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Top Line: The debate continues on the best way to radiate spinal cord compression.
The Study: Many hoped the phase 3 SCORAD trial would provide some answers. Initial results were presented in abstract form at ASCO....2.5 years ago. Here we finally have the full manuscript. And for a trial with a primary endpoint measured at 8 weeks, that leaves a whole lot of time for statistical analyses—if that’s not foreshadowing, we don’t know what is. As a reminder, 686 patients receiving upfront conventional palliative radiation (aka non-surgical management) for solid tumor cord compression across 43 centers in the UK and Australia were randomized 1:1 to 4 Gy x 5 = 20 Gy versus 8 Gy x 1. The primary endpoint was ambulatory status at 8 weeks as measured on a 4-point scale (grade 1-2 = walking / grade 3-4 = not). Two-thirds of patients in each arm were ambulatory at baseline. The first big, maybe even the biggest, takeaway here is that less than half of patients made it to follow-up at 8 weeks as over one-third had already died. Among the 342 patients with available data, the rates of grade 1-2 ambulation after five versus one fraction, respectively, were 64% and 64% (week 1), 68% versus 67% (week 4), 73% versus 69% (week 8), and 72% versus 68% (week 12). In other words, it was statistically non-inferior at all time points except the primary timepoint of 8 weeks where the lower boundary of the confidence interval (−11.5%) eeked over the a priori line in the sand of −11%. Grade 3-4 adverse events were recorded in 20% of patients in both arms, almost half being fatigue.
TBL: There is no clinically significant difference after five versus one conventional radiation treatment for non-surgical solid tumor cord compression...other than the number of days a patient comes for treatment. | Hoscan, JAMA 2019