No abstract

BackgroundTwo main therapies, pazopanib and sunitinib, are used in the first-line setting for metastatic renal cell carcinoma (mRCC). These two tyrosine kinase inhibitors (TKI) are equally effective in terms of survival; however, they frequently induce adverse events. In this setting, Health-Related Quality of life (HRQoL) is a key element in the choice between these two treatments and the evaluation of treatment effectiveness. It could be of interest to evaluate HRQoL in daily clinical practice to aid adequate therapy choice and management. Currently, the development of information and communication technology may allow HRQoL monitoring in routine practice. The objective of the QUANARIE study is to evaluate the use of HRQoL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic patient-reported outcomes (e-PRO). The present article describes the key elements of the study protocol.MethodsThe QUANARIE study is an interventional, prospective, multicentre trial. Patients diagnosed with mRCC initiating sunitinib or pazopanib treatment will be invited to complete the EORTC QLQ-C30 questionnaire, nine additional questions from the EORTC items library, and the EuroQoL EQ-5D, prior to each visit with the physician. Questionnaires will be completed by patients using tablets and/or computer terminals via the e-PRO software. The physician will have real-time access to a visual summary of the HRQoL evaluation. The primary objective is to assess the proportion of patients having good compliance with Routine Electronic Monitoring of HRQoL (REMOQOL) during the first 12 months. Physicians’ satisfaction with REMOQOL will be assessed as a secondary objective. We hypothesise that 80% of patients having good compliance with REMOQOL would be meaningful. A sample size of 56 patients would be needed.DiscussionThe results of this study will show whether REMOQOL is feasible on a large scale and whether patients are receptive to this new practice. This study will also determine how real-time multidimensional evaluation of patient perception can help physicians in their daily practice and how they used it in conjunction with other clinical information to manage patient care.Trial registrationClinicalTrials.gov; Identifier: NCT03062410; First Posted: February 23, 2017; Last Update Posted: August 9, 2017.

The development of eosinophilic gastritis immediately after Helicobacter pylori eradication has not previously been described: A 62-year-old woman developed eosinophilic gastritis immediately after a triple therapy for Helicobacter pylori eradication, consisting of pantoprazole, amoxicillin and clarithromycin. She suffered from burning epigastric pain and loss of appetite. Blood eosinophilia, gastritis and eosinophilic infiltration of the gastric corpus wall were detected. The treatment with low-dose prednisolone led to remission of the blood eosinophilia, complaints, gastritis and eosinophilic infiltration. The remission persisted after the prednisolone treatment had been finished. Eosinophilic gastritis can be diagnosed only by pathohistological examination. This need for biopsy should be stressed, because the usual gastritis treatment with proton pump inhibitors fails in cases of eosinophilic gastritis. Helicobacter pylori does not seem to play a significant role in the aetiopathology of this disorder. In our case, we suggest that the eradication drug therapy actually caused the disease.

No abstract