The Barbara Ann Karmanos Cancer Institute

facility📍 Detroit, United States
2
Alpha-gal Syndrome Publications
0
Alpha-gal Syndrome Researchers

Associated Institutions

Wayne State University
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McLaren Health Care
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Publications

A randomized phase 2 trial of gemcitabine/cisplatin with or without cetuximab in patients with advanced urothelial carcinoma.

Hussain M, Daignault S, Agarwal N, Grivas PD, Siefker-Radtke AO, et al.
Cancer •

Epidermal growth factor receptor overexpression is associated with poor outcomes in urothelial carcinoma (UC). Cetuximab (CTX) exhibited an antitumor effect in in vivo UC models. The efficacy of gemcitabine/cisplatin (GC) with or without CTX in patients with advanced UC was evaluated. Patients with advanced UC, measurable disease, and adequate organ function were randomized 1:2 to cisplatin (70 mg/m(2) ) on day 1 plus gemcitabine (1000 mg/m(2) ) on days 1, 8, and 15 (arm A) or GC plus CTX (500 mg/m(2) ) on days 1 and 15 (arm B). The primary endpoint was the overall response rate. The secondary endpoints were the response duration, safety, progression-free survival, overall survival, determination of whether or not CTX sensitized nonresponders to GC, and exploratory biomarker analysis. The accrual targets were 27 and 54 patients for the 2 arms, respectively. The overall response rate was reported by arm with binomial confidence intervals (CIs). Kaplan-Meier methods were used for time-to-event endpoints. Eighty-eight eligible patients were randomized; 87 were toxicity-evaluable, and 85 were response-evaluable. The overall response rates were 57.1% for arm A (95% CI = 37%-76%) and 61.4% for arm B (95% CI = 48%-74%). The median progression-free survival times were 8.5 months for arm A (95% CI = 5.7-10.4 months) and 7.6 months for arm B (95% CI = 6.1-8.7 months). The median overall survival times were 17.4 months for arm A (95% CI = 12.8 months to unreached) and 14.3 months for arm B (95% CI = 11.6-22.2 months). The most common grade 3/grade 4 adverse events in both arms were myelosuppression and nausea. Thromboembolism, acneiform rash, fatigue, pain, hypersensitivity reactions, elevated transaminases, hyponatremia, and hypomagnesemia were more common in arm B; 3 grade 5 adverse events occurred in arm B. The presence of primary disease significantly correlated with thromboembolism. An increased soluble E-cadherin level after cycle 2 correlated with a higher risk of death. GC plus CTX was feasible but was associated with more adverse events and no improvements in outcomes.

Possible case of levofloxacin-induced thrombocytopenia.

Salloum R, Liu CY, Weise AM
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists •

A possible case of levofloxacin-induced thrombocytopenia is reported. A 73-year-old Caucasian woman with stage IV squamous cell cancer of the oral cavity arrived at the hospital with a 6-day history of epistaxis; petechiae over her arms, legs, and abdomen; and bruises over her forearms. Her comorbidities included hypertension, type 2 diabetes mellitus, and coronary artery disease. Two weeks before arrival at the hospital, the patient had been admitted to the hospital with community-acquired pneumonia (CAP) and given a 10-day course of levofloxacin 500 mg daily, which she completed 4 days before this admission. Her platelet count was 7,000 cells/mm(3) on admission. Her home medications included aspirin 325 mg daily, ranitidine 150 mg twice daily, alprazolam 0.25 mg daily, and methadone 10 mg twice daily. She last received cetuximab six weeks before this hospital admission. No other new medications were recently introduced. She had no known drug allergies and no recent heparin exposure. The patient was given a platelet transfusion and treated empirically with prednisone for possible immune thrombocytopenic purpura, though drug-induced thrombocytopenia (DIT) was also suspected. She was restarted on her home medications except for aspirin. She was discharged with a 7-day course of oral corticosteroids. At discharge, her platelet count was 38,000 cells/mm(3). Corticosteroids were discontinued when DIT was established to be the most likely diagnosis. A 73-year-old woman with stage IV squamous cell cancer of the oral cavity developed a possible case of levofloxacin-induced thrombocytopenia after receiving the drug for 10 days for treatment of CAP.