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Background: Lung cancer is the leading cause of cancer deaths worldwide in both men and women, and non-small cell lung cancer (NSCLC) accounts for the majority (~ 85%) of lung cancers. This post-marketing surveillance (PMS) study aimed to evaluate the safety of Pemetrexed (Alvopem®, NanoAlvand, Iran) in Iranian patients with lung cancer or mesothelioma. Methods: The present study is an observational, single-center, open-label, and post-authorization study. All eligible non-squamous NSCLC and malignant pleural mesothelioma (MPM) patients who received pemetrexed based on the physicians' decision, were enrolled. Results: A total of 199 patients with non-squamous NSCLC [186 patients (93.47%) or MPM (12 patients (6.03%)] were enrolled from March 2016 to February 2020. The most common reported adverse event (AE) was anemia (89.39%), followed by neutropenia (28.79%) and leukopenia (24.75%). The most important grade 3 AEs were anemia and neutropenia, with the incidence rate of 3.54% and 7.58%, respectively. No grade 4 AEs were reported. Moreover, the results of our study showed negative statistically significant correlations between patients' age and mean neutrophil count (r = − 0.17; P = 0.0156) and hemoglobin (r = − 0.16; P = 0.0201) in all six visits. Conclusions: The results of this open-label, observational PMS showed that Pemetrexed (Alvopem®) is safe in patients with non-squamous NSCLC patients receiving pemetrexed-containing regimens. Trial registration: The trial was registered at ClinicalTrials.gov (NCT04843007) in April 13th, 2021. [ABSTRACT FROM AUTHOR]

Background: Thymoma is relatively rare tumor. Prognosis and patients' outcome vary across different studies. We aimed to study the predisposing factors causing tumor recurrence in thymoma patients. Materials and Methods: A total of 43 thymoma or thymic carcinoma patients treated at the National Institute of Tuberculosis and Lung Disease (NRITLD), Masih Daneshvari Hospital from September 2005 to January 2017 were evaluated. The primary endpoint was the progression free survival (PFS). The relation of predisposing factors to PFS was studied. Results: Median age was 55 years old. The mean of follow-up duration was 22.9 months. The most prevalent pathology was thymoma unspecified. Pure red cell aplasia (n=3, 6.9%) was the most prevalent Para neoplastic syndrome. Most of the patients (n=23, 54%) were in stage III and IV Masaoka-Koga staging system. Disease progression was observed in 17 patients (39. 5%). Most recurrences occurred locally. None of demographic characteristics differed between patients who experienced disease recurrence and those who did not. After univariate and multivariate analysis, predisposing factor for disease progression was only Masaoka-Koga stage (P- value=0.015 and 0.031 respectively). Conclusion: In this study, among different probable predisposing factors, only Masaoka-Koga stage had significant effect on disease recurrence. Large casecontrol studies may be required for better evaluation of risk factors. [ABSTRACT FROM AUTHOR]

We report a 45 year-old woman who had bilateral breast masses with extradural involvement. Pathologic report revealed malignant high-grade lymphoblastic lymphoma. Systemic chemotherapy was performed but 3 months later, lesions indicating relapse in bone and breast re-appeared. She received salvage chemotherapy, but 4 months after that she was expired. [ABSTRACT FROM AUTHOR]

Lung cancer is one of the common types of malignant disorders and the most prevalent cause of cancer mortality worldwide. Few studies have examined the association of dietary inflammatory index (DII) with lung cancer and findings from these studies are conflicting. Moreover, no study has examined this association in the Middle East. Therefore, the current case-control study was conducted to examine the association between DII and lung cancer among Iranian adults. We recruited 140 pathologically confirmed cases of lung cancer and 140 healthy controls who were matched with cases in terms of age. Dietary intakes were assessed using a 142-item Willett-format dish-based semi-quantitative food frequency questionnaire. DII scores were calculated using the method developed by Shivappa et al. Overall, we found a significant positive association between DII and lung cancer so that after controlling for potential confounders, individuals in the highest tertile of DII scores had 2.03 times more odds of lung cancer compared to those in the lowest tertile (OR: 2.01; 95% CI: 1.02-4.01). This significant positive association was also seen in men, but not in women. In conclusion, adherence to a pro-inflammatory diet was associated with increased odds of lung cancer in adults, particularly in male adults. [ABSTRACT FROM AUTHOR]

