Efficacy of focal high-dose-rate brachytherapy in the treatment of patients diagnosed with low or favourable: intermediate-risk prostate cancer-a protocol for a randomised controlled trial.

INTRODUCTION: Prostate cancer (PCa) is men's second most predominant cancer worldwide. Because the prostate-specific antigen test is used in diagnostics, PCa is more often diagnosed in the early stages, making radical treatment of the disease possible. However, it is estimated that over a million men worldwide suffer from radical treatment-related complications. Thus, focal treatment has been proposed as a solution, which aims to destroy the predominant lesson that determines the progression of the disease. The main objective of our study is to compare the quality of life and efficacy of patients diagnosed with PCa before and after the treatment with focal high-dose-rate brachytherapy and to compare results with focal low-dose-rate brachytherapy and active surveillance. METHODS AND ANALYSIS: 150 patients diagnosed with low-risk or favourable intermediate-risk PCa who meet the inclusion criteria will be enrolled in the study. Patients are going to be randomly assigned to the study groups: focal high-dose-rate brachytherapy (group 1), focal low-dose-rate brachytherapy (group 2) and active surveillance (group 3). The study's primary outcomes are quality of life after the procedure and time without biochemical disease recurrence. The secondary outcomes are early and late genitourinary and gastrointestinal reactions after the focal high-dose and low-dose-rate brachytherapies and evaluation of the importance and significance of in vivo dosimetry used for high-dose-rate brachytherapy. ETHICS AND DISSEMINATION: Bioethics committee approval was obtained before this study. The trial results will be published in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: Vilnius regional bioethics committee; approval ID 2022/6-1438-911.

Incidence, mortality and survival trends of penile cancer in Lithuania 1998-2017.

Background and objectives: The aim of this study was to analyse trends in penile cancer incidence, mortality, and relative survival in Lithuania during the period of 1998-2017. Materials and methods: The study was based on all cases of penile cancer reported to the Lithuanian Cancer Registry between 1998 and 2017. Age-specific rates standardized rates were calculated, using the direct method (World standard population). The Joinpoint regression model was used to provide estimated average annual percentage change (AAPC). One-year and five-year relative survival estimates were calculated using period analysis. Relative survival was calculated as the ratio of the observed survival of cancer patients and the expected survival of the underlying general population. Results: During the study period, the age-standardized incidence rate of penile cancer varied between 0.72 and 1.64 per 100 000, with AAPC 0.9% (95% CI -0.8-2.7). The mortality rate of penile cancer in Lithuania during this period varied from 0.18 to 0.69 per 100 000, with AAPC of -2.6% (95% CI -5.3-0.3). Relative one-year survival of patients, diagnosed with penile cancer improved over the time from 75.84% in period 1998-2001 to 89.33% in period 2014-2017. Relative five-year survival rate of patients, diagnosed with penile cancer changed from 55.44% in period 1998-2001 to 72.90% in period 2014-2017. Conclusions: The incidence rates of penile cancer showed an increasing trend, while mortality rates were decreasing in Lithuania during 1998-2017. One-year and five-year relative survival increased, however, it does not reach the highest scores of Northern European countries.

Incidence, Mortality, and Survival Trends in Cancer of the Gallbladder and Extrahepatic Bile Ducts in Lithuania.

Background and Objectives: Gallbladder cancer is a rare type of cancer, with aggressive clinical behavior. Limited treatment options provide poor survival prognosis. We aimed to investigate the incidence, mortality trends, and survival of gallbladder and extrahepatic bile duct cancer in Lithuania between 1998 and 2017. Materials and Methods: The study was based on the Lithuanian Cancer Registry database. The study included all cases of cancer of the gallbladder and extrahepatic bile ducts reported to the Registry in the period 1998-2017. Age-specific and age-standardized incidence rates were calculated. In addition, 95% confidence intervals for APC (Annual Percent Change) were calculated. Changes were considered statistically significant if p was <0.05. Relative survival estimates were calculated using period analysis according to the Ederer II method. Results: Age-standardized rates for gallbladder cancer and extrahepatic bile duct cancer among females decreased from 3.91 to 1.93 cases per 100.000 individuals between 1998 and 2017, and from 2.32 to 1.59 cases per 100.000 individuals between 1998 and 2017 among males. The highest incidence rates were found in the 85+ group with 27.5/100,000 individuals in females and 26.8/100,000 individuals in males. The 1-year as well as 5-year relative survival rates of both genders were 34.29% (95% CI 32.12-36.48) and 16.29% (95% CI 14.40-18.27), respectively. Conclusions: Incidence and mortality from gallbladder and extrahepatic bile duct cancer decreased in both sexes in Lithuania. Incidence and mortality rates were higher in females than in males. Relative 1-year and 5-year survival rates showed a steady increase during the study period among males and females.

