Ovarian cancer is often diagnosed at advanced stages, when poorly responsive to standard treatment. First-line treatment consists in schemes including cytoreductive surgery followed by adjuvant chemotherapy schemes with platinum and taxane derivatives. Second-line regimens are based on gemcitabine and liposomal doxorubicin. Third line is often not worthwhile because of the high toxicity with poor response to treatment. Previously, we showed that paclitaxel (PTX) carried in non-protein lipid core nanoparticles (LDE) resembling the chemical structure of LDL has remarkably reduced toxicity. Here, the hypothesis was tested whether PTX-LDE could safely benefit patients in third-line treatment setting. Fourteen women unresponsive to second-line chemotherapy for ovarian cancer, aged 61 ± 10 years, clinical stage IV and TqNqM1, were included. PTX-LDE was administered at 175 mg/m, 3/3 week dose. Patients were submitted to clinical examinations before each chemotherapy cycle. Serum biochemistry and imaging examinations to monitor disease progression were performed. In total, 74 cycles of chemotherapy were done and, in all cycles, clinical or laboratorial toxicities were not observed. Median progression-free survival (PFS) was 3.0 months (95% CI 2.0-3.9). In four patients, PFS was >6 months and in 2 > 1 year. The unpreceded, striking absence of toxicity and consistently long PFS, compared to previous results, indicate that at least 4 among 14 patients had tumor arrest by the treatment and clear benefit of PTX-LDE at third-line setting. The absence of observable toxicity allows dose escalating to improve response to treatment, as perspective to be tested in the ensuing studies.

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Radiodermatitis is a constant complication after radiotherapy with no efficient drug for prevention and treatment. Its physiopathology is complex, possibly related to injury of epidermis and endothelial cells from the basal layer by radiolysis, overproduction of free radicals, pro-inflammatory cytokines, and inflammation. PTCTS gel is an after sun cosmetic gel composed by antioxidative plant extract rich in natural nanoparticles and thermal water (Complex A) and recombinant protein of Trypanosoma cruzi transialidase (Complex B), with high anti-oxidative and antiapoptotic effects, presenting anti-aging and healing cutaneous properties. Objective: To study the safety and efficacy of PTCTS gel for topic use in volunteer subjects with healthy skin, and in patients with radiodermatitis, in different concentrations of Complexes A and B. Material and Methods: The project was approved by the Ethical Committee of Arnaldo Vieira de Carvalho Institute, Sao Paulo, Brazil. The individuals were submitted to laboratorial toxicity study through tests for liver and kidney function, levels of blood glucose and blood count before and after 7 days of PTCTS application. We studied two groups: GI-22 volunteers with healthy skin, presenting articular or skeletal muscle pain and GII-38 patients in radiotherapy for breast or head and neck cancer, with radiodermatitis grade 2 or 3. The patients were evaluated before and after 1.0 ml/cm 2 PTCTS gel application, twice a day. We tested Complex B in four different concentrations, and Complex A concentrations varied inversely. Results: No irritation signs were observed in GI nor GII group, 64% of GI had important decrease in the intensity of the muscular or articular pain, and 99% of GII showed regression of radiodermatitis, all exhibiting relief of pain. No patient presented hematologic, renal or hepatic toxicity. Conclusion: PTCTS cosmetic gel is a safe option for radiodermatitis treatment, with no side effects or laboratorial toxicity in different concentrations. This product presented excellent clinical results even if used diluted 4 times more than the original product and may be a good option for treatment of radiodermatitis. Further studies may show if it is also indicated in the prevention of the lesion, and if it is better than products containing corticoids. S. R. Graziani et al.328

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