MR-guided stereotactic radiotherapy of infra-diaphragmatic oligometastases: Evaluation of toxicity and dosimetric parameters.

MR-linac Oligometastatic disease Risk-adaption SABR SBRT Stereotactic ablative radiotherapy Stereotactic body radiotherapy Toxicity

Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
13 Jan 2024
Historique:
received: 21 04 2023
revised: 15 11 2023
accepted: 08 01 2024
medline: 16 1 2024
pubmed: 16 1 2024
entrez: 15 1 2024
Statut: aheadofprint

Résumé

The SOFT trial is a prospective, multicenter, phase 2 trial investigating magnetic resonance (MR)-guided stereotactic ablative radiotherapy (SABR) for abdominal, soft tissue metastases in patients with oligometastatic disease (OMD) (clinicaltrials.gov ID NCT04407897). We present the primary endpoint analysis of 1-year treatment-related toxicity (TRAE). Patients with up to five oligometastases from non-hematological cancers were eligible for inclusion. A risk-adapted strategy prioritized fixed organs at risk (OAR) constraints over target coverage. Fractionation schemes were 45-67.5 Gy in 3-8 fractions. The primary endpoint was grade ≥ 4 TRAE within 12 months post-SABR. The association between the risk of gastrointestinal toxicity and clinical and dosimetric parameters was tested using a normal tissue complication probability model. We included 121 patients with 147 oligometastatic targets, mainly located in the liver (41%), lymph nodes (35%), or adrenal glands (14%). Nearly half of all targets (48%, n = 71) were within 10 mm of a radiosensitive OAR. No grade 4 or 5 TRAEs, 3.5 % grade 3 TRAEs, and 43.7% grade 2 TRAEs were reported within the first year of follow-up. We found a significant association between grade ≥ 2 GI toxicity and the parameters GI OAR D

Sections du résumé

BACKGROUND AND PURPOSE OBJECTIVE
The SOFT trial is a prospective, multicenter, phase 2 trial investigating magnetic resonance (MR)-guided stereotactic ablative radiotherapy (SABR) for abdominal, soft tissue metastases in patients with oligometastatic disease (OMD) (clinicaltrials.gov ID NCT04407897). We present the primary endpoint analysis of 1-year treatment-related toxicity (TRAE).
MATERIALS AND METHODS METHODS
Patients with up to five oligometastases from non-hematological cancers were eligible for inclusion. A risk-adapted strategy prioritized fixed organs at risk (OAR) constraints over target coverage. Fractionation schemes were 45-67.5 Gy in 3-8 fractions. The primary endpoint was grade ≥ 4 TRAE within 12 months post-SABR. The association between the risk of gastrointestinal toxicity and clinical and dosimetric parameters was tested using a normal tissue complication probability model.
RESULTS RESULTS
We included 121 patients with 147 oligometastatic targets, mainly located in the liver (41%), lymph nodes (35%), or adrenal glands (14%). Nearly half of all targets (48%, n = 71) were within 10 mm of a radiosensitive OAR. No grade 4 or 5 TRAEs, 3.5 % grade 3 TRAEs, and 43.7% grade 2 TRAEs were reported within the first year of follow-up. We found a significant association between grade ≥ 2 GI toxicity and the parameters GI OAR D

Identifiants

pubmed: 38224916
pii: S0167-8140(24)00011-2
doi: 10.1016/j.radonc.2024.110090
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04407897']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

110090

Informations de copyright

Copyright © 2024 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Mette van Overeem Felter (M)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark. Electronic address: mette.van.overeem.felter@regionh.dk.

Pia Krause Møller (P)

Department of Oncology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; OPEN, Open Patient data Explorative Network at Odense University Hospital, J. B. Winsløws Vej 9a, 5000 Odense C, Denmark.

Mirjana Josipovic (M)

Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark; hOPEN, Open Patient data Explorative Network at Odense University Hospital, J. B. Winsløws Vej 9a, 5000 Odense C, Denmark.

Susanne Nørring Bekke (S)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark.

Uffe Bernchou (U)

Department of Oncology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3. 5000 Odense C, Denmark.

Eva Serup-Hansen (E)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark.

Kasper Madsen (K)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark.

Parag Parikh (P)

Department of Oncology, Henry Ford Hospital, 2800 W Grand Blvd, Detroit, MI 48202, United States.

Joshua Kim (J)

Department of Oncology, Henry Ford Hospital, 2800 W Grand Blvd, Detroit, MI 48202, United States.

Poul Geertsen (P)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark.

Claus P Behrens (CP)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Health Technology, Technical University of Denmark, Frederiksborgvej 3994000 Roskilde, Denmark.

Ivan R Vogelius (IR)

Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark; hOPEN, Open Patient data Explorative Network at Odense University Hospital, J. B. Winsløws Vej 9a, 5000 Odense C, Denmark.

Mette Pøhl (M)

Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.

Tine Schytte (T)

Department of Oncology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3. 5000 Odense C, Denmark.

Gitte Fredberg Persson (G)

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark; hOPEN, Open Patient data Explorative Network at Odense University Hospital, J. B. Winsløws Vej 9a, 5000 Odense C, Denmark.

Classifications MeSH