{"id":1778,"date":"2019-05-06T13:01:44","date_gmt":"2019-05-06T12:01:44","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=1778"},"modified":"2022-05-24T16:34:56","modified_gmt":"2022-05-24T15:34:56","slug":"2019-estro-randomized-nbtxr3-trial-in-sts","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2019-estro-randomized-nbtxr3-trial-in-sts\/","title":{"rendered":"2019 \u2013 ESTRO \u2013 Randomized NBTXR3 trial 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.-P. Sunyach5<\/span>, E. Saada-Bouzid6<\/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, France
\n2 \u2013 Soft Tissue\/Bone Sarcoma and Melanoma, The Maria Sk\u0142odowska Curie Memorial Cancer Centre and Institute of Oncology (MCMCC), Warsaw, Poland
\n3 \u2013 Radiation Oncology, Centre Fran\u00e7ois Baclesse, Caen, France
\n4 \u2013 Oncological surgery, Centre Regional De Lutte Contre Le Cancer Paul Lamarque, Montpellier, France
\n5 \u2013 Radiation Oncology, Centre L\u00e9on B\u00e9rard, Lyon, France
\n6 \u2013 Medical Oncology, Centre Anticancer Antoine Lacassagne, Nice, France
\n7 \u2013 Radiation Oncology, Orsz\u00e1gos Onkologiai Int\u00e9zet, Budapest, Hungary
\n8 \u2013 Radiation Oncology, Chris O’Brien Lifehouse, Camperdown, Austria
\n9 \u2013 Radiation Oncology, Institut de Cancerologie de l’Ouest- Rene Gauducheau, Saint-Herblain, France;
\n10 \u2013 Surgical Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy
\n11 \u2013 Medical Oncology, Institut Gustave Roussy, Villejuif, France
\n12 \u2013 Medical Oncology, Hospital Fundaci\u00f3n Jimenez Diaz, Madrid, Spain
\n13 \u2013 Medical Oncology, St. Luke\u2019s Medical Center, Quezon City, Philippines
\n14 \u2013 Medical Oncology, The Medical City Cancer Center, Pasay City, Philippines
\n15 \u2013 Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain, 16Surgery, Fondazione IRCCS – Istituto Nazionale dei Tumori, Milan, Italy
\n17 \u2013 Oncotherapy, University of Pecs, Pecs, Hungary
\n18 \u2013 Surgical Oncology & Thoracic Surgery, Universit\u00e4tsklinikum Mannheim, Mannheim, Germany
\n19 \u2013 Radiation Oncology, Institut Claudius Regaud, Toulouse, France
\n20 \u2013 Medical Centre, Hungarian Defence Forces, Budapest, Hungary
\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(s):<\/strong> Preoperative radiotherapy (RT) is an option for a subset of patients with locally advanced primary or relapsed tumors. Yet, its impact on efficacy in terms of pathological response is limited, highlighting the need for novel multimodal therapies aimed at local control with low toxicity. NBTXR3 is made of hafnium oxide nanoparticles which, injected intratumorally (IT) and activated by ionizing radiation, yield a tumor-localized high energy deposit and increase cell death compared to the same dose of RT alone. We report here the results of a phase II\/III randomized clinical trial of NBTXR3 given as preoperative treatment to patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall [NCT02379845].<\/p>\n

Methods:<\/strong> Act.In.Sarc is an international, multicenter, open-label, active-controlled phase II\/III trial in which patients (pts) with locally advanced STS of the extremity or trunk wall were randomized 1:1 to receive a single IT NBTXR3 injection and RT (Arm A) or RT alone (Arm B), followed by surgical resection. RT consisted of Intensity Modulated RT or 3D-RT of 2Gy*25 fractions (total 50 Gy) over 5 weeks. The primary endpoint was pathological Complete Response Rate (pCRR), defined as the proportion of pts presenting <5% of residual viable cancer cells evaluated by a Central Review Board on anonymized tumor specimen. Key secondary endpoints included negative surgical margin (R0) and general safety.<\/p>\n

Results:<\/strong> Among the 180 randomized pts, 176 were included in the intent-to-treat full analysis set (ITT-FAS). In the ITT-FAS population, pCRR was 16.1% in Arm A vs 7.9% in Arm B (p=0.0448). R0 margin was achieved in 77.0% of pts in Arm A vs 64.0% in Arm B (p=0.0424). The limb amputation rate, another secondary outcome, was decreased by 50% in Arm A as compared to Arm B. NBTXR3 showed very good local tolerance without any modification of RT alone safety profile. In all the treated pts in Arm A, who received any amount of NBTXR3 or at least one RT dose, the IT administration of NBTXR3 caused injection-site pain in 12 (13.5%) pts. NBTXR3 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, in some cases, resolved spontaneously. Long-term efficacy and safety results will be presented.<\/p>\n

Conclusion:<\/strong> In this study both the primary and secondary endpoints (pCRR and R0 rate, respectively) were met with a safety profile of NBTXR3 activated by RT comparable to that of RT alone. As pCR is associated with improved progression-free and overall survival, NBTXR3 activated by RT represents a new preoperative treatment option for locally advanced STS. These data support ongoing studies investigating NBTXR3 in recurrent\/metastatic HNSCC or metastatic non-small cell lung cancer [NCT03589339]; HNSCC [NCT01946867; NCT02901483]; prostate cancer [NCT02805894], liver cancer [NCT02721056] and rectal cancer [NCT02465593].[\/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":"

Preoperative radiotherapy (RT) is an option for a subset of patients with locally advanced primary or relapsed tumors. Yet, its impact on efficacy in terms of pathological response is limited, highlighting the need for novel multimodal therapies aimed at local control with low toxicity. NBTXR3 is made of hafnium oxide nanoparticles which, injected intratumorally (IT) and activated by ionizing radiation, yield a tumor-localized high energy deposit and increase cell death compared to the same dose of RT alone. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":1781,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,674],"tags":[548,196,545,342,200,334,513],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1778"}],"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=1778"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1778\/revisions"}],"predecessor-version":[{"id":1784,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1778\/revisions\/1784"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/1781"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=1778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=1778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}