Preliminary Results Of Patients With Advanced Ovarian Carcinoma Treated With Paclitaxel Associated To Nanoemulsions.

e16539 Background: Ovarian cancer is often diagnosed at advanced stages and is poorly responsive. First-line treatment consists in schemes including platin and taxane derivatives and second-line regimens are based in gemcitabine and liposomal doxorubicin. Thereafter, the disease progresses rapidly and chemotherapy is no longer indicated for lack of response together with high toxicity. We showed that non-protein nanoemulsions resembling LDL associated with antineoplastic agents, after injection into the bloodstream, can target neoplastic cells through the internalized by the LDL receptors that are up-regulated in cancer cells, and reduces toxicity. We tested the hypothesis whether paclitaxel associated to the nanoemulsion could be safely benefit patients with advanced ovarian cancer refractory to previous treatments, thus not eligible for further conventional chemotherapy. Methods: Twelve women with advanced ovarian cancer aged 63±9yrs were included, with Stage IV (TNM scale) ovarian carcinomas that were unresponsive for second line chemotherapy treatments. Treatment consisted with paclitaxel associated to the nanoemulsion at 175mg/m2 body surface dose, every 3 weeks. The patients were submitted to clinical examination three days before each chemotherapy cycle. Serum biochemistry determinations and ultrasound imaging were performed at each cycle and CT imaging every 3 cycles. Treatment should be discontinued whenever disease progression or grade 3-4 toxicity would be diagnosed. Results: Total 59 cycles was performed, and in none of them clinical and laboratorial toxicities were observed. In all patients, the quality of life improved (SF36 questionnaire). In none of the patients disease progression occurred < 9 weeks after treatment commencement. The mean time without disease progression was 30 weeks, but two patients were dropped for surgery, without presenting disease progression; they are still alive 2 years after treatment ending. Conclusions: Treatment with paclitaxel-nanoemulsion achieved longer periods of progression-free disease and improved life-quality with non-observable toxicity. Thus, the novel preparation is candidate for future larger clinical studies.