ICD-11 adjustment disorder following diagnostic procedures of prostate cancer: A 12-month follow-up study.

OBJECTIVE: The medical procedures in diagnosing or treating prostate cancer may impair adjustment and quality of life. The current prospective study aimed to evaluate the trajectories of symptoms of ICD-11 adjustment disorder in patients diagnosed vs. non-diagnosed with prostate cancer before (T1), after diagnostic procedures (T2), and at 12-month follow-up (3). METHODS: In total, 96 male patients were recruited before prostate cancer diagnostic procedures. The mean age of the study participants at baseline was 63.5 (SD = 8.4), ranging from 47 to 80 years; 64% were diagnosed with prostate cancer. Adjustment disorder symptoms were measured using the Brief Adjustment Disorder Measure (ADNM-8). RESULTS: The prevalence of ICD-11 adjustment disorder was 15% at T1, 13% at T2, and 3% at T3. The effect of cancer diagnosis was not significant on adjustment disorder. A medium main effect for time was detected on adjustment symptom severity, F(2, 134) = 19.26, p < .001, partial η2 = 0.223, with symptoms significantly lower at 12-month follow-up, compared to T1 and T2, p < .001. CONCLUSIONS: The study's findings reveal the increased levels of adjustment difficulties in males undergoing the diagnostic process of prostate cancer.

Androgen-deprivation therapy and risk of death from cardio-vascular disease in prostate cancer patients: a nationwide lithuanian population-based cohort study.

Purpose: The main purpose of this study was to evaluate the risk of CVD mortality in the national cohort of patients diagnosed with prostate cancer and treated with ADT compared with the ADT non-users.Materials and methods: We performed a retrospective cohort study of patients aged 40-79 years and diagnosed with prostate cancer between 1 January 2012 and 31 December 2016 using the Lithuanian Cancer registry data. In total, 13 343 prostate cancer patients were included in the final study cohort who exclusively used gonadotropin-releasing hormone agonists. The primary outcomes that were registered during the follow-up of this study were overall CVD death.Results: There was a higher risk of CVD death in the cohort of patients treated with ADT than in ADT non-users (HR 2.14, 95% CI [1.86-2.45], p < 0.001). Moreover, there was an increased risk of death from ischemic heart disease and stroke (HR 1.42, 95% CI [1.16-1.73] and 1.70, 95% CI [1.18-2.45], respectively) among ADT users. Finally, the risk of CVD-related mortality was highest in the 70-79 age group of ADT users (HR 4.78, 95% CI [3.79-6.04]).Conclusions: This study shows that ADT usage is associated with increased CVD-related mortality risk for patients diagnosed with prostate cancer compared with ADT non-users. The highest mortality risk was found for ischemic heart disease and stroke. CVD-related mortality was increased in the elder group of patients also.

A Case Report and Review of the Literature of Penile Metastasis From Rectal Cancer.

Background: Metastatic involvement of the penis in cases of rectal cancer is exceptionally rare condition. Our clinical case report and review of the literature will contribute in complementing currently limited data on penile metastasis from rectal cancer. Case report: We report a case of a 64-year-old male diagnosed with penile metastasis from rectal cancer. The patient was treated with neoadjuvant chemoradiotherapy followed by total mesorectal excision (TME). However, penile metastasis developed 3 years later, clinically presenting as penile pain and solid formations along the entire length of the penis with visible tumor in the head of the penis. The amputation of penis was performed, and adjuvant chemotherapy was prescribed. The patient survived only 6 months. Conclusion: Penile metastasis from rectal cancer in most cases is a lethal pathology that indicates wide dissemination of oncological disease and has a very poor prognosis. Aggressive surgical treatment is doubtful in metastatic disease as this will negatively affect the quality of life.

Association between Androgen Deprivation Therapy and the Risk of Inflammatory Rheumatic Diseases in Men with Prostate Cancer: Nationwide Cohort Study in Lithuania.

