Corticosteroids, as premedication, were given to approximately 60% of patients. In the HL and sALCL, 9.9% and 12.9% of patients, respectively, received combination antitumor therapies with brentuximab vedotin for treatment of their disease. 6.3%), neutropenia (34.5%; grade??3, 22.2%) and lymphopenia (7.0%; grade??3, 5.3%). Ten patients had fatal ADRs including interstitial lung disease (doxorubicin, bleomycin, vinblastine and dacarbazine, brentuximab vedotin, cyclophosphamide, doxorubicin, vincristine and prednisolone, Eastern Cooperative Oncology Group, Hodgkin lymphoma, hematopoietic stem cell transplant, sALCL, systemic anaplastic large cell lymphoma Treatment The extent of exposure of patients to brentuximab vedotin is summarized in Table ?Table2.2. In total, 87.4% of patients with HL and 86.1% of those with sALCL received a starting dose of 1 1.8?mg/kg and Mouse Monoclonal to E2 tag 77.5% of patients with HL and 71.3% of those with sALCL received a mean dose per cycle of 1 1.8?mg/kg throughout treatment. The median number of delivered treatment cycles in HL and sALCL were 5.5 (range 1C16) and 4 (range 1C17), respectively. The proportion of patients who received the full 16 cycles of brentuximab vedotin treatment was 11.0% in HL and Oglufanide 10.9% in sALCL; one patient with sALCL received 17 cycles of treatment. Reasons for treatment discontinuation were lack of efficacy in 40.7% and 39.6%, AEs in 23.1% and 20.8%, and achievement of treatment objectives according to the physicians decision in 19.2% and 24.8% of patients with HL and sALCL, respectively (Table ?(Table22). Table 2 Exposure to brentuximab vedotin adverse event, brentuximab vedotin, Hodgkin lymphoma, hematopoietic stem cell transplant, systemic anaplastic large cell lymphoma Prior to the first dose of brentuximab vedotin, premedication for infusion reactions was administered in 59.9% and 74.3% of patients in the HL and sALCL, respectively. Corticosteroids, as premedication, were given to approximately 60% of patients. In the HL and sALCL, 9.9% and 12.9% of patients, respectively, received combination antitumor therapies with brentuximab vedotin for treatment of their disease. The most common drugs were prednisolone and dexamethasone, which were given to 16 (5.6%) patients with either disease; a total of 15 (5.3%) patients received one or more cytotoxic agents (Supplementary Table 1). Safety In the safety population, the incidence of ADRs was 74.3%, with Oglufanide the most commonly reported ADRs being peripheral sensory neuropathy (39.1%; grade??3, 6.3%), neutropenia (34.5%; grade??3, 22.2%), and lymphopenia (7.0%; Oglufanide grade??3, 5.3%) (Table ?(Table33). Table 3 Common ADRs occurring in??2% of all patients (%)Preferred termadverse drug reaction, Hodgkin lymphoma, not available, systemic anaplastic large cell lymphoma The most common serious ADRs that occurred in??2% of all patients were neutropenia (4.9%), interstitial lung disease (3.9%), pneumonia (2.1%), and peripheral sensory neuropathy (2.1%) (Table ?(Table4).4). Ten patients had fatal ADRs; of these, six patients had fatal ADRs classified as drug-related, which were: interstitial lung disease ((%)Preferred termpneumonia3 (1.1)2 (1.1)1 (1.0)Blood and lymphatic system disorders20 (7.0)14 (7.7)6 (5.9)?Febrile neutropenia4 (1.4)2 (1.1)2 (2.0)?Neutropenia14 (4.9)12 (6.6)2 (2.0)Nervous system disorders7 (2.5)6 (3.3)1 (1.0)?Peripheral motor neuropathy5 (1.8)4 (2.2)1 (1.0)?Peripheral sensory neuropathy6 (2.1)5 (2.8)1 (1.0)Respiratory, thoracic and mediastinal disorders13 (4.6)10 (5.5)3 (3.0)?Interstitial lung disease11 (3.9)8 (4.4)3 (3.0) Open in a separate window aIncludes one patient with diffuse large B-cell lymphoma adverse drug reaction, Hodgkin lymphoma, systemic anaplastic large cell lymphoma With regards to the assessment of ADRSIs, peripheral neuropathy events were reported in 39.4% of overall patients, with 6.7% of patients experiencing grade??3 peripheral neuropathy (Table ?(Table5).5). Of 17 patients who had grade 2 peripheral neuropathy prior to starting brentuximab vedotin, two (11.8%) patients reported worsening to grade 3. The only patient having grade 3 peripheral neuropathy prior to starting brentuximab vedotin also reported grade 3 peripheral neuropathy during treatment. Of 35 events of grade??3 peripheral neuropathy that occurred during brentuximab vedotin treatment, five (14.3%) required.