A Dutch phase III randomized multicenter trial: Whole brain radiotherapy versus stereotactic radiotherapy for 4-10 brain metastases

Dianne Hartgerink, Anna Bruynzeel, Danielle Eekers, Ans Swinnen, Coen Hurkmans, Ruud Wiggenraad, Annemarie Swaak-Kragten, Edith Dieleman, Peter Paul Van Der Toorn, Bing Oei, Lieneke Van Veelen, Joost Verhoeff, Frank Lagerwaard, Dirk De Ruysscher, Philippe Lambin, Jaap Zindler*

*Corresponding author for this work

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Abstract

Background. The clinical value of whole brain radiotherapy (WBRT) for brain metastases (BM) is a matter of debate due to the significant side effects involved. Stereotactic radiosurgery (SRS) is an attractive alternative treatment option that may avoid these side effects and improve local tumor control. We initiated a randomized trial (NCT02353000) to investigate whether quality of life is better preserved after SRS compared with WBRT in patients with multiple brain metastases. Methods. Patients with 4-10 BM were randomized between the standard arm WBRT (total dose 20 Gy in 5 fractions) or SRS (single fraction or 3 fractions). The primary endpoint was the difference in quality of life (QOL) at 3 months post-treatment. Results. The study was prematurely closed due to poor accrual. A total of 29 patients (13%) were randomized, of which 15 patients have been treated with SRS and 14 patients with WBRT. The median number of lesions were 6 (range: 4-9) and the median total treatment volume was 13.0 cc3 (range: 1.8-25.9 cc3). QOL at 3 months decreased in the SRS group by 0.1 (SD = 0.2), compared to 0.2 (SD = 0.2) in the WBRT group (P = .23). The actuarial 1-year survival rates were 57% (SRS) and 31% (WBRT) (P = .52). The actuarial 1-year brain salvage-free survival rates were 50% (SRS) and 78% (WBRT) (P = .22). Conclusion. In patients with 4-10 BM, SRS alone resulted in 1-year survival for 57% of patients while maintaining quality of life. Due to the premature closure of the trial, no statistically significant differences could be determined.

Original languageEnglish
Article numbervdab021
JournalNeuro-oncology advances
Volume3
Issue number1
DOIs
Publication statusPublished - 1 Jan 2021

Bibliographical note

Funding Information:
The funders provided financial support but had no other role in the study design, data collection, analysis, interpretation, or writing of the report. The MAASTRO Clinic has a research agreement with Varian Medial Systems, Palo Alto in which funding was provided for this trial. Varian was not involved in writing the study protocol or manuscript, the storage of data, nor the analysis of data. The Data Center was responsible for the collection and maintenance of the data. The authors acknowledge financial support from the Dutch Technology Foundation STW (grant n° 10696 DuCAT), which is the applied science division of NWO, and the Technology Programme of the Ministry of Economic Affairs. The authors also acknowledge financial support from the EU 7th framework program (ARTFORCE - n° 257144, REQUITE - n° 601826), SME Phase 2 (RAIL – n°673780), the European Program H2020-PHC-2015 (BD2decide - n°210274050), and Kankeronderzoekfonds Limburg from the Limburg Health Foundation. The corresponding author and principal investigator of the study had full access to all the data and final responsibility.

Publisher Copyright:
© The Author(s) 2021.

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