Drug-induced Adverse Events

Temporal course of avascular femoral head necrosis in patients with pemphigus vulgaris.
Temporal course of avascular femoral head necrosis in patients with pemphigus vulgaris.
J Dtsch Dermatol Ges. 2016 Oct;14(10):1016-1021
Authors: Balighi K, Daneshpazhooh M, Aghazadeh N, Saeidi V, Shahpouri F, Hejazi P, Chams-Davatchi C
Abstract
BACKGROUND AND OBJECTIVES: Pemphigus vulgaris (PV) is typically treated with systemic corticosteroids and immunosuppressive agents. Avascular necrosis (AVN) of the femoral head is a well-recognized major complication of corticosteroid therapy. The characteristics of this serious complication in PV remain unknown.
PATIENTS AND METHODS: Uncontrolled, retrospective study of all PV-related AVN cases diagnosed at an Iranian autoimmune bullous disease clinic between 1985 and 2013.
RESULTS: Of the 2,321 medical records of PV patients reviewed, 45 (1.93 %) cases showed femoral AVN, with 30 (66.7 %) individuals being male. The mean age at diagnosis of AVN was 47.4 ± 14.2 years. The mean interval between the diagnosis of PV and the onset of AVN was 25.3 ± 18.3 months. With the exception of eight cases (17.8 %), the majority of patients developed AVN within three years after the diagnosis of PV. The mean cumulative dose of prednisolone in patients with AVN was 13,115.8 ± 7041.1 mg. There was a strong correlation between the total prednisolone dose and the time of onset of AVN (p = 0.001). In patients with a history of alendronate intake, that interval was significantly shorter (p = 0.01).
CONCLUSIONS: Occurring in about 2 % of patients, AVN is a serious complication of corticosteroid treatment in patients with PV, predominantly in the first three years of treatment. In individuals receiving higher doses of prednisolone, AVN tends to occur earlier.
PMID: 27767268 [PubMed - indexed for MEDLINE]
The 12-year follow-up of survival, chronic adverse effects, and retention of arsenic in patients with acute promyelocytic leukemia.
The 12-year follow-up of survival, chronic adverse effects, and retention of arsenic in patients with acute promyelocytic leukemia.
Blood. 2016 09 15;128(11):1525-8
Authors: Zhu H, Hu J, Chen L, Zhou W, Li X, Wang L, Zhao X, Zhang Y, Zhao H, Wang A, Chen Y, Sun H, Chen Q, Chen Y, Zhao W, Mi J, Shen Z, Wang Z, Chen Z, Chen S, Li J
PMID: 27402972 [PubMed - indexed for MEDLINE]
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +13 new citations
13 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")
These pubmed results were generated on 2018/02/06
PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +16 new citations
16 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")
These pubmed results were generated on 2018/02/05
PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +16 new citations
16 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:
("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")
These pubmed results were generated on 2018/02/03
PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
Benefits of and Barriers to Pharmacogenomics-Guided Treatment for Major Depressive Disorder.
Benefits of and Barriers to Pharmacogenomics-Guided Treatment for Major Depressive Disorder.
Clin Pharmacol Ther. 2018 Feb 01;:
Authors: Ahmed AT, Weinshilboum R, Frye MA
Abstract
Antidepressants have reduced the symptom burden for many Major Depressive Disorder (MDD) patients, but drug-related side effects and treatment resistance continue to present major challenges. Pharmacogenomics represents one approach to enhance antidepressant efficacy and avoid adverse reactions, but concerns remain with regard to the overall "value equation," and several barriers must be overcome to achieve the full potential of MDD pharmacogenomics.
PMID: 29388201 [PubMed - as supplied by publisher]
[Development of "Patient Friendly Formulations" to Counter the Side Effects of Cancer Chemotherapy].
[Development of "Patient Friendly Formulations" to Counter the Side Effects of Cancer Chemotherapy].
