Infection of respiratory syncytial viruses (RSV) in the Czech Republic - analysis of hospitalizations and deaths in 2017-2022.

OBJECTIVES: Given the lack of data on the seriousness of respiratory syncytial virus (RSV) infections in the Czech Republic, an analysis was made of available data on hospitalizations and the hospitalization risk was estimated by age group. METHODS: Data from the National Registry of Reimbursed Health Services and the National Registry of Hospitalizations were used for the analyses. Hospitalizations and deaths due to RSV infection (diagnoses J12.1, J20.5, J21.0) from 2017-2022 were analyzed by age group. RESULTS: Over the six-year period, there were 6,138 hospitalizations with the above diagnoses, ranging between years from 307 to 2,162. The estimated overall hospitalization risk per 100,000 population and year for diagnoses J12.1, J20.5, and J21.0 was 9.64, varying between 2.87 (2020) and 20.56 (2021). Age-group analysis showed the highest risk for children under 6 months of age (891.6/100,000 population and year) and the lowest for 20-34-year-olds (0.1/100,000 population and year). Children under 1 year of age accounted for 63.1% of hospitalizations with the above diagnoses. For patients 65 years and older, the annual hospitalization rates varied between 3.3-15.3%. The most frequent cause of RSV-associated hospitalizations was bronchitis, diagnosed in 55.4% of patients. Among those hospitalized with diagnoses J12.1, J20.5, and J21.0, 38 deaths were reported, representing a case fatality rate of 0.62%. The highest case fatality rate (6.5%) was observed in the age group 35-49 years. CONCLUSIONS: RSV-associated hospitalizations have been reported in all age groups in the Czech Republic. The highest RSV-associated hospitalization risk in 2017-2022 was estimated among children under 6 months of age. Passive surveillance using the available registries could currently provide the basis for measures specifically tailored to the youngest age categories. Data on the hospitalization of adults, particularly senior citizens, must be improved and complemented with active surveillance.

Preoperative staging of ovarian cancer: comparison between ultrasound, CT and whole-body diffusion-weighted MRI (ISAAC study).

OBJECTIVES: To compare the performance of transvaginal and transabdominal ultrasound with that of the first-line staging method (contrast-enhanced computed tomography (CT)) and a novel technique, whole-body magnetic resonance imaging with diffusion-weighted sequence (WB-DWI/MRI), in the assessment of peritoneal involvement (carcinomatosis), lymph-node staging and prediction of non-resectability in patients with suspected ovarian cancer. METHODS: Between March 2016 and October 2017, all consecutive patients with suspicion of ovarian cancer and surgery planned at a gynecological oncology center underwent preoperative staging and prediction of non-resectability with ultrasound, CT and WB-DWI/MRI. The evaluation followed a single, predefined protocol, assessing peritoneal spread at 19 sites and lymph-node metastasis at eight sites. The prediction of non-resectability was based on abdominal markers. Findings were compared to the reference standard (surgical findings and outcome and histopathological evaluation). RESULTS: Sixty-seven patients with confirmed ovarian cancer were analyzed. Among them, 51 (76%) had advanced-stage and 16 (24%) had early-stage ovarian cancer. Diagnostic laparoscopy only was performed in 16% (11/67) of the cases and laparotomy in 84% (56/67), with no residual disease at the end of surgery in 68% (38/56), residual disease ≤ 1 cm in 16% (9/56) and residual disease > 1 cm in 16% (9/56). Ultrasound and WB-DWI/MRI performed better than did CT in the assessment of overall peritoneal carcinomatosis (area under the receiver-operating-characteristics curve (AUC), 0.87, 0.86 and 0.77, respectively). Ultrasound was not inferior to CT (P = 0.002). For assessment of retroperitoneal lymph-node staging (AUC, 0.72-0.76) and prediction of non-resectability in the abdomen (AUC, 0.74-0.80), all three methods performed similarly. In general, ultrasound had higher or identical specificity to WB-DWI/MRI and CT at each of the 19 peritoneal sites evaluated, but lower or equal sensitivity in the abdomen. Compared with WB-DWI/MRI and CT, transvaginal ultrasound had higher accuracy (94% vs 91% and 85%, respectively) and sensitivity (94% vs 91% and 89%, respectively) in the detection of carcinomatosis in the pelvis. Better accuracy and sensitivity of ultrasound (93% and 100%) than WB-DWI/MRI (83% and 75%) and CT (84% and 88%) in the evaluation of deep rectosigmoid wall infiltration, in particular, supports the potential role of ultrasound in planning rectosigmoid resection. In contrast, for the bowel serosal and mesenterial assessment, abdominal ultrasound had the lowest accuracy (70%, 78% and 79%, respectively) and sensitivity (42%, 65% and 65%, respectively). CONCLUSIONS: This is the first prospective study to document that, in experienced hands, ultrasound may be an alternative to WB-DWI/MRI and CT in ovarian cancer staging, including peritoneal and lymph-node evaluation and prediction of non-resectability based on abdominal markers of non-resectability. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Association of triple positivity with prognostic parameters and overall survival in a population-based study of 6,122 HER2-positive breast cancer patients: analysis of real-world clinical practice based on a research database.