Background: In cystic fibrosis patients, the mucus is an excellent place for opportunistic bacteria and pathogens to cover. Chronic infections of upper and lower airways play a critical role in the mortality of cystic fibrosis. This study aimed to introduce the microbiota profiles in patients with cystic fibrosis. Materials and Methods: In this study, a comprehensive literature search was done for studies on upper and lower airway microbiota in cystic fibrosis patients. International and national databases were searched for the following MeSH words: microbiota, microbiome, upper airway, lower airway, cystic fibrosis, cystic fibrosis, upper airway microbiome, lower airway microbiome, microbiome pattern in cystic fibrosis, microbiome pattern in cystic fibrosis, upper airway microbiota, lower airway microbiota, and microbiota pattern. Results: Streptococcus spp. are in significantly higher relative abundance in infants and children with cystic fibrosis; however, Pseudomonas spp. are in higher relative abundance in adults with cystic fibrosis. Molecular diagnostic techniques can be remarkably accurate in detecting microbial strains. Conclusion: For the detection and isolation of most bacterial species, independent-culture methods in addition to the standard culture method are recommended, and sampling should include both upper and lower airways. [ABSTRACT FROM AUTHOR]

Background: Maintenance strategy has been used to improve survival in nonsmall cell lung cancer (NSCLC). We investigated whether switch maintenance therapy with vinorelbine improved progression free survival (PFS) after firstline chemotherapy with gemcitabine plus carboplatin. Materials and Methods: In this single blind, parallel, phase 2, randomized trial, patients with NSCLC pathology, age >18 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2, and advanced stage (IIIB and IV) were treated with up to 6 cycles of gemcitabine 1250 mg/m2 (day 1 and 8) plus carboplatin AUC 5 (day 1) every 3 weeks. Patients who did not show progression after first-line chemotherapy were randomly assigned to receive switch maintenance with vinorelbine (25 mg/m2, day 1, 15) or the best supportive care until disease progression. Results: A total of 100 patients were registered, of whom 34 had a nonprogressive response to first-line chemotherapy and randomly received maintenance vinorelbine (n=19) or best supportive care (n=15). The hazard ratio of PFS in the vinorelbine group relative to the best supportive care group was 1.097 (95% confidence interval = 0.479-2.510; P-value =0.827). There was no significant difference between the overall survival for the two groups (P=0.068). Conclusion: Switch maintenance strategies are beneficial, but defining the right candidates for treatment is a problem. Moreover, the trial designs do not always reflect the real-world considerations. Switch maintenance therapy with vinorelbine, though had tolerable toxicity, did not improve PFS in patients with NSCLC. Therefore, other agents should be considered in this setting. [ABSTRACT FROM AUTHOR]

Purpose: Phase IV clinical trials are required to evaluate the real-world safety and effectiveness of drugs. This study aimed to evaluate the safety and effectiveness of once-per-cycle administration of PegaGen® (pegfilgrastim, CinnaGen, Iran) in cancer patients.Methods: In this open-label, multicenter, prospective, real-world, post-marketing surveillance study, patients with any type of cancer receiving chemotherapy regimens with a high risk of febrile neutropenia (FN) were included if they were prescribed pegfilgrastim for FN prophylaxis. The primary objective of this study was to assess the safety and the secondary objective was to assess the effectiveness of pegfilgrastim in the prevention of FN in cancer patients.Results: A total of 654 patients (51.73 ± 15.12 years of age) were enrolled and 3615 cycles of pegfilgrastim injections were recorded. The most common malignancies among the study patients were breast cancer (n = 192, 29.36%), lymphoma (n = 131, 20.03%), and gastric cancer (n = 65, 9.94%). The median (Q1, Q3) number of pegfilgrastim cycles per patient was 6 (4, 7). A single 6 mg dose was injected in 99.17% of the cycles. A total number of 816 adverse events (AEs) were reported in 246 patients (37.62%). Bone pain was recorded in 141 patients (21.56%) and in 440 cycles (12.17%). Among all patients, 45 patients (6.88%) experienced FN 51 times, and FN frequency was 1.4% among cycles. Moreover, 14 (2.14%) patients were hospitalized following FN. Antibiotics were administered to 24 patients (3.67%) for FN treatment.Conclusion: The results from this post-marketing surveillance study support the safety and effectiveness of PegaGen® used for the prevention of chemotherapy-induced FN in patients with various types of cancer and treatment regimens.Trial Registration: Clinicaltrials.gov identifier: NCT04460079. [ABSTRACT FROM AUTHOR]

