{"id":2645,"date":"2022-05-26T09:26:57","date_gmt":"2022-05-26T08:26:57","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=2645"},"modified":"2022-05-26T09:27:20","modified_gmt":"2022-05-26T08:27:20","slug":"2019-nbtxr3-for-the-treatment-of-locally-advanced-hnscc-in-frail-and-or-elderly-patients-a-phase-i-ii-study","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2019-nbtxr3-for-the-treatment-of-locally-advanced-hnscc-in-frail-and-or-elderly-patients-a-phase-i-ii-study\/","title":{"rendered":"2019 \u2013 NBTXR3 for the treatment of locally advanced HNSCC in frail and\/or elderly patients: a phase I\/II study"},"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]Le Tourneau1<\/span>, V. Calugaru1<\/span>, V. Moreno Garcia2<\/span>, X. Mirabel3<\/span>, B. Doger2<\/span>, E. Calvo2<\/span>, J. Fijuth4<\/span>, T. Rutkowski5<\/span>, N. Magne6<\/span>, M. Sanz Taberna7<\/span>, J. Contreras8<\/span>, I. Brana Garcia9<\/span>, Z. Papai10<\/span>, Z. Takacsi-Nagy11<\/span>, X. Liem3<\/span>, S. Salas12<\/span>, S. Wong Hee Kam13<\/span>, C. Florescu14<\/span>, J.O. Thariat15<\/span>, and C. Hoffmann1<\/span>
\n
\n1 \u2014 Institut Curie, Paris, France
\n2 \u2014 START Madrid, Madrid, Spain
\n3 \u2014 Centre Oscar Lambret, Lille, France
\n4 \u2014 Provita Prolife, Tomaszow Mazowiecki, Poland
\n5 \u2014 Sk\u0142odowska-Curie Institute of Oncology, Gliwice, Poland
\n6 \u2014 Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France
\n7 \u2014 Institut Catala d\u2019Oncologia (ICO L\u2019Hospitalet) Hospital Duran i Reynals, Barcelona, Spain
\n8 \u2014 Hospital Universitario Regional de Malaga, Malaga, Spain
\n9 \u2014 Vall D\u2019Hebron Institute of Oncology, Barcelona, Spain
\n10 \u2014 Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary
\n11 \u2014 National Institute of Oncology, Budapest, Hungary
\n12 \u2014 Assistance Publique H\u00f4pitaux de Marseille, Timone Hospital, Marseille, France
\n13 \u2014 H\u00f4pital Timone, APHM, Marseille, France
\n14 \u2014 Unicancer – Fran\u00e7ois Baclesse Center, Caen, France
\n15 \u2014 Centre Fran\u00e7ois Baclesse, Caen, 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:<\/b> 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.
\nMethod and materials: 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.<\/p>\n

Results:<\/b> 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.<\/p>\n

Conclusion:<\/b> NBTXR3 was well tolerated at all tested doses and demonstrated a good safety profile. A dose expansion phase has started with the identified RP2D.
\nNBTXR3 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.<\/p>\n

Clinical relevance:<\/b> 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=\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":"

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. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2650,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,668],"tags":[193,473,474,197,475,200],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2645"}],"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=2645"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2645\/revisions"}],"predecessor-version":[{"id":2651,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2645\/revisions\/2651"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2650"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=2645"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=2645"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=2645"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}