Triple-positive breast cancer (TPBC), i.e. HER2-positive (HER2+) and hormone receptors-positive breast cancer, is a specific subgroup of breast cancers. TPBC biology is characterized by strong mutual interactions between signaling pathways stimulated by estrogens and HER2 amplification. The present study aims to carry out a population-based analysis of treatment outcomes in a cohort of hormone receptor (HR) positive and negative breast cancer patients who were treated with anti-HER2 therapy in the Czech Republic. The BREAST research database was used as the data source for this retrospective analysis. The database covers approximately 95% of breast cancer patients treated with targeted therapies in the Czech Republic. The analysis included 6,122 HER2-positive patients. The patients were divided into two groups, based on estrogen receptor (ER) or progesterone receptor (PR) positivity: hormone receptor negative (HR-) patients had both ER- and PR-negative tumors (n=2,518), unlike positive (HR+) patients (n=3,604). HR+ patients were more often diagnosed premenopausal at the time of diagnosis, presented more often at stage I or II and their tumors were less commonly poorly differentiated. The overall survival (OS) was significantly higher in subgroups of HR+ patients according to treatment setting. When evaluated by stages, significantly higher OS was observed in HR+ patients diagnosed at stages II, III, and IV and regardless of tumor grade.

Oncosurgery in the Czech Republic.

The article describes the development of oncosurgery in the Czech Republic since the beginning of the century, as well as other perspectives regarding this specialty. The development of surgical treatment of solid malignant tumours in the Czech Republic was evaluated according to the National Cancer Register database and compared to the neighbouring countries, and the educational system of surgeons in oncosurgery was assessed. Although surgery plays a key role in cancer therapy, starting from the beginning of this millennium it has been pushed aside as a service specialty for other disciplines in oncology. In 2002, these changes were supported by the activities of the newly founded Division of Oncosurgery under the Czech Society for Oncology, which became part of the Czech Surgical Society in 2016. An official educational programme of surgeons in oncology was successfully implemented and since 2011, a specialization examination in oncosurgery has been introduced, organized by the subdepartment of oncosurgery of the Institute of Postgraduate Medical Education (IPVZ), Prague. To date, this examination has been completed by 112 physicians and approximately the same number is currently registered in the educational programme. Currently, 34 centres are accredited for education in oncosurgery. The establishment of Complex Oncology Centres based on an initiative of the Czech Society for Oncology of 2006 only addressed pharmaceutical and radiation oncology. Despite progress in oncosurgery, more clearly defined conditions for this specialty are needed. Conclusion: The education of surgeons in oncosurgery should be continued. It is necessary to expand the number of centres with accreditation for oncosurgery and develop a concept for oncosurgery in the Czech Republic which would be associated with rational concentration of this treatment in connection with organization and provision of continuous urgent and acute surgical care in the Czech Republic, including control mechanisms to ensure its quality. This proposal should be discussed by the Czech Surgical Society in order to further enhance the quality of oncosurgery in the Czech Republic.

Prevalence and evolution of spasticity in patients suffering from first-ever stroke with carotid origin: a prospective, longitudinal study.

