Background: Prevalence of gestational diabetes mellitus (GDM) has increased steadily in recent years. Pregnant women with GDM are at risk for obstetrical and neonatal complications and require close multidisciplinary follow-up, which implies a significant use of hospital resources. Methods: A prospective noninferiority and controlled clinical trial was designed. The telehomecare (THCa) initiative is a clinical remote patient management project in women with GDM. The main objective was to evaluate the cost-effectiveness of THCa by assessing the direct costs, including the related reduction in medical visits. Secondary outcomes were to evaluate the impact of THCa on diabetes control, GDM-related complications, and patient satisfaction. Results: A total of 161 women were assigned to either an intervention group provided with a THCa system for transmission and online analysis of capillary glucose data (n = 80) or a control group receiving usual care in the clinic (n = 81). A decrease in medical visits by 56% (P < 0.001) in the THCa group was observed. There was no difference between the two groups in diabetes control or maternal and fetal complications. However, results showed a 10-fold increase in nursing interventions in THCa group (mainly by phone calls and e-mails). Satisfaction with care was high. Direct cost analysis revealed savings of 16% in patients followed by THCa compared with the control group. Conclusion: THCa monitoring significantly decreases medical visits and direct costs in GDM women without compromising pregnancy outcomes, quality of care, or patient satisfaction. THCa was shown to be costeffective despite placing an additional burden on nursing time.
Introduction: Gastroenteropancreatic neuroendocrine carcinomas (GEPNEC) are characterised by a heterogeneous molecular profile and a poor prognosis. Circulating tumour DNA (ctDNA) analysis may be useful for NEC management. This study aimed at describing ctDNA mutations, to assess their predictive value for response to chemotherapies, and their change according to disease progression.
Methods: The CIRCAN-NEC study included patients with GEPNEC or NEC from an unknown primary, scheduled to begin first or second-line chemotherapy. Blood samples were collected prior to chemotherapy initiation, at first evaluation, and during disease progression. ctDNA were sequenced by next-generation sequencing (NGS). Molecular response was defined as a decrease of at least 30% of the mutant allele fraction (MAF).
Results: All 24 patients included received platinum-etoposide first-line chemotherapy; 19 received a FOLFIRI-based post first-line regimen. Twenty-two patients had at least one driver mutation: TP53 (n=21), RB1 (n=2), KRAS (n=4), BRAF (n=3). Ten (42%) had a “adenocarcinoma-like” profile. Five of six patients with matching ctDNA/tissue NGS harboured at least one concordant mutation (44% concordance at the gene level). The concordance rate between ctDNA-mutation/immunohistochemistry-profile was 64% (7/11) for TP53/p53+ and 14% (1/7) for RB1/pRb-. In this pilot study including few patients by subgroups, patients with KRAS (HR=3.60, 95%CI [1.06-12.04]) and BRAF (HR=4.25, 95%CI [1.11-16.40]) mutations had shorter progression-free survival (PFS) under platinum-etoposide, while the two patients with RB1 mutations had shorter PFS under FOLFIRI-based chemotherapy. Twenty-eight periods of treatment were assessed: 10 patients had a molecular response (7/10 had a morphological response), which was associated with longer PFS (HR=0.37, 95%CI [0.15; 0.91]).
Conclusion: This pilot study shows a high sensitivity of ctDNA assessment, which is encouraging for the future management of GEPNEC (tumour molecular diagnosis and evaluation of disease progression).
Neuroendocrine tumors (NETs) are rare and include a heterogeneous group of neoplasms derived from the gastrointestinal tract, the pancreas and the lung. The annual incidence of all NETs has been estimated to 6.98 per 100,000 person-years in 2012 and is steadily rising. 1 Approximately 40-50% of patients with NET present with distant metastases (m) at the time of diagnosis. 2 Current treatment options extend from locoregional (surgery, trans-arterial [chemo]-embolization, radiofrequency ablation) to
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