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Griggs, Jennifer J., Kari Bohlke, Edward P. Balaban, James J. Dignam, Evan T. Hall, R. Donald Harvey, Diane P. Hecht, et al. "Appropriate Systemic Therapy Dosing for Obese Adult Patients With Cancer: ASCO Guideline Update." Journal of Clinical Oncology 39, no. 18 (June 20, 2021): 2037–48. http://dx.doi.org/10.1200/jco.21.00471.
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PURPOSE To provide recommendations for appropriate dosing of systemic antineoplastic agents in obese adults with cancer. METHODS A systematic review of the literature collected evidence regarding dosing of chemotherapy, immunotherapy, and targeted therapies in obese adults with cancer. PubMed and the Cochrane Library were searched for randomized controlled trials, meta-analyses, or cohort studies published from November 1, 2010, through March 27, 2020. ASCO convened an Expert Panel to review the evidence and formulate recommendations. RESULTS Sixty studies, primarily retrospective, were included in the review. Overall, the evidence supported previous findings that obese adult patients tolerate full, body-size–based dosing of chemotherapy as well as nonobese patients. Fewer studies have addressed the dosing of targeted therapies and immunotherapies in relation to safety and efficacy in obese patients. RECOMMENDATIONS The Panel continues to recommend that full, weight-based cytotoxic chemotherapy doses be used to treat obese adults with cancer. New to this version of the guideline, the Panel also recommends that full, approved doses of immunotherapy and targeted therapies be offered to obese adults with cancer. In the event of toxicity, the consensus of the Panel is that dose modifications of systemic antineoplastic therapies should be handled similarly for obese and nonobese patients. Important areas for future research include the impact of sarcopenia and other measures of body composition on optimal antineoplastic dosing, and more customized dosing based on pharmacokinetic or pharmacogenetic factors. Additional information is available at www.asco.org/supportive-care-guidelines .
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Silva, Trajano Felipe Barrabas Xavier da, Humberto Costa, and Marcelo Montebello Ribeiro. "Chemical risks that nurses are exposed in antineoplastic therapy services in a hospital setting: a systematic review protocol." Scientific Electronic Archives 14, no. 3 (February 26, 2021): 112–15. http://dx.doi.org/10.36560/14320211304.
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Chemotherapy is a complex and highly specialized process that involves risk, and the success of the results largely depends on the nursing care provided to the patient. Contamination with antineoplastic chemotherapy can occur directly through the skin, membranes, mucous membranes and inhalation or indirectly through body fluids and excreta from patients who received medication within 72 hours. The effects of contamination may be immediate (dermatitis, skin hyperpigmentation and others) or late (partial alopecia, chromosomal abnormalities and increased risk of developing cancer), with risks arising from the inherent toxicity of the drug and the exposure time of individuals. antineoplastic agents. Indispensable care is required for the nursing staff in the administration of chemotherapy, in addition to the institutions providing adequate safety measures for the work of these professionals. Thus, a systematic review is proposed to obtain relevant information on these risks to plan appropriate future interventions to avoid related negative consequences. Thus, following the preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P), this systematic review protocol was designed to provide appropriate guidelines for the development of research that can provide results to meet the goal sought. Five databases will be accessed (SCOPUS, PubMed, Science Direct, EBSCOhost, and Web of Science) and a total of 9 keyword combinations will be used. This protocol is registered in PROSPERO under the code of PROSPERO CRD42019131696
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Benhabib, Amine, Saïd Ioughlissen, Christelle Ratignier-Carbonneil, and Patrick Maison. "The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study." BMJ Open 10, no. 3 (March 2020): e034033. http://dx.doi.org/10.1136/bmjopen-2019-034033.
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ObjectivesThe aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018.MethodsData from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the ANSM. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported on shortage between 2012 and 2018.ResultsThere were 3530 pharmaceutical products reported on shortage during the period, including 1833 different active substances. Drugs on shortage were mostly old products (63.4%) with national marketing authorisation procedures (62.8%), as well as injectable and oral forms (47.5% and 43.3%, respectively). Anti-infectives for systemic use ranked first (18%), followed by nervous and cardiovascular system drugs and by antineoplastic and immunomodulating agents (17.4%, 12.5% and 10.4%, respectively). The number of reported shortages presented a fourfold increase between 2012 and 2018 and a sharp rise in 2017 and 2018, along with a rise in the number of active substances on shortage. The therapeutic classes concerned remained similar over time. Manufacturing and material supply issues were the main reported reasons for the shortage each year (30%) and there was an overall rise of pharmaceutical market reasons.ConclusionDrug shortages were increasingly reported in France. Preventive measures should specifically target the products most on shortage, in particular old drugs, injectable, anti-infective, nervous system and cardiovascular system drugs as well as antineoplastic and immunomodulating agents.
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Healy, Regan, Deborah Passey, Derek Pinnell, Joshua Qualls, Clayton Hamilton, Zach Burningham, Elizabeth Tilley, Tanya Hood, Brian C. Sauer, and Ahmad Sami Halwani. "Veterans on anticancer medications in rural and community environment support (VA CARES) program: A pharmacist-led telemedicine medication management program for veterans receiving oral antineoplastic therapies through the MISSION Act." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 1545. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.1545.
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1545 Background: Cancer therapies are leveraging oral targeted treatments over traditional cytotoxic chemotherapy (CT) at an increasing rate. Compared to CT, use of oral antineoplastic treatments (OATs) shift some of the burden of medication management onto patients. To address these challenges, several health systems have developed multidisciplinary OAT management teams or ‘clinics’ whereby an Oncology Clinical Pharmacist (OCP) collaborates with oncology teams to ensure optimal use of these agents. Through the VA MISSION Act of 2018, Veterans can be prescribed treatments in the community which are dispensed by VA. These Veterans often live in rural areas and may lack access to comprehensive medication management resources. Methods: The VA CARES Program is a telemedicine medication management ‘clinic’ and care delivery model for patients receiving OATs leveraging custom designed health information technology (HIT) tools to remotely coordinate OAT related care. Veterans are automatically enrolled in the program if they have OATs prescribed by community providers which are to be dispensed by VA. An OCP provides telemedicine medication management services. The OCP performs a screening assessment, ensures appropriate indication and dosing, reviews baseline laboratory results, and performs a thorough drug-drug interaction analysis. The OCP then provides OAT education. Throughout the duration of therapy the OCP ensures necessary therapeutic monitoring, and regularly follows up with the Veterans. Subsequent encounters are to assess knowledge, adherence, toxicities, new drug-drug interactions, and need for OAT refills. The outcome measures for the VA CARES Program include safety (number and type of pharmacist interventions), economic benefits (cost savings or cost avoidance), and patient satisfaction. Results: In the initial 13 months, the VA CARES Program screened N = 78 and enrolled N = 64 (82%) Veterans from three VA medical facilities in VISN-19 from January 2020 to January 2021. The CPS performed n = 342 telemedicine visits and n = 80 interventions leading to improved safety, effectiveness, and/or an economical benefit. The most common interventions included detection and/or prevention of drug-drug interactions (n = 45) and adverse events (n = 18), drug not indicated (n = 13), alternative therapy suggested (n = 7), and limited-quantity dispensed (n = 7). The CPS interventions saved an estimated $210,864 in medication-related costs or avoidance. The Veterans surveyed were highly satisfied with the program services. Conclusions: Telemedicine delivery of oncology medication management by an OCP across systems is feasible, and provides clinical and economic benefits.
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Graeve, Catherine Utecht, Patricia Marie McGovern, Bruce Alexander, Timothy Church, Andrew Ryan, and Martha Polovich. "Occupational Exposure to Antineoplastic Agents." Workplace Health & Safety 65, no. 1 (October 7, 2016): 9–20. http://dx.doi.org/10.1177/2165079916662660.
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Approximately 8 million health care workers are unnecessarily exposed to highly toxic drugs used to treat cancer; antineoplastic drugs can contribute to negative health effects for these workers. The drugs have been detected in the urine of workers and on the floors and counters of worksites. Safety precautions that could reduce the risk of exposure are underutilized. This cross-sectional study of 163 oncology health care workers used a survey to measure workplace and individual factors, and environmental sampling to measure surface contamination. The study objective was to identify potential exposures to antineoplastic drugs and factors influencing safety behavior. Personal protective equipment (PPE) use was lower than recommended; unit of employment was significantly associated with PPE use. Chemical residue from antineoplastic drugs was found, revealing potential exposures. Workplace safety must be a higher organizational priority. The contamination of common work areas where PPE use is not expected was of utmost concern.
