Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East.

Incidence rates of Merkel cell carcinoma (MCC), an uncommon skin cancer with an aggressive disease course, have increased in recent decades. Limited treatment options are available for patients with metastatic MCC (mMCC). Avelumab, an anti-programmed cell death-ligand 1 monoclonal antibody, became the first approved treatment for mMCC after the results of the phase 2 JAVELIN Merkel 200 study. Prior to its regulatory approval, an expanded access program (EAP) enabled compassionate use of avelumab in patients with mMCC. Here we report findings from patients enrolled in the EAP in Europe and the Middle East. Efficacy and safety data were provided at the discretion of treating physicians. Between March 2, 2016, and December 22, 2018, 403 requests for avelumab were received from 21 countries, and avelumab was supplied to 335 patients. Most patients (96.7%) received avelumab as second-line or later treatment. In 150 patients for whom response data were available, the objective response rate was 48.0%, and in responding patients, median duration of treatment was 7.4 months (range, 1.0-41.7 months). The most common treatment-related adverse events were infusion-related reaction (2.4%) and pyrexia (2.1%), and no new safety signals were observed. Overall, results from European and Middle Eastern patients enrolled in this EAP confirm the efficacy and safety of avelumab treatment observed in previous studies in patients with mMCC.

The use of medications with anticholinergic properties and risk factors for their use in hospitalised elderly patients.

PURPOSE: The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS: The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during the period between 1 January 2008 and 31 December 2009 in three municipal hospitals. To evaluate the factors influencing the use of anticholinergic medications, we compared two groups-users and non-users of such drugs-in terms of sociodemographic and clinical characteristics as well as comorbid conditions. The most important risk factors were identified using the binary logistic regression model. RESULTS: Hospitalisation led to a significant increase in the prevalence of anticholinergic medication users, when comparing their occurrence at the time of hospital admission and discharge (10.5% and 14.2%, respectively; p < 0.001). A significantly higher total number of prescribed drugs were found in the group of users compared with non-users, at both hospital admission (7.2 ± 3.5 vs 5.7 ± 3.1; p < 0.001) and discharge (8.7 ± 3.1 vs 7.5 ± 2.9; p < 0.001). Immobilisation, urinary incontinence and retention, constipation, gastroduodenal ulcer disease as well as neurologic and psychiatric comorbidities (depression, Parkinson's disease, epilepsy) appeared as the most important risk factors of using anticholinergic medications. CONCLUSIONS: Physicians should be aware of the greater risk of adverse anticholinergic effects of drugs in certain therapeutic classes in the elderly. In patients with risk factors mentioned previously, special attention should be paid to active identification of anticholinergic effects of medications.