A Case Report of a Cutaneous Mucinous Reaction Associated with Erlotinib Therapy Used in the Treatment of Metastatic Tonsillar Sinus Squamous Cell Carcinoma

Cutaneous mucinoses are a diverse group of diseases that are occasionally seen in the context of an adverse drug reaction. We report the case of a 59-year-old male who presented with an asymptomatic, acneiform rash on his forehead, scalp, nose, upper chest, and upper back that had developed after treatment with erlotinib therapy used in the treatment of metastatic tonsillar sinus squamous cell carcinoma. Biopsy of these lesions demonstrated atypical histology that had features of both follicular mucinosis and myxedema. This histologic phenomenon is a rare drug reaction that has not previously been described in association with erlotinib

Characterization of Cutaneous Adverse Events Associated With PI3K Inhibitors in 11 Patients

Introduction: Phosphoinositide 3-kinase (PI3K) inhibitors are a new class of cancer therapeutics that inhibits one or more enzymes in the PI3K/AKT/mTOR tumor growth pathway. As compared to other tyrosine kinase inhibitors, there is evidence that PI3K inhibitors have a higher incidence of severe cutaneous adverse events (CAEs) ranging from 2-21%. There is a lack of further characterization of clinical trials and management options for these CAEs. Methods: A retrospective chart review of our institution's records between January 2015 and May 2019 was conducted; electronic medical records were queried by using a pharmacy database and ICD-10 codes for patients receiving PI3K inhibitor who experienced CAEs during therapy. These CAEs were characterized by two board-certified dermatologists at a major cancer center. Results: Eleven patients were identified as having 12 cumulative CAEs. Average time to rash onset was 4 weeks, and the most common identified rashes were eczematous (25%) and morbilliform (17%). Four patients experienced a dose delay, and one patient immediately discontinued their PI3K inhibitor. Conclusion: Although most CAEs caused by PI3K inhibitors in this study were limited to grade 1–2 and were controlled with topical corticosteroids and oral antihistamines, a number of patients experienced dose impact. This highlights the dermatologist's role in managing and minimizing interruption of therapy while maintaining quality of life

Edoxaban versus warfarin in patients with atrial fibrillation

Contains fulltext : 125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)