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Brana, Irene, Geoffrey Shapiro, Melissa Lynne Johnson, Helena Alexandra Yu, Debbie Robbrecht, Daniel Shao-Weng Tan, Lillian L. Siu, et al. "Initial results from a dose finding study of TNO155, a SHP2 inhibitor, in adults with advanced solid tumors." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 3005. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.3005.
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3005 Background: SHP2 transduces signals from activated receptor tyrosine kinases to downstream pathways including MAPK. TNO155 is a selective, allosteric, oral inhibitor of SHP2. Methods: CTNO155X2101 (NCT03114319) is an ongoing first-in-human, open-label dose escalation/expansion trial of TNO155 in adults with advanced solid tumors. The primary objective is to characterize the safety and tolerability of TNO155 and identify regimen(s) for future study. Secondary assessments included pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy. Here we present data from TNO155 single agent escalation. Results: As of 10/26/2020, 118 patients received TNO155 in variable schedules: once (QD; 1.5–70 mg; n = 55) or twice daily (BID; 30–50 mg; n = 25) in a 2 weeks on/1 week off (2w/1w) cycle; or QD in a 3w/1w cycle (30–60 mg; n = 32), or continuously (40 or 50 mg QD; n = 6). The most common cancer diagnoses treated were colorectal (54%), gastrointestinal stromal tumor (16%), non-small cell lung (12%), and head & neck (8%). The median number of prior antineoplastic therapies was 4 (range 1–10). Overall 109 patients (92%) have discontinued study treatment, 94 (80%) for progressive disease and 6 (5%) for adverse events (AEs). TNO155 showed rapid absorption (median day 1 Tmax ̃1.1 hours), an effective median T½ of ̃34 hours, and near dose-proportional exposure at day 14 (power model: AUCτ beta = 1.09 [90% CI 1.02–1.16]). AEs were mostly Grade 1/2 and generally consistent with on-target effects of SHP2 inhibition. The most common treatment-related AEs (all grades) were increased blood creatine phosphokinase (n = 33, 28%), peripheral edema (n = 31, 26%), diarrhea (n = 31, 26%), and acneiform dermatitis (n = 27, 23%). The most common treatment-related Grade ≥3 AEs were decreased platelets (n = 5, 4%), increased aspartate aminotransferase, diarrhea, and decreased neutrophils (each n = 4, 3%). The best observed response was stable disease (SD) per RECIST 1.1, reported in 24 (20%) patients, with a median duration of SD of 4.9 months (range 1.7–29.3). Evidence of SHP2 inhibition, as measured by change in DUSP6 expression by qPCR in paired pre- vs. on-treatment tumor samples, was seen in the majority of patients treated with TNO155 doses ≥20 mg/day (≥25% reduction, 38/42 [90%]; ≥50% reduction, 25/42 [60%]). Analysis of tumor whole-transcriptome RNA sequencing data is ongoing. Conclusions: TNO155 shows favorable pharmacokinetic properties and promising early safety and tolerability data at doses with evidence of target inhibition. The optimal dose using several schedules is still under evaluation. Studies of TNO155 in combination with other agents, including nazartinib (mutant-selective EGFR inhibitor[i]), adagrasib (KRAS G12Ci), spartalizumab (anti-PD-1 antibody), ribociclib (CDK4/6i), and dabrafenib (BRAFi) with LTT462 (ERKi), are ongoing (NCT03114319, NCT04330664, NCT04000529, NCT04294160). Clinical trial information: NCT03114319.
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Sewell, Graham J. "Pharmaceutical issues: preparation and handling." Journal of Oncology Pharmacy Practice 1, no. 1_suppl (May 1995): 6–12. http://dx.doi.org/10.1177/1078155295001001s03.
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The preparation and safe handling of antineoplastic agents as presented during the Fourth International Symposium on Oncology Pharmacy Practice are reviewed. Included are discussions of the class II safety cabinets versus negative pressure isolators, a new type of drug vial that may facilitate safer han dling of antineoplastic agents, and a robotic system being developed for the preparation of large-vol ume cytotoxic infusions. Newer infusion devices, monitoring for occupational exposure to cytotoxic agents, and problems with drug stability, particu larly in the ambulatory setting, are also discussed.
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Kruse, R. H., W. H. Puckett, and J. H. Richardson. "Biological safety cabinetry." Clinical Microbiology Reviews 4, no. 2 (April 1991): 207–41. http://dx.doi.org/10.1128/cmr.4.2.207.
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The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents.
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Vucicevic, Jelica, Katarina Nikolic, and John B. O. Mitchell. "Rational Drug Design of Antineoplastic Agents Using 3D-QSAR, Cheminformatic, and Virtual Screening Approaches." Current Medicinal Chemistry 26, no. 21 (September 19, 2019): 3874–89. http://dx.doi.org/10.2174/0929867324666170712115411.
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Background: Computer-Aided Drug Design has strongly accelerated the development of novel antineoplastic agents by helping in the hit identification, optimization, and evaluation. Results: Computational approaches such as cheminformatic search, virtual screening, pharmacophore modeling, molecular docking and dynamics have been developed and applied to explain the activity of bioactive molecules, design novel agents, increase the success rate of drug research, and decrease the total costs of drug discovery. Similarity, searches and virtual screening are used to identify molecules with an increased probability to interact with drug targets of interest, while the other computational approaches are applied for the design and evaluation of molecules with enhanced activity and improved safety profile. Conclusion: In this review are described the main in silico techniques used in rational drug design of antineoplastic agents and presented optimal combinations of computational methods for design of more efficient antineoplastic drugs.
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Passamonti, Francesco, Martin Griesshammer, Michele Cavo, Miklos Egyed, Giulia Benevolo, Timothy Devos, Jeannie Callum, et al. "Demographics, Baseline Characteristics, and Disease Symptom Burden in RESPONSE-2: A Randomized, Phase 3 Study of Ruxolitinib in Polycythemia Vera Patients (pts) Who Are Resistant to or Intolerant of Hydroxyurea (HU)." Blood 126, no. 23 (December 3, 2015): 2807. http://dx.doi.org/10.1182/blood.v126.23.2807.2807.
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Abstract BACKGROUND: Polycythemia vera (PV) is characterized by increased red cell mass often associated with elevated leukocyte and platelet counts, splenomegaly and significant symptom burden. In the RESPONSE study, which only enrolled PV patients with splenomegaly, ruxolitinib (Rux) demonstrated superior improvements in hematocrit (HCT) control and reductions in spleen volume compared with best available therapy (BAT) in pts who were resistant to or intolerant of HU. Supportive data included clinically meaningful improvements in PV-related symptom burden and quality of life (QOL) measures. Here, we describe the baseline (BL) characteristics and symptom burden of PV pts resistant to or intolerant of HU enrolled in the RESPONSE-2 study, which unlike RESPONSE, enrolled PV patients with a nonpalpable spleen. METHODS: RESPONSE-2 is an open-label, randomized (1:1), multicenter, phase 3 study evaluating the efficacy and safety of Rux vs BAT in PV pts who are HU-resistant/-intolerant, require phlebotomy (PBT), and have no palpable spleen. Pts' BL symptom burden, BL QOL and BL pt-reported outcomes (PRO) were assessed by using 10-items modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS), the Pruritus Symptom Impact Scale (PSIS), European QOL Questionnaire (EQ-5D-5L), and Work Productivity and Activity Impairment: Polycythemia Vera V2.0 (WPAI: PV). RESULTS: A total of 149 pts were enrolled. BL demographic data from both arms combined are summarized in the Table. Forty percent of the patients were resistant whereas 60% were intolerant of HU treatment. Other than HU, prior treatments included interferons (15.4%), alkylating agents (8.1%), alkyl sulfonates (2.7%), pyrimidine analogs (0.7%), and other antineoplastic agents (1.0%). Ninety-seven percent of pts had at least 1 PBT within 16 weeks (wks) prior to screening and 72% had ≥ 2 PBT within 24 wks prior to screening. Past medical histories included hypertension (49%), pruritus (23%) and fatigue (9%). BL demographics of pts in RESPONSE-2 were generally comparable with previous PV studies (Table). Despite using frequent phlebotomy and cytoreductive agents during the screening period prior to randomization, 55% and 52% of pts had WBC counts greater than 10 × 109/L and platelet counts greater than 400 × 109/L, respectively, suggesting inadequately controlled disease