BACKGROUND AND PURPOSE: The main aim of the study was to document the occurrence and evolution of post-stroke spasticity (PSS). The secondary goal was to identify predictors for increases and decreases in PSS rates during 12 months of subsequent follow-up. METHODS: In a longitudinal, multicenter, prospective cohort study, assessments were done at 7 days (V1), 6 months (V2), and 12 months (V3) after stroke onset. A total of 307 consecutive patients from four comprehensive stroke centers with the first-ever stroke of carotid origin and the presence of motor deficit at day 7 were included. The demographic data, baseline characteristics, Barthel index, degree and pattern of paresis and muscle tone were evaluated and recorded. Spasticity was assessed using the modified Ashworth scale. RESULTS: Spasticity was present in 45.0% of patients at V1, in 49.5% at V2, and in 43.2% at V3. A significant number of patients experienced changes in spasticity between visits: increased/new occurrence of spasticity in 32.5% (V1 and V2) and in 13.6% (V2 and V3) of patients; decreased occurrence/disappearance of spasticity in 18.5% (V1 and V2) and in 18.3% (V2 and V3) of patients. The number of patients with severe spasticity increased throughout the year, from 2.6% to 13.0% (V2) and 12.5% (V3). CONCLUSIONS: Spasticity developed in almost half of the included patients. The degree of spasticity often changed over time, in both directions. The rate of severe spasticity increased during the first year, with the maximum at 6 months following stroke onset.

Epidemiology of Plasma Cell Leukemia in the Czech Republic.

BACKGROUND: Plasma cell leukemia (PCL) is a rare but most aggressive form of monoclonal gammopathies. PCL is characterized by the presence of clonal plasma cells in peripheral blood. There are two forms of PCL - primary which presents de novo in patients with no evidence of previous multiple myeloma and secondary which is a leukemic transformation of relapsed or refractory dis-ease in patients with previously recognized multiple myeloma. MATERIALS AND METHODS: This is the first study to provide information on PCL epidemiology in the Czech population us-ing The Czech National Cancer Registry (CNCR) as the basic source of data for the population-based evaluation of PCL epidemiology. RESULTS: Accord-ing to CNCR data, there were on average six newly dia-gnosed cases of PCL and four deaths caused by PCL each year in the Czech Republic in the period 2000- 2015. PCL incidence in the Czech Republic was reported at 0.57 per million in 2000- 2015. We suppose that most reported cases of PCL are primary PCL because secondary PCL is a relapse of a previously reported myeloma and, in most cases, is not coded as an independent dia-gnosis in the CNCR. CONCLUSION: Data from registries such as the CNCR can provide useful information on epidemiology of various dis-eases. These data, however, have several limitations, such as dia-gnostic criteria and proper cod-ing of not only the dis-ease itself, but also its various forms. These limitations have to be taken into account dur-ing the process of results interpretation. Key words plasma cell leukemia -  epidemiology -  Czech National Cancer Registry (CNCR) -  Czech Republic.

Is There a Benefit of HER2-Positive Breast Cancer Subtype Determination in Clinical Practice?

BACKGROUND: Breast cancer (BC) with increased expression of human epidermal growth factor receptor 2 with tyrosine kinase activity (HER2+) is a clinically and bio-logically heterogeneous dis-ease. In terms of gene expression, there are four major molecular subtypes - Luminal A, Luminal B, HER2-enriched (HER2-E), and Basal-like. The most common subtype is HER2-E (50- 60%). In hormone-dependent (HR+) HER2-positive tumors, the subgroup HER2-E represents 40- 50% of cases; others are luminal A and B subtypes. PURPOSE: The aim of this review is to provide information on the significance of the distribution of HER2-positive tumors accord-ing to subtype, which is considered a predictive parameter for guid-ing treatment decisions. For example, HER2-E subtype is characterized by a higher probability of achiev-ing complete pathological remission when treated with chemother-apy and antiHER2 ther-apy, and it is thought that it could be treated us-ing a dual HER2 blockade without chemother-apy. Currently, triple-positive tumors, a specific subtype of breast cancer characterized by HER2+ and HR+, are more often subjects of interest. Their unique bio-logical properties are due to complex interactions between HER2 and estrogen receptor (ER) signalling, which result in lower effectiveness of endocrine ther-apy in these patients than in HR+ and HER2-negative patients and, at the same time, the ER positivity in HER2+ tumors can result in resistance to antiHER2 ther-apy. This type of BC is a non-homogeneous group where the impacts of HER2 positivity on tumor malignant behavior and activity of the estrogen-driven signal-ing pathway are inconsistent. Current studies focus on test-ing new treatments such as dual HER2 block-ing or immunother-apy, in combination with antiHER2 targeted ther-apy with fulvestrant, aromatase inhibitors, cyclin dependent kinase 4/ 6 inhibitors, or inhibitors of the PI3K (phosphatidylinositol-3-kinase) pathway. CONCLUSION: The distribution of HER2+ BC accord-ing to individual subtype provides information that can contribute to achiev-ing more accurate decisions about the most appropriate ther-apy. Key words breast cancer - subtype - HER2 - trastuzumab - HER2 positive - triple positive - HER2 enriched The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers. Submitted: 27. 9. 2018 Accepted: 26. 11. 2018.

