Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission.

OBJECTIVE: To investigate the efficacy and safety of hu3S193, a humanized anti-Lewis-Y monoclonal antibody, as a consolidation strategy in patients with platinum-sensitive recurrent epithelial ovarian cancer who achieved a second complete response after salvage platinum-doublet chemotherapy. METHODS: This single-arm phase II study accrued patients with recurrent epithelial ovarian cancer with Lewis-Y expression by immunohistochemistry who had achieved a second complete response after five to eight cycles of platinum-based chemotherapy. Patients received intravenous infusions of hu3S193, 30 mg/m2 every 2 weeks starting no more than 8 weeks after the last dose of chemotherapy and continuing for 12 doses, until disease progression, or unacceptable toxicity. The primary endpoint was progression-free survival of the second remission. Secondary objectives were safety and pharmacokinetics. RESULTS: Twenty-nine patients were enrolled. Most had a papillary/serous histology tumor (94%), stage III disease at diagnosis (75%), and five (17%) underwent secondary cytoreduction before salvage chemotherapy. Two patients were not eligible for efficacy but were considered for toxicity analysis. Eighteen patients (62%) completed the full consolidation treatment while nine patients progressed on treatment. At the time of analysis, 23 patients (85%) of the eligible population had progressed and seven of these patients (26%) had died. Median progression-free survival of the second remission was 12.1 months (95% CI: 10.6-13.9), with a 1-year progression-free survival of the second remission rate of 50.1%. The trial was terminated early since it was unlikely that the primary objective would be achieved. The most commonly reported treatment-related adverse events were nausea (55%) and vomiting (51%). CONCLUSIONS: Hu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy. TRIAL REGISTRATION: NCT01137071.

Avaliaçäo do efeito imunoprotetor de diferentes vacinas contra Corynebacterium pseudotuberculosis em caprinos / Levels of immunoprotection induced in goats against Corynebacterium pseudotuberculosis using several types of vaccines

Com o objetivo de observar a imunoproteçäo desenvolvida em caprinos contra Corynebacterium pseudotuberculosis esses animais foram submetidos a diferentes esquemas de imunizaçäo, sendo utilizados inóculos de diferentes preparados antigênicos desta bactéria em intervalos de tempo variados e com diversos adjuvantes. Os resultados revelaram que o percentual de imunoproteçäo nos animais imunizados e desafiados 180 dias após estava abaixo de 60%. Já os animais desafiados dez meses após a primeira inoculaçäo apresentaram níveis de imunoproteçäo entre 44,5 e 22,3%. O menor índice da doença foi observado nos animais desafiados entre 30 e 60 dias após a última inoculaçäo do preparado antigênico