Background: The aim of this study was to assess the association between androgen deprivation therapy (ADT) and the risk of inflammatory rheumatic diseases in men with prostate cancer. Methods: Patients with prostate cancer between 2012 and 2016 were identified from the Lithuanian Cancer Registry and the National Health Insurance Fund database, on the basis of rheumatic diseases diagnoses and information on prescriptions for androgen deprivation therapy. Cox proportional hazard models were used to estimate hazard ratios (HR) to compare the risks of rheumatic diseases caused by androgen deprivation therapy exposure in groups of prostate cancer patients. Results: A total of 12,505 prostate cancer patients were included in this study, out of whom 3070 were ADT users and 9390 were ADT non-users. We observed a higher risk of rheumatic diseases in the cohort of prostate cancer patients treated with ADT compared with ADT non-users (HR 1.55, 95% confidence interval (CI) 1.01−2.28). Detailed risk by cumulative use of ADT was performed for rheumatoid arthritis, and a statistically significant higher risk was found in the group with longest cumulative ADT exposure (>105 weeks) (HR 3.18, 95% CI 1.39−7.29). Conclusions: Our study suggests that ADT usage could be associated with increased risk of rheumatoid arthritis, adding to the many known side effects of ADT.

All-Cause Mortality Risk in National Prostate Cancer Cohort: An Impact of Population-Based Prostate Cancer Screening.

The aim of this study is to evaluate all-cause mortality risk differences before and during prostate cancer screening, with a profound focus on the differences between screened and not-screened patient groups. Prostate cancer cases diagnosed between 1998 and 2016 were identified from the population-based Lithuanian Cancer Registry and linked with screening status in the National Health Insurance Fund database. The analysis was stratified by a period of diagnosis and screening status. Standardized mortality ratios (SMRs) were used to assess all-cause and cause-specific mortality risk. The SMRs were calculated by dividing the observed number of deaths among prostate cancer patients by the expected number of deaths from the general population. All-cause SMR (1.45 (95% CI 1.42-1.48)) in the pre-screening period was higher compared to the screening period (SMR = 1.17 (95% CI 1.15-1.19)). An increased all-cause mortality risk among prostate cancer patients was observed in the not-screened patient population (SMR = 1.76 (95% CI 1.71-1.82)), while all-cause mortality risk in the screened patient population was similar to the general population (SMR = 1.00 (95% CI 0.97-1.02)). Screened patients with localized stage of disease had lower all-cause mortality risk than the general population (SMR = 0.72 (95% CI 0.70-0.75)). In conclusion, men with prostate cancer in Lithuania had excess all-cause mortality risk compared to the general population. The all-cause mortality risk among screened patients was not higher than expected.

Retrospective cohort study of androgen deprivation therapy and the risk of diabetes in men with prostate cancer in Lithuania.

OBJECTIVES: To examine the risk of type 2 diabetes in patients with prostate cancer and its association with androgen deprivation therapy (ADT). DESIGN AND PARTICIPANTS: We performed a retrospective cohort study of patients diagnosed with prostate cancer in the Lithuanian male population between 1 January 2003 and 31 December 2012 who were identified through the Lithuanian Cancer registry. All prostate cancer cases were linked to the National Health Insurance Fund database to obtain information regarding the diagnosis of diabetes mellitus and information on prescriptions of antiandrogens and gonadotropin-releasing hormone (GnRH) agonists. Patients with prostate cancer were followed up until the diagnosis of type 2 diabetes, or 31 December 2017, or date of death, whichever came first. Cox proportional hazard models were used to estimate the risk of type 2 diabetes in patients with prostate cancer with or without ADT exposure. RESULTS: 27 580 men were diagnosed with prostate cancer, out of whom 14 502 (52.6%) did not receive ADT and 13 078 (47.4%) were treated with ADT. The incidence of type 2 diabetes for all patients with prostate cancer was 7.4/1000 person-years, for men on GnRH agonists 9.0/1000 person-years and 5.8/1000 person-years for men on antiandrogens. There was an increased risk of developing type 2 diabetes comparing ADT users and non-users (HR=1.49, 95% CI 1.34 to 1.66). CONCLUSION: This study showed an increased risk of diabetes in patients with prostate cancer treated with ADT in comparison to ADT-free patient cohort. GnRH agonist users showed higher susceptibility, while the group on antiandrogen monotherapy showed no such increase.

National Colorectal Cancer Screening Program in Lithuania: Description of the 5-Year Performance on Population Level.

