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Background: BAY 1862864 is an α-particle emitting 227Th-labeled CD22-targeting antibody. This first-in-human dose-escalation phase I study evaluated BAY 1862864 in patients with CD22-positive relapsed/refractory B cell non-Hodgkin lymphoma (R/R-NHL). Materials and Methods: BAY 1862864 intravenous injections were administered at the starting 227Th radioactivity dose of 1.5 MBq (2 or 10 mg antibody), and the radioactivity dose escalated in ∼1.5 MBq increments (10 mg antibody) until the maximum tolerated dose (MTD) was reported. The primary objective was to determine the safety, tolerability, and MTD. Results: Twenty-one patients received BAY 1862864. Two dose-limiting toxicities (grade 3 febrile neutropenia and grade 4 thrombocytopenia) were reported in one patient in the 4.6 MBq (10 mg antibody) cohort. The MTD was not reached. Ten (48%) patients reported grade ≥3 treatment-emergent adverse events, with the most common being neutropenia, thrombocytopenia, and leukopenia, each occurring in 3 (14%) patients. Pharmacokinetics demonstrated the dose proportionality and stability of BAY 1862864 in the blood. The objective response rate (ORR) was 25% (5/21 patients) according to the LUGANO 2014 criteria, including 1 complete and 4 partial responses. The ORR was 11% (1/9) and 30% (3/10) in patients with relapsed high- and low-grade lymphomas, respectively. Conclusions: BAY 1862864 was safe and tolerated in patients with R/R-NHL. Clinical Trial Registration numbers: NCT02581878 and EudraCT 2014-004140-36. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text Objective: The aim of this study was to compare the safety of single- versus two-stage conversion of adjustable gastric band (AGB) to gastric bypass (RYGB) or sleeve gastrectomy (SG). Summary Background Data: AGB patients often present for conversion to RYGB or SG. The impact of single- or two-stage approach of such conversion remains unclear. Methods: A statewide database was used to identify all patients who underwent AGB removal and concurrent (single-stage) or interval (two-stage) RYGB or SG. Propensity score matching schemes were constructed to account for differences in baseline comorbidities and demographics, allowing for matched pairs available for comparisons. Results: A total of 4330 patients underwent AGB conversion. Complications, readmissions, and ED visits were noted in 394 (9.1%), 278 (6.42%), and 589 (13.6%) patients, respectively. Three hundred sixty-seven matched pairs underwent RYGB; single-stage patients experienced shorter length of stay (LOS) (median difference −1 d, P < 0.0001), less complications [risk difference (RD): −8.4%, 95% confidence interval (CI), −13.4% to −3.5%], readmissions (RD: −5.2%, 95% CI, −9.6% to −0.8%), and ED visits (RD: −5.7%, 95% CI, −11.3% to −0.2%). Eight hundred seventy-five matched pairs underwent SG; single-stage patients experienced improved outcomes in all measures examined. For single-stage procedures (809 pairs), RYGB was associated with longer LOS, and more complications (RD: 3.3%, 95% CI, 0.9%–5.8%), with similar readmissions, and ED visits. Conclusions: AGB conversion procedures have low morbidity. Single-stage conversion is associated with lower morbidity compared with the two-stage approach. Conversion to SG seems to be safer than RYGB. [ABSTRACT FROM AUTHOR]

Background: To quantify the impact of body mass index (BMI) on surgical site infection (SSI) following abdominal wall reconstruction (AWR) using component separation techniques and attempt to identify obesity-related targets, such as BMI, that can be potentially used to guide preoperative patient optimization. Though AWR has established perioperative outcomes for hernia repair, the applicability in the obese population is not well established.Methods: The 2005-2013 ACS-NSQIP participant use file was reviewed to compare SSI, severe, and overall morbidity in non-emergent AWR patients based on BMI. Multivariable logistic regression was used to control for patient demographics and comorbidities. Odds ratios (OR) with 95% confidence intervals were reported.Results: We identified 4488 patients. The average BMI was 32.76 ± 7.70 kg/m2. The majority of cases (76.8%) had wound classified as clean. The SSI rate significantly increased at a BMI of ≥ 35 kg/m2 compared to < 35 (18.5% vs. 10.5%, p < 0.0001). There was no significant different in SSI rate between BMI 35-40 and > 40. After controlling for differences in baseline characteristics and wound classification, BMI ≥ 35 kg/m2 was independently associated with SSI (OR 1.47, 1.21-1.78), minor complications (OR 1.65, 1.41-1.94), major complications (OR 1.91, 1.60-2.27), re-operation (OR 1.59, 1.23-2.05), and hospital re-admission (OR 1.93, 1.23-3.02).Conclusion: There is a significant increase in SSI and other perioperative complications in patients with a BMI ≥ 35 kg/m2 undergoing AWR. Higher BMI is also independently associated with higher resource utilization in this patient population. Severely obese patients in need of AWR may benefit from a structured preoperative weight loss intervention. [ABSTRACT FROM AUTHOR]

Background: BAY 1862864 is an α-particle emitting 227 Th-labeled CD22-targeting antibody. This first-in-human dose-escalation phase I study evaluated BAY 1862864 in patients with CD22-positive relapsed/refractory B cell non-Hodgkin lymphoma (R/R-NHL). Materials and Methods: BAY 1862864 intravenous injections were administered at the starting 227 Th radioactivity dose of 1.5 MBq (2 or 10 mg antibody), and the radioactivity dose escalated in ∼1.5 MBq increments (10 mg antibody) until the maximum tolerated dose (MTD) was reported. The primary objective was to determine the safety, tolerability, and MTD. Results: Twenty-one patients received BAY 1862864. Two dose-limiting toxicities (grade 3 febrile neutropenia and grade 4 thrombocytopenia) were reported in one patient in the 4.6 MBq (10 mg antibody) cohort. The MTD was not reached. Ten (48%) patients reported grade ≥3 treatment-emergent adverse events, with the most common being neutropenia, thrombocytopenia, and leukopenia, each occurring in 3 (14%) patients. Pharmacokinetics demonstrated the dose proportionality and stability of BAY 1862864 in the blood. The objective response rate (ORR) was 25% (5/21 patients) according to the LUGANO 2014 criteria, including 1 complete and 4 partial responses. The ORR was 11% (1/9) and 30% (3/10) in patients with relapsed high- and low-grade lymphomas, respectively. Conclusions: BAY 1862864 was safe and tolerated in patients with R/R-NHL. Clinical Trial Registration numbers: NCT02581878 and EudraCT 2014-004140-36.