even while receiving therapy. Additionally, pts had significant symptom burden at BL as measured by the MPN-SAF with fatigue (3.6) and pruritus (3.4) (Table). As measured by EQ-5D-5L scale, 26% and 19% of pts reported moderate to extreme pain/discomfort and depression, respectively. In WPAI outcomes, 40 of 149 pts reported missing work due to PV accounting for 14.3% of their working time. SUMMARY/CONCLUSION: Demographic and BL data from the RESPONSE-2 study highlight the significant unmet medical need in this inadequately controlled HU-resistant/-intolerant PV population. As expected, pts in RESPONSE-2 reported lower scores for symptoms associated with splenomegaly (early satiety, 1.8 vs 2.0; abdominal discomfort, 1.7 vs 2.0) as compared with RESPONSE population. In comparison to PV pts with splenomegaly in the RESPONSE trial, pts without splenomegaly in the RESPONSE-2 trial have a distinct but comparable disease burden with marked fatigue and pruritus. Table 1. Baseline demographics and symptoms (n = 149) Age, median (range), years 66.0 (26.0, 87.0) Time since diagnosis of PV, median, months 80.7 Male, % 57.7 Female, % 42.3 ECOG performance status, % 0 1 72.5 26.8 Hematocrit (%), median,(n=149) 43.0 n (%) < 40 ≥ 40 to ≤ 45 > 45 2 (1.3) 146 (98.0) 1 (0.7) WBC count (x 109/L), median (n=149) 10.6 n (%) ≤ 10 > 10 and ≤ 15 > 15 67 (45.0) 43 (28.9) 39 (26.2) PLT count (x 109/L), median (n=148) 420.0 n (%) < 100 ≥ 100 and < 400 ≥ 400 to < 600 ≥ 600 2 (1.3) 68 (45.6) 38 (25.5) 40 (26.8) JAK2 mutation, n (%) (n=149) Positive Negative Unknown 143 (96.0) 4 (2.7) 2 (1.3) MPN-SAF Symptom (n) Mean (SD) Total score (n=145) 2.0 (1.67) Fatigue (n=146) 3.6 (2.72) Early satiety (n=145) 1.8 (2.47) Abdominal discomfort (n=143) 1.7 (2.44) Inactivity (n=142) 2.1 (2.77) Concentration problem (n=146) 2.3 (2.75) Night sweats (n=145) 2.2 (3.07) Pruritus (n=145) 3.4 (3.37) Bone pain (n=144) 2.1 (2.89) Fever (n=144) 0.2 (0.92) Weight loss (n=142) 0.7 (1.72) Disclosures Passamonti: Novartis: Consultancy. Cavo:JANSSEN, CELGENE, AMGEN: Consultancy. Vannucchi:Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Other: Research Funding paid to institution (University of Florence), Research Funding; Shire: Speakers Bureau; Baxalta: Membership on an entity's Board of Directors or advisory committees. Bensasson:Novartis: Employment. Khan:Novartis: Employment. Mounedji:Novartis: Employment.
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Li, Edward C., Glen Schumock, and Samuel Hong. "Spending on antineoplastic agents in the United States: 2011-2016." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 6618. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.6618.
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6618 Background: Novel antineoplastic therapies confer advantages in efficacy and safety over traditional cytotoxic agents, but they are costly. There is little information on recent trends in actual antineoplastic expenditures representative of the overall U.S. health care system or by healthcare sector. The objective of this study was to describe antineoplastic expenditures by year and healthcare sector in the U.S. Methods: Quintiles IMS National Sales Perspective data for the period of Jan 1, 2011, to Dec 31, 2016, were evaluated to describe antineoplastic agent expenditures. Actual expenditures were totaled by health care sector and calendar year, and then adjusted for U.S. medical-cost inflation (part of the overall consumer price index) to 2016 dollars. Growth was calculated as the percentage increase from previous years. Descriptive statistical analysis was used. Results: Total antineoplastic expenditures increased from $26.8 billion in 2011 to $38.9 billion in 2016. Compared to the previous year, spending increased by 13.7%, 15.6%, 13.4%, 6.3%, and 0.4% in 2016, 2015, 2014, 2013, and 2012, respectively. In hospitals and clinics, spending on biologics grew by 80% from 2011 to 2016. Rituximab, bevacizumab, and trastuzumab expenditures continue to be high ($3.7, $3.0, and $2.6 billion in 2016, respectively) while nivolumab spending increased from $765 million in 2015 to $2.6 billion in 2016. Cytotoxic drug spending remained flat during the study period due to the availability of multiple generic products. Large percentage decreases in spending were seen for oxaliplatin (-97%), docetaxel (-98%), gemcitabine (-92%), bendamustine (-56%) and decitabine (-94%) in 2016 compared to 2011. Conclusions: Antineoplastic expenditures increased significantly since 2011 and are expected to continue to do so with the anticipated approval of additional novel but costly cancer therapies, and because of an aging population. [Table: see text]
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Escudero-Vilaplana, Vicente, Jose Luis Revuelta-Herrero, Roberto Collado-Borrell, Belen Marzal-Alfaro, Alvaro Gimenez-Manzorro, Ana Herranz-Alonso, and María Sanjurjo-Saez. "Oral antineoplastic agents: assessment of safety and dose adjustments in clinical practice." Expert Opinion on Drug Safety 18, no. 9 (July 15, 2019): 861–68. http://dx.doi.org/10.1080/14740338.2019.1641197.
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Sessink, Paul J. M., Barry C. J. Wittenhorst, Rob B. M. Anzion, and Rob P. Bos. "Exposure of Pharmacy Technicians to Antineoplastic Agents: Reevaluation after Additional Protective Measures." Archives of Environmental Health: An International Journal 52, no. 3 (May 1997): 240–44. http://dx.doi.org/10.1080/00039899709602893.
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Vail, David M., Douglas H. Thamm, Daniel B. Tumas, Hans Reiser, Adrian S. Ray, Grushenka H. I. Wolfgang, Darius Babusis, et al. "GS-9219 - A Novel Prodrug of the Acyclic Nucleotide PMEG Demonstrates Significant Therapeutic Activity Against Spontaneous Non-Hodgkin’s Lymphoma as Modeled in Pet Dogs." Blood 110, no. 11 (November 16, 2007): 1380. http://dx.doi.org/10.1182/blood.v110.11.1380.1380.
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Abstract Non-Hodgkin’s lymphoma (NHL) is the fifth leading cause of cancer deaths and the second fastest growing form of cancer in the United States. While clinical remission can be induced using currently available antineoplastic agents, drug resistant relapse is common. Canine NHL has proven to be a relevant model for preclinical testing of novel therapeutics prior to human trials. GS-9219, a novel double prodrug of the anti-proliferative nucleotide analog 9-(2-phosphonylmethoxyethyl) guanine (PMEG), has been shown to have potent cytotoxic activity in lymphoblasts and leukemia cell lines and was designed to load and functionally target malignant lymphoid cell populations upon intravenous administration. To generate proof-of-concept, activity and safety data in lymphoid malignancies, a dose-finding and activity trial with GS-9219 monotherapy was initiated in pet dogs (N = 38) with naturally occurring chemotherapy naïve or refractory NHL. Dose cohorts of 3 to 6 dogs were treated using several schedules including daily treatments for 5 consecutive days out of every 21 days, once weekly, once biweekly and once every 3 weeks. Adverse events, when observed, were manageable and reversible, dose- and regimen-dependent and included predominantly Grade 1 to 2 transient neutropenia, gastrointestinal signs, lethargy, dermatopathy and proteinuria. Major antitumor responses were noted in 79% of dogs treated with GS-9219 monotherapy (61% complete and 18% partial responses) as measured by tumor size (RECIST criteria). Responses were similar across the different treatment regimens evaluated. Importantly, responses were noted in both previously untreated dogs (N=16) and dogs with chemotherapy-refractory NHL (N=22), implying a role both in induction therapy and in the rescue of drug resistant disease. B and T cell phenotypes were both found to respond to GS-9219 therapy; however, first remission durations were significantly longer in dogs with B cell NHL. The overall median first remission duration of 4.5 months observed compares favorably to other monotherapies reported in dogs with NHL. Furthermore, in dogs retreated with GS-9219 after recrudescence of their NHL, 78% achieved a second remission. A subset of nine dogs were further evaluated with 18F-fluorothymidine (FLT) PET/CT imaging prior to and after their first treatment with GS-9219; 8 of 9 displayed initially high FLT uptake (mean standardized uptake values [SUV] of 81.55) prior to treatment which decreased significantly after GS-9219 monotherapy (SUV of 13.39; p < 0.05). Given these very promising results in this relevant preclinical model, a Phase I study of GS-9219 in humans with NHL has been initiated.
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Escudero-Vilaplana, V., A. Ribed, R. M. Romero-Jimenez, A. Herranz-Alonso, and M. Sanjurjo-Saez. "Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents." European Journal of Cancer Care 26, no. 3 (February 12, 2016): e12463. http://dx.doi.org/10.1111/ecc.12463.