Background: Activating mutations in the epidermal growth factor receptor (EGFR) are initially responsive to tyrosine kinase inhibitors (TKIs), but responses to TKIs is not permanent and drug resistance eventually happens for almost all patients. Subsequent studies found different resistance mechanisms, among which (EGFR) T790M mutation is the most important mechanism of TKI treatment failure. Using cell-free DNA (cfDNA) is a new way for diagnosing resistance mutations in EGFR. The aim of present study is to determine cfDNAidentified recurrence mutation rate and their association with clinical outcome in lung Adenocarcinoma patients. Materials and Methods: Patients who were diagnosed with metastatic adenocarcinoma of the lung and acquired resistance to TKIs were enrolled. The incidence of T790M positivity, overall survival (OS) and median duration of TKI treatment before progression was calculated. Polymerase chain reaction (PCR) and sequencing were used to identify the T790M mutation in cfDNA. Results: The incidence of T790M mutations was higher in men, younger cases (<59 years), in patients with L858R primary mutation and never smokers although they were not significantly different (P-values= 041, 0.316, 0.316 and 0.158, respectively). There was significant longer OS in the Del19 subgroup than the L858R subgroup (p = 0.014). In multivariable analysis, significant longer OS was associated with younger age (<59 years) and primary EGFR mutation exon 19 (P-values= 0.028 and 0.050, respectively). Conclusion: T790M mutations frequency may differ by ethnicity, genetic factors and EGFR primary mutations. Detecting T790M mutations in plasma is considered as an indicator of treatment with third generation EGFR-TKIs. [ABSTRACT FROM AUTHOR]

Background & Objective: Various studies showed the use of epidermal growth factor receptors (EGFRs) gene mutations in the therapeutic plan of patients with advanced lung cancer. This study aimed to investigate the frequency and types of EGFR gene mutations among Iranian patients with lung adenocarcinoma referred to a specialized lung diseases hospital from 2014 to 2019. Methods: The data of all patients with lung adenocarcinoma referred to the Molecular Department of Masih Daneshvari Hospital Laboratory (National Research Institute of Tuberculosis and Lung Diseases) from 2014 to 2019 for EGFR mutation tests were collected. Patients' characteristics data and information on the frequency and types of EGFR gene mutations were obtained from the hospital information system (HIS). The collected data were analyzed using SPSS 25. Results: A total of 570 individuals (Mean age of 58.74, 51.6% Male) were included in the study; 113 out of 570 patients (19.8%) were diagnosed with gene mutation. In terms of the type of mutation, 65 participants (57%) showed deletion, 48 patients (42.1%) were diagnosed with replacement, and one (0.9%) case demonstrated both. Notably, the mutation rate detected among the female patients was significantly higher than the male ones (P=0.001); in particular, deletion type of mutation was found more among women, although both genders were the same in terms of the replacement frequency. However, the age had no effect on the mutation in this study (P=0.05). Conclusion: Among Iranian patients with lung adenocarcinoma, 19.8% harbored EGFR gene mutation. This mutation was found in association with lung cancer and could affect the patient's therapeutic plan. [ABSTRACT FROM AUTHOR]