Yakugaku Zasshi. 2018;138(2):169-175
Authors: Hanawa T, Kawano Y, Satoh M
Abstract
Anticancer drug-induced stomatitis develops in 30% to 40% of cancer patients undergoing chemotherapy. However, medications for this condition are not commercially available in Japan. The "hospital formulation" is a customized medicine which hospital pharmacists prepare when doctors cannot carry out the medical therapy most suitable for a patient using commercial medicines. However, as the duties of pharmacists increase, use of the "hospital fomulation" decreases. Therefore, development of "hospital fomulations" based on individual evidence has a limit. Irsogladine maleate (IM) is a drug with gastric mucosal protective properties. IM increases intracellular cAMP levels in the gastric mucosa and activates communication between cells. It has been reported that the oral administration of IM reduces the incidence of 5-FU-based chemotherapy-induced stomatitis. However, there have been no reports on the effect of the direct use of IM in treating stomatitis. Therefore, we studied the development of an IM oral spray for stomatitis treatment, and obtained evidence of a direct effect in an animal experiment using a stomatitis model. Next, rebamipide mouthwash was administered to patients who had stomatitis caused by cancer chemotherapy. The total scores were classified into Grades 0 to 4 and evaluated as a stomatitis evaluation score (SES). When comparing SES and changes in the stomatitis area in patients, gradual reductions in the extent of stomatitis were observed, even during the period when SES did not change. Having patients fill in an observation chart was effective for grasping changes in symptoms in outpatients.
PMID: 29386430 [PubMed - in process]
Analysis of Adverse Events Associated With Adult Moderate Procedural Sedation Outside the Operating Room.
Analysis of Adverse Events Associated With Adult Moderate Procedural Sedation Outside the Operating Room.
J Patient Saf. 2017 Sep;13(3):111-121
Authors: Karamnov S, Sarkisian N, Grammer R, Gross WL, Urman RD
Abstract
INTRODUCTION: Moderate sedation outside the operating room is performed for a variety of medical and surgical procedures. It involves the administration of different drug combinations by nonanesthesia professionals. Few data exist on risk stratification and patient outcomes in the adult population. Current literature suggests that sedation can be associated with significant adverse outcomes.
OBJECTIVES: The aims of this study were to evaluate the nature of adverse events associated with moderate sedation and to examine their relation to patient characteristics and outcomes.
METHODS: In this retrospective review, 52 cases with moderate sedation safety incidents were identified out of approximately 143,000 cases during an 8-year period at a tertiary care medical center. We describe types of adverse events and the severity of associated harm. We used bivariate and multivariate analyses to examine the links between event types and both patient and procedure characteristics.
RESULTS: The most common adverse event and unplanned intervention were oversedation leading to apnea (57.7% of cases) and the use of reversal agents (55.8%), respectively. Oversedation, hypoxemia, reversal agent use, and prolonged bag-mask ventilation were most common in cardiology (84.6%, 53.9%, 84.6%, and 38.5% of cases, respectively) and gastroenterology (87.5%, 75%, 87.5%, and 50%) suites. Miscommunication was reported most frequently in the emergency department (83.3%) and on the inpatient floor (69.2%). Higher body mass index was associated with increased rates of hypoxemia and intubation but lower rates of hypotension. Advanced age boosted the rates of oversedation, hypoxemia, and reversal agent use. Women were more likely than men to experience oversedation, hypotension, prolonged bag-mask ventilation, and reversal agent use. Patient harm was associated with age, body mass index, comorbidities, female sex, and procedures in the gastroenterology suite.
CONCLUSIONS: Providers should take into account patient characteristics and procedure types when assessing the risks of harmful sedation-related complications.
PMID: 25203503 [PubMed - indexed for MEDLINE]
Outpatient treatment of acute bacterial skin and skin structure infections (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States: Subgroup analysis of 2 randomized phase 3 trials.
Outpatient treatment of acute bacterial skin and skin structure infections (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States: Subgroup analysis of 2 randomized phase 3 trials.
