Feasibility and safety
pleural effusion, hypophosphatemia, fatigue, fever, toxicities, anemia, lymphopenia, hyperglycemia
PLEURAL EFFUSION, VIRUS, HYPOPHOSPHATEMIA, ADVERSE EVENTS, ADVERSE EVENT, ANEMIA, LYMPHOPENIA, HYPERGLYCEMIA, VACCINIA, HYPOCALCEMIA
Attenuated vaccinia virus (Olvi-vec) was administered intrapleurally as a bolus through a pleural catheter after complete evacuation of pleural effusion in all patients (Protocol schema Adverse events that occurred during the phase I trial (n=18).*Shown are adverse events that occurred in 15% or more of the study population up to day 60 post-treatment.ALT, alanine aminotransferase; AST, aspartate aminotransferase; INR, international normalized ratio.There was 1 reversible grade-4 laboratory abnormality (hypocalcemia). The most frequent grade 3 adverse events were lymphopenia (3 patients, 17%), fatigue (2 patients, 11%), and hypophosphatemia (2 patients, 11%). The most frequent grade 2 adverse events were anemia (5 patients, 28%), hyperglycemia (5 patients, 28%), and fever (4 patients, 22%). There were no dose-limiting toxicities, and maximally tolerated dose was not reached. As a result, the primary objective of establishing a recommended dose was not reached.