177 research outputs found

    INCREASE OF REPORTS OF SUSPECTED ADVERSE DRUG REACTIONS IN ONCOLOGY

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    Objective: The information of safety of antineoplastic agents derives solely from clinical studies that have a number of limitations, such as the number of patients enrolled, selected case studies, follow-up of short duration; therefore, it is not possible to identify the complete profile of safety and possible side effects of the drugs under study. ADRs monitoring and reporting programmes aim to identifying and quantifying the risks associated with the use of drugs provided in a hospital setting. The main objectives of this study were to evaluate the ADRs that occurred during hospitalization for chemotherapy in 7 cancer centers, and to facilitate the development of a monitoring system of pharmacovigilance. Methods: An observational study was conducted in 7 cancer centers in the Emilia Romagna region over a period of 2 years, from January 2012 to January 2014. This study was based on an analysis of ADRs reported. Several parameters were utilised in the data evaluation, including drug and reaction characteristics. Results: From January 2012 to January 2014 No. 884 ADRs were included in National Network of pharmacovigilance. The highest ADR rate (57.4%) was found in the adult females with a mean age of 62. The oncology drug most frequently reported were taxanes and platinum derivates. Conclusion: The results obtained will contribute to the development of strategies for the pharmacovigilance service in 7 cancer centers, which will improve the quality of ADR reporting and ensure safer oncology drug use

    Increase of reports of suspected adverse drug reactions in oncology

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    Methods: An observational study was conducted in 7 cancer centersin the Emilia Romagna region over a period of 2 years, from January 2012 to January 2014. This study was based on an analysis of ADRs reported. Several parameters were utilised in the data evaluation, including drug and reaction characteristics.Results: From January 2012 to January 2014 No. 884 ADRs were included in National Network of pharmacovigilance. The highest ADR rate (57.4%) was found in the adult femaleswith a mean age of 62. The oncology drug most frequently reported were taxanes and platinum derivates.Conclusion: The results obtained will contribute to the development of strategies for the pharmacovigilance service in 7 cancer centers, which will improve the quality of ADR reporting and ensure safer oncology drug use.Objective: The information of safety of antineoplastic agents derives solely from clinical studies that have a number of limitations, such as the number of patients enrolled, selected case studies, follow-up of short duration; therefore, it is not possible to identify the complete profile of safety and possible side effects of the drugs under study. ADRs monitoring and reporting programmes aim to identifying and quantifying the risks associated with the use of drugs provided in a hospital setting. The main objectives of this study were to evaluate the ADRs that occurred during hospitalization for chemotherapy in 7 cancer centers, and to facilitate the development of a monitoring system of pharmacovigilance

    The perceived ability of gastroenterologists, hepatologists and surgeons can bias medical decision making

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    Medical errors are a troubling issue and physicians should be careful to scrutinize their own decisions, remaining open to the possibility that they may be wrong. Even so, doctors may still be overconfident. A survey was here conducted to test how medical experience and self-confidence can affect physicians working in the specific clinical area. Potential participants were contacted through personalized emails and invited to contribute to the survey. The \u201crisk-intelligence\u201d test consists of 50 statements about general knowledge in which participants were asked to indicate how likely they thought that each statement was true or false. The risk-intelligence quotient (RQ), a measure of self-confidence, varies between 0 and 100. The higher the RQ score, the better the confidence in personal knowledge. To allow for a representation of 1000 physicians, the sample size was calculated as 278 respondents. A total of 1334 individual emails were sent to reach 278 respondents. A control group of 198 medical students were also invited, of them, 54 responded to the survey. The mean RQ (SD)of physicians was 61.1 (11.4) and that of students was 52.6 (9.9). Assuming age as indicator of knowledge, it was observed that physicians 6434 years had a mean RQ of 59.1 (10.1); those of 35\u201342 years had 61.0 (11.0); in those of 43\u201351 years increased to 62.9 (12.2); reached a plateau of 63.0 (11.5) between 52\u201359 years and decreased to 59.6 (12.1) in respondents 6560 years (r2:0.992). Doctors overestimate smaller probabilities and under-estimate higher probabilities. Specialists in gastroenterology and hepato-biliary diseases suffer from some degree of self-confidence bias, potentially leading to medical errors. Approaches aimed at ameliorating the self-judgment should be promoted more widely in medical education

    Treatment of squamous cell carcinoma of the anal canal: A new strategies with anti-EGFR therapy and immunotherapy

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    The incidence of squamous cell carcinoma of the anal canal (SCAC) is increasing in both sexes but the standard treatment remains that of 20 years ago. However, interesting data have recently emerged on the use of anti-epidermal growth factor receptor (EGFR) agents and immunotherapy in advanced disease. Thus, new avenues of research are opening up that will hopefully lead to more effective therapeutic strategies. We provide an overview of the latest studies published on this tumor and discuss the possible future therapeutic options for combination therapy, anti-EGFR treatment and radiotherapy

