Efficacy and safety of diphereline 11.25 mg, microrelin 11.25 mg, and microrelin 3.75 mg in premenopausal patients with breast cancer: a non-inferiority randomized clinical trial.

BACKGROUND: Diphereline is a Gonadotropin-Releasing Hormone agonist commonly used in patients with breast cancer. This study aimed to compare the efficacy and safety of one-month and three-month Microrelin injections produced by Homa Pharmed Company with three-month Diphereline injections manufactured by IPSEN, France. METHODS: The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy. The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg). The participants' menopausal symptoms, estradiol, and FSH serum levels were recorded in three-month intervals for one year. The efficacy of each medication and its side effects were compared among the three groups by statistical analysis during the one-year follow-up. RESULTS: The study included 133 patients with breast cancer. A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study. No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed. Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A. Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant. Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A. CONCLUSIONS: It can be concluded that injections of both Microrelin 11.25 mg and 3.75 mg, produced by Homa Pharmed, Iran, are non-inferior in terms of effectiveness and incidence of menopausal symptoms compared to Diphereline, manufactured by IPSEN, France. TRIAL REGISTRATION: IRCT.ir, IRCT20201227049847N1; Registered on 09/01/2021.

Anti-cancer effect of COVID-19 vaccines in mice models.

AIMS: Without any doubt, vaccination was the best choice for Coronavirus disease 2019 (COVID-19) pandemic control. According to the American Society of Clinical Oncology (ASCO) and European Society for Medical Oncology (ESMO), people with cancer or a history of cancer have a higher risk of dying from Covid-19 than ordinary people; hence, they should be considered a high-priority group for vaccination. On the other hand, the effect of the Covid-19 vaccination on cancer is not transparent enough. This study is one of the first in vivo studies that try to show the impact of Sinopharm (S) and AstraZeneca (A) vaccines on breast cancer, the most common cancer among women worldwide. MATERIALS AND METHODS: Vaccination was performed with one and two doses of Sinopharm (S1/S2) or AstraZeneca (A1/A2) on the 4T1 triple-negative breast cancer (TNBC) mice model. The tumor size and body weight of mice were monitored every two days. After one month, mice were euthanized, and the existence of Tumor-infiltrating lymphocytes (TILs) and expression of the important markers in the tumor site was assessed. Metastasis in the vital organs was also investigated. KEY FINDINGS: Strikingly, all of the vaccinated mice showed a decrease in tumor size and this decrease was highest after two vaccinations. Moreover, we observed more TILs in the tumor after vaccination. Vaccinated mice demonstrated a decrease in the expression of tumor markers (VEGF, Ki-67, MMP-2/9), CD4/CD8 ratio, and metastasis to the vital organs. SIGNIFICANCE: Our results strongly suggest that COVID-19 vaccinations decrease tumor growth and metastasis.

Association between burnout and nurses' quality of life in neonatal intensive care units: During the COVID-19 pandemic.

Background: Neonatal intensive care unit (NICUs) nurses could suffer from job stress and burnout, which could cause increased turnover rates and decreased Quality of Life (QoL) among nurses. Purpose: To determine the association between burnout and nurses' QoL in NICUs. Study design: This correlational study was performed in 2020 on 140 nurses working in NICUs. The Maslach burnout and WHO Quality of Life-BREF was used to collect data. Results: There is a positive association between personal accomplishment and all dimensions of QoL (r = 0.40 to 0.56) and a negative association between emotional exhaustion, depersonalization of burnout and all dimensions of QoL (r = -0.47 to -0.79). Conclusion: It is suggested that several interventions must be taken to prevent burnout and increased QoL in NICU nurses. The findings could provide scientific evidence for managers and encourage evidence-based decision-making to reduce burnout and improve the QoL of nurses especially during the Covid-19 pandemic.

Breast cancer risk factors in Iranian women: a systematic review and meta-analysis of matched case-control studies.

