The extravasation of chemotherapeutic agents is a challenge for oncologic care teams. The management of nonliposomal (conventional) anthracyclines is well established in clinical practice guidelines, including general measures and specific antidotes, such as dexrazoxane. However, there is little scientific evidence on the management of liposomal and pegylated liposomal anthracyclines. The aim of this paper was to review the scientific literature on the extravasation of liposomal and pegylated liposomal anthracyclines and determine the clinical impact of this type of extravasation, focusing on dexrazoxane. The literature was searched using two databases: PubMed and Embase. Three searches were conducted, using liposomal anthracycline extravasation, pegylated liposomal anthracycline extravasation, and liposomal doxorubicin extravasation as keywords, respectively. Seven articles fulfilled the study eligibility criteria and included seventeen cases in humans. Extravasation occurred with three drugs: liposomal doxorubicin in nine (53%) patients, liposomal daunorubicin in four (23.5%) patients, and pegylated liposomal doxorubicin in four (23.5%) patients. General measures for extravasations were applied in all patients, but only three patients received dexrazoxane. All cases were completely resolved at 2-3 months, except for one patient, in whom dexrazoxane was not used. In animals, dexrazoxane decreased both the frequency of wounds produced by pegylated liposomal doxorubicin and their extent. The pharmacokinetic profiles of liposomal and pegylated liposomal anthracyclines differ from those of conventional anthracyclines, modifying their effectiveness and safety. General measures may be inadequate to heal areas affected by extravasation, which may require the administration of dexrazoxane. However, each case should be evaluated individually for the administration of dexrazoxane in off-label use until scientific evidence is available on its effectiveness and safety as an antidote for these formulations of anthracyclines.
Background Calciphylaxis (calcific uremic arteriolopathy) is the ischemic ulceration of the skin caused by the disseminated calcification of the subcutaneous tissue and small arteries as a consequence of hyperparathyroidism in uremic patients. Purpose To describe the method of preparation and checking of an injectable solution of 25% sodium thiosulfate for the treatment of intradialytic calciphylaxis in renal patients. Materials and MethodsSodium thiosulfate is an antioxidant, vasodilator and calcium chelator. The preparation process for the solution of 25% sodium thiosulfate is: Ingredients: Sodium thiosulfate pentahydrate: 25 g, water for injection (WFI): qs 100 ml. Preparation: Weigh the amount of sodium thiosulfate in a sterile beaker. Then, working in a horizontal laminar flow hood, boil WFI to eliminate CO2. Dissolve the thiosulfate in about 80 ml of boiled water. Check that the pH of the solution is between 6 and 9.5, if it is not, adjust with HCl or NaOH. Flush into a 100 ml volumetric flask and make up to volume. Filter with a double 0.22 micron philtre. Finally pack with 50 ml syringe into a sterile glass bottle and label. Results The result is a solution of 100 ml of 25% sodium thiosulfate, transparent, sterile and stable for 30 days in refrigerator. For QC a visual particulate sterility cheque is performed by sowing in aerobic and anaerobic cultures and a bubble point test to verify the integrity of the philtres. Conclusions Proper preparation and checking of the 25% solution of sodium thiosulfate has guaranteed its parenteral administration is safe. The treatment is effective and well tolerated, helping patients and improving their quality of life. No conflict of interest.
BackgroundHormone treatment based on analogues of gonadotropin releasing hormone (GnRH) with antiandrogens is the first-line treatment for prostate cancer. This treatment produces a PSA reduction, improvement of symptoms and tumour regression. When PSA increases again it is considered to have developed resistance and other treatment lines such as abiraterone are used.Abiraterone is an androgen synthesis inhibitor in the testes, adrenals and prostate tumour tissue.PurposeTo analyse the response to, and safety of, abiraterone in the population of a tertiary level hospital.Material and methodsA retrospective observational study was carried out including all patients who started on abiraterone from 2011 to present. Demographical, diagnostic, therapeutic and clinical variables were gathered.The response was assessed by a 50% PSA reduction or more as compared to baseline values. To assess the safety, abiraterone-related adverse events were recorded.Outpatient dispensing application Farmatools and electronic medical records were used for patient identification and data collection.Results18 patients were included, 89% diagnosed with metastatic prostate cancer. 50% had poor tumour differentiation with high aggressiveness (Gleason 7–10).As a first-line of treatment, 83% received GnRH analogues plus an antiandrogen, 11% GnRH analogues alone and 6% ketoconazole. No patients orchiectomized. As a second-line treatment, 28% received docetaxel, 44% estramustine, 22% abiraterone and 6% ketoconazole. Abiraterone was started as third-line or later treatment and after tumour progression, except in 3 patients who received it as second-line treatment.44% were considered responders and 56% non-responders because of an increase or non-reduction of PSA.The median duration of treatment was 5 months (1–25). In all cases, the reason for suspension was disease progression.17% had fatigue as the only adverse effect.ConclusionAbiraterone is a well-tolerated drug that has shown low activity in previously-treated prostate cancer patients who had responded poorly to ketoconazole, docetaxel and estramustine.Best responding patients were those who received only GnRH analogues as pre-treatment.References and/or AcknowledgementsNo conflict of interest.
