Stereotactic radiosurgery versus whole-brain radiotherapy in patients with 4-10 brain metastases: A nonrandomized controlled trial.

Linear accelerator Multiple brain metastases Oligometastasis Radiation therapy Single-isocenter Stereotactic Radiosurgery

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:
09 2023
Historique:
received: 11 11 2022
revised: 09 05 2023
accepted: 07 06 2023
medline: 21 8 2023
pubmed: 18 6 2023
entrez: 17 6 2023
Statut: ppublish

Résumé

There is no randomized evidence comparing whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases. This prospective nonrandomized controlled single arm trial attempts to reduce the gap until prospective randomized controlled trial results are available. We included patients with 4-10 brain metastases and ECOG performance status ≤ 2 from all histologies except small-cell lung cancer, germ cell tumors, and lymphoma. The retrospective WBRT-cohort was selected 2:1 from consecutive patients treated within 2012-2017. Propensity-score matching was performed to adjust for confounding factors such as sex, age, primary tumor histology, dsGPA score, and systemic therapy. SRS was performed using a LINAC-based single-isocenter technique employing prescription doses from 15-20Gyx1 at the 80% isodose line. The historical control consisted of equivalent WBRT dose regimens of either 3Gyx10 or 2.5Gyx14. Patients were recruited from 2017-2020, end of follow-up was July 1st, 2021. 40 patients were recruited to the SRS-cohort and 70 patients were eligible as controls in the WBRT-cohort. Median OS, and iPFS were 10.4 months (95%-CI 9.3-NA) and 7.1 months (95%-CI 3.9-14.2) for the SRS-cohort, and 6.5 months (95%-CI 4.9-10.4), and 5.9 months (95%-CI 4.1-8.8) for the WBRT-cohort, respectively. Differences were non-significant for OS (HR: 0.65; 95%-CI 0.40-1.05; P =.074) and iPFS (P =.28). No grade III toxicities were observed in the SRS-cohort. This trial did not meet its primary endpoint as the OS-improvement of SRS compared to WBRT was non-significant and thus superiority could not be proven. Prospective randomized trials in the era of immunotherapy and targeted therapies are warranted.

Sections du résumé

BACKGROUND AND PURPOSE
There is no randomized evidence comparing whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases. This prospective nonrandomized controlled single arm trial attempts to reduce the gap until prospective randomized controlled trial results are available.
MATERIAL AND METHODS
We included patients with 4-10 brain metastases and ECOG performance status ≤ 2 from all histologies except small-cell lung cancer, germ cell tumors, and lymphoma. The retrospective WBRT-cohort was selected 2:1 from consecutive patients treated within 2012-2017. Propensity-score matching was performed to adjust for confounding factors such as sex, age, primary tumor histology, dsGPA score, and systemic therapy. SRS was performed using a LINAC-based single-isocenter technique employing prescription doses from 15-20Gyx1 at the 80% isodose line. The historical control consisted of equivalent WBRT dose regimens of either 3Gyx10 or 2.5Gyx14.
RESULTS
Patients were recruited from 2017-2020, end of follow-up was July 1st, 2021. 40 patients were recruited to the SRS-cohort and 70 patients were eligible as controls in the WBRT-cohort. Median OS, and iPFS were 10.4 months (95%-CI 9.3-NA) and 7.1 months (95%-CI 3.9-14.2) for the SRS-cohort, and 6.5 months (95%-CI 4.9-10.4), and 5.9 months (95%-CI 4.1-8.8) for the WBRT-cohort, respectively. Differences were non-significant for OS (HR: 0.65; 95%-CI 0.40-1.05; P =.074) and iPFS (P =.28). No grade III toxicities were observed in the SRS-cohort.
CONCLUSION
This trial did not meet its primary endpoint as the OS-improvement of SRS compared to WBRT was non-significant and thus superiority could not be proven. Prospective randomized trials in the era of immunotherapy and targeted therapies are warranted.

Identifiants

pubmed: 37330054
pii: S0167-8140(23)00282-7
doi: 10.1016/j.radonc.2023.109744
pii:
doi:

Types de publication

Randomized Controlled Trial Controlled Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

109744

Informations de copyright

Copyright © 2023 The Authors. Published by 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

Raphael Bodensohn (R)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany; Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany.

Anna-Lena Kaempfel (AL)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Anne-Laure Boulesteix (AL)

Institute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.

Anna Maria Orzelek (AM)

Institute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.

Stefanie Corradini (S)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Daniel Felix Fleischmann (DF)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany; German Cancer Consortium (DKTK), Munich, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.

Robert Forbrig (R)

Institute of Neuroradiology, University Hospital, LMU Munich, Munich, Germany.

Sylvia Garny (S)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Indrawati Hadi (I)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Jan Hofmaier (J)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Giuseppe Minniti (G)

Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy; IRCCS Istituto Neurologico Mediterraneo Neuromed, Pozzilli, Italy.

Ulrich Mansmann (U)

Institute for Medical Information Processing, Biometry and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.

Montserrat Pazos Escudero (M)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.

Niklas Thon (N)

Department of Neurosurgery, University Hospital, LMU Munich, Munich, Germany.

Claus Belka (C)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany; German Cancer Consortium (DKTK), Munich, Germany; Department of Neurosurgery, University Hospital, LMU Munich, Munich, Germany.

Maximilian Niyazi (M)

Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany; Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany; German Cancer Consortium (DKTK), Munich, Germany; Bavarian Cancer Research Center (BZKF), Munich, Germany. Electronic address: maximilian.niyazi@med.uni-tuebingen.de.

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