BACKGROUND: Identifying breast cancer risk factors is a critical component of preventative strategies for this disease. This study aims to identify modifiable and non-modifiable risk factors of breast cancer in Iranian women. METHODS: We used international databases (PubMed/Medline, Scopus, Web of Knowledge, and Embase) and national databases (SID, Magiran, and ISC) to retrieve relevant studies until November 13, 2022. The odds ratio (OR) with a 95% confidence interval using the random-effect model was used to estimate the pooled effect. The publication bias was assessed by the Egger and Begg test. A sensitivity analysis was conducted to evaluate the effect of each included study on the final measurement. RESULTS: Of the 30,351 retrieved articles, 24 matched case-control records were included with 12,460 participants (5675 newly diagnosed cases of breast cancer and 6785 control). This meta-analysis showed that of the known modifiable risk factors for breast cancer, obesity (vs normal weight) had the highest risk (OR = 2.17, 95% CI 1.47 to 3.21; I2 = 85.7) followed by age at marriage (25-29 vs < 18 years old) (OR = 2.00, 95% CI 1.53 to 2.61; I2 = 0), second-hand smoking (OR = 1.86, 95% CI 1.58 to 2.19; I2 = 0), smoking (OR = 1.83, 95% CI 1.41 to 2.38; I2 = 18.9), abortion history (OR = 1.44, 95% CI 1.02 to 2.05; I2 = 66.3), oral contraceptive use (OR = 1.35, 95% CI 1.11 to 1.63; I2 = 74.1), age at marriage (18-24 vs < 18 years old) (OR: 1.22, 95% CI 1.02 to 1.47; I2 = 0). Of non-modifiable risk factors, history of radiation exposure (OR = 3.48, 95% CI 2.17 to 5.59; I2 = 0), family history of breast cancer (OR = 2.47, 95% CI 1.83 to 3.33; I2 = 73), and age at menarche (12-13 vs ≥ 14 years old) (OR = 1.67, 95% CI 1.31-2.13; I2 = 25.4) significantly increased the risk of breast cancer. CONCLUSIONS: Since most risk factors related to breast cancer incidence are modifiable, promoting healthy lifestyles can play an influential role in preventing breast cancer. In women with younger menarche age, a family history of breast cancer, or a history of radiation exposure, screening at short intervals is recommended.

Prediction of lymphedema occurrence in patients with breast cancer using the optimized combination of ensemble learning algorithm and feature selection.

BACKGROUND: Breast cancer-related lymphedema is one of the most important complications that adversely affect patients' quality of life. Lymphedema can be managed if its risk factors are known and can be modified. This study aimed to select an appropriate model to predict the risk of lymphedema and determine the factors affecting lymphedema. METHOD: This study was conducted on data of 970 breast cancer patients with lymphedema referred to a lymphedema clinic. This study was designed in two phases: developing an appropriate model to predict the risk of lymphedema and identifying the risk factors. The first phase included data preprocessing, optimizing feature selection for each base learner by the Genetic algorithm, optimizing the combined ensemble learning method, and estimating fitness function for evaluating an appropriate model. In the second phase, the influential variables were assessed and introduced based on the average number of variables in the output of the proposed algorithm. RESULT: Once the sensitivity and accuracy of the algorithms were evaluated and compared, the Support Vector Machine algorithm showed the highest sensitivity and was found to be the superior model for predicting lymphedema. Meanwhile, the combined method had an accuracy coefficient of 91%. The extracted significant features in the proposed model were the number of lymph nodes to the number of removed lymph nodes ratio (68%), feeling of heaviness (67%), limited range of motion in the affected limb (65%), the number of the removed lymph nodes ( 64%), receiving radiotherapy (63%), misalignment of the dominant and the involved limb (62%), presence of fibrotic tissue (62%), type of surgery (62%), tingling sensation (62%), the number of the involved lymph nodes (61%), body mass index (61%), the number of chemotherapy sessions (60%), age (58%), limb injury (53%), chemotherapy regimen (53%), and occupation (50%). CONCLUSION: Applying a combination of ensemble learning approach with the selected classification algorithms, feature selection, and optimization by Genetic algorithm, Lymphedema can be predicted with appropriate accuracy. Developing applications by effective variables to determine the risk of lymphedema can help lymphedema clinics choose the proper preventive and therapeutic method.

Status of breast cancer screening strategies and indicators in Iran: A scoping review.