SLN biopsy in cervical cancer patients with tumors larger than 2cm and 4cm.

OBJECTIVES: The aim of this study was to assess the detection rate, false-negative rate and sensitivity of SLN in LN staging in tumors over 2cm on a large cohort of patients. METHODS: Data from patients with stages pT1a - pT2 cervical cancer who underwent surgical treatment, including SLN biopsy followed by systematic pelvic lymphadenectomy, were retrospectively analyzed. A combined technique with blue dye and radiocolloid was modified in larger tumors to inject the tracer into the residual cervical stroma. RESULTS: The study included 350 patients with stages pT1a - pT2. Macrometastases, micrometastases, and isolated tumor cells were found in 10%, 8%, and 4% of cases. Bilateral detection rate was similar in subgroups with tumors<2cm, 2-3.9cm, and ≥4cm (79%, 83%, 76%) (P=0.460). There were only two cases with false-negative SLN ultrastaging for pelvic LN status among those with bilateral SLN detection. The false negative rate was very low in all three subgroups of different tumor sizes (0.9%, 0.9%, and 0.0%; P=0.999). Sensitivity reached 96% in the whole group and was high in all three groups (93%, 93%, 100%; P=0.510). CONCLUSIONS: If the tracer application technique is adjusted in larger tumors, SLN biopsy can be equally reliable in pelvic LN staging in tumors smaller and larger than 2cm. The bilateral detection rate and false negative rate did not differ in subgroups of patients with tumors<2cm, 2-3.9cm, and ≥4cm.

Trends in incidence of childhood cancers in the Czech Republic: population- based analysis of national registries (1994-2014).

The purpose of this study is to summarize incidence and trends in the pediatric cancer burden in the Czech Republic over the period 1994-2014. The recently established Childhood Cancer Registry was combined with retrospective data from the Czech National Cancer Registry to analyze the annual patterns of incidence and long-term trends of pediatric cancer patients aged 0-14 years diagnosed between 1994 and 2014. Malignancies were classified according to the International Classification of Childhood Cancer. The distribution of incidence was stratified according to gender, age at diagnosis, type of cancer and geographic area. Annual age-standardized rates were adjusted using the world standard population. Changes over time were quantified as the average annual percentage change. This analysis comprised records of 5,605 children diagnosed with cancer within the period 1994-2014, annually 267 records on average; the overall age-standardized average annual incidence rate was 169 cases per million. Boys were affected more frequently than girls: the M/F crude incidence ratio was 1.2:1. The highest incidence rates were observed for ICCC groups I (27.8%), III (21.8%), II (12.4%) and IV (7.8%); other groups formed 30.2%. There are significant differences in the geographic distribution of incidence between regions. A borderline statistically significant increase (0.6%) in the overall average annual percentage change was detected between 1994 and 2014 (95% CI: 0.01 to 1.12; p = 0.05). This study provides reliable recent information on trends in the incidence of childhood cancers in the Czech Republic.

Current state of surgical treatment of cancer of the stomach and gastro-esophageal junction in the Czech Republic.