We aimed to report the results of the implementation of the National Colorectal Cancer (CRC) Screening Program covering all the country. The National Health Insurance Fund (NHIF) reimburses the institutions for performing each service; each procedure within the program has its own administrative code. Information about services provided within the program was retrieved from the database of NHIF starting from the 1 January 2014 to the 31 December 2018. Exact date and type of all provided services, test results, date and results of biopsy and histopathological examination were extracted together with the vital status at the end of follow-up, date of death and date of emigration when applicable for all men and women born between 1935 and 1968. Results were compared with the guidelines of the European Union for quality assurance in CRC screening and diagnosis. The screening uptake was 49.5% (754,061 patients) during study period. Participation rate varied from 16% to 18.1% per year and was higher among women than among men. Proportion of test-positive and test-negative results was similar during all the study period-8.7% and 91.3% annually. Between 9.2% and 13.5% of test-positive patients received a biopsy of which 52.3-61.8% were positive for colorectal adenoma and 4.6-7.3% for colorectal carcinoma. CRC detection rate among test-positive individuals varied between 0.93% and 1.28%. The colorectal cancer screening program in Lithuania coverage must be improved. A screening database is needed to systematically evaluate the impact and performance of the national CRC screening program and quality assurance within the program.

Suicide risk among prostate cancer patients before and after the implementation of prostate-specific antigen-based prostate screening in Lithuania in 2006.

Despite good prognosis, increased suicide rates are reported for prostate cancer. The aim of this study was to assess the risk of suicide among prostate cancer patients before and after the start of nation-wide prostate-specific antigen (PSA)-based screening programme. Prostate cancer cases diagnosed between 2000 and 2011 were identified from the population-based Lithuanian Cancer Registry and analysis was conducted in 2018. Analysis was stratified by period of diagnosis, age, Gleason score, extent of disease, and time since diagnosis. Standardized mortality ratios (SMRs) were used to assess suicide risk. SMRs were calculated by dividing the observed number of suicides among prostate cancer patients by the expected number of suicides from the general population. Overall, 25 786 prostate cancer cases were diagnosed 2000-2011, and 135 suicides occurred among them compared with expected number of 133 (SMR: 1.10; 95% confidence interval (CI) 0.85-1.20). The suicide risk among prostate cancer patients was 1.08 before and 0.97 after the start of nation-wide PSA-based screening programme. Statistically significant increase in suicide risk was associated with Gleason score 8-10 in the prescreening period (SMR: 2.45; 95% CI 1.23-4.90). Suicide risk among prostate cancer patients before and after introduction of nation-wide PSA-based screening programme is similar to that in the general population.

Prostate Cancer Screening with PSA: Ten Years' Experience of Population Based Early Prostate Cancer Detection Programme in Lithuania.

The aim of this study is to report key performance estimates from the ten years of a population-based prostate cancer screening programme in Lithuania. Retrospective analysis of screening activities recorded in 2006-2015 among men aged 50-74 years was performed. We estimated screening coverage, cancer detection rate, compliance to biopsy, and positive predictive values in each screening round inside and outside the target population. In the first 10 years of screening, 16,061 prostate cancer cases were registered within the screening programme, 10,202 were observed among screened men but reported outside the screening programme, and 1455 prostate cancers were observed in a screening-naïve population. Screening cover reached up to 45.5% of the target population in the recent rounds. The proportion of prostate specific antigen (PSA) test-positive men decreased from 16.9% in 2006 to 10.7% in 2014-2015. Up to 40.0% of PSA test-positive men received a biopsy, of whom 42.0% were positive for prostate cancer. The cancer detection rate was 10.4-15.0% among PSA test-positives and 1.4-1.9% among screened individuals. Screening participants were more likely to be diagnosed with organ-confined disease as compared to non-participants. Despite the unorganized screening practices being employed and low coverage per screening round, 70% of the target population were screened at least once in the first 10 years of screening.

The impact of metformin on survival in patients with melanoma-national cohort study.

PURPOSE: The primary study outcome was melanoma-specific mortality in patients with type 2 diabetes mellitus (T2DM) using metformin. METHODS: Data regarding patients were provided by the Lithuanian Cancer Registry and were linked with National Health Insurance Fund in accordance with unique personal identification numbers during the period of thirteen years. RESULTS: About 2817 patients met eligibility criteria and were included in the retrospective cohort study. About 163 patients had pre-existing T2DM and 103 of them were treated with metformin. In the multivariable analysis, there was significant risk difference in melanoma-specific survival between diabetic, metformin-using patients, and nondiabetic patients (P=0.02) in favor of metformin users. CONCLUSION: Melanoma patients with T2DM treated with metformin had lower risk of melanoma-specific mortality; however, prospective controlled studies are mandatory to confirm this finding.

