Objective. Familial cold autoinflammatory syndrome (FCAS) is caused by mutations in the CIAS1gene, leading to excessive secretion of interleukin-1 (IL-1), which is associated with cold-induced fevers, joint pain, and systemic inflammation. This pilot study was conducted to assess the safety and efficacy of rilonacept (IL-1 Trap), a long-acting IL-1 receptor fusion protein, in patients with FCAS.Methods. Results. In all patients, clinical symptoms typically induced by cold (rash, fever, and joint pain/ swelling) improved within days of rilonacept administration. Markers of inflammation (ESR, hsCRP, and SAA) showed statistically significant reductions (P < 0.01, P < 0.001, and P < 0.001, respectively) at doses of 100 mg. Dosage escalation to 160 mg and 320 mg resulted in subjectively better control of the rash and joint pain. Furthermore, levels of the acute-phase reactants ESR, hsCRP, and SAA were lower at the higher doses; the difference was statistically significant only for the ESR. All patients continued taking the study drug. The drug was well-tolerated. Weight gain in 2 patients was noted. No study drug-related serious adverse events were seen.Conclusion. In this study, we present 2-year safety and efficacy data on rilonacept treatment in 5 patients with FCAS. The dramatic improvement in clinical and laboratory measures of inflammation, the sustained response, and the good tolerability suggest that this ClinicalTrials.gov identifier: NCT00094900.
Investigations of the lymphogenic metastatic spread of VX2 carcinomas in New Zealand White rabbits require an exact knowledge of the topography of cervical and facial lymph nodes. The topography of neck lymph nodes was evaluated from 16 rabbits macroscopically, histologically and by lymphographic investigations, and the possibility of their surgical removal (neck dissection) was examined. The upper aerodigestive tract and the ear of New Zealand White rabbits drain via four consistent groups of 12-18 lymph nodes. Except for the paratracheal lymph node, they are all easily accessible to surgery. The data presented in this study encourage the use of induced VX2 carcinomas in New Zealand White rabbits as an animal model to study the lymphogenic metastatic spread of squamous cell carcinomas of the head and neck. Such investigations could lead to an improvement of surgical and pharmaceutical treatment of this tumour entity.
It has been demonstrated that in patients with epithelial ovarian cancer and malignant germ cell tumors of the ovary, macrophage colony-stimulating factor (M-CSF) is significantly elevated in the serum compared to healthy individuals. Therefore, M-CSF has been suggested as a tumor marker in these malignancies. In the present study, the tumor marker potential of the serum M-CSF concentration in patients with squamous cell carcinomas of the head and neck (SCCHN) was investigated. The serum M-CSF concentration was determined by a quantitative sandwich enzyme immunoassay in 59 patients suffering from SCCHN and 59 healthy controls. A significant difference in the mean serum concentration of M-CSF between the patients with SCCHN and the control group was found (p = 0.002). The M-CSF serum concentration correlated neither with the stage of disease nor with histopathological grading, and no correlation with serum C-reactive protein was found. The serum M-CSF concentration could be of interest as a tumor marker in SCCHN.
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