INTRODUCTION: Analysis of the epidemiology and treatment of cancer of the stomach (CS) and gastro-esophageal junction (GEJ) in the Czech Republic (CR). METHOD: Analysis from the National Cancer Registry (NCR) of the CR examined data up to the year 2013. RESULTS: In CS and GEJ, the incidence is 14.3, mortality is 10.5 and prevalence is 51.1 per 100,000 population. The Karlovy Vary, Olomouc and Moravian-Silesian regions had the highest incidences. The median age at diagnosis is 69 years for men and 72 years for women. Location in the stomach prevails in 85% of the patients, cancer of the gastric cardia occurring in 15%. In men, this ratio is 81 to 19%, in women 90 to 10%. The disease is usually diagnosed late; in 2013, 36% of CS and 32% of GEJ tumors were stage I and II. 53% of CS and 56% of tumors of the GEJ were diagnosed as stage III and IV, and in 11% and 12%, the stage was not determined. In the years 2009-2013 (1,580 patients with CS and GEJ), only 22% were treated surgically, surgery and oncological treatment was given to 21.3%, only non-surgical treatment was received by 15.7% and 41% of patients received no oncological treatment. Overall five-year survival in patients treated between 2010 and 2013 was 32%. At stage I it was 69%, at stage II 41%, at stage III 23% and at stage IV it was 6%. Five-year survival rates according to disease stage and type of treatment given and median of survival were analysed on 8,348 patients with CS and GEJ between 2004 and 2013. Surgery only was performed in 4,116 patients, surgery and radiotherapy was administered to 113 patients, surgery and chemotherapy to 1,855 patients, and 1,125 patients received chemotherapy alone. In 98% of the treated patients, chemotherapy and/or radiotherapy was administered adjuvantly after the surgery. Primary operations were performed at a total of 175 surgical centers, only 22 of them performing more than 10 operations annually. The median of survival differed depending on the number of operations performed: at enters performing more than 20 operations, the median was 24.8 months (m); at enters performing 10-19 operations, the median was 18.2 m; at centers performing 6-9 operations the median was 18.1 m; and at centers performing less than 6 operations, the median was 13.1 m. CONCLUSION: Early diagnosis is key for five-year survival. Treatment is based on surgery; greatest improvement is seen when surgery is combined with chemoradiotherapy, which is usually administered adjuvantly in the CR. At stage I in CS +9.5%, GEJ cancer +26.5%, at stage II in CS +14.7%, GEJ cancer +16.4% and at stage III in CS +13.3%, GEJ cancer +2.6%. Palliative chemo and/or radiotherapy does not prolong five-year survival and must be selected on an individual basis with regard to the expected benefit for the patient. Facilities performing a greater number of surgical procedures have better long-term results. Key words: malignant esophageal tumors - epidemiology - treatment - results.

Pelvic floor reconstruction by modified rectus abdominis myoperitoneal (MRAM) flap after pelvic exenterations.

OBJECTIVE: To describe the technique and report experiences with pelvic floor reconstruction by modified rectus abdominis myoperitoneal (MRAM) flap after extensive pelvic procedures. METHODS: Surgical technique of MRAM harvest and transposition is carefully described. The patients in whom pelvic floor reconstruction with MRAM after either infralevator pelvic exenteration and/or extended lateral pelvic sidewall excision was carried out were enrolled into the study (MRAM group, n=16). Surgical data, post-operative morbidity, and disease status were retrospectively assessed. The results were compared with a historical cohort of patients, in whom an exenterative procedure without pelvic floor reconstruction was performed at the same institution (control group, n=24). RESULTS: Both groups were balanced in age, BMI, tumor types, and previous treatment. Substantially less patients from the MRAM group required reoperation within 60days of the surgery (25% vs. 50%) which was due to much lower rate of complications potentially related to empty pelvis syndrome (1 vs. 7 reoperations) (p=0.114). Late post-operative complication rate was substantially lower in the MRAM group (any grade: 79% vs. 44%; grade≥3: 37% vs. 6%) (p=0.041). The performance status 6months after the surgery was ≤1 in the majority of patients in MRAM (81%) while in only 38% of patients from the control group (p=0.027). There was one incisional hernia in MRAM group while three cases were reported in the controls. CONCLUSIONS: Pelvic floor reconstruction by MRAM in patients after pelvic exenterative procedures is associated with a substantial decrease in postoperative complications that are potentially related to empty pelvis syndrome.

Accuracy of ultrasound in prediction of rectosigmoid infiltration in epithelial ovarian cancer.

OBJECTIVE: To examine prospectively the accuracy of ultrasound in predicting rectosigmoid tumor infiltration in patients with epithelial ovarian cancer. METHODS: Patients referred for a suspicious pelvic mass between 2012 and 2014 were examined by ultrasound following the standard protocol for assessment of tumor infiltration. Of the 245 patients examined, 191 had proven ovarian cancer and underwent primary surgery and were included in the analysis. Patients with apparently benign or inoperable disease were excluded. Rectosigmoid infiltration was evaluated by histopathology or according to perioperative findings. Clinical, pathological and laboratory parameters were analyzed as factors potentially affecting the sensitivity and specificity of sonography. RESULTS: The sensitivity of ultrasound in detecting rectosigmoid infiltration in patients with ovarian cancer was 86.3%, with specificity of 95.8%, positive predictive value of 92.6%, negative predictive value of 91.9% and overall accuracy of 92.1%. CONCLUSION: Ultrasound is a highly accurate method for detecting rectosigmoid tumor infiltration in ovarian cancer patients, and thus, can be used for planning adequate management, including patient consultation, surgical team planning, suitable operating time and postoperative care. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Ultrasound in preoperative assessment of pelvic and abdominal spread in patients with ovarian cancer: a prospective study.