Medicine (Baltimore). 2017 Dec;96(52):e9163
Authors: De Anda C, Anuskiewicz S, Prokocimer P, Vazquez J
Abstract
BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSI) are a frequent cause of hospital admissions in the United States. Safe and effective outpatient treatments may lower ABSSSI-associated health care costs by reducing unnecessary hospital admissions. Using data from 2 phase 3 trials (ESTABLISH-1, NCT01170221; ESTABLISH-2, NCT01421511), this post-hoc analysis explored the efficacy and safety of tedizolid in an outpatient setting.
METHODS: Subgroup analysis was performed on US outpatients (defined as patients who were not in hospital at the time of treatment initiation) with ABSSSI caused by presumed or proven gram-positive pathogens. Patients were randomly assigned to receive tedizolid phosphate 200 mg once daily for 6 days (n = 403) or linezolid 600 mg twice daily for 10 days (n = 410). The primary end point was early clinical response (48-72 hours after the start of treatment). Secondary end points included investigator-assessed clinical response at end of therapy (EOT) and post-therapy evaluation (PTE; 7-14 days after therapy). Additional assessments included the patient-reported level of pain using a visual analog scale (VAS) and the per-pathogen favorable microbiological response rate at the PTE visit. Compliance with treatment and safety outcomes was also recorded.
RESULTS: Early clinical response was similar between treatment groups (tedizolid, 82.4%; linezolid, 79.0%), as was investigator-assessed clinical response at EOT (tedizolid, 87.1%; linezolid, 86.1%) and PTE (tedizolid, 83.1%; linezolid, 83.7%). Mean changes from baseline to days 10 to 13 in VAS scores were identical between treatment groups (tedizolid, -51.9 mm; linezolid, -51.9 mm). Microbiological eradication rates were generally similar in both treatment groups for all key pathogens. Patients in both groups had favorable response at PTE. More tedizolid-treated patients (89.3%) than linezolid-treated patients (77.3%) were compliant with treatment. The most frequently reported drug-related treatment-emergent adverse events were nausea (tedizolid, 10.7%; linezolid, 13.8%), diarrhea (tedizolid, 4.5%; linezolid, 5.9%), and headache (tedizolid, 5.5%; linezolid, 4.4%). Treatment discontinuation rates were low for both treatment groups (tedizolid, 0.7%; linezolid, 1.0%).
CONCLUSION: Short-course therapy with tedizolid can successfully treat patients with ABSSSI caused by presumed or proven gram-positive pathogens in an outpatient setting.
PMID: 29384903 [PubMed - in process]
Frequency and type of drug-related side effects necessitating treatment discontinuation in the Swiss Inflammatory Bowel Disease Cohort.
Frequency and type of drug-related side effects necessitating treatment discontinuation in the Swiss Inflammatory Bowel Disease Cohort.
Eur J Gastroenterol Hepatol. 2018 Jan 30;:
Authors: Godat S, Fournier N, Safroneeva E, Juillerat P, Nydegger A, Straumann A, Vavricka S, Biedermann L, Greuter T, Fraga M, Abdelrahman K, Hahnloser D, Sauter B, Rogler G, Michetti P, Schoepfer AM, on behalf of the Swiss IBD Cohort Study Group
Abstract
BACKGROUND AND AIM: Systematic analyses of inflammatory bowel disease (IBD) drug-related side effects necessitating treatment cessation in large cohorts of patients with IBD are scarce. We aimed to assess the frequency and type of drug-related side effects requiring drug cessation in patients included in the Swiss IBD Cohort.
PATIENTS AND METHODS: A retrospective review was performed of data from the Swiss IBD Cohort physician questionnaires documenting a treatment cessation for the following drug categories: aminosalicylates, topical and systemic steroids, thiopurines, methotrexate, tumor necrosis factor-antagonists, and calcineurin inhibitors (tacrolimus, cyclosporine).
