Drug Exposure and Post-Transplantation Adverse Events after Restart of Gilteritinib Therapy
neutropenia, diarrhea, peripheral edema, thrombocytopenia, pyrexia, acute gastrointestinal GVHD, weight gain, hypokalemia
PLEURAL EFFUSION, DERMATOMYOSITIS, NEUTROPENIA, INCREASED BLOOD LACTATE, PERIPHERAL EDEMA, THROMBOCYTOPENIA, ACUTE GVHD, RESPIRATORY FAILURE, PLEURAL THICKENING, PANCYTOPENIA
In the patients who resumed gilteritinib after HSCT, the median dose of gilteritinib was 120 mg (range, 40 to 200), and the median duration of posttransplant gilteritinib maintenance therapy was 258.5 days (IQR, 51.5 to 823 days). The rate of grade ≥II acute GVHD after the restart of gilteritinib was 33% (n = 13 of 40). Among the patients with grade ≥III acute GVHD after resuming gilteritinib therapy (10%; n = 4 of 40), 1 case of fatal acute gastrointestinal GVHD was observed. The most frequent AEs of any grade occurring after resuming gilteritinib were increased alanine aminotransferase (ALT) level (45%), pyrexia (43%), and diarrhea (40%) (The most common grade ≥3 AEs of interest were increased liver transaminase (ALT or aspartate aminotransferase) level (8%) (Seven of the 40 patients (18%) who resumed gilteritinib after HSCT experienced AEs that led to dosage reductions (1 each with grade 4 thrombocytopenia and neutropenia, grade 3 hypokalemia, grade 1 peripheral edema and grade 3 weight gain, grade 2 pleural effusion, grade 3/4 increased blood creatine phosphokinase, grade 1 pleural thickening, and grade 2 increased ALT). AEs leading to dosage interruptions occurred in 19 of the 40 patients (48%) who resumed gilteritinib after HSCT. Overall, 14 of 40 patients (35%) experienced grade ≥3 AEs leading to dosage interruptions; 6 patients (15%) experienced drug-related grade ≥3 AEs (pancytopenia, increased blood lactate dehydrogenase, hypokalemia, dermatomyositis, respiratory failure, and thrombocytopenia).