Inotuzumab-ozogamicin
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Various toxicities: 4 case reports In a case report, 4 women aged 52–77 years were described, who developed thrombocytopenia, liver damage or elevation of AST or bilirubin levels during treatment with inotuzumab-ozogamicin for relapsed acute lymphoblastic leukaemia (ALL) [routes, dosages and duration of treatments to reactions onsets not stated; not all outcomes not stated]. Case 1: The 52-year-old woman had a history of Philadelphia (Ph) positive ALL with the T315I mutation, which was first relapsed during the third cycle of consolidation therapy. She also underwent cytoreduction by combination chemotherapy consisting of steroids (methylprednisolone), cyclophosphamide, doxorubicin, vincristine due to extremely high absolute peripheral blood blast counts (ABC). She achieved complete remission (CR) with a 5-log reduction of Breakpoint cluster region-Abelson (BCR/ABL) transcripts with one cycle of inotuzumab-ozogamicin. However, after the second cycle of inotuzumab-ozogamicin, her AST levels increased to more than 2.5 times the upper limit of normal (ULN). According to the instructions of the package insert, inotuzumabozogamicin was withdrawn temporarily. During the third cycle of inotuzumab-ozogamicin, a second relapse was observed. Hence, she was switched to ponatinib. Seven months after the starting inotuzumab-ozogamicin, she died of disease progression with a total duration of CR (DuCR) of 2 months. Case 2: The 55-year-old woman had a history of ALL, which relapsed after 12 years of initial diagnosis. She also underwent cytoreduction with steroids due to extremely high ABC. She achieved CR with 1 cycle of inotuzumab-ozogamicin. However, her AST and bilirubin levels increased and inotuzumab-ozogamicin was stopped after the fourth cycle because of these grade 2 adverse events (AEs). Although she survived for 15 months and relapsed 13 months after achieving CR with inotuzumab-ozogamicin. At the time of this report, she was enrolled in the clinical trial of chimeric antigen receptor (CAR) T-cell therapy. Case 3: The 72-year-old woman had a history of Ph-negative ALL, which relapsed for the third time after 8 years of the initial diagnosis. She achieved CR with 2 cycles of inotuzumab-ozogamicin. However, she temporarily stopped receiving inotuzumabozogamicin after receiving the third and fourth cycles because of grade 3 thrombocytopenia and an elevation of the bilirubin and AST levels to over 2.5 times the ULN. The platelet counts recovered and liver damage disappeared. Therefore, she was started on fifth cycle of inotuzumab-ozogamicin. However, both liver damage and thrombocytopenia reappeared. Hence inotuzumabozogamicin was stopped during the the fifth cycle, as she was considered intolerant this treatment. She then survived for 13 months with no relapse, with total DuCR of 11 months. Case 4: The 77-year-old woman had a history of Ph-negative ALL, which relapsed with tumour formation at the uterine cervix after 6 years of the initial diagnosis. She achieved CR and the tumour was reduced with CHOP-chemotherapy c
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