Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma.

Multiple myeloma (MM) remains an incurable malignancy originating from plasma cells. Despite significant advances in treatment, relapses remain inevitable, and novel therapies continue to be needed. Teclistamab-cqyv is a first-in-class, bispecific T-cell engager (BiTE) antibody for the treatment of MM. Teclistamab-cqyv activates the immune system by binding to the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and to the B-cell maturation antigen (BCMA) expressed on the surface of MM cells and some healthy B-lineage cells. Teclistamab-cqyv has been shown to be effective in a pivotal trial that demonstrated an overall response rate of more than 60% in heavily pretreated patients. Compared with other BCMA-targeted agents, the side effect profile of teclistamab-cqyv suggests a more tolerable option for elderly patients. Teclistamab-cqyv is now approved by the US Food and Drug Administration (FDA) as monotherapy for the treatment of adult patients with relapsed or refractory MM.

The Effectiveness of Shared Compared to Informed Decision Making for Prostate Cancer Screening in a High-Risk African American Population: A Randomized Control Trial.

BACKGROUND: Prostate cancer incidence and mortality in the United States in African Americans (AA) are higher than in Caucasians. Eastern Cuyahoga County in Ohio is majority AA and is considered an underserved population particularly vulnerable to healthcare disparities. There is a paucity of data about shared decision making among high-risk AA men with regard to prostate cancer screening. This study aims to examine shared versus informed decision making (SDM versus IDM) in a randomized, control trial among a large, high-risk AA population. METHODS: Patients were included in annual one-day outreach events, each held over 3 years (2017-2019), and were randomized at each event into IDM (control) and SDM (investigational) groups and then were offered screening via prostate specific antigen (PSA) and digital rectal exam (DRE). The primary endpoints were proportion of participants over 40 who did not demonstrate decisional conflict about prostate cancer screening measured by the SURE score, as well as change of knowledge score about prostate cancer screening. RESULTS: Overall, 175 patients were enrolled in the trial; 79 in the SDM arm and 96 in the IDM arm. The investigational (SDM) arm had 3/79 (3.9%) conflict versus 6/96 (6.4%) in the control (IDM) arm (p = 0.74). With regard to knowledge improvement, the SDM cohort demonstrated improvement following educational tools for 66/79 (81%) of participants versus 76/96 (79%) in the IDM cohort (p = 0.85). There was no difference in the proportion (63%) of participants in either group who found the information very helpful (using a Likert scale). CONCLUSIONS: Our education-based study showed no significant difference between SDM and IDM with regard to decisional conflict about prostate cancer screening. The study also demonstrated significant improvement in knowledge about prostate cancer screening in a high-risk AA population in both groups. Our results should be interpreted with caution due to several limitations; however, the study can serve as a benchmark for future studies in this very important topic.

Outcomes of Cardiovascular Surgery Utilizing Heparin versus Direct Thrombin Inhibitors in Cardiopulmonary Bypass in Patients with Previously Diagnosed HIT.

Heparin-induced thrombocytopenia (HIT) is a life-threatening complication of heparin therapy. Heparin is generally avoided in patients with a history of HIT; however, it remains the anticoagulant of choice for cardiac surgery requiring cardiopulmonary bypass (CPB) because of limited experience with alternative anticoagulants such as direct thrombin inhibitors (DTIs) during CPB. We report outcomes of surgery requiring CPB (30-day mortality, rate of thrombosis, and hemorrhage) in patients with prior HIT who received either heparin or a DTI intraoperatively. Seventy-two patients with a prior diagnosis of HIT confirmed by a positive serotonin release assay underwent CBP with a positive HIT antibody at the time of surgery. Thirty-day mortality was 0 and 8.5% in the DTI and heparin cohorts (p = 0.277). Thrombotic events occurred in 1 (7.7%) of the patients treated with DTI and 15 (25.4%) receiving heparin (p = 0.164). In the DTI cohort, 7 (53.8%) had minimal bleeding, 5 (38.5%) had mild bleeding, 1 (7.8%) had moderate bleeding, and none had severe bleeding. In the heparin group, 16 (27.1%) had minimal bleeding, 14 (23.7%) had mild bleeding, 25 (42.4%) had moderate bleeding, and 4 (6.8%) had severe bleeding (p = 0.053). DTI was associated with a lower rate of moderate to severe hemorrhage than heparin (odds ratio 0.097 [95% confidence interval 0.011-0.824], p = 0.033) in a logistic regression model adjusted for thrombocytopenia and length on bypass. DTI appears to be safe in selected patients undergoing CPB after a diagnosis of HIT, and was not associated with higher rates of 30-day mortality, thrombosis, or hemorrhage.