RESUMO
Introduction: At present, more than half of patients diagnosed with early-stage breast cancer (BC) and express hormonal receptors will receive some adjuvant chemotherapy scheme, but only a few of them would benefit in terms of survival. Genomic platforms allow a better understanding of the heterogeneity of different types of hormonal receptor-positive and HER2-negative BC. They have proven their validity as tools to identify those patients who will obtain a clear benefit with the indication of chemotherapy treatment. The aim of this study is to analyze the use of the genomic platform, namely, Oncotype Dx® and its impact on the indication of adjuvant treatment, evaluated mainly as the change in treatment indication. Methods: Multicenter observational cohort study was performed in different Mastology units in Argentina. Patients underwent the Oncotype Dx to clarify the adjuvant treatment. Treatment decisions were settled before and after performing Oncotype Dx. Results: From January 2013 to December 2018, 211 patients with luminal A or B and HER2-negative breast carcinomas, who underwent the Oncotype Dx, were included. Based on our records, 40% of the patients change the indication of adjuvant treatment after the performance of the Oncotype Dx. Of these, 24% of patients who underwent initial endocrine therapy only adjusted their treatment with the addition of chemotherapy. Among patients with an initial CTH recommendation, 49% were able to receive endocrine therapy only when, due to traditional prognostic factors, they would have received chemotherapy. Conclusions: In our population, the use of the Recurrence Score was clinically significant in relation to the change of the established treatments. Consequently, it is a very important tool and a decisive factor in the adjuvant indication in patients with positive hormonal receptors and HER2neu-negative early BC.
RESUMO
In developing countries, the introduction of human papillomaviruses (HPV) DNA testing as an adjunct to cytological screening programs has been delayed due to the lack of high performance and cost effective diagnostic nucleic acid methods. In this study we report the development and evaluation of the L1HPVPCR, a PCR-based method for the detection and typing of five of the most prevalent high-risk HPV types. The L1HPVPCR assay combines amplification with the MY09/11 HPV consensus primer system, liquid hybridization of the PCR products with no radioactive probes and enzyme immunoassay analysis. The technique is a user-friendly system that allows accurate HPV DNA detection and typing with inexpensive instrumentation that could be performed with not sophisticated reagents in almost any laboratory. Different cutoff points for generic and specific HPV detection were determined using reproducibility analysis and receiver operating characteristic curves to ensure good analytical sensitivity and clinical effectiveness. We used the L1HPVPCR assay to estimate the prevalence of HPV infection in 127 women at risk of cervical cancer from the city of Rosario (Argentina), where no epidemiological data has been previously reported. Further, we explored the clinical utility of the L1HPVPCR assay respect the Pap smear using a combined diagnosis of cytology, histology and colposcopy as gold standard. In conclusion, our results indicate that the assay described here provides a tool for accurate HPV DNA testing and could be applied in regions where no commercial tests are available.