Increased Mortality Risk in People with Type 2 Diabetes Mellitus in Lithuania.

This retrospective cohort study aimed to analyze overall and cause-specific mortality risk in people with type 2 diabetes mellitus (T2DM) in Lithuania. Information on the diagnosis of T2DM and glucose-lowering medication was obtained from the National Health Insurance Fund database, causes of death-from death certificates. Sex, age, and calendar period-standardized mortality ratios (SMRs) were calculated. In addition, 89,512 patients were followed-up between 2010 and 2017, contributing to the observation period of 592,321 person-years. Overall mortality risk was increased for both sexes (overall SMR = 1.35, 95% confidence interval (CI) 1.34-1.37). Greatest mortality risk was in the age group of 40-49 years at diabetes diagnosis (SMR = 1.68, 95% CI 1.60-1.76) and among those who had died before the age of 50 (SMR = 22.04, 95% CI 18.82-25.81). Patients treated with insulin only had the highest SMR (2.43, 95% CI 2.32-2.55). Mortality risk increased with increasing diabetes duration and was higher in women in all these groups. The highest cause-specific SMRs were infection-related causes (SMR = 1.44), particularly septicemia (SMR = 1.78), diseases of the circulatory system (SMR = 1.42), especially ischemic heart (SMR = 1.46) and cerebrovascular diseases (SMR = 1.38), as well as diseases of the digestive system (SMR = 1.35). Cancer mortality risk was elevated for women (SMR = 1.13), but not for men (SMR = 0.93). In conclusion, people with T2DM had an excess mortality risk, which was higher in women compared to men, younger people, in those who were diagnosed with T2DM at a younger age, had longer diabetes duration, and who required treatment with insulin.

Preexisting diabetes, metformin use and long-term survival in patients with prostate cancer.

OBJECTIVE: To assess prostate cancer-specific and overall survival in prostate cancer patients with or without preexisting type 2 diabetes mellitus (T2DM) with regards to metformin use. METHODS: Patients diagnosed with prostate cancer in the Lithuanian population between 2001 and 2005 were identified through the Lithuanian Cancer Registry and followed until 2016, date of death, loss to follow-up or whichever came first. Information regarding the diagnosis of T2DM and antihyperglycemic medications were obtained from the National Health Insurance Fund database. Prostate cancer-specific and overall survival outcomes were analysed using univariate and multivariate Cox proportional hazard models. RESULTS: Out of 6689 men included, 254 (3.8%) had preexisting T2DM. There were 4807 deaths during follow-up, including 2084 from prostate cancer. No differences were found in prostate cancer-specific survival between men with or without T2DM. The risk of overall mortality was higher (HR = 1.24, 95% CI = 1.07-1.43) in diabetic men. Univariate analysis showed cancer stage at diagnosis and age to be significant predictors of survival. After adjustment for age and stage at diagnosis, there was no difference in prostate-specific survival between non-diabetic patients compared to metformin users or metformin non-users. However, overall survival was lower in T2DM patients, with a higher mortality risk for metformin non-users (HR = 1.63, 95% CI = 1.27-2.10). Prostate cancer-specific mortality risk was insignificantly lower in diabetic men on metformin (HR = 0.74, 95% CI = 0.54-1.02). CONCLUSION: There was no difference in long-term prostate cancer-specific survival in patients with or without T2DM. Overall survival was lower in T2DM patients not treated with metformin.

Cohort Study of Antihyperglycemic Medication and Pancreatic Cancer Patients Survival.

BACKGROUND: We assessed the association between the use of metformin and other antihyperglycemic medications on overall survival in diabetic patients with pancreatic cancer. METHODS: Patients with pancreatic cancer and diabetes between 2000 and 2015 were identified from the Lithuanian Cancer Registry and the National Health Insurance Fund database. Cohort members were classified into six groups according to type 2 diabetes mellitus treatment: sulfonylurea monotherapy; metformin monotherapy; insulin monotherapy; metformin and sulfonylurea combination; metformin and other antihyperglycemic medications; all other combinations of oral antihyperglycemic medications. Survival was calculated from the date of cancer diagnosis to the date of death or the end of follow-up (31 December 2018). RESULTS: Study group included 454 diabetic patients with pancreatic cancer. We found no statistically significant differences in overall survival between patients by glucose-lowering therapy. However, highest mortality risk was observed in patients on insulin monotherapy, and better survival was observed in the groups of patients using antihyperglycemic medication combinations, metformin alone, and metformin in combination with sulfonylurea. Analysis by cumulative dose of metformin showed significantly lower mortality risk in the highest cumulative dose category (HR 0.76, 95% CI 0.58-0.99). CONCLUSIONS: Our study showed that metformin might have a survival benefit for pancreatic cancer patients, suggesting a potentially available option for the treatment.

