LA HNSCC) is concurrent chemoradiation with high dose cisplatin or cetuximab in case of contra-indication to cisplatin. However elderly patients, and those with poor performance status, comorbidities, and\/or intolerance, may not benefit from these SOC treatments and represent a high unmet need. New approaches are thus needed to improve clinical outcomes without adding toxicity. NBTXR3, a novel radioenhancer, composed of functionalized hafnium oxide nanoparticles, is injected once intratumorally and activated by radiotherapy(RT). NBTXR3 increases the RT energy deposit inside tumor cells and subsequently increases tumor cell death, while sparing healthy tissues compared to RT alone. In addition NBTXR3 subsequently primes an adaptive immune response. Results of the phase I dose expansion study are presented.<\/p>\n

Materials and Methods:<\/b> Patients with stage III-IVA or T3\/T4 (AJCC\/UICC TNM staging system 8th ed.) HNSCC of the oropharynx or oral cavity, ineligible to cisplatin or cetuximab and amenable for RT, received a single intratumoral injection of NBTXR3 and IMRT (70 Gy in35 fractions \/7 weeks). A 3 + 3 dose escalation design tested four doses of NBTXR3, equivalent to 5, 10, 15, and 22% of baseline theoretical tumor volume. The RP2D established as 22% is further tested in the dose expansion part. The primary endpoints of the dose expansion part are objective response rate (ORR) and complete response rate(CRR) of the primary tumor, according to RECIST 1.1. Safety is also evaluated.<\/p>\n

Results:<\/b> As of March 26, 2021, 52 patients have been treated in the phase I dose expansion part. The median age was 71.6 years old (range:44.5\u201389.9). The median tumor volume was 60.6 mL (range: 2.5\u2013259.4). At a median time of 8.1 months after NBTXR3 injection, the ORR of the primary lesion was 82.5% and the CRR 62.5% in the evaluable population for efficacy (N = 40). RT-related toxicity was as expected with IMRT. Six patients (11.5%) experienced at least 1 G3-4serious adverse event (AE) related to the injection procedure and\/orNBTXR3 which represented less than 1% of all reported AEs. Four deaths related to RT were observed. Also,1 death from sepsis possibly related to NBTXR3, RT, and cancer disease was reported. Recruitment is ongoing.<\/p>\n

Conclusions:<\/b> NBTXR3 intratumoral administration followed by IMRT may represent an option in elderly patients or patients with multiple comorbidities with LA-HNSCC who have limited therapeutic options. NBTXR3 activated by RT showed promising anti-tumor efficacy, supporting further evaluation in a phase III randomized trial.[\/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":"

The non-surgical standard of care (SOC) for the treatment of locally advanced head and neck squamous cell carcinoma(LA HNSCC) is concurrent chemoradiation with high dose cisplatin or cetuximab in case of contra-indication to cisplatin. However elderly patients, and those with poor performance status, comorbidities, and\/or intolerance, may not benefit from these SOC treatments and represent a high unmet need. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,676,668],"tags":[197,545,342,200,203],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2834"}],"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=2834"}],"version-history":[{"count":2,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2834\/revisions"}],"predecessor-version":[{"id":2978,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2834\/revisions\/2978"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2976"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=2834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=2834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=2834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}