{"id":1647,"date":"2018-10-31T07:50:14","date_gmt":"2018-10-31T07:50:14","guid":{"rendered":"http:\/\/bibliography.nanobiotix.com\/?p=1647"},"modified":"2022-05-24T16:42:11","modified_gmt":"2022-05-24T15:42:11","slug":"2018-esmo-phase-ii-iii-nbtxr3-in-sts","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2018-esmo-phase-ii-iii-nbtxr3-in-sts\/","title":{"rendered":"2018 \u2013 ESMO \u2013 Phase II\/III NBTXR3 in STS"},"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]S. Bonvalot1<\/span>, P.L. Rutkowski2<\/span>, J. Thariat3<\/span>, S. Carrere4<\/span>, M. Sunyach5<\/span>, E. Saada6<\/span>, P. Agoston7<\/span>, A. Hong8<\/span>, A. Mervoyer9<\/span>, M. Rastrelli10<\/span>, C. Le Pechoux11<\/span>, V. Moreno12<\/span>, R. Li13<\/span>, B. Tiangco14<\/span>, A. Casado Herraez15<\/span>, A. Gronchi16<\/span>, L. Mangel17<\/span>, P. Hohenberger18<\/span>, M. Delannes19<\/span>, Z. Papai20<\/span>
\n
\n1 \u2013 Surgery, Institut Curie, Paris, FR
\n2 \u2013 Soft Tissue\/bone Sarcoma And Melanoma, The Maria Sk\u0142odowska Curie Memorial Cancer Centre and Institute of Oncology (MCMCC), Warsaw, PL
\n3 \u2013 Radiation Oncology, Centre Fran\u00e7ois Baclesse, Caen, FR
\n4 \u2013 Oncological Surgery, Centre Regional De Lutte Contre Le Cancer Paul Lamarque, Montpellier, FR
\n5 \u2013 Radiation Oncology, Centre L\u00e9on B\u00e9rard, Lyon, FR
\n6 \u2013 Medical Oncology, Centre Anticancer Antoine Lacassagne, Nice, FR
\n7 \u2013 Radiation Oncology, Orsz\u00e1gos Onkologiai Int\u00e9zet, Budapest, HU
\n8 \u2013 Radiation Oncology, Chris O’Brien Lifehouse, Camperdown, AU
\n9 \u2013 Radiation Oncology, Institut de Cancerologie de l’Ouest \u2013 Rene Gauducheau, Saint-Herblain, FR
\n10 \u2013 Surgical Oncology, Istituto Oncologico Veneto IRCCS, Padova, IT
\n11 \u2013 Medical Oncology, Institut Gustave Roussy, Villejuif, FR
\n12 \u2013 Medical Oncology, Hospital Fundaci\u00f3n Jimenez Diaz, Madrid, ES
\n13 \u2013 Medical Oncology, St. Luke\u2019s Medical Center, Quezon City, PH
\n14 \u2013 Medical Oncology, The Medical City Cancer Center, Pasay City, PH
\n15 \u2013 Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, ES
\n16 \u2013 Surgery, Fondazione IRCCS – Istituto Nazionale dei Tumori, Milan, IT
\n17 \u2013 Oncotherapy, University of Pecs, Pecs, HU
\n18 \u2013 Surgical Oncology & Thoracic Surgery, Universit\u00e4tsklinikum Mannheim, DE
\n19 \u2013 Radiation Oncology, Institut Claudius Regaud, Toulouse, FR
\n20 \u2013 Medical Centre, Hungarian Defence Forces, Budapest, HU
\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″]NBTXR3 is a first-in-class Hafnium-Oxide nanoparticle intratumorally (IT) injected. When activated by radiotherapy (RT), it allows for a higher energy deposit than RT alone, yielding an increased tumoral cell death.<\/p>\n

A phase I study in soft tissue sarcoma (STS) showed that a single NBTXR3 IT injection at 10% of the baseline tumor volume with preoperative RT was technically feasible with manageable toxicity and clinical activity was observed.<\/p>\n

In this international, multicenter, randomized, open-label phase II\/III study, patients (pts) with locally advanced STS of the extremity and trunk wall received either a single IT injection of NBTXR3 followed by RT or RT alone (1:1 ratio), both followed by surgical resection. RT was by Intensity Modulated RT or 3D-RT of 2Gy\/25 fractions (total 50 Gy). The primary endpoint was the pathological Complete Response Rate (pCRR) defined as the percentage of pts presenting \u22645% of residual viable cancer cells (EORTC guidelines) evaluated by a blind Central Review Board. Key secondary endpoints included negative surgical margins (R0) and safety.<\/p>\n

In the intent-to-treat full analysis set population (n=179), which included all pts who were randomized and stratified by STS histological subtype, the pCRR was 16.1% vs 7.9 (p=0.0448) and the R0 rate was 77.0% vs 64.0% (p=0.0424) for NBTXR3+RT and RT alone respectively. NBTXR3 caused injection-site pain in 12 (13.5%) pts. It was also associated with grade 3-4 acute immune reactions in 7 (7.9%) pts, but these adverse events were of short duration, manageable, and resolved spontaneously in some cases. Outside the injection, NBTXR3 was very well tolerated and its safety profile was comparable to RT alone.<\/p>\n

NBTXR3 activated by RT was signicantly superior to RT alone and this trial met both primary and secondary endpoint with a positive safety profile. NBTXR3 represents a new option for preoperative treatment for locally advanced STS.[\/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":"

NBTXR3 is a first-in-class Hafnium-Oxide nanoparticle intratumorally (IT) injected. When activated by radiotherapy (RT), it allows for a higher energy deposit than RT alone, yielding an increased tumoral cell death. A phase I study in soft tissue sarcoma (STS) showed that a single NBTXR3 IT injection at 10% of the baseline tumor volume with preoperative RT was technically feasible with manageable toxicity and clinical activity was observed. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":1619,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,674],"tags":[196,342,510,511,512,334,513],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1647"}],"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=1647"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1647\/revisions"}],"predecessor-version":[{"id":1648,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1647\/revisions\/1648"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/1619"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1647"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=1647"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=1647"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}