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Kawasaki, Yoichi, Noriko Yokoyama, Naoyuki Matsuka, Michihiro Izushi, Rieko Kawashima, Takeo Okada, Toshiaki Sendo, and Yutaka Gomita. "Sterility Management for Preparation of Antineoplastic Agents in a Class II Biological Safety Cabinet." Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 32, no. 12 (2006): 1261–66. http://dx.doi.org/10.5649/jjphcs.32.1261.
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Badescu, Minerva Codruta, Oana Viola Badulescu, Dragos Viorel Scripcariu, Lăcrămioara Ionela Butnariu, Iris Bararu-Bojan, Diana Popescu, Manuela Ciocoiu, et al. "Myocardial Ischemia Related to Common Cancer Therapy—Prevention Insights." Life 12, no. 7 (July 12, 2022): 1034. http://dx.doi.org/10.3390/life12071034.
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Modern antineoplastic therapy improves survival and quality of life in cancer patients, but its indisputable benefits are accompanied by multiple and major side effects, such as cardiovascular ones. Endothelial dysfunction, arterial spasm, intravascular thrombosis, and accelerated atherosclerosis affect the coronary arteries, leading to acute and chronic coronary syndromes that negatively interfere with the oncologic treatment. The cardiac toxicity of antineoplastic agents may be mitigated by using adequate prophylactic measures. In the absence of dedicated guidelines, our work provides the most comprehensive, systematized, structured, and up-to-date analyses of the available literature focusing on measures aiming to protect the coronary arteries from the toxicity of cancer therapy. Our work facilitates the implementation of these measures in daily practice. The ultimate goal is to offer clinicians the necessary data for a personalized therapeutic approach for cancer patients receiving evidence-based oncology treatments with potential cardiovascular toxicity.
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Arablinskiy, N. A., O. D. Ostroumova, and A. V. Filippova. "Antineoplastic agents associated with the development of drug-induced pancreatitis." Meditsinskiy sovet = Medical Council, no. 9 (August 7, 2021): 114–21. http://dx.doi.org/10.21518/2079-701x-2021-9-114-121.
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The frequency of drug-induced pancreatitis (LIP) is from 2 to 5% of all cases of acute pancreatitis (OP), but it is much more common in risk groups – among children and HIV-infected patients. The use of a number of drugs (drugs) is associated with the development of lipids, among them a special place is occupied by antitumor drugs due to the great medical and social significance of oncological diseases and the appearance in recent years of a large number of new antitumor drugs. The purpose of this review was to review the literature data on antitumor drugs, the use of which is associated with the development of lipids. LI OP developed in 1.8% of patients treated with nivolumab or pembroluzumab. In total, in 14 phase 1-3 studies on the efficacy and safety of ipilimumab, the development of OP was reported in less than 1% of the subjects. Therapy with molecular-targeted targeted drugs, such as tyrosine kinase inhibitors (TKI) or other representatives of the kinase inhibitor class, is also associated with the development of OP. The HP database of the World Health Organization (WHO, World Health Organization Adverse Drug Reaction database) contains reports of individual clinical cases of OP development during treatment with proteosome inhibitors and antibody-drug conjugates. It is known that the following antitumor drugs are also associated with the development of pancreatitis: 6-mercaptopurine, L-asparaginase, tamoxifen, cisplatin, cytarabine, ifosfamide, paclitaxel, docetaxel, oxaliplatin, capecitabine, periwinkle alkaloids, cytosine, cisplatin, interferon alpha-2b, doxorubicin, tamoxifen, gefitinib, vinorelbine, levamizole, methotrexate, 5-fluorouracil, capecitabine, trans-retinoic acid.
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Hu, Lang-Yue, Wen-Li Mi, Gen-Cheng Wu, Yan-Qing Wang, and Qi-Liang Mao-Ying. "Prevention and Treatment for Chemotherapy-Induced Peripheral Neuropathy: Therapies Based on CIPN Mechanisms." Current Neuropharmacology 17, no. 2 (January 7, 2019): 184–96. http://dx.doi.org/10.2174/1570159x15666170915143217.
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Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible adverse effect of many antineoplastic agents, among which sensory abnormities are common and the most suffering issues. The pathogenesis of CIPN has not been completely understood, and strategies for CIPN prevention and treatment are still open problems for medicine. Objectives: The objective of this paper is to review the mechanism-based therapies against sensory abnormities in CIPN. Methods: This is a literature review to describe the uncovered mechanisms underlying CIPN and to provide a summary of mechanism-based therapies for CIPN based on the evidence from both animal and clinical studies. Results: An abundance of compounds has been developed to prevent or treat CIPN by blocking ion channels, targeting inflammatory cytokines and combating oxidative stress. Agents such as glutathione, mangafodipir and duloxetine are expected to be effective for CIPN intervention, while Ca/Mg infusion and venlafaxine, tricyclic antidepressants, and gabapentin display limited efficacy for preventing and alleviating CIPN. And the utilization of erythropoietin, menthol and amifostine needs to be cautious regarding to their side effects. Conclusions: Multiple drugs have been used and studied for decades, their effect against CIPN are still controversial according to different antineoplastic agents due to the diverse manifestations among different antineoplastic agents and complex drug-drug interactions. In addition, novel therapies or drugs that have proven to be effective in animals require further investigation, and it will take time to confirm their efficacy and safety.
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Szwamel, Katarzyna, Żaneta Dębicka, and Marta Gawlik. "Antineoplastic agents and the use of personal protective equipment: nursing staff awareness." Medical Science Pulse 13, no. 4 (March 31, 2020): 1–20. http://dx.doi.org/10.5604/01.3001.0014.1208.
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Introduction. Along with an increasing number of cancer patients, the need for cytostatic drugs is also increasing. Nursing staff are the largest professional group exposed to the potential dangers of these substances. Aim of the study. Assess the awareness of nursing staff who have direct contact with cytostatic drugs in the use of personal protective equipment (PPE). Material and methods. The research group consisted of 101 nurses routinely exposed to cytostatic drugs. A diagnostic survey and questionnaire technique were used along with the author’s original questionnaire. Results. Of the respondents, 58.42% (n=59) never used protective shoes while dealing with cytostatics, while 53.4% (n=54) never used long-sleeved, waterproof uniforms; 49.50% (n=50) did not apply half masks, and 34.65% (n=35) failed to protect their eyes with protective glasses. The most common cause of not using the protective equipment was identified as lack of time (72; 71.29%). Deficiency of training on protective measures while working with hazardous cytostatics was cited by 37.62% (n=38) as the reason for their behavior, while almost 22% of them claimed that their employer did not provide them with a sufficient amount of protective equipment for individual use. The older, more experienced and higher-educated the staff, the higher awareness among them about the need for using PPE. Conclusions. Higher-educated and more experienced nursing staff should constitute the source of ‘good practices’ and educate younger undergraduate colleagues theoretically and practically. Employers and management staff should provide employees with more training on the correct application of protective measures and increase the intensity of control of the use of personal protective equipment.
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Mescherina, Natalia S., Tatiana S. Mikhailenko, Elena M. Khardikova, Igor A. Sarayev, and Tatiana S. Leontieva. "Cardiovascular toxicity induced by chemotherapy and target drugs: mechanisms, diagnostic and preventive approaches." Человек и его здоровье 24, no. 4 (2021): 24–33. http://dx.doi.org/10.21626/vestnik/2021-4/04.
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The article aims at presenting the review of literature data concerning mechanisms, diagnostic methods, and preventive approaches for cardiovascular toxicity induced by chemotherapy and target drugs. The review is devoted to the currently important issue of cardiotoxicity with antineoplastic therapy. Modern cytostatic agents cause clinically significant myocardial damage, which definitely impair the quality of life and decrease the life expec-tancy in oncological patients. Compared to traditional chemotherapy, target cancer therapy is a new strategy which inhibits key molecules of signal pathways participating in carcinogenesis and tumor spread. Target cancer therapy is characterized by lesser unfavorable effects on normal cells and considered the future of chemotherapy. However, cardiovascular toxicity induced by target cancer therapy sometimes becomes a critical issue in patients administered novel antineoplastic agents. Cardiac oncology is a new sphere of medicine which comes under scrutiny of experts despite the fact that many mechanisms of cardiovascular complications for the antineoplastic therapy have not been thoroughly studied. The current review presents the state-of-the-art information concerning mechanisms, diagnostic and monitoring problems for cardiovascular safety, a contemporary view of preventing cardiotoxicity induced by chemotherapy and target drugs.