RESULTS: A total of 3192 patients were analyzed, of whom 1792 (56.1%) had Crohn's disease, 1322 (41.4%) had ulcerative colitis, and 78 (2.5%) had IBD unclassified. Of 3138 patients treated with IBD drugs, 2129 (67.8%) presented with one or several drug-related side effects necessitating drug cessation. We found a significant positive correlation between the number of concomitantly administered IBD drugs and the occurrence of side effects requiring drug cessation (P<0.001). Logistic regression modeling identified Crohn's disease diagnosis [odds ratio (OR)=1.361, P=0.017], presence of extraintestinal manifestations (OR=2.262, P<0.001), IBD-related surgery (OR=1.419, P=0.006), and the increasing number of concomitantly used IBD drugs [OR=2.007 (P<0.001) for two concomitantly used IBD drugs; OR=3.225 (P<0.001) for at least three concomitantly used IBD drugs] to be associated significantly with the occurrence of IBD drug-related adverse events that necessitated treatment cessation.
CONCLUSION: Physicians should keep in mind that the number of concomitantly administered IBD drugs is the main risk factor for drug-related adverse events necessitating treatment cessation.
PMID: 29384798 [PubMed - as supplied by publisher]
A Case of Drug-Induced Severe Endocrinopathies: What Providers in the Emergency Department Need to Know.
A Case of Drug-Induced Severe Endocrinopathies: What Providers in the Emergency Department Need to Know.
Adv Emerg Nurs J. 2018 Jan/Mar;40(1):16-20
Authors: Villarreal J, Townes D, Vrablik M, Ro K
Abstract
The purpose of this article is to present a discussion of immune checkpoint inhibitors (ICIs) that are relatively new, yet growing, form of cancer therapy. Immune checkpoint inhibitors increase host immune response against neoplastic cells. Strengthened immunological response increases the potential for adverse events such as life-threatening endocrinopathies. The case of a 66-year-old man with metastatic melanoma treated with nivolumab and ipilimumab presented to the emergency department with marked hyperglycemia and elevated anion gap 19 days after receiving both agents is discussed. The patient received a diagnosis of immune-mediated diabetes requiring ongoing insulin even after discontinuation of ICIs. As treatment with this class of agents expands, emergency department providers will need to become familiar with the identification of their adverse reactions to provide the proper management of care.
PMID: 29384770 [PubMed - in process]
Prevalence of Nausea and Vomiting in Adults Using Ropinirole: A Systematic Review and Meta-Analysis.
Prevalence of Nausea and Vomiting in Adults Using Ropinirole: A Systematic Review and Meta-Analysis.
Dig Dis Sci. 2018 Jan 30;:
Authors: Kurin M, Bielefeldt K, Levinthal DJ
Abstract
BACKGROUND: Nausea and vomiting are commonly associated with medication use. Dopaminergic agonists have been associated with these symptoms, but their impact in patients without Parkinson's disease, such as those with restless legs syndrome (RLS), is not well characterized.
AIMS: We sought to determine whether the non-ergoline dopamine agonist ropinirole is associated with nausea and vomiting in adults with RLS.
METHODS: We conducted a systematic review using PUBMED, EMBASE, and clinical trial databases to identify placebo-controlled clinical trials of ropinirole for RLS treatment. We extracted data including dosing schedule and the proportion of patients reporting nausea and/or vomiting. We also determined hazard ratios (HR) using a random effects proportional hazard model.
RESULTS: We extracted data from a pool of 13 studies. The prevalence of nausea in the ropinirole-treated RLS group (RLS-R; N = 1528) was 37.2% compared to 9.4% in the placebo-treated RLS group (RLS-P; N = 1395) (p < 0.0001). The prevalence of vomiting in the RLS-R group was 10.9% compared to 2.6% in the RLS-P group (p < 0.0001). Ropinirole use was associated with a higher risk of reporting nausea (HR 5.924 [4.410-7.959], p < 0.001) and experiencing vomiting (HR 4.628 [3.035-7.057], p < 0.0001). Nausea and vomiting represented nearly 50% of all adverse events reported.