Background: This scoping review aimed to investigate the status of breast cancer (BC) preventive behaviors and screening indicators among Iranian women in the past 15 years. BC, as the most common cancer in women, represents nearly a quarter (23%) of all cancers. Presenting the comprehensive view of preventive modalities of BC in the past 15 years in Iran may provide a useful perspective for future research to establish efficient services for timely diagnosis and control of the disease. Materials and Methods: The English and Persian articles about BC screening modalities and their indicators in Iran were included from 2005 to 2020. English electronic databases of Web of Science, PubMed, and Scopus, and Persian databases of Scientific Information Database (SID) and IranMedex were used. The critical information of articles was extracted and classified into different categories according to the studied outcomes. Results: A total of 246 articles were assessed which 136 of them were excluded, and 110 studies were processed for further evaluation. Performing breast self-examination, clinical breast examination, and mammography in Iranian women reported 0%-79.4%, 4.1%-41.1%, and 1.3%-45%, respectively. All of the educational interventions had increased participants' knowledge, attitude, and practice in performing the screening behaviors. The most essential screening indicators included participation rate (3.8% to 16.8%), detection rate (0.23-8.5/1000), abnormal call rate (28.77% to 33%), and recall rate (24.7%). Conclusion: This study demonstrated heterogeneity in population and design of research about BC early detection in Iran. The necessity of a cost-effective screening program, presenting a proper educational method for increasing women's awareness and estimating screening indices can be the priorities of future researches. Establishing extensive studies at the national level in a standard framework are advised.

Long-term Survival and Prognostic Factors of Breast Cancer.

BACKGROUND: Breast cancer survival rate is an important index for assessment of treatment effect in reducing the mortality. Weaimed to determine the fifteen-year survival rate for breast cancer at a referral center in Iran and its correlated factors. METHODS: This survival study enrolled patients with breast cancer who referred to Motamed Cancer Institute (MCI) from 1998 to2016. The survival rate was calculated using the Kaplan-Meier method. The relationship of demographic, clinical and therapeuticfactors with overall survival (OS) was studied using Cox's proportional hazard model. RESULTS: Totally, 3443 patients were studied. Their mean age and follow-up period were 47.7 (±11.43) years and 61.66 (±52.1)months, respectively. The median follow-up time was 48.4 months (range: 1-413 months), 49.7% of the patients had high schoolor higher education, and 71.3% presented in the early stage of the disease. Death occurred in 505 (14.7%) of the patients. Theoverall 2-, 5-, 7-, 10- and 15-year survival rates were 93%, 82%, 78%, 74%, and 66%, respectively. Lymph node involvement(HR=2.07; 95% CI: 1.38-3.09), tumor size≥5 cm (HR=2.83; 95% CI: 1.59-2.04), being single/divorced/widowed (HR=1.65;95% CI: 1.13-2.4), and education level

Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial.

BACKGROUND: Breast cancer-related lymphedema (BCRL) and its associated symptoms harm the quality of life (QoL) of cancer survivors and can stimulate fear of cancer recurrence (FCR). Self-management education for lymphedema has been introduced as an effective method in controlling FCR. This study investigates the effect of lymphedema group-based education compared to the social network-based and control group on QoL and FCR in breast cancer patients. METHODS: This three-arm clinical trial studied 105 patients with breast cancer-related lymphedema referred to Seyed_Khandan rehabilitation center. Sampling was done by random allocation method in blocks of 3 with 35 subjects in each group. All subjects received routine lymphedema treatments. The group-based education (GE) and social network-based education (SNE) groups received self-management education in the clinic and Telegram™ messenger channel, respectively. Impairment in QoL and mean score of FCR were assessed before, immediately after, and three months after the intervention by using the Persian version of Lymphedema Life Impact Scale (LLIS) and Fear of Progression Questionnaire-Short Form (FoPQ-SF), respectively. Mixed-model ANOVA was applied for statistical analysis. RESULTS: There was a significant time effect on total LLIS (P = 0.007), psychosocial (P = 0.038) and functional (P = 0.024) subscale changes in three groups of study. Interaction between the main effect of group and time on psychosocial subscale changes was statistically significant (P = 0.017). The multicomparison results illustrated that the main effect of time, the main effect of group, and interaction of them on the mean score of FCR were P = 0.084, P = 0.380, and P = 0.568, respectively. CONCLUSION: Despite no significant reduction in the FCR score, results showed the improvement of most QoL aspects after three months of intervention. Although the social network-based education method was effective, the group-based education method was more beneficial. Applying these educational methods in lymphedema treatment protocols needs cost-effectiveness studies. TRIAL REGISTRATION: This study was registered at the Iranian Registry of Clinical Trials (IRCT2017052834176N1).