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BACKGROUND: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). This post-marketing surveillance evaluates the safety of a trastuzumab biosimilar (AryoTrust), produced by AryoGen Co. Iran in Iranian women with HER2-positive non-metastatic breast cancer (BC). RESEARCH DESIGN AND METHODS: The patients who had undergone adjuvant chemotherapy regimens received trastuzumab every 3 weeks for nine cycles. The study started in February 2017 and finished in August 2022. Data regarding safety were collected using booklets and then analyzed. RESULTS: A total of 597 women with a mean ±SD age of 48.13 ± 10.18 years underwent 5,313 injection cycles. They received pre-study chemotherapies consisting of anthracyclines, taxanes, both, or other medications in 6.70, 7.20, 82.41, and 2.01% of the cases, respectively. One hundred and thirty-nine patients experienced at least one adverse event (AE). The most common AEs were decreased ejection fraction (EF, 5.7%), peripheral neuropathy (5.36%), and nausea (5.19%). Meningioma was the only life-threatening serious AE. Furthermore, bone pain and infusion-related reactions were the two most common grade three AEs. Nevertheless, the mean EF of patients did not change notably during the study. CONCLUSIONS: The results demonstrate that this trastuzumab biosimilar is a generally well tolerated and safe treatment for HER2-positive BC. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06021379.

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PURPOSE: This project aimed to evaluate the relationship between the suppressor of cytokine signaling-1 (SOCS1) - 1478 CA > del genetic variation and breast cancer susceptibility. Moreover, we investigated the SOCS1 mRNA expression level in cancerous tissues. METHODS: A total of 100 patients with breast cancer and 120 healthy individuals were selected. Genomic DNA was extracted from blood. SOCS1 genotyping and relative gene expression were performed using ARMS-PCR (Amplification-Refractory Mutation System-Polymerase Chain Reaction) and real-time PCR, respectively. RESULTS: In breast cancer patients, the prevalence of genotype frequencies of SOCS1 (- 1478 CA > del) CA/CA, CA/del, and del/del was 52, 31, and 17%, respectively. Among controls, the distribution of CA/CA, CA/del, and del/del was 63, 15, and 22%, respectively. The chi-square test reported that a significant difference was observed in the genotypic distribution of SOCS1 (- 1478 CA > del) polymorphism between cases and controls (χ2 = 8.08, P = 0.01). In addition, the presence of the CA/del genotype was associated with an elevated risk of breast cancer (in the codominant model: OR 2.51; 95% CI 1.27-4.96, P = 0.007 and in the over dominant model: OR 2.54; 95% CI 1.32-4.90, P = 0.005). However, there was no significant difference in allelic distributions between the groups (P > 0.05). There was no significant difference in the breast cancer risk associated with the dominant and recessive genetic models when the reference was CA/CA and CA/CA + CA/del genotype, respectively (P = 0.09 and P = 0.38). Moreover, the expression of SOCS1 decreased in cancerous tissues as compared to the adjacent non-cancerous tissues (P < 0.0001). CONCLUSION: In conclusion, a functional SOCS1 promoter polymorphism (- 1478 CA > del) may affect breast cancer susceptibility.

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BACKGROUND: Evidence in the last decades has indicated an association between vitamin D and cardiovascular risk factors including blood pressure. The present study aimed to determine whether serum 25-hydroxyvitamin D is independently associated with blood pressure in a large population-based study. METHODS: The study was based on subjects from PERSIAN Guilan Cohort Study (PGCS), a prospective, population-based cohort study in Guilan, Iran. In 9520 men and women, aged 35-70 years, serum 25-hydroxyvitamin D, systolic and diastolic blood pressure were measured. Multiple logistic and linear regression analyses were conducted with adjustments for demographic factors (age and gender), anthropometric characteristics (waist circumference and body mass index), lifestyle variables (physical activity, alcohol, and smoking consumption), and renal function (serum creatinine). RESULTS: Fully adjusted linear regression analyses revealed a weak but statistically significant negative association between serum 25-hydroxyvitamin D levels and systolic blood pressure (ß = -0.02, 95% CI= -0.052 to -0.0001, P-value=0.04), whereas vitamin D status was not significantly associated with diastolic blood pressure (ß = -0.01, 95% CI= -0.026 to 0.009, P-value=0.3). Serum 25-hydroxyvitamin D status showed no significant association with the presence of hypertension (OR 1.09, 95% CI=0.94 to 1.25 for the lowest (25OHD <12 ng/mL) versus the highest (25OHD ≥20 ng/mL) category). CONCLUSION: Lower serum vitamin 25 (OH) D levels were associated with higher systolic blood pressure; however, it was not associated with diastolic blood pressure and presence of hypertension.

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