BackgroundCross-sex hormone therapy (CHT) is known to lead to alterations in the cardiovascular risk factor (CVRF).PurposeTo assess changes in lipid profile and other CVRF in transsexual participants receiving CHT.Material and methodsRetrospective longitudinal study. We evaluated individuals with gender identity disorder following CHT, assisted in the Gender Identity Unit from 2015 to 2017. The primary endpoint was lipid profile change from baseline at 24 months. Secondary endpoints included change in body mass index (BMI), weight, blood pressure (BP) and glycaemic parameters. Statistical analysis was performed with SPSS Statistics 20.0: the Student t-test to compare means for paired quantitative data and Chi-square for qualitative variables.ResultsForty transsexuals, 19 male-to-female (MtF: 47.5%) and 21 female-to-male (FtM: 52.5%). Mean age 23.86±11.25 years, mean duration of CHT 24.7±39.9 months. Mean age and mean duration of CHT was similar in both groups.In the MtF group, weight and BMI increased significantly, from 72.12±19.04 to 75.17±19.96 kg (p=0.01) and from 23.84±5.79 to 25.02±5.85 kg/m2 (p=0.02), respectively, as well as diastolic blood pressure (DBP) (from 71.80±15.59 to 75.6±14.72 mmhg (p=0.03)) and triglycerides (TG) (from 102.90±83.69 to 108.81±88.37 mg/dl (p=0.035)). FtM transsexuals also presented an increase in weight (70.02±11.14 to 72.17±11.17 kg (p=0.02) and BMI (from 24.03±4.04 to 25.32±4.11 kg/m2 (p=0.035)). No significant differences in lipid profile and blood pressure were observed in this group, even though final levels were all within the normal range. No significant differences were observed with regard to gender (MtF vs. FtM).ConclusionMtF transsexuals experienced alterations in weight, serum lipid profile and diastolic BP because of CHT, while FtM only experienced changes in weight and BMI, although final levels were all within the normal range. No significant differences were observed with regard to gender (MtF vs. FtM). We suggest that clinicians should monitor glucose and lipid metabolism and blood pressure regularly, according to established guidelines.No conflict of interest
BackgroundExtravasation of cytostatic agents is one of the major complications in cancer treatment with anthracyclines. There is a lot of information about the management of extravasations with ‘classical’ anthracyclines but liposomal anthracyclines have distinctive pharmacokinetics and a different toxic-effect profile. Currently, dexrazoxane is only licensed to treat extravasation with ‘classical’ anthracyclines. However, the efficacy of desrazoxane has been reported in some cases reports. This review collects all extravasation cases that have been published with liposomal and pegylated liposomal anthracyclines, with special emphasis on the use of dexrazoxane.PurposeTo review the scientific literature on the development and managenement of anthracycline extravasation injuries, including clinical evidence for desrazoxane.Material and methodsA bibliographic review was conducted using the Pubmed database with the following keywords: antracyclines, extravasations and chemotherapy. The period covered was from database inception to September 2015, inclusive. Articles about clinical cases and literature in English or Spanish were included. Practice guidelines and expert consensus were also analysed.ResultsPractice guidelines and expert consensus were not found. 7 articles fulfilled the inclusion criteria: 5 cases reports (including 6 patients) and 2 series of cases (each series treated in the same way).Extravasated drugs: 3 liposomal doxorubicin, 1 liposomal daunorubicin and 4 pegylated liposomal doxorubicin. General therapy: local cold packs, topical and subcutaneous corticosteroids, painkillers, subcutaneous lidocaine and low weight molecular heparin. Desrazoxane was administered in 3 cases but only 1 article reported the dosage. Symptoms: local oedema, pain, burning, erythema and haematoma. Outcome: only 1 patient treated with local cold packs and washing had necrotic areas and scars; the rest of the cases completely resolved in 2 or 3 months with no skin injury. Since 2006, the date of approval of desrazoxane, 3 of 4 reported cases have been treated with this medicine.ConclusionThere is a lack of consensus in the management of extravasations with liposomal anthracyclines, and desrazoxane could be used to treat severe extravasations of liposomal anthracyclines. Therefore, the introduction of this antidote for this medicine needs further study to ensure its efficacy and safety. Hence all oncology services should make a protocol including general interventions and the off-label use of this medicine.No conflict of interest.
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