Final Safety and Health-Related Quality of LIfe Results of the Phase 2/3 Act.In.Sarc Study With Preoperative NBTXR3 Plus Radiation Therapy Versus Radiation Therapy in Locally Advanced Soft-Tissue Sarcoma

被引：21

作者：

Bonvalot, Sylvie ^{[1
]}

Rutkowski, Piotr L. ^{[2
]}

Thariat, Juliette ^{[3
,4
]}

Carrere, Sebastien ^{[5
]}

Ducassou, Anne ^{[6
]}

Sunyach, Marie-Pierre ^{[7
]}

Agoston, Peter ^{[8
]}

Hong, Angela M. ^{[9
]}

Mervoyer, Augustin ^{[10
]}

Rastrelli, Marco ^{[11
,12
]}

Moreno, Victor ^{[13
]}

Li, Rubi K. ^{[14
]}

Tiangco, Beatrice J. ^{[15
]}

Herra, Antonio Casado ^{[16
]}

Gronchi, Alessandro ^{[17
]}

Sy-Ortin, Teresa ^{[18
]}

Hohenberger, Peter ^{[19
]}

de Baere, Thierry ^{[20
]}

Le Cesne, Axel ^{[21
]}

Helfre, Sylvie ^{[22
]}

Saada-Bouzid, Esma ^{[23
]}

Anghel, Rodica M. ^{[24
]}

Kantor, Guy ^{[25
]}

Montero, Angel ^{[26
]}

Loong, Herbert H. ^{[27
]}

Verges, Ramona ^{[28
]}

Kacso, Gabriel ^{[29
]}

Austen, Lyn ^{[30
]}

Servois, Vincent F. ^{[31
]}

Wardelmann, Eva ^{[32
]}

Dimitriu, Mikaela ^{[33
]}

Said, Patricia ^{[34
]}

Lazar, Alexander J. ^{[35
]}

Bovee, Judith V. M. G. ^{[36
]}

Le Pechoux, Cecile ^{[37
]}

Papai, Zsusanna ^{[37
]}

机构：

[1] Paris Univ, Inst Curie, Dept Surg Oncol, Paris, France

[2] Maria Sklodowska Curie Natl Res Inst Oncol, Dept Soft Tissue Bone Sarcoma & Melanoma, Warsaw, Poland

[3] Ctr Francois Baclesse, Dept Radiat Oncol, Caen, France

[4] Ctr Lacassagne, Dept Radiat Oncol, Nice, France

[5] Ctr Reg Lutte Canc Paul Lamarque, Dept Surg Oncol, Montpellier, France

[6] Inst Univ Canc Toulouse Oncopole IUCT O, Inst Claudius Regaud ICR, Dept Radiat Oncol, Toulouse, France

[7] Leon Berard Canc Ctr, Dept Radiotherapy, Lyon, France

[8] Orszagos Onkol Intezet, Ctr Radiat Oncol, Budapest, Hungary

[9] Chris OBrien Lifehouse & Univ Sydney, Dept Radiat Oncol, Chris O&39, Camperdown, NSW, Australia

[10] Inst Cancerol Ouest Rene Gauducheau, Dept Radiat Oncol, St Herblain, France

[11] Univ Padua, Dept Surg Oncol & Gastroenterol DISCOG, Padua, Italy

[12] Veneto Inst Oncol IOV IRCCS, Dept Surg Oncol, Padua, Italy

[13] Hosp Fdn Jimenez Diaz, Dept Med Oncol, START Madrid FJD, Madrid, Spain

[14] St Lukes Med Ctr, Dept Med Oncol, Quezon City, Philippines

[15] Med City Canc Ctr, Dept Med Oncol, Pasay City, Philippines

[16] Hosp Clin Univ San Carlos, Dept Med Oncol, Madrid, Spain

[17] Fdn IRCCS Ist Nazl Tumori, Dept Surg, Milan, Italy

[18] Univ St Tomas Hosp, Benavides Canc Inst, Dept Radiat Oncol, Manila, Philippines

[19] Heidelberg Univ, Mannheim Univ Med Ctr, Med Fac Mannheim, Div Surg Oncol & Thorac Surg, Mannheim, Germany

