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Purpose: The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ treated with and without ALND., Methods: The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point., Results: In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor-positive/human epidermal growth factor receptor 2-negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% v 7%, P < .001), have ITCs detected on frozen section (62% v 8%, P < .001), have lymphovascular invasion (38% v 24%, P < .001), and receive adjuvant chest wall (89% v 78%, P = .024) and nodal radiation (82% v 75%, P = .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery., Conclusion: The nodal burden in patients with ypN0(i+) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i+).

Background: There is little information on the effectiveness of therapies for severe chronic constipation. In a phase 3 trial, we previously demonstrated that a vibrating capsule was significantly more efficacious than a placebo in chronic constipation., Aim: To examine the effects of a vibrating capsule and placebo on symptoms and health-related quality of life (HRQoL) in patients with severe chronic constipation., Methods: We performed a post hoc analysis of phase 3, multicentre, randomised, double-blind, and placebo-controlled 8-week clinical trial of a vibrating capsule to specifically assess outcomes among subjects who reported 0 complete spontaneous bowel movements (CSBMs) during the 2-week baseline period. We assessed effects of treatment on bowel symptoms, patient satisfaction, and HRQoL. CSBM responders were defined as subjects with increases of ≥1 or ≥2 or ≥3 weekly CSBMs (CSBM1 or CSBM2, CSBM3, respectively) over baseline for ≥6 out of 8 weeks of treatment., Results: The severe chronic constipation subgroup comprised 175 (56%) of the 312 subjects. Significantly more subjects with severe chronic constipation who received the vibrating capsule than those who received the placebo were CSBM1 (44.9% vs. 20.9%, p = 0.007), CSBM2 (29.2% vs. 11.6%, p = 0.004), and CSBM3 (19.10% vs 6.98%, p = 0.017) responders. Straining effort, stool consistency, patient satisfaction, and HRQoL significantly improved in the severe chronic constipation subgroup. A mild vibrating sensation was reported in 10%., Conclusion: The vibrating capsule significantly improved constipation-related symptoms and HRQoL in patients with severe constipation, affirming its efficacy and safety across the spectrum of chronic constipation., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Introduction: Irritable bowel syndrome (IBS), a disorder of gut-brain interaction, imposes a significant economic burden because of its high prevalence and the chronic nature of its symptoms. IBS currently has 7 United States Food and Drug Administration-approved treatments. Despite efforts to improve diversity in randomized controlled trials' participation, significant disparities remain in various medical fields; yet, these have not been thoroughly examined within the context of IBS. We aimed to investigate the demographic, socioeconomic, educational, and geographic disparities in IBS drug trials., Methods: We conducted a systematic review of phase 3 randomized controlled trials on United States Food and Drug Administration-approved drugs for the treatment of IBS with constipation and IBS with diarrhea in the United States. Data on participant demographics and trial site locations were extracted and analyzed to identify disparities., Results: Our analysis included 17 studies encompassing 21 trials with 17,428 participants. Approximately 77.3% of participants were female, with a mean age of 45.4 years. Race was reported in 95% of the trials, but only 35% disclosed ethnicity. White participants constituted the majority at 79.3%. Hispanics accounted for only 5.9%. Counties without trial sites had smaller average population sizes compared with trial and trial-adjacent counties. Socioeconomic indicators such as poverty rates, median household income, educational attainment, and broadband internet access were lower in counties without trial sites, with higher average Area Deprivation Index scores indicating greater deprivation., Discussion: The findings highlight significant disparities in IBS trial participation across race, ethnicity, gender, and socioeconomic backgrounds. This raises potential concerns about generalizability of trial outcomes and underscores the need for strategies to enhance inclusivity in clinical research., (Copyright © 2024 by The American College of Gastroenterology.)

The aims of this Oncoplastic Breast Consortium and European Breast Cancer Research Association of Surgical Trialists initiative were to identify uncertainties and controversies in axillary management of early breast cancer and to recommend appropriate strategies to address them. By use of Delphi methods, 15 questions were prioritized by more than 250 breast surgeons, patient advocates and radiation oncologists from 60 countries. Subsequently, a global virtual consensus panel considered available data, ongoing studies and resource utilization. It agreed that research should no longer be prioritized for standardization of axillary imaging, de-escalation of axillary surgery in node-positive cancer and risk evaluation of modern surgery and radiotherapy. Instead, expert consensus recommendations for clinical practice should be based on current evidence and updated once results from ongoing studies become available. Research on de-escalation of radiotherapy and identification of the most relevant endpoints in axillary management should encompass a meta-analysis to identify knowledge gaps, followed by a Delphi process to prioritize and a consensus conference to refine recommendations for specific trial designs. Finally, treatment of residual nodal disease after surgery was recommended to be assessed in a prospective register., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Although the Mammography Quality Standards Act (MQSA) passed when analog mammography and film processors were used across the United States, now most health care facilities have full-field digital mammography. This article reviews MQSA requirements including qualifications for personnel, the clinical image evaluation process, and components of a quality control program. In light of technological advances, the U.S. Food and Drug Administration's extension certificate for digital breast tomosynthesis is discussed, along with the American College of Radiology's Breast Imaging Center of Excellence designation and laws regarding density notification.

A diagnostic quality 111In capromab pendetide study depends on parameters such as the quality control of the camera, thorough patient preparation, adequate imaging time and accurate computer processing. Comparisons of different patient preparation methods, imaging times, and camera and processing parameters were evaluated to provide high-quality 111In capromab pendetide images and to develop acquisition and processing parameters for 111In capromab pendetide imaging. SPECT images provide the best views of metastatic pelvic nodal involvement. Volume rendered three-dimensional registration best differentiates between normal vasculature and metastatic disease. Optimal acquisition parameters for delayed imaging included 128 x 128 matrix and 65 sec/step. The LFOV dual-head SPECT camera required only one SPECT acquisition that encompassed both the pelvis and abdomen. Planar and SPECT positioning was critical in evaluating questionable lymph nodes. In processing these images, the most diagnostic results were obtained with a three-dimensional low-pass post filter. The most effective patient preparation consisted of an oral cathartic, enema and catheterization when needed.

As group purchasing matures, alliances and GPOs will need to expand their contract portfolio to include specialty products. As groups and manufacturers negotiate successful specialty products agreements and hospitals actively support those contracts, the industry as a whole stands to benefit. If alliance and manufacturers do not attempt to negotiate specialty products agreements that bring value to both parties, hospitals will miss out on savings, and suppliers will lose market share opportunities.

Because the accumulation and activation of mononuclear phagocytes are critical to the host response to intracellular microbial pathogens, we evaluated mechanisms of peripheral monocyte leucotactic regulation in leprosy. Plasma from 53 of 67 patients was found to inhibit the locomotion of normal human monocytes. Neither the prevalence nor the magnitude of plasma leucotactic inhibitory activity correlated with disease histology or duration, type or duration of chemotherapy, or history of erythema nodosum leprosum. Plasma leucotactic inhibitory activity resided principally in a non-immunoglobulin, cell-directed inhibitor of 230,000 daltons molecular weight. Fractionation of plasma from patients with lepromatous leprosy revealed an additional, immunoglobulin-containing inhibitor of approximately 400,000 daltons weight, possibly an IgG-IgA immune complex. Production of leucotactic inhibitors by unstimulated and concanavalin A-stimulated peripheral mononuclear cells was normal; however, cutaneous explants from these patients spontaneously produced the 230,000 dalton leucotactic inhibitor in vitro. The ability of the lesions of leprosy to impede monocyte traffic may be an important pathogenetic mechanism.