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Crul, M., and K. Simons-Sanders. "Carry-over of antineoplastic drug contamination in Dutch hospital pharmacies." Journal of Oncology Pharmacy Practice 24, no. 7 (April 28, 2017): 483–89. http://dx.doi.org/10.1177/1078155217704990.
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Background To prevent occupational exposure of hospital staff to cytostatics, a mandatory national guideline describing a set of safety measures was issued in the Netherlands in 2004. The guideline includes, among other directives, obligatory annual wipe testing to assess the efficacy of the local cleaning protocol. Full implementation of this guideline was executed in all Dutch hospital pharmacies over the next couple of years. Objective We aimed to investigate the effect of the national guideline on contamination levels, and specifically on the phenomenon of carry-over of traces of antineoplastic drugs through contact with surfaces, since this is a potential route of exposure. Methods From a database including wipe sample results of 9 hospitals over 10 years, we extracted all sampled locations in the compounding areas as well as in adjacent or bypass rooms and locks. We considered only the locations outside safety cabinets or isolators, to examine the containment of contamination and to address possible routes of how a contamination can migrate through the preparation and distribution areas. The dataset consisted of 2647 wipe samples. Results In adjacent rooms, 18 out of 275 wipe samples were contaminated (6%). Inside the compounding room, the extracted locations away from the safety workbench showed a positive percentage for contamination of 13% (39 out of 297). When stratifying the data to sample year, it was shown that contaminations outside the preparation room were no longer detectable after 2008. Conclusion With this study, we show that implementation of a set of guidelines on safety measures can prevent spreading of cytostatic traces from the compounding area in hospital pharmacies.
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강민경, 이연주, 김다진, 김재연, 여미진, 이연홍, 문진영, 허영설, 박향민, and 이윤선. "Survey of Work Environment and Healthcare Workers Safety for Handling Antineoplastic Agents in Korean Hospitals." Journal of Korean Society of Health-System Pharmacists 32, no. 2 (May 2015): 104–18. http://dx.doi.org/10.32429/jkshp.2015.32.2.002.
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Noseda, Roberta, Laura Müller, Francesca Bedussi, Michele Fusaroli, Emanuel Raschi, and Alessandro Ceschi. "Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System." Cancers 15, no. 1 (December 28, 2022): 173. http://dx.doi.org/10.3390/cancers15010173.
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In pregnancy, immune checkpoint pathways are involved in the maintenance of fetomaternal immune tolerance. Preclinical studies have shown that immune checkpoint inhibitors (ICIs) increase the risk of fetal death. Despite the fact that using ICIs in pregnant women and women of childbearing potential is not recommended, some case reports of ICI exposure in pregnancy have been published showing favorable fetal outcomes. This study aimed to gain further insight into ICI safety in pregnancy by querying VigiBase®, the World Health Organization’s spontaneous reporting system. We performed raw and subgroup disproportionality analyses using the reporting odds ratio and comparing ICIs with the entire database, other antineoplastic agents, and other antineoplastic agents gathered in VigiBase® since 2011. Across 103 safety reports referring to ICI exposure during the peri-pregnancy period, 56 reported pregnancy-related outcomes, of which 46 were without concomitant drugs as potential confounding factors. No signals of disproportionate reporting were found for spontaneous abortion, fetal growth restriction, and prematurity. In light of the expanding indications of ICIs, continuous surveillance by clinicians and pharmacovigilance experts is warranted, along with pharmacoepidemiological studies on other sources of real-world evidence, such as birth records, to precisely assess ICI exposure during the peri-pregnancy period and further characterize relevant outcomes.
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Gidwani, Bina, and Amber Vyas. "A Comprehensive Review on Cyclodextrin-Based Carriers for Delivery of Chemotherapeutic Cytotoxic Anticancer Drugs." BioMed Research International 2015 (2015): 1–15. http://dx.doi.org/10.1155/2015/198268.
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Most of the cytotoxic chemotherapeutic agents have poor aqueous solubility. These molecules are associated with poor physicochemical and biopharmaceutical properties, which makes the formulation difficult. An important approach in this regard is the use of combination of cyclodextrin and nanotechnology in delivery system. This paper provides an overview of limitations associated with anticancer drugs, their complexation with cyclodextrins, loading/encapsulating the complexed drugs into carriers, and various approaches used for the delivery. The present review article aims to assess the utility of cyclodextrin-based carriers like liposomes, niosomes, nanoparticles, micelles, millirods, and siRNA for delivery of antineoplastic agents. These systems based on cyclodextrin complexation and nanotechnology will camouflage the undesirable properties of drug and lead to synergistic or additive effect. Cyclodextrin-based nanotechnology seems to provide better therapeutic effect and sustain long life of healthy and recovered cells. Still, considerable study on delivery system and administration routes of cyclodextrin-based carriers is necessary with respect to their pharmacokinetics and toxicology to substantiate their safety and efficiency. In future, it would be possible to resolve the conventional and current issues associated with the development and commercialization of antineoplastic agents.
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Mugala, Prabhavathy. "In Vitro Cell Culture Drug Resistance Testing." Mapana - Journal of Sciences 2, no. 2 (June 17, 2004): 69–75. http://dx.doi.org/10.12723/mjs.4.8.
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Drug development and screening programme for the identification Of a novel concer chemotherapeutic agent involves extensive preclin iCal evaluation of vast n umber Of chemicals for detection 0' their antineoplastic activity. The safety Of drugs the screening strategies (Freshney, 1992). The development Of drug resistance is a rnaior obstacle to effectiveness Of chemoåterapeutic treatment 0/ human tumors with cytotoxic agents. Drug resistance is described as a multifactor phenomenon, involving the expression Of defense ' factors
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Machado-Alba, Jorge Enrique, Anyi Liliana Jiménez-Morales, Yulieth Carolina Moran-Yela, Ilsa Yadira Parrado-Fajardo, and Luis Fernando Valladales-Restrepo. "Adverse drug reactions associated with the use of biological agents." PLOS ONE 15, no. 12 (December 18, 2020): e0240276. http://dx.doi.org/10.1371/journal.pone.0240276.
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Introduction Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs). Objective To identify the ADRs associated with the use of biological drugs in Colombia. Methods This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified. Results In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%). Conclusions The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.
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Beg, Usman, Brianna Snyder, Sarosh Madhani, Nima Hamidi, and Alireza Mansouri. "RADT-46. SYSTEMATIC REVIEW OF RADIOSENSITIZERS FOR MALIGNANT BRAIN TUMORS: POTENTIAL FOR LEARNING FROM PAST FAILURES." Neuro-Oncology 22, Supplement_2 (November 2020): ii191. http://dx.doi.org/10.1093/neuonc/noaa215.799.
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Abstract INTRODUCTION Radiation therapy (RT) is the cornerstone of management of malignant CNS tumors but its efficacy is limited in hypoxic tumors. Although numerous radiosensitizer compounds have been developed to enhance the effect of RT, progress has been stagnant. Through this systematic review of the literature on radiosensitizers for malignant CNS tumors, we have sought to provide an overview of radiosensitizers developed to date, summarize their safety and efficacy, and evaluate areas for possible improvement. METHODS PUBMED, EMBASE, Cochrane, and Web of Science were searched using terminology pertaining to radiosensitizers for brain tumor RT according to PRISMA guidelines. Publications reporting clinical evidence of non-antineoplastic radiosensitizers with RT for malignant CNS tumors were included. Pre-specified variables were extracted. Outcomes of interest were overall survival, progression-free survival, adverse events, and quality-of-life outcomes. RESULTS Forty-eight publications were identified which included 20 unique non-antineoplastic radiosensitizing agents. Only 2/20 agents, fluosol with oxygen, and efaproxiral, showed improvement in outcomes in patients with glioblastoma and brain metastasis, respectively. A larger study was not able to confirm the latter. While molecular similarities between these two agents were not identifiable, the effective mechanism of action allowed them to modulate hypoxia from within blood vessels, without crossing blood-brain barrier. Nine agents required dose modification, change of schedule, or complete discontinuation due to toxicities. CONCLUSION Despite decades of research, progress in the field of radiosensitizers for malignant CNS tumors has been limited. Available data demonstrates the lack of progress in identifying effective radiosensitizers for brain tumors. Of the many non-antineoplastic radiosensitizers that have been tested, only two have showed (limited) efficacy by targeting tumor oxygenation. Alternative strategies such as synthetic drug design, based on a mechanism of action that is independent of crossing the blood-brain barrier, may be necessary. Such studies are currently underway.
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Lee, Euipyeong. "Analysis of the Problems and Safety Measures of Magnesium Fires." Journal of the Korean Society of Hazard Mitigation 20, no. 2 (April 30, 2020): 95–104. http://dx.doi.org/10.9798/kosham.2020.20.2.95.
