Obinutuzumab treatment in the elderly patient with chronic lymphocytic leukemia

Karen Seiter, Aleksandra Mamorska-DygaDepartment of Medicine, Division of Hematology/Oncology, New York Medical College, Valhalla, NY, USA Abstract: Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western countries. Fludarabine-based regimens demonstrate higher response rates in younger patients but have a significant risk of infection and are thus poorly tolerated by older, frail patients. Anti-CD20 monoclonal antibodies have added to the efficacy of chemotherapy in CLL. Obinutuzumab is a potent Type II anti-CD20 monoclonal antibody with enhanced antibody-dependent cellular toxicity and direct cell death compared with rituximab. In Phase I studies, infusion reactions and neutropenia were the predominant toxicities. Phase II studies demonstrated efficacy both as a single agent and in combination with chemotherapy in patients with CLL. The CLL11 trial was a Phase III randomized trial of chlorambucil alone or with either obinutuzumab or rituximab in elderly, unfit patients. Progression-free survival (the primary end point) was 26.7 months for patients receiving obinutuzumab plus chlorambucil versus 16.3 months for those receiving rituximab plus chlorambucil and 11.1 months for those receiving chlorambucil alone (P<0.001). Overall survival was improved for patients receiving obinutuzumab plus chlorambucil versus chlorambucil alone (P=0.002). This trial led to the US Food and Drug Administration (FDA) approval of obinutuzumab in this patient population.Keywords: chronic lymphocytic leukemia, obinutuzumab, chlorambucil, elderl

Changes in Mechanical Fragility and Free Hemoglobin Levels after Processing Salvaged Cardiopulmonary Bypass Circuit Blood with a Modified Ultrafiltration Device

Modified ultrafiltration (MUF) is available for the salvage of post-cardiopulmonary bypass circuit blood. This study evaluated the extent of hemolysis, the mechanical fragility index (MFI), and the amount of plasma free hemoglobin (PFHb) created after processing with the MUF device. Several RBC parameters were measured on pre- and post-MUF device processed samples of blood from 12 patients undergoing cardiac surgery. The MFI and total amount of PFHb did not change significantly between the pre- and post-processing samples: MFI, pre: .19 ± .06 versus post: .19 ± .06, p = .76; total amount of PFHb, pre: .24 ± .21 g versus post: .20 ± .12 g, p = .42. There was significantly more hemolysis in the post-processing samples compared with the pre-processing samples, .33 ± .24% versus .96 ± .48%, respectively, p < .001. Although percent hemolysis was increased following processing with the MUF device, the total amount of PFHb and RBC sublethal injury were not increased. The clinical significance of these findings needs to be determined