Clinical assessment of levocetirizine and budesonide in treatment of persistent allergic rhinitis regarding to symptom severity.

OBJECTIVE: To compare effectiveness of levocetirizine and budesonide in treatment of persistent allergic rhinitis (PER) in patients with high and low total symptom scores (TSS). MATERIAL AND METHOD: Randomized, parallel-group study. Patients with PER were randomized to receive levocetirizine 5 mg (n = 50) or budesonide 256 microg (n = 50) daily for 4 week and were followed-up for another 4 weeks post-treatment. TSS combining itching, sneezing, rhinorrhea, daytime and nighttime nasal congestion was recorded daily during and after treatment for an entire period of 8 weeks. Efficacy variables included area under curves depicting reduction and increase in TSSs over time relative to baselines and time to response and symptom relapses. RESULTS: Symptoms were categorized as high and low using a median TSS of 8 as cutoff. Levocetirizine was as effective in control of high and low symptoms except for time to achieve maximum effect (2 days versus 1 week, respectively, p = 0.002) but was more effective in preventing relapses of high symptoms (p = 0.001). Budesonide was more effective against high than low symptoms (p < 0.001) but showed no difference in preventing relapses. Typical response rate of levocetirizine and budesonide were demonstrated in treatment of high symptoms. Levocetirizine achieved its full effectiveness in 2 days while budesonide required 2 weeks. Budesonide at full effect (after 2 weeks) was superior to levocetirizine (p = 0.004) but comparable for the entire treatment of 4 weeks (p =.059) and was inferior to in preventing relapses (p = 0.001). No such difference could be observed between these drugs in control of low symptoms. CONCLUSION: The effectiveness of the drug treatment in the present study is dependent of symptom severity. Levocetirizine bases on its rate of response and relapse was superior to budesonide in treatment of the high symptom group and is comparable in the low symptom group.

Plasma vascular endothelial growth factor dysregulation in defining aggressiveness of head and neck squamous cell carcinoma.

Background. High circulating vascular endothelial growth factor (VEGF) levels tend to reflect tumor aggressiveness for being associated with tumor progression and prognosis. Measurement of soluble VEGF receptor-1 (sVEGFR-1) may improve diagnostic power of VEGF assay. Methods. This study investigated regulation of plasma VEGF by sVEGFR-1 in 82 patients with head and neck squamous cell carcinoma compared with 32 healthy subjects to obtain information for assay characterization. Results. Normality or abnormality of VEGF/sVEGFR-1secretion patterns was rated into five diagnostic levels from definitely abnormal (likelihood ratios) (LRs = 4-∞) to definitely normal (LRs = 0-0.17). Because of ineffective VEGF regulation, high grade tumor had a greater chance (62.5%) than low grade tumor (20%) in expressing a definitely abnormal pattern and a lower chance to express the normal pattern (P = 0.007). VEGF alone had much lower diagnostic power in differentiating between normal (LRs = 0.3-0.9) and abnormal secretion patterns (LRs = 2.2-2.4). Conclusions. VEGF dysregulation is suggestive of tumor aggressiveness for causing persistent plasma VEGF elevation. sVEGFR-1 improves diagnostic power of VEGF assay particularly in identifying subset of low grade tumor with underlying aggressive disease and ruling out aggressiveness in subset of high grade tumor.

Vascular endothelial growth factor a and proliferation marker in prediction of lymph node metastasis in oral and pharyngeal squamous cell carcinoma.

OBJECTIVE: To explore the effect of Ki-67 and vascular endothelial growth factor A (VEGF-A) expression on the risks of advanced T category (T3,4) and positive lymph node involvement (N+) in oral and pharyngeal squamous cell carcinoma (SCC) compared with laryngeal SCC. DESIGN: Immunohistochemical analysis of prospectively recruited patients. SETTING: University-affiliated hospital. PATIENTS: A total of 147 previously untreated patients with different stages of SCC in the oral cavity, pharynx, and larynx. MAIN OUTCOME MEASURES: Relative risks of T3,4 tumor and N+, a risk ratio comparing risks under high vs low marker expression. RESULTS: A significant association of Ki-67 and VEGF-A expression with tumor T category was observed for oral and pharyngeal SCC and for laryngeal SCC (P < or = .006). Regarding nodal status, Ki-67 expression was a significant risk factor for N+ in all tumors (P < or = .009), whereas VEGF-A expression was related to N+ in oral and pharyngeal SCC only (P < .03). Analytically, Ki-67 expression alone in oral and pharyngeal SCC was associated with a relative risk of N+ of 3.83 (95% confidence interval, 1.22-11.99; P = .009), and additional expression of VEGF-A raised the value to 6.12 (2.09-17.93; P < .001). Moreover, the combined expression of both markers was 3.25 times more effective in predicting N+ for T1,2 tumor compared with T3,4 tumor. CONCLUSIONS: Proliferative status was a common risk factor for N+ in all of the tumors in this series. Exploitation of VEGF-A in lymph node metastasis in addition to proliferation by oral and pharyngeal SCC but not by laryngeal SCC explains the clinical aggressiveness of oral and pharyngeal SCC, especially the early lymphatic invasion. In the management of cervical lymph nodes, combined expression of Ki-67 and VEGF-A may help identify patients at risk for occult metastases. This study suggests anti-VEGF-A therapy, an additional intervention to the classic antiproliferative regimen, for preventing lymphatic progression of oral and pharyngeal SCC.