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The problems and safety measures for magnesium fires were analyzed based on the fire case analysis in this study. The following problems were analyzed: ① the fire occurs in areas where there is no regulation under the Hazardous Goods Safety Management Act, ② the lack of safety measures during the firefighting of magnesium fires, ③ absence of adaptive fire fighting agents or equipment, ④ absence of suitable fire fighting tactics. For safety measures, the following were analyzed: ① enactment of magnesium fire guidelines, ② the education and publicity regarding fire prevention and countermeasures by fire organizations, ③ the obligation to have appropriate fire extinguishing agents in the places where magnesium is stored and handled, ④ the development of suppression equipment and fire fighting tactics, and ⑤ the research and development of fire extinguishing agents.
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Pisani, Silvia, Giulia Bertino, Adriele Prina-Mello, Laura Deborah Locati, Simone Mauramati, Ida Genta, Rossella Dorati, Bice Conti, and Marco Benazzo. "Electroporation in Head-and-Neck Cancer: An Innovative Approach with Immunotherapy and Nanotechnology Combination." Cancers 14, no. 21 (October 31, 2022): 5363. http://dx.doi.org/10.3390/cancers14215363.
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Squamous cell carcinoma is the most common malignancy that arises in the head-and-neck district. Traditional treatment could be insufficient in case of recurrent and/or metastatic cancers; for this reason, more selective and enhanced treatments are in evaluation in preclinical and clinical trials to increase in situ concentration of chemotherapy drugs promoting a selectively antineoplastic activity. Among all cancer treatment types (i.e., surgery, chemotherapy, radiotherapy), electroporation (EP) has emerged as a safe, less invasive, and effective approach for cancer treatment. Reversible EP, using an intensive electric stimulus (i.e., 1000 V/cm) applied for a short time (i.e., 100 μs), determines a localized electric field that temporarily permealizes the tumor cell membranes while maintaining high cell viability, promoting cytoplasm cell uptake of antineoplastic agents such as bleomycin and cisplatin (electrochemotherapy), calcium (Ca2+ electroporation), siRNA and plasmid DNA (gene electroporation). The higher intracellular concentration of antineoplastic agents enhances the antineoplastic activity and promotes controlled tumor cell death (apoptosis). As secondary effects, localized EP (i) reduces the capillary blood flow in tumor tissue (“vascular lock”), lowering drug washout, and (ii) stimulates the immune system acting against cancer cells. After years of preclinical development, electrochemotherapy (ECT), in combination with bleomycin or cisplatin, is currently one of the most effective treatments used for cutaneous metastases and primary skin and mucosal cancers that are not amenable to surgery. To reach this clinical evidence, in vitro and in vivo models were preclinically developed for evaluating the efficacy and safety of ECT on different tumor cell lines and animal models to optimize dose and administration routes of drugs, duration, and intensity of the electric field. Improvements in reversible EP efficacy are under evaluation for HNSCC treatment, where the focus is on the development of a combination treatment between EP-enhanced nanotechnology and immunotherapy strategies.
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Maluf, Sharbel Weidner, and Bernardo Erdtmann. "Evaluation of occupational genotoxic risk in a Brazilian hospital." Genetics and Molecular Biology 23, no. 2 (June 2000): 485–88. http://dx.doi.org/10.1590/s1415-47572000000200040.
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Many therapeutic, diagnostic and prophylactic procedures used in hospitals are of potential genetic risk. An evaluation was made of genotoxic occupational risk in 42 workers from the Hospital de Clínicas de Porto Alegre, RS, Brazil, who had been occupationally exposed to lead (solder), ethylene oxide (sterilization area), antineoplastic drugs (nurses and pharmacists) or ionizing radiation. They were compared with 42 unexposed individuals. There was an increase in the frequency of binucleated cytochalasin-blocked lymphocytes with micronuclei, though it was not significant (P = 0.058). The groups exposed to antineoplastic drugs and radiation had a significant increase in micronuclei frequency (P = 0.038 and P = 0.022, respectively). The high frequencies of dicentric bridges suggest the action of clastogenics in these two groups. These results suggest that the safety procedures adopted were very important to protect workers from exposure to mutagenic agents and should be improved in the radiological and chemotherapeutical areas.
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Roger, Inés, Paula Montero, Antonio García, Javier Milara, Pilar Ribera, Jose Alejandro Pérez-Fidalgo, and Julio Cortijo. "Evaluation of Antineoplastic Delayed-Type Hypersensitivity Skin Reactions In Vitro." Pharmaceuticals 15, no. 9 (September 6, 2022): 1111. http://dx.doi.org/10.3390/ph15091111.
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Delayed-type hypersensitivity (DTH) is caused by a broad number of drugs used in clinic, and antineoplastic drugs show an elevated proportion of DTH, which potentially affects the quality of life of patients. Despite the serious problem and the negative economic impact deriving from market withdrawal of such drugs and high hospitalization costs, nowadays, there are no standard validated methods in vitro or in vivo to evaluate the sensitizing potential of drugs in the preclinical phase. Enhanced predictions in preclinical safety evaluations are really important, and for that reason, the aim of our work is to adapt in vitro DPRA, ARE-Nrf2 luciferase KeratinoSensTM, and hCLAT assays for the study of the sensitizing potential of antineoplastic agents grouped by mechanism of action. Our results reveal that the above tests are in vitro techniques able to predict the sensitizing potential of the tested antineoplastics. Moreover, this is the first time that the inhibition of the VEGFR1 pathway has been identified as a potential trigger of DTH.
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Aziz, Khalid, Hafiza Sayyar, and Ambreen Shahzad. "Precautions and Safety Measures at Workplace During Pandemic." Journal of Bahria University Medical and Dental College 10, no. 4 (October 1, 2020): 327. http://dx.doi.org/10.51985/jbumdc2020047.
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Pandemic is a worldwide disease outbreak, caused by various types of agents for example influenza and coronaviruses. Recent pandemic has been the third outbreak of coronavirus COVID-19 (Corona virus disease-19) declared by World Health Organization (WHO), spread in more than 213 continent including Pakistan.1 Transmission of disease during pandemic expected in workplaces not only from patient to healthcare personnel but also between the co-workers and people of general public and individuals from other workplaces
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O'Shaughnessy, J. A., R. E. Wittes, G. Burke, M. A. Friedman, J. R. Johnson, J. E. Niederhuber, M. L. Rothenberg, J. Woodcock, B. A. Chabner, and R. Temple. "Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials." Journal of Clinical Oncology 9, no. 12 (December 1991): 2225–32. http://dx.doi.org/10.1200/jco.1991.9.12.2225.
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Expeditious clinical development and approval of new drugs that are beneficial to patients are matters of high priority. There has been a great deal of discussion within the oncology community about what should constitute evidence of effectiveness of new anticancer agents for purposes of drug approval. This commentary is intended to illustrate a variety of end points that can lead to approval of new anticancer agents for specific clinical situations. Although the ultimate hope of antineoplastic therapy is prolongation of life, there are other effects of anticancer drugs that constitute clear clinical benefit and represent evidence of effectiveness. The guiding principle is that the beneficial effects obtained from a new drug should sufficiently outweigh the adverse effects such that the potential risk:benefit ratio achieved by an individual patient is favorable. The assessment of a new drug should flexibly evaluate safety and efficacy in the context of the specific clinical condition being treated. Early discussions with the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) are recommended to identify prospectively the end points and trial designs needed to demonstrate effectiveness of a new drug. The general principles discussed will likely apply to the drug approval process for other medical disciplines as well.
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Park, Seon-Ja, and Hyun-Ju Kim. "Nurses’ Compliance with Safety Guidelines for the Use of Antineoplastic Agents, Observable Symptoms, and Stress from Occupational Exposure." Journal of Korean Academy of Fundamentals of Nursing 25, no. 4 (November 30, 2018): 293–300. http://dx.doi.org/10.7739/jkafn.2018.25.4.293.
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Yun, Ji Hyun, and Jeong Yun Park. "Oncology Nurses' Knowledge of Safety Guidelines and Compliance with Safe Handling of Antineoplastic Agents in a Tertiary Hospitall." Asian Oncology Nursing 16, no. 4 (2016): 251. http://dx.doi.org/10.5388/aon.2016.16.4.251.
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Ribed, Almudena, Vicente Escudero-Vilaplana, Rosa Maria Romero-Jimenez, Irene Iglesias-Peinado, Ana Herranz-Alonso, and Maria Sanjurjo-Saez. "Guiding pharmacist clinical interviews: a safety tool to support the education of patients treated with oral antineoplastic agents." Expert Opinion on Drug Safety 15, no. 4 (March 9, 2016): 427–35. http://dx.doi.org/10.1517/14740338.2016.1150998.