CONCLUSIONS: Nausea and vomiting are quite common side effects in those using ropinirole for RLS. As RLS is more widely recognized and treated; the prevalence of ropinirole-induced nausea and vomiting could grow substantially. Ropinirole use should be considered as a cause of chronic nausea and vomiting.
PMID: 29383607 [PubMed - as supplied by publisher]
Severe cutaneous adverse drug reactions of Chinese inpatients: a meta-analysis.
Severe cutaneous adverse drug reactions of Chinese inpatients: a meta-analysis.
An Bras Dermatol. 2017 May-Jun;92(3):345-349
Authors: Deng Q, Fang X, Zeng Q, Lu J, Jing C, Huang J
Abstract
BACKGROUND: The rate of severe cutaneous adverse drug reactions is low, and these reactions can result in death or disability. An evidence-based epidemiological study of severe cutaneous adverse drug reactions in China has not been reported.
OBJECTIVE: The aim of this study was to analyze epidemiology and characteristics of severe cutaneous adverse drug reactions of Chinese inpatients during the recent 15 years with meta-analysis.
METHODS: We retrospectively reviewed Chinese literature reporting severe cutaneous adverse drug reactions and collecting data from 2000 to 2015, which were in accordance with our inclusion criteria. All included data were analyzed with the Launch Open Meta-Analyst software.
RESULTS: Twenty-five articles involving 928 cases with severe cutaneous adverse drug reactions were included. Men to women ratio was 1.14:1. Twenty-one per cent of the patients had drug allergy history. Antibiotics (26.0%), sedative hypnotics and anticonvulsants (21.6%), and antipyretic analgesics (17.1%) were the most common causative drugs. The most frequent clinical subtype was Stevens-Johnson syndrome (50.1%), followed by toxic epidermal necrolysis (25.4%), exfoliative dermatitis (21.0%) and drug-induced hypersensitivity syndrome (1.6%). In addition to skin rashes, patients with severe cutaneous adverse drug reactions suffered mostly from fever (73%), and blood routine abnormality (66.7%).
STUDY LIMITATIONS: This meta-analysis is limited by its retrospective design and by its methodological variation.
CONCLUSION: The most common causative drugs were antibiotics and sedative hypnotics and anticonvulsants. Stevens-Johnson syndrome was the most frequent clinical subtype of severe cutaneous adverse drug reactions. In addition to skin rashes, patients with severe cutaneous adverse drug reactions suffered mostly from fever, mucosal lesion, and hematologic abnormalities.
PMID: 29186246 [PubMed - indexed for MEDLINE]
FDA Adds Online REMS Table.
FDA Adds Online REMS Table.
Am J Nurs. 2017 Nov;117(11):21
Authors: Aschenbrenner DS
PMID: 29076851 [PubMed - indexed for MEDLINE]
Interactions between brain and spinal cord mediate value effects in nocebo hyperalgesia.
Interactions between brain and spinal cord mediate value effects in nocebo hyperalgesia.
Science. 2017 10 06;358(6359):105-108
Authors: Tinnermann A, Geuter S, Sprenger C, Finsterbusch J, Büchel C
Abstract
Value information about a drug, such as the price tag, can strongly affect its therapeutic effect. We discovered that value information influences adverse treatment outcomes in humans even in the absence of an active substance. Labeling an inert treatment as expensive medication led to stronger nocebo hyperalgesia than labeling it as cheap medication. This effect was mediated by neural interactions between cortex, brainstem, and spinal cord. In particular, activity in the prefrontal cortex mediated the effect of value on nocebo hyperalgesia. Value furthermore modulated coupling between prefrontal areas, brainstem, and spinal cord, which might represent a flexible mechanism through which higher-cognitive representations, such as value, can modulate early pain processing.
