title: Stereotactic radiotherapy of the tumor bed compared to whole brain radiotherapy after surgery of single brain metastasis: Results from a randomized trial.
abstract: To evaluate if neurological/cognitive function outcomes in patients with resected single brain metastasis (BM) after stereotactic radiotherapy of the tumor bed (SRT-TB) are not inferior compared to those achieved with whole-brain radiotherapy (WBRT).
  
  
  
  Patients with total/subtotal resection of single BM were randomly assigned either to SRT-TB (n=29) or WBRT (n=30). SRT-TB arm consisted of 15Gy/1 fraction, or 5×5Gy. WBRT consisted of 30Gy/10 fractions. Neurological/cognitive failure was defined as a decrease of neurological score by one point or more, or a worsening of the MiniMental test by at least 3 points, or neurological death. Cumulative incidence of neurological/cognitive failure (CINCF), neurological death (CIND), and overall survival (OS) were compared.
  
  
  
  Median follow-up was 29months (range: 8-45) for 15 patients still alive. The difference in the probability of CINCF at 6months (primary endpoint) was -8% in favor of WBRT (95% confidence interval: +17% -35%; non-inferiority margin: -20%). In the intention-to-treat analysis, two-year CIND rates were 66% vs. 31%, for SRT-TB and WBRT arm, respectively, p=.015. The corresponding figures for OS were 10% vs. 37%, p=.046.
  
  
  
  Non-inferiority of SRT-TB was not demonstrated in our underpowered study. More data from randomized studies are needed for confirmation of the value of this method.
authors: Independent Public Health Care Facility of the Ministry of the Interior and Warmian & Mazurian Oncology Centre, Olsztyn, Poland. Electronic address: lucynak@coi.pl.
authors: Lucyna
authors: L
authors: Kępka
authors: Maria Sklodowska-Curie Memorial Oncology Center and Institute of Oncology, Warsaw, Poland.
authors: Dobromira
authors: D
authors: Tyc-Szczepaniak
authors: Maria Sklodowska-Curie Memorial Oncology Center and Institute of Oncology, Warsaw, Poland.
authors: Krzysztof
authors: K
authors: Bujko
authors: Maria Sklodowska-Curie Memorial Oncology Center and Institute of Oncology, Warsaw, Poland.
authors: Marta
authors: M
authors: Olszyna-Serementa
authors: Maria Sklodowska-Curie Memorial Oncology Center and Institute of Oncology, Warsaw, Poland.
authors: Wojciech
authors: W
authors: Michalski
authors: Maria Sklodowska-Curie Memorial Oncology Center and Institute of Oncology, Warsaw, Poland; Centre of Oncological Diagnostics and Therapy, Tomaszów Mazowiecki, Poland.
authors: Arkadiusz
authors: A
authors: Sprawka
authors: Department of Radiotherapy, Medical University of Lodz, Poland.
authors: Berenika
authors: B
authors: Trąbska-Kluch
authors: Independent Public Health Care Facility of the Ministry of the Interior and Warmian & Mazurian Oncology Centre, Olsztyn, Poland.
authors: Katarzyna
authors: K
authors: Komosińska
authors: Independent Public Health Care Facility of the Ministry of the Interior and Warmian & Mazurian Oncology Centre, Olsztyn, Poland.
authors: Ewa
authors: E
authors: Wasilewska-Teśluk
authors: Independent Public Health Care Facility of the Ministry of the Interior and Warmian & Mazurian Oncology Centre, Olsztyn, Poland.
authors: Beata
authors: B
authors: Czeremszyńska
mesh_terms: D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000532:radiotherapy* / Q000556:secondary*; D003131:Combined Modality Therapy; D016371:Cranial Irradiation / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016634:Radiosurgery / Q000379:methods*
keywords: Brain metastases; Non-inferiority trial; Radiosurgery; Tumor bed; WBRT