In Pursuit of Optimal Outcomes: A Framework for Quality Standards in Immune Effector Cell Therapy.

Immune effector cell (IEC) therapy represents a transformative advancement in oncology, leveraging the immune system to combat various malignancies. This article outlines a comprehensive framework for establishing and maintaining quality standards in IEC therapy amidst rapid scientific and clinical advancements. We emphasize the integration of structured process measures, robust quality assurance, and meticulous outcome evaluation to ensure treatment efficacy and safety. Key components include multidisciplinary expertise, stringent accreditation protocols, and advanced data management systems, which facilitate standardized reporting and continual innovation. The collaborative effort among stakeholders-ranging from patients and healthcare providers to regulatory bodies-is crucial in delivering high-quality IEC therapies. This framework aims to enhance patient outcomes and cement the role of IEC therapy as a cornerstone of modern oncology, promoting continuous improvement and adherence to high standards across the therapeutic spectrum.

Illness Perception Mediates the Relationship Between the Severity of Symptoms and Perceived Health Status in Patients With Behçet Disease.

OBJECTIVE: The aim of this study was to investigate the relationship between psychological representations of illness, perceived health status, and self-assessment of symptom severity in patients with Behçet disease, a rare long-term incurable condition with unclear etiology. METHODS: Using cross-sectional survey design, data on self-administered questionnaires on illness perception, health status, symptoms severity, and demographic characteristics were collected from 273 patients with Behçet disease (age range, 18-65 years). The data were subjected to mediation analysis to test whether cognitive and emotional components of illness perception mediate the relationship between the severity of symptoms and heath status. RESULTS: The results support our hypotheses that cognitive components of illness perception (perceived consequences and identity of the illness) mediate the link between symptom activity and pain, whereas emotional components of the illness (emotional representations about the illness) mediate the relationship between disease activity and perceived energy level. CONCLUSIONS: The robustness of these mediation effects suggests potential directions for clinical psychologists and health care practitioners in developing support programs. We supplement our study with Open Access database containing information about type of medication, comorbid mood disorder, and detailed measurement of the severity of BD symptoms for sharing and accumulating multidisciplinary knowledge aiming to support the development of interventions. Addressing psychological aspects of BD will help to manage complex patients effectively.

A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy.

BACKGROUND: The appropriate second-line therapy for patients with advanced gastroesophageal (GE) or esophageal (E) cancer after failure of first-line platinum-based therapy is unclear. Pralatrexate and docetaxel have independently been shown to have efficacy in the treatment of these cancers. Thus, we performed a clinical trial examining the efficacy of the combination of these agents in the treatment of GE and E cancer. METHODS: A Fleming phase II design with a single stage of 32 patients was planned. Pralatrexate 120 mg/m(2) and docetaxel 35 mg/m(2) were administered on day 1 of 14-day cycles. The primary end-point was to evaluate the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and secondary end-points were to evaluate for progression-free survival (PFS) and overall survival (OS). RESULTS: The study was halted prematurely due to loss of funding after the accrual of six patients. Two patients had stable disease (SD) and four patients had disease progression per RECIST. When applying PERCIST criteria in four evaluable patients, two had a partial response (PR) and two had SD. Median PFS was 1.9 months (95% CI, 0.8-7.2) and median OS was 5.5 (0.8-11.7) months. CONCLUSIONS: Pralatrexate and docetaxel as therapy in refractory esophageal and GE adenocarcinoma did not demonstrate meaningful preliminary activity. PERCIST may prove to better assess the meaningfulness of anatomic SD.

A new apolipoprotein E mutation, apoE Las Vegas, in a European-American with lipoprotein glomerulopathy.

Lipoprotein glomerulopathy is a rare disease diagnosed by unique histopathologic findings of glomerular capillary dilatation by lipoprotein thrombi. The disease is caused by mutations in apoE, the gene that encodes apolipoprotein E. To date, <80 cases have been reported in the medical literature, nearly all of which are from Japan or China. Only five cases from the United States have previously been reported, of which three patients were of European ancestry. Here, we present the fourth case of lipoprotein glomerulopathy in a European-American man. Whereas prior European-American patients with lipoprotein glomerulopathy were found to have the previously reported apoE Kyoto genotype, the patient presented here was found to have a novel mutation that we have named apoE Las Vegas.