Indicators of breast cancer severity and appropriateness of surgery based on hospital administrative data in the Lazio Region, Italy

BACKGROUND: Administrative data can serve as an easily available source for epidemiological and evaluation studies. The aim of this study is to evaluate the use of hospital administrative data to determine breast cancer severity and the appropriateness of surgical treatment. METHODS: the study population consisted of 398 patients randomly selected from a cohort of women hospitalized for first-time breast cancer surgery in the Lazio Region, Italy. Tumor severity was defined in three different ways: 1) tumor size; 2) clinical stage (TNM); 3) severity indicator based on HIS data (SI). Sensitivity, specificity, and positive predictive value (PPV) of the severity indicator in evaluating appropriateness of surgery were calculated. The accuracy of HIS data was measured using Kappa statistic. RESULTS: Most of 387 cases were classified as T1 and T2 (tumor size), more than 70% were in stage I or II and the SI classified 60% of cases in medium-low category. Variation from guidelines indications identified under and over treatments. The accuracy of the SI to predict under-treatment was relatively good (58% of all procedures classified as under-treatment using pT where also classified as such using SI), and even greater predicting over-treatment (88.2% of all procedures classified as over treatment using pT where also classified as such using SI). Agreement between clinical chart and hospital discharge reports was K = 0.35. CONCLUSION: Our findings suggest that administrative data need to be used with caution when evaluating surgical appropriateness, mainly because of the limited ability of SI to predict tumor size and the questionable quality of HIS data as observed in other studies

Bupivacaine in alginate and chitosan nanoparticles: an in vivo evaluation of efficacy, pharmacokinetics, and local toxicity

Cíntia Maria Saia Cereda,1 Daniel Sebbe Mecatti,2 Juliana Zampoli Boava Papini,1 Diego Valério Bueno,2 Michelle Franz-Montan,3 Thalita Rocha,2 José Pedrazzoli Júnior,2 Eneida de Paula,4 Daniele Ribeiro de Araújo,5 Renato Grillo,6 Leonardo Fernandes Fraceto,7 Silvana Aparecida Calafatti,2 Giovana Radomille Tofoli1 1Institute and Research Center São Leopoldo Mandic, Campinas, São Paulo, Brazil; 2UNIFAG, São Francisco University, Bragança Paulista, São Paulo, Brazil; 3Department of Physiological Sciences, University of Campinas, Piracicaba, São Paulo, Brazil; 4Department of Biochemistry and Tissue Biology, University of Campinas, Campinas, São Paulo, Brazil; 5Human and Natural Science Centre, Federal University of ABC, Santo André, São Paulo, Brazil; 6Department of Physics and Chemistry, School of Engineering, São Paulo State University (UNESP), Ilha Solteira, São Paulo, Brazil; 7Department of Environmental Engineering, São Paulo State University (UNESP), Sorocaba, São Paulo, Brazil Objective: This study reports a preclinical evaluation of an alginate/chitosan nanoparticle formulation containing NovaBupi®, a racemic bupivacaine (BVC) containing 25% dextrobupivacaine and 75% levobupivacaine. Methods: New Zealand White rabbits (n=6) received intraoral or intrathecal injections of BVC 0.5% or BVC 0.5%-loaded alginate–chitosan nanoparticles (BVCALG). BVC plasma levels and pharmacokinetic parameters were determined in blood samples of these rabbits. An infraorbital nerve blockade was performed in male Wistar rats (n=7) with the same formulations and the vehicle (NPALG). Histological evaluation of local toxicity after 6 hours and 24 hours of the treatments was performed in rats’ (n=6) oral tissues. Results: No statistically significant difference was observed between plasma concentrations and pharmacokinetic parameters (p>0.05) after intraoral injections. However, after intrathecal injection BVCALG changed approximately three times the values of volume of distribution and area under the curve (AUC0–t; p<0.05). The total analgesic effect of BVC after infraorbital nerve blockade was improved by 1.4-fold (p<0.001) with BVCALG. BVC and BVCALG did not induce significant local inflammatory reaction. Conclusion: The encapsulation of BVC prolongs the local anesthetic effect after infraorbital nerve blockade and altered the pharmacokinetics after intrathecal injection. Keywords: local anesthetics, bupivacaine, polymeric nanoparticle, drug delivery, preclinical stud