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Fawzy, Nehmedo G., Siva S. Panda, Walid Fayad, May A. El-Manawaty, Aladdin M. Srour, and Adel S. Girgis. "Novel Curcumin Inspired Antineoplastic 1-Sulfonyl-4-Piperidones: Design, Synthesis and Molecular Modeling Studies." Anti-Cancer Agents in Medicinal Chemistry 19, no. 8 (August 21, 2019): 1069–78. http://dx.doi.org/10.2174/1871520619666190408131639.
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Background: Curcumin is a well-known example of plant origin exhibiting promising diverse biological properties such as, anti-inflammatory and antitumor as well as poor pharmacokinetic/pharmacodynamic properties. This is why effective agents based on its chemical scaffold were explored. Methods: A set of 3,5-bis(ylidene)-1-(alkylsulfonyl)piperidin-4-ones were synthesized in excellent yield (80- 96%) through dehydrohalogenation reaction of 3,5-bis(ylidene)-4-piperidinones with the corresponding alkane sulfonyl chloride in the presence of triethylamine. Antiproliferative properties of the synthesized compounds (dienone/curcumin inspired analogues) were studied by the standard MTT technique. Results: Most of the synthesized compounds revealed antiproliferative properties against HCT116 (colon) and A431 (skin/squamous) cancer cell lines with IC50 values at sub-micromolar level. Compound 36 also exhibited potency against MCF7 (breast) and A549 (lung) cancer cell lines (IC50 = 2.23, 4.27µM, respectively) higher than that of the reference standards (IC50 = 3.15, 5.93µM for 5-fluorouracil and doxorubicin against MCF7 and A549 cell lines, respectively). Cytotoxic properties of the synthesized compounds against non-cancer RPE1 cell line supported the safety profile of the effective agents against normal cells. Molecular modeling (3Dpharmacophore and 2D-QSAR) studies validated the observed bio-properties and explained the parameters governing activity. Inhibitory properties of compounds 27 and 29 (representative examples of the promising antiproliferative agents synthesized) supported their mode of action against topoisomerase IIα Conclusion: The synthesized scaffold is a promising antitumor agent (with special selectivity against colon and skin/squamous cancer cell lines) so, it can be considered for further investigation and development of highly effective hits/leads based on the computational models obtained.
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Silva, Ana Elisa Bauer de Camargo, Adriano Max Moreira Reis, Adriana Inocenti Miasso, Jânia Oliveira Santos, and Silvia Helena De Bortoli Cassiani. "Adverse drug events in a sentinel hospital in the State of Goiás, Brazil." Revista Latino-Americana de Enfermagem 19, no. 2 (April 2011): 378–86. http://dx.doi.org/10.1590/s0104-11692011000200021.
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This was a retrospective, descriptive and documental study with the aim of identifying adverse drug events which occurred in the medication administration process and to classify these medication errors. This study was developed in the internal medicine unit of a general hospital of Goiás, Brazil. Report books used by nursing staff from the period 2002 to 2007, were analyzed. A total of 230 medication errors were identified, most of which occurred in the preparation and administration of the medications (64.3%). Medication errors were of omission (50.9%), of dose (16.5%), of schedule (13.5%) and of administration technique (12.2%) and were more frequent with antineoplastic and immunomodulating agents (24.3%) and anti-infective agents (20.9%). It was found that 37.4% of drugs were high alert medications. Considering the medication errors detected it is important to promote a culture of safety in the hospital.
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Collado-Borrell, Roberto, Vicente Escudero-Vilaplana, Almudena Ribed, Rosa Romero Jiménez, Irene Iglesias Peinado, Ana Herranz-Alonso, and María Sanjurjo-Sáez. "Novel mobile application for direct communication between pharmacists and patients treated with oral antineoplastic agents." American Journal of Health-System Pharmacy 77, no. 17 (July 4, 2020): 1393–402. http://dx.doi.org/10.1093/ajhp/zxaa144.
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Abstract Purpose Initial experience with use of a smartphone application to enhance communication with and home monitoring of hematology/oncology patients under treatment with oral antineoplastic agents (OAAs) is described. Summary Broad use of OAAs is changing the landscape of hematology/oncology patient care, with this form of therapy giving patients greater autonomy but also raising concerns about correct OAA administration and management of adverse effects (AEs) or interactions. Information and communication technologies, specifically mobile health technologies, are ideal tools in this new environment. A multidisciplinary team at a large hospital in Spain developed a smartphone application for patients receiving OAA therapy that consists of 5 modules or functionalities: (1) a treatment agenda, or electronic journal of patient activity, including medication use; (2) a treatment record; (3) continuous recording of vital signs (blood pressure and temperature), health-related quality of life, and AEs, with management of AEs based on an algorithm that displays different recommendations according to AE severity; (4) 2-way messaging capability; and (5) information and links to websites of interest. From June through November 2017, 37 patients downloaded and used the application. About two-thirds (68%) of the patients sent a total of 182 messages to the pharmacist on duty; 58% of the patients registered at least 1 AE. The mean time of registration of the first AE after initiation of OAA therapy was 8 days. As a result of patient use of the application, 2 emergency room visits were avoided and 3 patients were referred to a general practitioner. Conclusion The application has allowed real-time monitoring of patients treated with OAAs. This new patient-pharmacist communication channel has facilitated the early detection of AEs, contributing to the safety of treatment and patient satisfaction with healthcare.
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Whitley, Richard J. "The past as Prelude to the Future: History, Status, and Future of Antiviral Drugs." Annals of Pharmacotherapy 30, no. 9 (September 1996): 967–71. http://dx.doi.org/10.1177/106002809603000911.
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OBJECTIVE: To review the first generation of antiviral agents (e.g., idoxuridine, amantadine, vidarabine) that paralleled discovery of antineoplastic agents. DATA SOURCES: A MEDLINE search (1962 to 1996) of the English-language literature pertaining to antiviral agents was performed. DATA EXTRACTION: All articles were considered for this review. Pertinent references on antiviral therapy, as judged by the author, were selected. DATA SYNTHESIS: Acyclovir, the first second-generation antiviral agent, has a known selective mechanism of action and provides the model for development of future antiviral therapies. Despite the safety and clinical value of acyclovir, therapy does not prevent establishment of latency or decrease frequency of occurrences, resistance has been documented, and outcome is frequently poor. With the emergence of the HIV/AIDS epidemic, several antiretroviral agents have been developed and approved. However, none of the four available nucleoside analogs provides a cure. CONCLUSIONS: Viral resistance has emerged as an important component of antiviral therapy. Improved therapies for cytomegalovirus are needed. Several new therapies for herpes zoster, including prodrugs, are licensed or in Phase III clinical trials. Future directions include the use of molecular biologic techniques to identify enzymes unique to viral replication and to accelerate diagnosis of viral diseases.
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Chiang, Shao-Chin, Mandy Shen, Chen-Chia Lin, and Hui-Ping Chang. "Establishing a protocol for the compatibilities of closed-system transfer devices with multiple chemotherapy drugs under simulated clinical conditions." PLOS ONE 16, no. 9 (September 28, 2021): e0257873. http://dx.doi.org/10.1371/journal.pone.0257873.
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Closed-system drug transfer devices (CSTDs) are used to prevent occupational exposure to hazardous drugs in health care providers. They are considered Class II medical devices by the US FDA and are cleared but not approved before marketing. While compatibility tests are conducted by CSTD manufacturers, the procuring institution needs to consider performing its own studies before buying these devices. Herein we tested the compatibility of the components of the Needleless® DualGuard CSTD system (vial access clips, vial access spikes, and administration adaptors) with 10 antineoplastic drugs, under simulated clinical conditions, including compounding and administration, and examined drug potency maintenance, plasticizer migration, and device functionality. All drugs maintained potency within 5%. Diisononyl phthalate leakage was observed from the administration adaptors for paclitaxel and concentrated etoposide solution. In addition, white particles were discovered in CSTDs storing busulfan solution and small cracks were observed on devices which stored melphalan. Thus, it was concluded that even in simulated clinical conditions, instead of extreme conditions, there are still concerns regarding the efficacy and safety of CSTD components. The methodology may be used to implement and detect possible interactions between antineoplastic agents and CSTD components before procurement.
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Spano, Jean-Philippe, Dominique Costagliola, Christine Katlama, Nicolas Mounier, Eric Oksenhendler, and David Khayat. "AIDS-Related Malignancies: State of the Art and Therapeutic Challenges." Journal of Clinical Oncology 26, no. 29 (October 10, 2008): 4834–42. http://dx.doi.org/10.1200/jco.2008.16.8252.
