Use of indocyanine green dye for sentinel lymph node mapping in patients with endometrial cancer and a history of iodinated contrast allergy.

Objectives: Sentinel lymph node (SLN) mapping is a surgical technique with high accuracy in detecting metastases while limiting morbidity associated with full lymphadenectomy in endometrial cancer. Cervical injection of indocyanine green (ICG) dye is associated with very high SLN detection rates; however, iodinated contrast allergy has traditionally been viewed as a contraindication to ICG use. The objective of this study was to describe the use of ICG in a population of patients with iodinated contrast allergies undergoing surgical staging for endometrial cancer. Methods: IRB approval was obtained. All patients with clinically early-stage endometrial cancer who underwent minimally invasive surgical staging with SLN mapping with ICG at a single academic institution from 1/1/2017 to 12/31/2020 were identified retrospectively. Patients with reported iodinated contrast allergies prior to surgery were identified. Data were collected through electronic medical record review and compared using descriptive statistics. Results: 820 patients who underwent minimally invasive surgical staging with SLN mapping with ICG were identified, and 25 had documented iodinated contrast allergies. Documented reactions included rash/hives (n = 10, 40 %), anaphylaxis (n = 6, 24 %), shortness of breath (n = 5, 20 %), diarrhea (n = 1, 4 %), and not specified (n = 3, 12 %). A majority (24/25, 96 %) received 4 mg intravenous dexamethasone during induction of general anesthesia as per the institutional enhanced recovery after surgery (ERAS) protocol. No patients experienced allergic reactions or other adverse events after ICG injection. Conclusions: No patients in this cohort demonstrated an adverse reaction after ICG injection for SLN mapping. This study supports the reasonable safety of ICG in patients with contrast allergies, particularly when routine ERAS protocols containing dexamethasone are utilized.

The effect of a neonatal sleep intervention on maternal postpartum hypertension: a randomized trial.

BACKGROUND: In nonpregnant adults, poor sleep is associated with higher blood pressure. Poor sleep is common in the postpartum period and is often attributed to infant caretaking needs. However, its effects on cardiovascular health in individuals with a hypertensive disorder of pregnancy are unknown. OBJECTIVE: This study aimed to determine the effect of a neonatal sleep intervention on maternal postpartum blood pressure in individuals with a hypertensive disorder of pregnancy. STUDY DESIGN: In this single-institution pilot randomized controlled trial from July 2021 to March 2022, 110 individuals with a hypertensive disorder of pregnancy were randomized to receive a neonatal sleep intervention (SNOO responsive bassinet) plus usual care of safe sleep education (n=54) or usual care alone (n=56). Remote follow-up visits were conducted at 1 week, 6 weeks, and 4 months after delivery and involved blood pressure and weights, sleep and mood questionnaires, and self-reported infant and maternal sleep logs. Based on institutional data, the sample size had 80% power to detect a 4.5-mm Hg difference in the primary outcome of mean arterial pressure at 6 weeks after delivery. RESULTS: Baseline characteristics were similar between the arms. At 1 week after delivery, the intervention arm had lower mean arterial pressure and less antihypertensive medication use than the control arm (99±10 vs 103±7 mm Hg [P=.04] and 23% vs 35% [P=.15], respectively). At 6 weeks after delivery, mean arterial pressure was similar between arms (93±8 vs 94±8 mm Hg; P=.54), but there was a lower rate of antihypertensive use in the intervention arm (15% vs 26%; P=.19). Scores from maternal sleep and mood questionnaires at 6 weeks after delivery and self-reported infant and maternal sleep duration at 6 weeks and 4 months after delivery were similar between arms (P>.05). CONCLUSION: The SNOO responsive bassinet as a neonatal sleep intervention did not result in improved mean arterial pressure at 6 weeks after delivery after hypertensive disorders of pregnancy.

Influencing the Tumor Microenvironment: A Phase II Study of Copper Depletion Using Tetrathiomolybdate in Patients with Breast Cancer at High Risk for Recurrence and in Preclinical Models of Lung Metastases.

PURPOSE: Bone marrow-derived progenitor cells, including VEGFR2+ endothelial progenitor cells (EPCs) and copper-dependent pathways, model the tumor microenvironment. We hypothesized that copper depletion using tetrathiomolybdate would reduce EPCs in high risk for patients with breast cancer who have relapsed. We investigated the effect of tetrathiomolybdate on the tumor microenvironment in preclinical models. EXPERIMENTAL DESIGN: Patients with stage II triple-negative breast cancer (TNBC), stage III and stage IV without any evidence of disease (NED), received oral tetrathiomolybdate to maintain ceruloplasmin (Cp) between 8 and 17 mg/dL for 2 years or until relapse. Endpoints were effect on EPCs and other biomarkers, safety, event-free (EFS), and overall survival (OS). For laboratory studies, MDA-LM2-luciferase cells were implanted into CB17-SCID mice and treated with tetrathiomolybdate or water. Tumor progression was quantified by bioluminescence imaging (BLI), copper depletion status by Cp oxidase levels, lysyl oxidase (LOX) activity by ELISA, and collagen deposition. RESULTS: Seventy-five patients enrolled; 51 patients completed 2 years (1,396 cycles). Most common grade 3/4 toxicity was neutropenia (3.7%). Lower Cp levels correlated with reduced EPCs (P = 0.002) and LOXL-2 (P < 0.001). Two-year EFS for patients with stage II-III and stage IV NED was 91% and 67%, respectively. For patients with TNBC, EFS was 90% (adjuvant patients) and 69% (stage IV NED patients) at a median follow-up of 6.3 years, respectively. In preclinical models, tetrathiomolybdate decreased metastases to lungs (P = 0.04), LOX activity (P = 0.03), and collagen crosslinking (P = 0.012). CONCLUSIONS: Tetrathiomolybdate is safe, well tolerated, and affects copper-dependent components of the tumor microenvironment. Biomarker-driven clinical trials in high risk for patients with recurrent breast cancer are warranted. Clin Cancer Res; 23(3); 666-76. ©2016 AACR.