PMID: 28983051 [PubMed - indexed for MEDLINE]
Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infection in elderly patients with underlying disease.
Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infection in elderly patients with underlying disease.
J Microbiol Immunol Infect. 2017 Aug;50(4):541-544
Authors: Takamatsu K, Marumo S, Fukui M, Hata A
Abstract
We retrospectively analyzed data of 38 elderly patients, each with an underlying disease, to evaluate peramivir safety and efficacy. Six patients (15.8%) experienced adverse events, all tolerated. Median time from administration until the return to normal temperatures was 31.5 h (95% CI: 22.4-40.6). Results confirm intravenous peramivir's usefulness.
PMID: 28720319 [PubMed - indexed for MEDLINE]
High-risk prescribing in an Irish primary care population: trends and variation.
High-risk prescribing in an Irish primary care population: trends and variation.
Br J Clin Pharmacol. 2017 Dec;83(12):2821-2830
Authors: Byrne CJ, Cahir C, Curran C, Bennett K
Abstract
AIMS: The aims of the present study were to examine the prevalence of high-risk prescribing (HRP) in community-dwelling adults in Ireland from 2011-2015 using consensus-validated indicators, factors associated with HRP, and the variation in HRP between general practitioners (GPs) and in the dispensing of high-risk prescriptions between pharmacies.
METHODS: A repeated cross-sectional national pharmacy claims database study was conducted. Prescribing indicators were based on those developed in formal consensus studies and applicable to pharmacy claims data. Multilevel logistic regression was used to examine factors associated with HRP and dispensing.
RESULTS: There were significant reductions in the rates of most indicators over time (P < 0.001). A total of 66 022 of 300 906 patients at risk in 2011 [21.9%, 95% confidence interval (CI) 21.8, 22.1%], and 42 109 of 278 469 in 2015 (15.1%, 95% CI 15.0, 15.3%), received ≥1 high-risk prescription (P < 0.001). In 2015, indicators with the highest rates of HRP were prescription of a nonsteroidal anti-inflammatory drug (NSAID) without gastroprotection in those ≥75 years (37.2% of those on NSAIDs), coprescription of warfarin and an antiplatelet agent or high-risk antibiotic (19.5% and 16.2% of those on warfarin, respectively) and prescription of digoxin ≥250 μg day-1 in those ≥65 years (14.0% of those on digoxin). Any HRP increased significantly with age and number of chronic medications (P < 0.001). a) After controlling for patient variables, the variation in the rate of HRP between GPs was significant (P < 0.05); and b) after controlling for patient variables and the prescribing GP, the variation in the rate of dispensing of high-risk prescriptions between pharmacies was significant (P < 0.05).
CONCLUSIONS: HRP in Ireland has declined over time, although some indicators persist. The variation between GPs and pharmacies suggests the potential for improvement in safe medicines use in community care, particularly in vulnerable older populations.
PMID: 28701029 [PubMed - indexed for MEDLINE]
Emerging In Vitro Liver Technologies for Drug Metabolism and Inter-Organ Interactions.
Emerging In Vitro Liver Technologies for Drug Metabolism and Inter-Organ Interactions.
Tissue Eng Part B Rev. 2016 Oct;22(5):383-394
Authors: Bale SS, Moore L, Yarmush M, Jindal R
Abstract
In vitro liver models provide essential information for evaluating drug metabolism, metabolite formation, and hepatotoxicity. Interfacing liver models with other organ models could provide insights into the desirable as well as unintended systemic side effects of therapeutic agents and their metabolites. Such information is invaluable for drug screening processes particularly in the context of secondary organ toxicity. While interfacing of liver models with other organ models has been achieved, platforms that effectively provide human-relevant precise information are needed. In this concise review, we discuss the current state-of-the-art of liver-based multiorgan cell culture platforms primarily from a drug and metabolite perspective, and highlight the importance of media-to-cell ratio in interfacing liver models with other organ models. In addition, we briefly discuss issues related to development of optimal liver models that include recent advances in hepatic cell lines, stem cells, and challenges associated with primary hepatocyte-based liver models. Liver-based multiorgan models that achieve physiologically relevant coupling of different organ models can have a broad impact in evaluating drug efficacy and toxicity, as well as mechanistic investigation of human-relevant disease conditions.