OBJECTIVE: To analyze the accuracy of ultrasound in assessing pelvic and intra-abdominal spread in patients with ovarian cancer. METHODS: This prospective study enrolled all consecutive patients referred to a single gynecological oncology center for suspected ovarian cancer. We analyzed only data from patients with histologically confirmed primary ovarian cancer who were evaluated following predefined preoperative ultrasound, intraoperative and pathology protocols. We evaluated the agreement of depth of infiltration of the rectosigmoid wall, tumor spread in different peritoneal compartments and presence of metastatic retroperitoneal and inguinal lymph nodes, as determined at ultrasound, with intraoperative and histopathological findings. RESULTS: In total, 578 patients were enrolled between March 2008 and January 2013, of whom 394 met the study inclusion criteria and were analyzed; 74% of these suffered from advanced-stage cancer. Our results showed excellent agreement between ultrasound and histology in assessment of rectosigmoid wall infiltration (kappa value, 0.812; area under the receiver-operating characteristics curve, 0.898). The overall accuracy in evaluating different peritoneal compartments, retroperitoneal and inguinal lymph nodes and depth of rectosigmoid wall infiltration was 85.3%, 84.8%, 99.7% and 91.1%, respectively. Ultrasound showed high sensitivity only in the assessment of rectosigmoid wall infiltration (83.1%), peritoneal spread into the pelvis (81.4%) and omentum (67.3%), and inguinal metastatic lymph nodes (100%). The specificity of ultrasound in detection of all evaluated parameters was > 90%. CONCLUSION: This is the largest imaging study to date on ovarian cancer staging. Ultrasound can be used as the method of choice to plan rectosigmoid wall resection and dissection of infiltrated inguinal lymph nodes. In assessing different peritoneal and retroperitoneal compartments, ultrasound was accurate and highly specific. However, similar to other modern imaging techniques, it had relatively low sensitivity, further supporting the role of comprehensive surgical staging. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Epidemiology of Multiple Myeloma in the Czech Republic.

BACKGROUND: Multiple myeloma (MM) is a cancer of plasma cells with an incidence of 4.8 cases per 100,000 population in the Czech Republic in 2014; the burden of MM in the Czech Republic is moderate when compared to other European countries. This work brings the latest information on MM epidemiology in the Czech population. MATERIAL AND METHODS: The Czech National Cancer Registry is the basic source of data for the population-based evaluation of MM epidemiology. This database also makes it possible to assess patient survival and to predict probable short-term as well as long-term trends in the treatment burden of the entire population. RESULTS: According to the latest Czech National Cancer Registry data, there were 504 new cases of MM and 376 deaths from MM in 2014. Since 2004, there has been a 26.9% increase in MM incidence and an 8.3% increase in MM mortality. In 2014, there were 1,982 persons living with MM or a history of MM, corresponding to a 74.4% increase when compared to MM prevalence in 2004. The 5-year survival of patients treated in the period 2010-2014 was nearly 40%. CONCLUSION: The available data make it possible to analyse long-term trends in MM epidemiology and to predict the future treatment burden as well as treatment results.Key words: multiple myeloma - epidemiology - Czech National Cancer Registry - Registry of Monoclonal Gammopathies - Czech Republic.

[Evaluation of Anti-cancer Therapies with Reimbursement Limited to Comprehensive Cancer Centres Using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale]. / Hodnocení klinického benefitu protinádorových léku limitovaných na komplexní onkologická centra podle metodiky ESMO-MCBS.

