procarbazine, spironolactone, sunitinib, tacrolimus, thalidomide and topotecan) compounding oral information was found. No information was obtained for 12 API (20.3%) (bexarotene, bosutinib, cabozantinib, fingolimod, fludarabine, ixazomib, lenalidomide, nilotinib, pazopanib, pomalidomide, regorafenib and vinorelbine) for which avoiding their handling and seeking other therapeutic alternative was advised. For the remaining 79.7% of API, priority was given to the recommendation of the lowest dust inhalation risk handling alternative. Conclusion and relevance Safe handling alternatives were found for most of the analysed oral HD in the sample, with potential to minimise workers' handling risk and ensure safety measures in hospital units.
BackgroundThere is only limited information about the sequential use of abiraterone acetate (AA) and enzalutamide (ENZ) in metastatic castration-resistant prostate cancer (mCRPC) patients. Patients who receive AA or ENZ as first-line therapy and subsequently become resistant have only a response rate of 15% to 30% to the alternative agent as second-line treatment. That finding clearly shows that cross-resistance occurs between ENZ and AA.PurposeTo evaluate the effectiveness of ENZ after failure of AA in patients with mCRPC.Material and methodsRetrospective study including all patients with mCRPC having sequential therapy with AA and ENZ from May 2012 to October 2017. Posttreatment changes in prostate-specific antigen (PSA) and differences in the median duration treatment (MDT) with AA and ENZ were used to determine the effectiveness of ENZ. A PSA reduction <30% and/or a MDT-ENZ/MDT-AA ratio <0.3 was considered as ineffective.ResultsThe study included 16 mCRPC patients treated sequentially with AA and ENZ. Only three patients had undergone prior docetaxel therapy. MDT-AA was 15 months (range: 3–38). During AA therapy 10 (67%) achieved a>50% decline in PSA, 12 (80%) a>30% and three (20%) did not achieve any decline in PSA. Subsequent MDT-ENZ was 4 months (range: 1–12), showing a MDT ratio of 0.27. Three patients did not have PSA levels after taking enzalutamide. None of the CRPC patients who were or not initially AA-sensitive showed a>30% PSA decline while taking ENZ. The medium PSA decline after abiraterone and enzalutamide were 37% and 17.8% respectively. Of the 15 patients, 7 (46.6%) were primarily ENZ-resistant and showed a rising PSA as the best response. Median time to progression was 7 months (range: 2–12) for five of 15 patients with at least one declining PSA value while taking enzalutamide (33.3%).ConclusionAlthough the number of patients included in this study is small, ENZ therapy after AA failure shows a low activity in terms of PSA response and/or medium duration of treatment. Results would be compatible with qualifying the use of ENZ after failure to AA as ineffective. Further properly designed studies to this aim are needed.Reference and/or Acknowledgements1. J Clin Oncol2014;32:125.No conflict of interest
BackgroundTenofovir alafenamide (TAF) is a new molecule that is being replaced for TDF, the original formulation of tenofovir (TDF), because of its improved efficacy and safety profile in HIV patients.PurposeTo analyse efficacy and renal safety of TAF/FTC/EVG/cobi antiretroviral therapy (ART) in real clinical practice.Material and methodsRetrospective study including all patients who started treatment with TAF/FTC/EVG/cobi from June 2016 to May 2017. Patients were divided into two subgroups: naive and pretreated with other ARTs patients. To determine effectiveness, plasma-HIV RNA (viral load) and CD4-T-lymphocyte (CD4) cell count were measured, and to analyse renal safety, glomerular filtration rate (GFR) and urinary protein to creatinine ratio were measured at baseline and after 6 months’ treatment. Viral load <20 copies/ml was considered as effective. Renal involvement was considered if GFR <60 ml/min. Sources of information: athosPRISMA™ (patient selection) and Diraya-Clinical-Station (analytical data).ResultsNinety-eight patients were analysed, 80% were males and mean age was 46 years. Naive-subgroup: eight patients (8%). After 6 months’ treatment, six of eight patients reduced their baseline viral load to <20 copies/ml. Mean CD4 ratio increased from an average of 181 to 221 cel/µL. Mean baseline GFR decreased from an average of 115 ml/min to 107.3 ml/min (7%) after 6 months’ treatment. Urinary protein to creatinine ratio worsened in one patient and improved in another after 6 months’ treatment. The rest of the patients remained at normal levels. Pretreated subgroup: 90 patients (92%). 68 patients had <20 copies/ml at baseline and also after 6 months’ therapy. Twenty-two patients had an average of 37 500 copies/ml, and 16 of these patients reduced their viral load to <20 copies/ml after 6 months’ treatment. The average CD4 count increased from 623 to 700 cel/µL in all patients. Mean GFR at baseline was 98.5 ml/min and did not change after treatment with TAF/FTC/EVG/cobi. The urinary protein to creatinine ratio worsened in two of 90 patients and improved in six patients after 6 months’ treatment. The rest of the patients remained at normal levels. Of all analysed patients, no one had renal involvement.ConclusionTAF/FTC/EVG/cobi therapy was described to be effective and safe in both naive and pretreated patients in clinical practice.Reference and/or Acknowledgements1. European Medicines Agency. Genvoya Product Information. Consulted: 13 October 2017.No conflict of interest
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