Reduced risk of prostate cancer in a cohort of Lithuanian diabetes mellitus patients.

BACKGROUND: During the past decade, a huge interest was devoted to the type-2 diabetes mellitus and their associations with prostate cancer development. OBJECTIVES: The aim of this study was to determine whether type 2 diabetes mellitus and treatment with metformin is associated with prostate cancer risk. MATERIALS AND METHODS: The cohort was composed of diabetic male patients identified in the National Health Insurance Fund database during 2000-2016 and cancer cases in national Cancer Registry. We calculated standardized incidence ratios (SIR) for prostate cancers as a ratio of observed number of cancer case in people with diagnosis of diabetes to the expected number of cancer cases in the underlying general population. RESULTS: 2754 prostate cancers were observed versus 3111.26 expected within the period of observation entailing an SIR of 0.89 (95% CI: 0.85-0.92). Significantly lower risk of prostate cancer was found in diabetes patients in all age groups, also was in metformin-users and never-users' groups, with higher risk reduction in metformin-users (SIR 0.71, 95% CI: 0.68-0.75) than in diabetes patients never-users (SIR 0.88, 95% CI: 0.80-0.96). CONCLUSION: In this large population-based study, we found a significantly decreased risk of prostate cancer among men with diabetes and metformin-users.

Increased kidney cancer risk in diabetes mellitus patients: a population-based cohort study in Lithuania.

BACKGROUND: Diabetes is associated with increased risk of various cancers but its association with kidney cancer is unclear. The objective of this study was to evaluate the association between T2DM with or without metformin use and the risk of kidney cancer in a population-based national cohort in Lithuania. METHODS: The cohort was composed of diabetic patients identified in the NHIF database during 2000-2012. Cancer cases were identified by record linkage with the national Cancer Registry. Standardized incidence ratios (SIRs) for kidney cancer as a ratio of observed number of cancer cases in diabetic patients to the expected number of cancer cases in the underlying general population were calculated. RESULTS: T2DM patients (11,592) between 2000 and 2012 were identified. Overall, 598 cases of primary kidney cancer were identified versus 393.95 expected yielding an overall SIR of 1.52 (95% CI: 1.40-1.64). Significantly higher risk was found in males and females. Significantly higher risk of kidney cancer was also found in both metformin users and never-users' groups (SIRs 1.45, 95% CI: 1.33-1.60 and 1.78 95% CI: 1.50-2.12, respectively). CONCLUSIONS: The patients with T2DM have higher risk for kidney cancer compared with the general Lithuanian population.

A Cohort Study of Antihyperglycemic Medication Exposure and Gastric Cancer Risk.

We assessed gastric cancer risk in type 2 diabetes mellitus patients. Gastric cancer patients with diabetes between 2001-2012 were identified. Four groups were analysed: combination therapy with metformin users; insulin and other medication users; metformin and insulin users; and sulfonylurea users. Standardised incidence ratios (SIRs) for gastric cancers as a ratio of the observed number of cancer cases in people with diabetes to the expected number of cancer cases in the underlying general population were calculated. A total of 99,992 patients with diabetes were analysed and 337 gastric cancer cases in patients with diabetes were observed when compared to the expected number of 400.54 gastric cancer cases, according to the cancer rates of the general population (SIR 0.84, 95% confidence interval (CI): 0.76-0.94). Lower risk of gastric cancer was found both in male and female patients with diabetes, however, risk among females was insignificantly lower. Higher gastric cancer risk was found in the group of diabetic patients treated with sulfonylureas (SIR 1.31, 95% CI: 1.04-1.65) and significantly lower risk than expected from the general population was found in the group of metformin users (SIR 0.75, 95% CI: 0.66-0.86). Type 2 diabetes mellitus was not associated with increased risk of gastric cancer. Metformin might decrease the risk of gastric cancer in patients with diabetes, while sulfonylureas may increase gastric cancer risk.