Ok so a few things here. First this was not a “small trial”, 99 patients is not a small trial by any means. Second we should try to minimize toxicity as much as safely possible, but this should not be the singular focus of our work. SBRT reportedly improved the 5 year survival by 22%!! Yes there were very rare but serious side effects, but that can occur with any radical therapy. Do we not perform organ transplants because there is perioperative mortality, or bone marrow transplants because there is also mortality? No we do these procedures because they can improve survival. If you read closely 2 of the 3 patients that died were likely from secondary complications (subdural bleed after surgery, and infection) both of these may have been associated with comorbidities the patients had and not caused by SBRT directly. In any case, also the concept that “ok well we need a phase III and nothing matters until we have a phase III study”. Well that is not true, these patients were Randomized. This is Level I evidence for the benefit of SBRT in improving OS in oligometastatic disease. The data also appears to agree with other Phase II studies in this space which are reporting improved PFS and OS with SBRT in oligometastatic disease.
I am not involved with either of these studies, but really looking forward to learning more about the data at ASTRO, for these potentially practice changing or practice confirming studies.