On October 24, 2019, a marketing authorization valid through the European Union (EU) was issued for gilteritinib monotherapy for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an Fms‐like tyrosine kinase 3 (FLT3) mutation. Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD. The recommended starting dose of gilteritinib is 120 mg (three 40 mg tablets) once daily. Gilteritinib was evaluated in one, phase III, open‐label, multicenter, randomized study of gilteritinib (n = 247, gilteritinib arm) versus salvage chemotherapy (n = 124, salvage chemotherapy arm) in patients with relapsed or refractory AML with FLT3 mutation. Overall survival (OS) was statistically significantly different between the two groups with a median OS of 9.3 months in the gilteritinib arm compared with 5.6 months for salvage chemotherapy (hazard ratio, 0.637; 95% confidence interval, 0.490–0.830; p = .0004 one‐sided log‐rank test). The most common adverse reactions with gilteritinib treatment were blood creatine phosphokinase increase, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, dizziness, hypotension, pain in extremity, asthenia, arthralgia, and myalgia. The objective of this article is to summarize the scientific review of the application leading to regulatory approval in the EU. Implications for Practice Xospata was approved in the European Union as monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms‐like tyrosine kinase 3 (FLT3) mutation. Gilteritinib resulted in a clinically meaningful and statistically significant improvement of overall survival compared with salvage chemotherapy. At the time of the marketing authorization of gilteritinib, there were no approved standard therapies specifically for adult patients diagnosed with relapsed or refractory AML with FLT3 mutation. In terms of safety, the overall accepted safety profile was considered manageable.

Summary Introduction. Many medical and conservative surgical treatment options are available but still hysterectomy remains the most common gynecological procedure performed worldwide. These procedures are performed because of actual and possible malignant diseases, and benign conditions including pelvic pain, dyspareunia, uterine myomas, adenomyosis, endometriosis, and menometrorrhagia. The impact of hysterectomy on sexual function has always been a great concern to women and is a major source of preoperative anxiety. Data regarding the impact of hysterectomy on women's sexual functioning are not clear and consistent, many women report improvement of sexual functioning after hysterectomy, which may be due to relief of symptoms, while others complain of sexual dysfunction as a result of hysterectomy. Also discussion about advantages of cervix sparing operations is still controversial. Aim of the study. Aim was to assess and compare pre- and post-operative quality of sexual life of gynecological patients undergoing planned hysterectomy, and to find out opinions of patients and their partners about expected impact of operation and changes after surgery. Material and methods. Questionnaire method was used to survey gynecologic patients undergoing planned subtotal / total hysterectomy due to benign indication. Sexual Quality of Life Questionnaire – Female (SQoL-F) was used to assess quality of sexual life before and after surgery. Questions about other influencing factors and patients' opinions before and after operation were added. 38 completed questionnaires were used for data analysis. Results. Only 55% of subtotal hysterectomy group and 38.9% of total hysterectomy group told their partners completely about planned surgery. Mean period of beginning sexual activities after operation was 5.15 weeks after surgery in subtotal hysterectomy and 5.78 weeks in total hysterectomy group. SQoL-F after three months post-operation period was 6.50 points less in total hysterectomy group, which was not statistically significant. There was a slight statistically insignificant decrease of SQoL-F points within each group after three months observation period: -0.44 points in subtotal hysterectomy group and -2.47 points in total hysterectomy group. Although patients of total hysterectomy more frequently (22.2% vs. 5%) indicated negative impact on sexual function after operation, differences were not statistically significant. There were no differences in co-morbidities, concomitant medications, hormone use history and post-operative complications between groups. Conclusions. Patients before hysterectomy are worried about possible negative impact of surgery on their sexual function, they do not talk to their partners candidly about planned surgery. There were no statistically significant changes of sexual quality of life found after subtotal and total abdominal hysterectomy operation after three months observation period.

Background and Objectives: Edentulism is considered to be an impediment impacting both patients’ quality of life and their nutrition. Conventional complete dentures are still a preferred treatment. However, there is no consensus on the most important factors which could substantially reduce the risk of patient dissatisfaction. This study evaluated the following determinants concerning patient satisfaction with complete maxillary and mandibular dentures: sex, denture-related functional and aesthetic aspects, and the degree of bone resorption. Materials and Methods: This study included 70 patients aged 34–81 years of age. All complete dentures were made by following the same technology. Visual analogue scales were used to assess patients’ overall satisfaction with dentures, comfort, ability to speak and chew, denture aesthetics, stability, and ease of prosthesis cleaning. Satisfaction with upper and lower dentures was rated separately. The degree of bone resorption was classified by using the Kalk and de Baat (1989) method. Results: The mean (SD) age of the study participants was 67.3 (10.4) years; 65.7% (n = 46) were females and 34.3% (n = 24) were males. There were no significant sex-based differences in resorption of the maxilla or mandibula. There were significant differences between maxillary and mandibular dentures, with lower mean satisfaction scores concerning chewing and maxillary complete dentures, and in regard to stability and comfort for mandibular complete dentures. There was a non-significant overall lower satisfaction with increased age. In multivariate analysis for mandibular complete dentures, aesthetics and stability significantly predicted the patient’s comfort levels, and the patient’s comfort significantly predicted overall satisfaction. For maxillary complete dentures, patient comfort and aesthetics significantly predicted overall patient satisfaction. Conclusions: Age, sex, and degree of resorption were not associated with patient satisfaction with complete dentures. Overall, patient satisfaction with both maxillary and mandibular complete dentures was related to their comfort level and denture aesthetics, and patient comfort itself was associated with stability of the mandibular denture.

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