Interim Safety And Toxicity Analysis Of A Prospective Phase Ii Randomized Trial Of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy In Advanced Metastatic Disease

ResultsWe have enrolled a total of 35 patients at this time. There were a total of 126 CTCAE toxicity events observed with 67 (53.2%) Low grade (CTCAE 1-2), and 59 (46.8%) High grade (CTCAE 3-5) events with a mean followup of 5.1 months. The most common toxicities were fatigue, nausea, pain, and rash. The most common SBRT treatment sites were lung, liver, adrenal gland, and soft tissue. Experimental treatment attributions are as follows: 18 events (14.3%) Unrelated, 44 events (34.9%) Unlikely, 48 events (38.1%) Possible, and 13 events (10.3%) Probable or Definite. There were 7 (5.5%) high grade events attributed as probably or definitely related to study: one grade 4 fatigue, one grade 3 weight loss, one grade 3 rash, and two grade 3 electrolyte abnormalities, and two grade 3 acute kidney injury. When comparing between CBI and CBI+ SBRT treatment groups there was no significant difference in any …