BACKGROUND: The costs of oncology treatments are increasing, due to the rising prevalence of malignant diseases and the introduction of expensive novel anti-cancer agents. The new European Society for Clinical Oncology (ESMO) has recently developed a new parametric system to evaluate the clinical benefit of drugs. The Magnitude of Clinical Benefit Scale (ESMO-MCBS) compares the contribution of a novel drug based on overall and progression-free survival and quality of life with those of current treatment options. MATERIAL AND METHODS: An expert group of the Czech Oncological Society conducted an assessment based on published data and an ESMO-MCBS methodology for antineoplastic agents used for the treatment of solid tumors with limited reimbursement to Comprehensive Cancer Centers. We evaluated drugs categorized as "S" that were eligible for public health insurance as of January 1, 2017. RESULTS AND CONCLUSION: The ESMO-MCBS score is a promising new parameter for the evaluation of new anticancer drugs. The ESMO-MCBS method for assessing the clinical benefit of drugs is simple, robust, and reproducible. The advantage of the assessment is that it is not based on a single index but rather combines several dimensions of drug performance. This parameter will be gradually added to Czech cancer guidelines. Scores obtained in the majority of cases correspond to the observed benefit of a drug in routine clinical practice.Key words: tumors - farmacotherapy - assesment study as a subject - survival - protocols of anti-cancer therapy The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers.Submitted: 3. 5. 2017Accepted: 20. 6. 2017.

Intraepidermal nerve-fibre density as a biomarker of the course of neuropathy in patients with Type 2 diabetes mellitus.

AIMS: This paper aims to investigate whether intraepidermal nerve-fibre density (IENFD) may be used as a marker of the course of neuropathy in patients with Type 2 diabetes mellitus. METHODS: Skin biopsies from the distal leg were serially evaluated in a group of 30 patients with Type 2 diabetes mellitus (median age 60 years, 17 men) with a short duration of diabetes (< 3 years) and good glucose control, and in 23 age- and sex-matched controls. The time intervals between biopsies were > 2 years (median 33.8 months). Eighteen patients with Type 2 diabetes mellitus had symptoms or signs of distal symmetrical diabetic polyneuropathy, 12 had no neuropathy. RESULTS: At first skin biopsy, IENFD was normal in all controls and in patients without neuropathy (mean 9.5 and 7.9 fibres/mm, respectively) compared with abnormal IENFD in 77.8% in patients with polyneuropathy (mean 3.4 fibres/mm). The annual rate of intraepidermal nerve-fibre (IENF) loss expressed as a percentage of the first IENFD value in patients with diabetic polyneuropathy was significantly higher [mean (se), 11.95 (3.82)%] compared with controls [1.92 (1.81)%, P < 0.001] and similar to patients without polyneuropathy [12.16 (4.38)%]. The rate of IENF loss did not correlate with degree of glucose control. CONCLUSIONS: The annual rate of IENF loss in patients with Type 2 diabetes mellitus was several times higher than that of healthy participants, irrespective of the presence of signs or symptoms of diabetic polyneuropathy at initial evaluation. The change in IENFD is not linear and should be expressed as a proportion of initial IENFD to serve as a marker of the course of diabetic neuropathy.

Risk of micrometastases in non-sentinel pelvic lymph nodes in cervical cancer.

OBJECTIVE: A high sensitivity of sentinel lymph nodes (SLN) for pelvic lymph node (LN) staging has been repeatedly shown in patients with cervical cancer. However, since only SLN are evaluated by pathologic ultrastaging, the risk of small metastases, including small macrometastases (MAC) and micrometastases (MIC), in non-SLN is unknown. This can be a critical limitation for the oncological safety of abandoning a pelvic lymphadenectomy. METHODS: The patients selected for the study had cervical cancer and were at high risk for LN positivity (stage IB-IIA, biggest diameter≥3cm). The patients had no enlarged or suspicious LN on pre-operative imaging; SLNs were detected bilaterally and were negative on intra-operative pathologic evaluation. All SLNs and all other pelvic LNs were examined using an ultrastaging protocol and processed completely in intervals of 150µm. RESULTS: In all, 17 patients were enrolled into the study. The mean number of removed pelvic LNs was 30. A total of 573 pelvic LNs were examined through ultrastaging protocol (5762 slides). Metastatic involvement was detected in SLNs of 8 patients (1× MAC; 4× MIC; 3× ITC) and in non-SLNs in 2 patients (2× MIC). In both cases with positive pelvic non-SLNs, there were found MIC in ipsilateral SLNs. No metastasis in pelvic non-SLNs was found by pathologic ultrastaging in any of the patients with negative SLN Side-specific sensitivity was 100% for MAC and MIC. There was one case of ITC detected in non-SLN, negative ipsilateral SLN, but MIC in SLN on the other pelvic side. CONCLUSIONS: After processing all pelvic LNs by pathologic ultrastaging, there were found no false-negative cases of positive non-SLN (MAC or MIC) and negative SLN. SLN ultrastaging reached 100% sensitivity for the presence of both MAC and MIC in pelvic LNs.