PMID: 27049038 [PubMed - indexed for MEDLINE]
High incidence and early onset of nivolumab-induced pneumonitis: four case reports and literature review.
High incidence and early onset of nivolumab-induced pneumonitis: four case reports and literature review.
BMC Pulm Med. 2018 Jan 30;18(1):23
Authors: Koyama N, Iwase O, Nakashima E, Kishida K, Kondo T, Watanabe Y, Takahashi H, Umebayashi Y, Ogawa Y, Miura H
Abstract
BACKGROUND: Nivolumab, an anti-programmed cell death-1 (PD-1) monoclonal antibody used as an immune checkpoint inhibitor, is commonly employed for its anti-tumor effects against various types of malignant tumors. However, its administration is complicated by immune-related adverse events (irAEs), including pneumonitis.
CASE PRESENTATION: We present a case series of four patients with malignant melanoma, non-small cell lung cancer, and hypopharyngeal carcinoma who demonstrated pneumonitis induced by nivolumab, and further review clinicopathological characteristics of these patients in comparison with those of previously reported patients with nivolumab-induced pneumonitis. In our series, 20% of patients who were treated with nivolumab developed pneumonitis, all of which occurred approximately 2 weeks after the initiation of nivolumab treatment. Prompt recognition of the nivolumab-induced pneumonitis allowed for successful resolution. Computed tomography scan images of the patients demonstrated predominantly cryptogenic organizing pneumonia patterns. All patients were males, who had been heavily treated with antitumor drugs prior to nivolumab.
CONCLUSIONS: Our case series showed that nivolumab had a high incidence of drug-induced pneumonitis with early onset, supporting the need for renewed attention to nivolumab-induced pneumonitis, particularly in patients with a history of heavy antitumor treatments.
PMID: 29378571 [PubMed - in process]
Infusion Room-Based Transition to Practice Model for Teaching Cancer Systemic Therapy Management.
Infusion Room-Based Transition to Practice Model for Teaching Cancer Systemic Therapy Management.
J Oncol Pract. 2017 Nov;13(11):e909-e915
Authors: Duff JM, Markham MJ, George TJ, Close JL
Abstract
PURPOSE: Oncology training requirements mandate that fellows demonstrate competence in delivery of cancer therapeutics, understand clinical indications for treatment, and manage toxicities by completion of training. An academic training environment may hinder fellows' engagement in prescribing, monitoring, and adjusting cancer therapy; thus, trainees may complete their fellowship with limited experience in developing such critical skills. To provide hands-on experience in cancer systemic therapy management, we created a novel infusion room-based rotation in the final year of training; here we report the structure, logistics, and evaluation of this innovative program.
METHODS: In 2004, The University of Florida Hematology Oncology Fellowship Program created an outpatient infusion room rotation called Transition to Practice (TTP). We surveyed 20 graduates of the program to assess the ability of the rotation to teach skills necessary for systemic therapy management and identify which fellowship rotations had an impact on their readiness to practice independently.
RESULTS: Nineteen graduates completed the survey. TTP was rated highest for promoting independence in making decisions related to therapy and adjustment to the treatment plan. It was less valuable in teaching the financial aspects of cancer therapy encounters. The Veterans Affairs Medical Center continuity clinic and the TTP rotation were highly regarded for preparing graduates to practice oncology independently.
CONCLUSION: We consider the TTP model an effective learning environment for oncology trainees to develop the essential skill set for managing cancer systemic therapy on the basis of this single-institution analysis of recent graduates. This model could be applied to training other oncology professionals, such as advanced practice providers, who are new to the field.
PMID: 28885879 [PubMed - indexed for MEDLINE]