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Autologous stem cell transplantation (ASCT) is considered standard therapeutic approach for patients with relapsed and refractory (R/R) diffuse large B cell lymphoma (DLBCL) that are transplant eligible. For transplant ineligible patients there are few therapeutic options and novel targeted therapies and immunotherapy that are still in development. Treatment of such patients with poor prognosis is considered to be a challenge and there is constant need for new salvage treatment regimens. The aim of this study was to evaluate patients’ characteristics and treatment strategies and considerations for diffuse large B cell lymphoma in our department, and to promote new therapeutic possibilities for R/R patients with NHL DLBCL. A total of 308 patients with NHL were treated at University Clinic for hematology from 2008 until 2020 and 49% (151) of patients with NHL DLBCL were included in this study. Survival analysis of all analyzed relapsed/refractory NHL patients revealed statistically significant better survival in patients with low risk IPI score, disease stage I/II and patients with age

Zolpidem is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs with known hypnotic properties. Zolpidem as conventional tablets is used as a hypnotic agent in the short-term management of insomnia, generally for periods not exceeding 7–10 days in duration. The objective of this study was to evaluate and compare the relative bioavailability, and therefore the bioequivalence of Zolpidem 10 mg test formulation versus a reference Zolpidem 10 mg formulation, following a single dose administration under fasting conditions The study was a single center, open, single dose, randomized, two - way crossover study in healthy male volunteers with a wash - out period of one week between study periods. Twenty-eight male healthy volunteers, aged 20-49 years were included into study. Blood samples for determination of zolpidem plasma concentrations were withdraw at 0 (pre-drug administration), 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-drug. The zolpidem concentrations in plasma were determined with HPLC, using fluorescence detection. The test formulation of zolpidem, dosed at 10 mg is bioequivalent for primary zolpidem parameters (Cmax, AUC0-t and AUC0-∞) to the reference formulation after a single oral administration of 10 mg zolpidem. Both medications are well tolerated with no serious adverse events. Thus, in view of the clinical use, both formulations are exchangeable without restrictions. Keywords: Zolpidem, bioavailability, bioequivalence study, single-dose

Clarithromycin is a semi-synthetic macrolide antibiotic, chemically 6-0-methylerythromycin, formulated as immediate-release tablets, extended-release tablets, and granules for oral suspension. The objective of this study was to evaluate and compare the relative bioavailability, and therefore the bioequivalence of Clarithromycin 500 mg test formulation versus a reference Klacid® forte 500 mg formulation, following a single dose administration under fasting conditions. The study was a single center, open, single dose, randomized, two-way crossover study in healthy male volunteers, with a wash-out period of one week between study periods. Twenty-four male healthy volunteers, aged 18-49 years were included into study. Blood samples for determination of clarithromycin and 14-OH clarithromycin concentrations were withdrawn at zero (pre-drug administration), 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 and 36 hours post-drug administration. The determination of clarithromycin and 14-OH clarithromycin concentrations in plasma was performed using validated LC/MS/MS method and internal standardization after liquid/liquid extraction with methyl t-butyl ether. The test formulation of clarithromycin, dosed at 500 mg is bioequivalent for primary clarithromycin and 14-OH clarithromycin parameters (Cmax, AUC0-t and AUC0-∞) to the reference formulation after a single oral administration of 500 mg clarithromycin. Both medications were well tolerated with no serious adverse events. Thus, in view of the clinical use, both formulations are exchangeable without restrictions. Keywords: clarithromycin, 14-OH clarithromycin, bioavailability, bioequivalence study, single-dose

BACKGROUND: Splenic inflammatory pseudotumor (IPT)/inflammatory myofibroblastic tumor (IMT) is a rare pseudotumor/tumor of unknown origin, which is usually benign, although atypical and aggressive cases have been reported. It is a lesion composed of proliferated myofibroblastic cells (hence IMT by some authors) with admixed pleomorphic inflammatory cells of varying proportions. CASE REPORT: Herein, we report a case of 61-year-old male patient with ill-defined abdominal discomfort and no other symptoms and signs. Clinical and imaging investigations revealed a mass in the spleen that was equivocally interpreted as secondary neoplasm, although primary neoplasm of the spleen was not excluded by the radiologists. Splenectomy was performed and on gross examination a well demarcated greyish-livid tumor measuring 3.5 cm × 3 cm × 3 cm was discovered. Microscopic examination showed proliferation of loosely arranged spindle cells admixed with inflammatory cells (histiocytes, lymphocytes, neutrophils, eosinophils, occasional plasma cells, and/or plasmacytoid cells) with varying density and multifocal clustering, multifocal hemorrhage, and fibrinoid-like deposition. We performed additional histochemical and immunohistochemical stainings which were consistent with the diagnosis of IPT/IMT. Next-generation sequencing (TruSight Tumor 15) showed common TP53 polymorphism (c.215C>G; p.Pro72Arg) along with several intronic and synonymous single nucleotide variations (SNVs), as well as five low confidence missense SNVs. Sixteen months after the operation the patient has uneventful follow-up. CONCLUSION: Although the incidence of IPT/IMT is low, awareness of its existence is necessary. The prognosis is favorable following splenectomy in most cases. Careful microscopic examination of the specimen is mandatory, due to possible misdiagnosis. We believe that extensive NGS analysis on archive samples would provide more data about the spectrum of possible genetic changes in lesions like IPM/IMT.

We performed a retrospective analysis of tumours of the kidneys and the lower urinary tract diagnosed at the Institute of Pathology, Faculty of Medicine, Ss. Cyril and Methodius University, Skopje, Macedonia, in a two-year period (2010-2011), with the aim of highlighting the main morphological characteristics and to present the statistical features of these tumours. All the cases were diagnosed on paraffin sections from surgical specimens routinely stained with HE, and immunohistochemically with a panel of monoclonal antibodies. The analysis revealed a total of 755 cases, of which 166 (14%) were located in the kidney including the renal pelvis, and 649 (86%) were tumours of the urinary bladder. Twelve of the renal tumours (11.3%) were benign, and the rest were malignant tumours. Most of them were adenocarcinomas (n=77; 72.6%) and 17 cases (16%) were transitional cell carcinomas originating from the renal pelvis. The analysis of the lower urinary tract tumours showed a strong prevalence of malignant urothelial tumours (96%), with a male to female ratio of almost 4:1. Low grade morphology was a predominant feature (71.7%) and 51 cases (22.9%) were of high grade. The percentage of urothelial tumours of the kidney in our series is higher than in most of the reported series, which should lead to an expanded analysis.