    Chemoradiotherapy (Gemox plus helical tomotherapy) for unresectable locally advanced pancreatic cancer: A phase II study

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    The aim of the study was to evaluate the safety and efficacy of a new chemo-radiotherapy regimen for patients with locally advanced pancreatic cancer (LAPC). Patients were treated as follows: gemcitabine 1000 mg/m2 on day 1, and oxaliplatin 100 mg/m2 on day 2, every two weeks (GEMOX regimen) for 4 cycles, 15 days off, hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days), 15 days off, 4 additional cycles of GEMOX, restaging. From April 2011 to August 2016, a total of 42 patients with non resectable LAPC were enrolled. Median age was 67 years (range 41\u201375). Radiotherapy was well tolerated and the most frequently encountered adverse events were mild to moderate nausea and vomiting, abdominal pain and fatigue. In total, 9 patients underwent surgical laparotomy (5 radical pancreatic resection 1 thermoablation and 3 explorative laparotomy), 1 patient became operable but refused surgery. The overall resectability rate was 25%, while the R0 resection rate was 12.5%. At a median follow-up of 50 months, the median progression-free survival and overall survival were 9.3 (95% CI 6.2\u201314.9) and 15.8 (95% CI 8.2\u201323.4) months, respectively. The results demonstrate the feasibility of a new chemo-radiotherapy regimen as a potential treatment for unresectable LAPC

    Lactate dehydrogenase in hepatocellular carcinoma: something old, something new

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    Hepatocellular carcinoma (HCC) is the most common primary liver tumour (80-90%) and represents more than 5.7% of all cancers. Although in recent years the therapeutic options for these patients have increased, clinical results are yet unsatisfactory and the prognosis remains dismal. Clinical or molecular criteria allowing a more accurate selection of patients are in fact largely lacking. Lactic dehydrogenase (LDH) is a glycolytic key enzyme in the conversion of pyruvate to lactate under anaerobic conditions. In preclinical models, upregulation of LDH has been suggested to ensure both an efficient anaerobic/glycolytic metabolism and a reduced dependence on oxygen under hypoxic conditions in tumour cells. Data from several analyses on different tumour types seem to suggest that LDH levels may be a significant prognostic factor. The role of LDH in HCC has been investigated by different authors in heterogeneous populations of patients. It has been tested as a potential biomarker in retrospective, small, and nonfocused studies in patients undergoing surgery, transarterial chemoembolization (TACE), and systemic therapy. In the major part of these studies, high LDH serum levels seem to predict a poorer outcome. We have reviewed literature in this setting trying to resume basis for future studies validating the role of LDH in this diseas

    Separate episodes of capillary leak syndrome and pulmonary hypertension after adjuvant gemcitabine and three years later after nab-paclitaxel for metastatic disease

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    Background: Systemic capillary leak syndrome is a rare disease with a high mortality rate. This syndrome is characterised by generalised edema, hypotension, hemoconcentration, and hypoproteinemia. The cause is the sudden onset of capillary hyperpermeability with extravasations of plasma from the intravascular to the extravascular compartment. We present the case of a patient who experienced two episodes of systemic capillary leak syndrome and pulmonary hypertension; the first after gemcitabine in an adjuvant setting and the second three years later after treatment with nab-paclitaxel for metastatic disease.Case presentation: A 65-year-old patient underwent a pancreatectomy in January 2010 for ductal carcinoma (pT3 N0 M0, stage IIa), followed by adjuvant chemotherapy. Seven days after the last cycle, she developed dyspnea associated with orthopnea and cough. A transthoracic cardiac ecocolordoppler was performed, with evidence of pulmonary hypertension (58 mmHg). Blood tests showed an increase in creatinine, pro-BNP and D-Dimer. She began high-dose diuretic therapy combined with cortisone. After a month, the patient was eupneic and the anasarca had resolved. We decided gradually to reduce the steroid and diuretic therapy. After ten days of the reduction, the patient began to re-present the same symptoms after treatment with gemcitabine. Corticosteroid therapy was restored with rapid clinical benefit and decreased pro-BNP after a week of treatment. After two years, the disease returned. As a first line treatment, it was decided to use nab-paclitaxel 100 mg/m2 weekly. After two doses, followed by approximately 14 days of treatment, the patient developed acute respiratory distress syndrome. The clinical suspicion was a relapse of capillary leak syndrome and treatment with a high-dose diuretic (furosemide 250 mg daily) was started combined with cortisone (40 mg methylprednisolone). The patient showed a progressive clinical benefit.Conclusions: In patients treated with gemcitabine and nab-paclitaxel who experience a sudden onset of diffuse edema with respiratory distress, capillary leak syndrome should be suspected. Immediate treatment with corticosteroids may be life-saving. © 2013 Casadei Gardini et al.; licensee BioMed Central Ltd
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