1. 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
- Author
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Bonvalot, S., Rutkowski, P.L., Thariat, J., Carrere, S., Ducassou, A., Sunyach, M.P., Agoston, P., Hong, A.M., Mervoyer, A., Rastrelli, M., Moreno, V., Li, R.K., Tiangco, B.J., Herra, A.C., Gronchi, A., Sy-Ortin, T., Hohenberger, P., Baere, T. de, Cesne, A. le, Helfre, S., Saada-Bouzid, E., Anghel, R.M., Kantor, G., Montero, A., Loong, H.H., Verges, R., Kacso, G., Austen, L., Servois, V.F., Wardelmann, E., Dimitriu, M., Said, P., Lazar, A.J., Bovee, J.V.M.G., Pechoux, C. le, Papai, Z., Institut Català de la Salut, [Bonvalot S] Department of Surgical Oncology, Institut Curie, Paris University, Paris, France. [Rutkowski PL] Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. [Thariat J] Department of Radiation Oncology, Centre François Baclesse, Caen, France. Department of Radiation Oncology, Centre Lacassagne, Nice, France. [Carrère S] Department of Surgical Oncology, Centre Regional De Lutte Contre Le Cancer Paul Lamarque, Montpellier, France. [Ducassou A] Department of Radiation Oncology, Institut Claudius Regaud (ICR), Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O), Toulouse, France. [Sunyach MP] Department of Radiotherapy, Léon Bérard Cancer Center, Lyon, France. [Vergés R] Servei d’Oncologia Radioteràpica, Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Adult ,Cancer Research ,Càncer - Radioteràpia ,Radiation ,Other subheadings::Other subheadings::/radiotherapy [Other subheadings] ,Otros calificadores::Otros calificadores::/radioterapia [Otros calificadores] ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Neoplasms::Neoplasms by Site::Soft Tissue Neoplasms [DISEASES] ,Antineoplastic Agents ,Sarcoma ,Soft Tissue Neoplasms ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Tumors de parts toves - Tractament ,Neoadjuvant Therapy ,Therapeutics::Combined Modality Therapy::Neoadjuvant Therapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Oncology ,Avaluació de resultats (Assistència sanitària) ,Quality of Life ,Humans ,terapéutica::tratamiento combinado::tratamiento neoadyuvante [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Radiology, Nuclear Medicine and imaging ,Radiopharmaceuticals ,neoplasias::neoplasias por localización::neoplasias de los tejidos blandos [ENFERMEDADES] - Abstract
Calidad de vida; Sarcoma de tejido blando localmente avanzado; Radioterapia Qualitat de vida; Sarcoma de teixit tou localment avançat; Radioteràpia Quality of life; Locally advanced soft-tissue sarcoma; Radiation therapy Purpose Act.In.Sarc (NCT02379845) demonstrated that the first-in-class radioenhancer NBTXR3, activated by preoperative radiation 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, volume 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.
- Published
- 2022