[20] Univ Paris Saclay, Dept Anesthesie Chirurg & Radiol Intervent, Gustave Roussy, France

[21] Gustave Roussy Canc Campus, Dept Med Oncol, Villejuif, France

[22] PSL Res Univ, Inst Curie, Dept Radiat Therapy, Paris, France

[23] Ctr Anticanc Antoine Lacassagne, Dept Med Oncol, Nice, France

[24] Inst Oncol Bucuresti Prof Dr Alexandru Trestiorea, Bucharest, Romania

[25] Univ Bordeaux, Inst Bergonie, Comprehens Canc Ctr, Dept Radiotherapy, Bordeaux, France

[26] Hosp HM Univ Sanchinarro, Radiat Oncol Dept, Madrid, Spain

[27] Prince Wales Hosp, Dept Clin Oncol, Sha Tin, Hong Kong, Peoples R China

[28] Vall Hebron Univ Hosp, Radiat Oncol Dept, Vall d&39, Barcelona, Spain

[29] Iuliu Hatieganu Univ Med & Pharm Cluj Napoca, RTC Amethyst, Cluj Napoca, Romania

[30] Canberra Reg Canc Ctr, Dept Radiat Oncol, Garran, Australia

[31] PSL Res Univ, Inst Curie, Dept Radiol, Paris, France

[32] Univ Hosp Munster, Gerhard Domagk Inst Pathol, Munster, Germany

[33] Nanobiotix SA, Paris, France

[34] Univ Texas MD Anderson Canc Ctr, Dept Pathol & Genom Med, Houston, TX USA

[35] Leiden Univ Med Ctr, Dept Pathol, Leiden, Netherlands

[36] Gustave Roussy Canc Campus, Dept Radiat Oncol, Villejuif, France

[37] Hungarian Def Forces, Med Ctr, Budapest, Hungary

来源：

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2022年 / 114卷 / 03期

关键词：

COMPLETE PATHOLOGICAL RESPONSE; POSTOPERATIVE RADIOTHERAPY; NEOADJUVANT RADIOTHERAPY; EXTREMITY; SURVIVAL; NECROSIS; SURGERY;

D O I：

10.1016/j.ijrobp.2022.07.001

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: Act.In.Sarc (NCT02379845) demonstrated that the first-in-class radioenhancer NBTXR3, activated by preoperative radi-ation therapy (RT), doubled the rate of pathologic complete response after resection compared with preoperative RT alone in adult patients with locally advanced soft tissue sarcoma of the extremity or trunk wall (16.1% vs 7.9%, P = .045), and more patients achieved R0 resections (77.0% vs 64.0%, P = .042). These are the toxicity and health-related quality of life (HRQoL) results.Methods and Materials: Act.In.Sarc randomized eligible patients 1:1 to either NBTXR3 (single intratumoral injection, vol-ume equivalent to 10% of baseline tumor volume, at 53.3 g/L) activated by external-beam RT (arm A) or external-beam RT alone (arm B) (50 Gy in 25 fractions), followed by surgery in both arms. Here, we report the safety analyses in the all-treated population with a long-term follow-up of at least 2 years, and HRQoL in the intention-to-treat full analysis set.Results: During the on-treatment period, serious adverse events (SAEs) of all grades related to NBTXR3 occurred in 10.1% (9/89) of patients (arm A), and SAEs related to RT occurred in 5.6% (5/89) (arm A) versus 5.6% (5/90) (arm B); postsurgery hospitalization owing to SAEs occurred in 15.7% (14/89) (arm A) versus 24.4% (22/90) (arm B). During the follow-up period, posttreatment SAEs (regardless of relationship) occurred in 13.5% (12/89) (arm A) versus 24.4% (22/90) (arm B). NBTXR3 did not negatively affect HRQoL; during the follow-up period, there was an improvement in most mean Toronto extremity salvage, EuroQoL 5-dimension (EQ-5D), EQ5D02-EQ visual analog scale, reintegration to normal living index, and musculoskeletal tumor rating scale scores.Conclusions: NBTXR3 did not negatively affect safety or HRQoL. Long-term safety results reinforce the favorable benefit -risk ratio of NBTXR3 plus RT. (c) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

引用

页码：422 / 432

页数：11

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