{"id":1770,"date":"2019-05-06T09:39:33","date_gmt":"2019-05-06T08:39:33","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=1770"},"modified":"2022-05-24T16:35:08","modified_gmt":"2022-05-24T15:35:08","slug":"2019-estro-nbtxr3-activated-by-sbrt-in-liver-cancers","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2019-estro-nbtxr3-activated-by-sbrt-in-liver-cancers\/","title":{"rendered":"2019 \u2013 ESTRO \u2013 NBTXR3 activated by SBRT in liver cancers"},"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]E. Chajon1<\/span>, M. Pracht12<\/span>, T. De Baere3<\/span>, T. V. F. Nguyen3<\/span>, J. P. Bronowicki4<\/span>, V. Vendrely5<\/span>, A. S. Baumann6<\/span>, V. V. Crois\u00e9-Laurent4, E. Rio7<\/span>, Y. Rolland1<\/span>, S. Le Sourd1<\/span>, P. Gustin3<\/span>, C. Perret7<\/span>, F. Mornex8<\/span>, D. Peiffert9<\/span>, P. Merle8<\/span>, and E. Deutsch3<\/span>
\n
\n1 \u2013 Centre Eug\u00e8ne Marquis \u2013 D\u00e9partement de Radioth\u00e9rapie, Rennes, France
\n2 \u2013 Centre Eugene Marquis, Rennes, France
\n3 \u2013 Gustave Roussy, Villejuif, France
\n4 \u2013 CHU de Nancy, Nancy, France
\n5 \u2013 University Hospital of Bordeaux, Bordeaux, France
\n6 \u2013 Institut de Canc\u00e9rologie de Lorraine, Nancy, France
\n7 \u2013 Institut de Canc\u00e9rologie de l\u2019Ouest, Nantes, France
\n8 \u2013 Centre Hospitalier Lyon Sud, Pierre B\u00e9nite, France
\n9 \u2013 Institut de Canc\u00e9rologie de Lorraine, Vandoeuvre-Les-Nancy, 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\/Objective:<\/strong> Patients with hepatocellular carcinoma (HCC) and liver metastasis (mets) present with a wide range of underlying liver dysfunctions and concomitant malignancies. Stereotactic body radiation therapy (SBRT) is well-tolerated and a valuable alternative for patients who are not eligible for invasive procedures. Yet, like all radiation therapy (RT) techniques, the energy dose deposit to tumor cells is limited by the surrounding healthy tissues. NBTXR3, composed of hafnium oxide nanoparticles, was designed to effectively absorb ionizing radiation and augment the dose deposit within the tumor cells only when activated by RT, thereby increasing tumor-specific physical killing through DNA damage\/cell destruction and enhancing the immunogenic tumor cell death.<\/p>\n

Material\/Methods:\u00a0<\/strong>Patients suffering from primary HCC (with\/without portal vein tumor thrombosis) or liver mets were included and treated with a single intralesional injection (IL) of NBTXR3 followed by SBRT (45 Gy\/3 fractions\/5 to 7 days).\u00a0The phase I part of the study was designed as a 3 + 3 escalation dose with tested dose levels at 10%, 15%, 22% and 33% of baseline tumor volume. Primary endpoints include the determination of the recommended dose and incidence of early dose limiting toxicities (DLTs). Secondary endpoints include assessment of global safety profile, characterization of the body kinetic profile, liver function evaluated\u00a0by Child-Pugh score (CPS), AST to Platelet Ratio Index (APRI), and response rate (mRECIST\/RECIST v1.1).<\/p>\n

Results:<\/strong>\u00a0The enrollment is complete in the first 3 dose levels: 10% (6 pts), 15% (4 pts) and 22% (4 pts) and is ongoing at the last IL dose level at 33% with no early DLTs, no AE related to NBTXR3, and no serious AE related to RT or the injection. So far, four AEs related to the IL were observed (Malaise, grade 2; two Abdominal pain, grade 3 and Bilateral pleural effusion, grade 1) at dose level 10%, 15% and 22% respectively. NBTXR3 remained localized within the tumor, validating the relevance of the single IL. No relevant change in CPS or APRI was observed over time which is consistent with the low toxicity observed.\u00a0In 7 HCC pts evaluable for response, the mRECIST assessment by MRI on target lesions resulted in the following best observed response: 3 complete responses, 3 partial responses and 1 stable disease. In 5 evaluable liver mets pts, the RECIST v1.1 assessment by MRI on target lesions resulted in the following best observed response: 1 partial response, 3 stable disease and 1 local progressive disease.<\/p>\n

Conclusion:<\/strong>\u00a0NBTXR3 was well tolerated and showed a promising safety profile. Recruitment at the highest dose level of 33% is ongoing for the IL part and, once completed, will be followed by the expansion phase.\u00a0NBTXR3 is also being evaluated in 6 other clinical trials, including a phase II\/III trial in soft tissue sarcoma [NCT02379845] and phase I\/II trials in prostate [NCT02805894], head and neck [NCT01946867] and rectum cancers [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":"

Patients with hepatocellular carcinoma (HCC) and liver metastasis (mets) present with a wide range of underlying liver dysfunctions and concomitant malignancies. Stereotactic body radiation therapy (SBRT) is well-tolerated and a valuable alternative for patients who are not eligible for invasive procedures. Yet, like all radiation therapy (RT) techniques, the energy dose deposit to tumor cells is limited by the surrounding healthy tissues. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":1773,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,669],"tags":[349,196,491,528,463,545,342,549,483,529],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1770"}],"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=1770"}],"version-history":[{"count":2,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1770\/revisions"}],"predecessor-version":[{"id":1787,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/1770\/revisions\/1787"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/1773"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=1770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=1770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}