Screening of Psychological Distress 4.5 Years after Diagnosis in Breast Cancer Patients Compared to Healthy Population.

BACKGROUND: Survival rate of breast cancer patients has improved significantly in recent years. Cancer diagnosis represents a great psychological distress for patients which may not stem solely from the disease itself. Patients may experience higher distress even several years after treatment. PATIENTS AND METHODS: The study was carried out at the Department of Obstetrics and Gynecology and Department of Internal Medicine, Haematology and Oncology, Faculty Hospital Brno. Results of 85 patients at 4.5 years after diagnosis of breast cancer compared to 72 healthy controls are presented in this paper. The data were collected in the form of semi-structured interviews, from the patients medical records and by Symp-tom Check List-90. RESULTS: The overall rate of psychological distress (GSI) 4.5 years after breast cancer dia-gnosis does not differ significantly (p = 0.703) from the healthy population. Also, we did not find any statistically significant relationship between the observed factors and the level of psychological distress in breast cancer patients. CONCLUSION: Screening investigation showed no difference in the psychological distress in breast cancer patients 4.5 years following diagnosis, compared with the healthy population.

Change in Quality of Life Measured over Time in Czech Women with Breast Cancer.

BACKGROUND: This study examined the impact of breast cancer on quality of life (QOL) of Czech women by comparing the QOL of breast cancer patients with that of age-matched healthy controls. METHODS: The sample consisted of 74 breast cancer patients who filled in self-assessment questionnaires retrospectively before treatment and at the time of the study. In addition, 73 healthy controls completed the same battery of questionnaires. QOL was assessed using the Rand 36-Item Health Survey, the Life Satisfaction Questionnaire, and the Czech research version of Functional Assessment of Breast Cancer Therapy. The Wilcoxon paired test and Mann-Whitney U test were used for data analysis. RESULTS: A statistically significant decline in QOL in breast cancer patients was found for the following components: Physical Functioning (p = 0.021), Role Functioning-Physical (p < 0.001), Bodily Pain (p = 0.001), General Health (p = 0.031), Role Functioning-Emotional (p = 0.023), and Physical Well-being (p = 0.001). The only significant increase over time was observed in Social/Family Well-being (p = 0.024). For most of the components, patients showed a statistically significant lower QOL than that of healthy controls. A recent diagnosis, advanced disease stage, more comorbidities, a higher BMI, and other sociodemographic characteristics were associated with a higher incidence of a lower QOL over time. CONCLUSION: Perceived QOL decreased over time in breast cancer patients mainly in components such as physical and emotional functioning, bodily pain, and general health, with several risk factors strongly influencing this change. The QOL of patients was lower than that of the non-cancer population, indicating that subsequent care should be improved to minimize the adverse effects that breast cancer has on QOL.

Predicting Vitality Change in Older Breast Cancer Survivors after Primary Treatment--an Approach Based on Using Time-related Difference of Pro-inflammatory Marker C-reactive Protein.

BACKROUND: We aimed to determine prognosis of vitality change and functional status of breast cancer survivors after primary oncological treatment using time-related differences of elevated levels of highly sensitive proinflammatory C-reactive protein (CRP). PATIENTS AND METHODS: The test group consisted of 46 elderly breast cancer survivors (median age was 65 years) who completed Vitality Scale of Short Form 36 (SF-36) after completing treatment and another retrospectively at diagnosis. Data on tumor-related factors, treatment, and outcomes were obtained retrospectively from medical records, and linear regression analysis was performed. CRP was followed at diagnosis and one year after primary treatment. Within the scope of this study, clinically important difference in the Vitality Scale was set at five points of change. RESULTS: Results showed a statistically significant relationship between CRP change and vitality component of SF-36 change (rs = - 0.350, p = 0.023) in which a decrease in CRP inversely correlated with the quality of life component. The overall change was 1.078 of the vitality scale score (approximately 1 point) for each 1 unit decrease of CRP (1 mg/ L). Association of CRP levels (before and after treatment, its difference between these time points) with age, number of comorbidities and stage of the disease was analyzed and no statistically significant relationship was found in our study. CONCLUSION: Preliminary results suggested time-related differences in elevated CRP levels as a potentially suitable predictor for change in vitality status for long term, chronic condition for older breast cancer survivors. We suggest the interpretation schema including an understanding that CRP change of 5 mg/ L and more should be considered a potential risk factor for subsequent negative clinical outcomes.