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Despite the impact of combination antiretroviral therapy (cART) on HIV-related mortality, malignancy remains an important cause of death in the current era. Although the advent of cART has resulted in reductions in the incidence of Kaposi's sarcoma and non-Hodgkin's lymphoma, non–AIDS-defining malignancies present an increased risk for HIV-infected patients, characterized by some common clinical features, generally with a more aggressive behavior and a more advanced disease at diagnosis, which is responsible for poorer patient outcomes. Specific therapeutic recommendations are lacking for these new nonopportunistic malignancies, such as Hodgkin's lymphoma, anal cancer, lung cancer, hepatocarcinoma, and many others. Antiretroviral agents have a propensity for causing drug interactions as a result of their ability to either inhibit or induce the cytochrome P450 (CYP) enzyme system. Because many antineoplastic drugs are also metabolized by the CYP system, coadministration with cART could result in either drug accumulation with increased toxicity, or decreased efficacy of one or both classes of drugs. Further research delineating the combined safety and pharmacokinetics of antiretrovirals and antineoplastic therapy is necessary. Special considerations of these AIDS-related and non–AIDS-related malignancies and their clinical and therapeutic aspects constitute the subject of this review.
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Zhang, Shengqi, Chengsong Ye, Jianguo Li, Xin Yu, and Mingbao Feng. "Treatment-driven removal efficiency, product formation, and toxicity evolution of antineoplastic agents: Current status and implications for water safety assessment." Water Research 206 (November 2021): 117729. http://dx.doi.org/10.1016/j.watres.2021.117729.
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Samuel, N., and S. Verma. "Cross-comparison of cancer drug approvals at three international regulatory agencies." Current Oncology 23, no. 5 (October 26, 2016): 454. http://dx.doi.org/10.3747/co.23.2803.
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Background The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities.Methods The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained.Results Overall, the tta for the 37 antineoplastic agents that met the study criteria was significantly less for the fda than for the ema (X̄ = 6.7 months, p < 0.001) or for Health Canada (X̄ = 6.4 months, p < 0.001). The tta was not significantly different for Health Canada and the ema (X̄ = 0.65 months, p = 0.89). An analysis of the review processes demonstrated that the primary reason for the identified discrepancies in tta was the disparate use of accelerated approval mechanisms.Summary In the present study, we systematically compared cancer drug approvals at 3 international regulatory bodies. The differences in tta reflect several important considerations in the regulatory framework of cancer drug approvals. Those findings warrant an enhanced dialogue between clinicians and government agencies to understand opportunities and challenges in the current approval processes and to work toward balancing drug safety with timely access
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Земский, Геннадий Тимофеевич, Леонид Петрович Вогман, and Наталья Валентиновна Кондратюк. "FIRE SAFETY OF HEAT-TRANSFER AGENTS FOR HEAT GENERATORS." Актуальные вопросы пожарной безопасности, no. 3(9) (September 1, 2021): 11–21. http://dx.doi.org/10.37657/vniipo.avpb.2021.31.82.002.
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Рассмотрены свойства двух групп теплоносителей, используемых для понижения рабочей температуры и для повышения рабочей температуры. В первую группу теплоносителей включены: этиленгликоль, диэтиленгликоль, триэтиленгликоль, пропиленгликоль, глицерин. Вторую группу теплоносителей составляют: дифенильная смесь, масло АМТ-300, масло ТЛВ-330, мобильтерм-600, дикумилметан, дитолилметан, тетрахлордифенил, тетракрезилсиликат, нафталин, тройная нафталиновая смесь, нитрит-нитратная смесь. Приводятся физико-химические и пожароопасные свойства названных теплоносителей, а также перечень профилактических противопожарных мероприятий и средств пожаротушения. There are considered the properties of two groups of heat-transfer agents used to reduce the operating temperature and to increase the operating temperature. The following substances are included in the first group of heat-transfer agents: ethylene glycol, diethylene glycol, triethylene glycol, propylene glycol, glycerin. The following substances are included in the second group of heat-transfer agents: diphenyl mixture, AMT-300 oil, TLV-330 oil, mobileterm-600, dicumylmethane, ditolylmethane, tetrachlorodiphenyl, tetracresyl silicate, naphthalene, triple naphthalene mixture, nitrite-nitrate mixture. There are cited the physicochemical and fire hazardous properties of the mentioned heat-transfer agents, as well as the list of preventive fire-fighting measures and fire-extinguishing facilities.
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Kahangi, Leila Sadat, and Narges Toghian Chaharsoughi. "Chemotherapy medication errors in patients with cancer: A narrative review." Journal of Multidisciplinary Care 10, no. 3 (September 30, 2021): 126–31. http://dx.doi.org/10.34172/jmdc.2021.25.
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Background and aims: Chemotherapy medications have narrow therapeutic index and high toxicity and hence, chemotherapy medications errors (CMEs) are very common and are associated with serious consequences. The aim of the present study was to evaluate the types, severity, contributing factors, and preventive strategies of CMEs in patients with cancer. Methods: This narrative review was conducted in 2021. Data were collected through searching the Google Scholar, Elsevier, PubMed, ProQuest, Scientific Information Database (SID), Magiran, IranDoc, and IranMedex databases. Search key terms were "adverse events", "medication error", "cancer", "patient safety", "safety management", "chemotherapy", "antineoplastic agents", "neoplasm", and "cancer". Results: In total, 125 articles were retrieved and finally, eighteen articles were reviewed. Findings came into four main categories, namely types of CMEs, causes of CMEs, severity of CMEs, and strategies to prevent CMEs. The four main types of CMEs are prescription, dispensing, preparation, and administration errors. Prescription and preparation errors are the most common CMEs. Conclusion: Strategies such as computerized physician order entry software, educational programs for nurses, improvement of nurses’ work conditions, and employment of well-trained nurses are recommended to reduce CMEs and improve patient safety.
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Patyashina, M. A., M. V. Trofimova, L. G. Avdonina, L. T. Garaeva, and G. R. Mansurova. "Provision of Biological Safety in the Territory of the Republic of Tatarstan during Preparation and Holding of FIFA World Cup-2018 in Kazan." Problems of Particularly Dangerous Infections, no. 1 (April 3, 2019): 113–17. http://dx.doi.org/10.21055/0370-1069-2019-1-113-117.
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Objective – assessment of effectiveness of the measures for biological safety provision at potentially hazardous facilities in the territory of the Republic of Tatarstan in the process of preparation and holding of FIFA World Cup-2018 in Kazan. Materials and methods. Regulatory-legal acts covering the requirements to the provision of biological safety during the work with pathogenic biological agents, international guidelines and documents determining inter-agency collaboration between the Rospotrebnadzor Administration in the Republic of Tatarstan and other departments and inter-agency task forces (Office of the Federal Security Bureau of Russia in the Republic of Tatarstan, Counter-Terrorism Commission in the Republic of Tatarstan, etc) were studied. Results and discussion. Considered were managerial-methodological approaches and matters of inter-agency cooperation on biological safety provision during preparation and holding of FIFA World Cup-2018 in Kazan. Biological safety was examined through the prism of its provision while working with pathogenic biological agents at potentially hazardous biological facilities and counterterrorism integrity of the objects. The guiding, directive document in the performance of the complex of measures on biological safety provision and inter-agency collaboration was the Order of the President of the Russian Federation dated May 09, 2017 No 202 “On peculiarities of application of reinforced security measures during holding of FIFA World Cup-2018 and FIFA Confederations Cup-2017 in Russia”. As the result of the measures conducted, biological safety, including counter-terrorism security of potentially hazardous biological objects and sanitary-epidemiological welfare, was fully provided.
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Park, Soo Been, Mira Moon, Hyun Hwa Kim, Ga-Yoon Park, Dong Yoon Kang, Ju-Yeun Lee, Yoon Sook Cho, Hye-Ryun Kang, and Sang-Heon Cho. "A 10-Year Single-Center Experience of Adverse Drug Reaction Monitoring." Korean Journal of Medicine 96, no. 4 (August 1, 2021): 341–51. http://dx.doi.org/10.3904/kjm.2021.96.4.341.
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Background/Aims: Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. Methods: Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. Results: During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). Conclusions: The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.
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Ezaki, Asami, Akihiro Hirakawa, Hideki Hanaoka, and Yoshiaki Uyama. "Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis." Therapeutic Innovation & Regulatory Science 55, no. 5 (June 9, 2021): 1075–81. http://dx.doi.org/10.1007/s43441-021-00309-5.
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