Effects of surgery with salvage stereotactic radiosurgery vs surgery with whole-brain radiation therapy in patients with one to four brain metastases (JCOG0504): A phase III, noninferiority, randomized controlled trial
Journal of Clinical Oncology Jul 03, 2018
Kayama T, et al. - Researchers evaluated the noninferiority of salvage stereotactic radiosurgery (SRS) vs whole-brain radiotherapy (WBRT) in patients with brain metastases (BMs). Based on the findings, they concluded that salvage SRS is noninferior to WBRT and has the potential to serve as a standard therapy for patients with four or fewer BMs.
Methods
- This study included patients who were 20 to 79 years old with performance status scores of 0 to 2 — and 3 if caused only by neurologic deficits — and with four or fewer surgically resected BMs with only one lesion > 3 cm in diameter.
- Within 21 days of surgery, randomization of patients to WBRT or salvage SRS arms was done.
- Overall survival was primary end point.
- They used a one-sided α of .05.
Results
- A total of 137 and 134 patients were enrolled in the WBRT and salvage SRS arms, respectively between January 2006 and May 2014.
- In both arms, the observed median overall survival was 15.6 months (hazard ratio, 1.05; 90% CI, 0.83 to 1.33; one-sided P for noninferiority=.027).
- In the WBRT arm vs the salvage SRS arm, a longer median intracranial progression-free survival was reported (10.4 months vs 4.0 months, respectively).
- Findings revealed similar proportions of patients in both arms showing no worsening of Mini-Mental Status Examination and performance status scores at 12 months; however, 16.4% of patients in the WBRT arm experienced grade 2 to 4 cognitive dysfunction after 91 days after enrollment, while only 7.7% of those in the SRS arm did (P=.048).
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