Background: Globally, lung cancer represents a major cause of cancer-related deaths. The regulation of gene expression is modulated by small noncoding RNAs called miRNAs that can act as both tumor suppressors and oncogenes. The maturation, expression and binding to target mRNAs is affected by single nucleotide polymorphisms (SNPs) in miRNA genomic regions thereby contributing to cancer susceptibility. SNPs Rs11614913 in miR196a and Rs3746444 in miR-499 are implicated in the development of cancers such as non-small cell lung cancer (NSCLC) in non-Arabic subjects. Materials and Methods: A small cohort of 204 participants including 104 lung cancer patients and 100 non-cancer controls subjects were enrolled into the study. The allele frequencies were determined by Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) and their correlation with lung cancer risk was determined. Results: The miR-196a rs11614913 polymorphism increased the risk of NSCLC (CC vs. TT+TC: OR= 2.26, 95%CI= 1.28 - 3.98, P= 0.0046) in a dominant genetic model. No statistically significant association was found between the miR-499 rs37464444 polymorphism and NSCLC. Conclusion: The rs11614913 polymorphism in miR-196a, but not the miR-499 rs37464444 polymorphism, increased the risk of NSCLC. Further studies with larger sample sizes in correlation with functional outcomes at the cellular level should be undertaken. [ABSTRACT FROM AUTHOR]

Coronavirus disease-19 (COVID-19) pandemic, caused by SARS-CoV-2, has gradually spread worldwide, becoming a major public health event. This situation requires designing a novel antiviral agent against the SARS-CoV-2; however, this is time-consuming and the use of repurposed medicines may be promising. One such medicine is favipiravir, primarily introduced as an anti-influenza agent in east world. The aim of this study was to evaluate the efficacy and safety of favipiravir in comparison with lopinavir-ritonavir in SARS-CoV-2 infection. In this randomized clinical trial, 62 patients were recruited. These patients had bilateral pulmonary infiltration with peripheral oxygen saturation lower than 93%. The median time from symptoms onset to intervention initiation was seven days. Favipiravir was not available in the Iranian pharmaceutical market, and it was decided to formulate it at the research laboratory of School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. The patients received favipiravir tablet at a dose of 1600 mg orally twice a day for day one and then 600 mg orally twice a day for days 2 to 6. In the second group, the patients received lopinavir-ritonavir combination tablet at a dose of 200/50 mg twice a day for seven days. Fever, cough, and dyspnea were improved significantly in favipiravir group in comparison with lopinavir-ritonavir group on days four and five. Mortality rate and ICU stay in both groups were similar, and there was no significant difference in this regard (P = 0.463 and P = 0.286, respectively). Chest X-ray improvement also was not significantly different between the two groups. Adverse drug reactions occurred in both groups, and impaired liver enzymes were the most frequent adverse effect. In conclusion, early administration of oral favipiravir may reduce the duration of clinical signs and symptoms in patients with COVID-19 and hospitalization period. The mortality rate also should be investigated in future clinical trials. [ABSTRACT FROM AUTHOR]

Background: Following the recent epidemic of coronavirus disease 2019 (COVID-19) in Wuhan, China, a novel betacoronavirus was isolated from two patients in Iran on February 19, 2020. In this study, we aimed to determine the clinical manifestations and outcomes of the first confirmed cases of COVID-19 infection (n=127). Materials and Methods: This prospective study was conducted on all COVID- 19-suspected cases, admitted to Masih Daneshvari Hospital (a designated hospital for COVID-19), Tehran, Iran, since February 19, 2020. All patients were tested for COVID-19, using reverse transcription-polymerase chain reaction (RT-PCR) assay. Data of confirmed cases, including demographic characteristics, clinical features, and outcomes, were collected and compared between three groups of patients, requiring different types of admission (requiring ICU admission, admission to the general ward, and transfer to ICU). Results: Of 412 suspected cases, with the mean age of 54.1 years (SD=13.4), 127 (31%) were positive for COVID-19. Following the patients' first visit to the clinic, 115 cases were admitted to the general ward, while ten patients required ICU admission. Due to clinical deterioration in the condition of 25 patients (out of 115 patients), ICU admission was essential. Based on the results, the baseline characteristics of the groups were similar. Patients requiring ICU admission were more likely to have multiorgan involvement (liver involvement, P<0.001; renal involvement, P<0.001; and cardiac involvement, P=0.02), low O2 saturation (P<0.001), and lymphopenia (P=0.05). During hospital admission, 21 (16.5%) patients died, while the rest (83.5%) were discharged and followed-up until March 26, 2020. Also, the survival rate of patients, who received immunoglobulin, was higher than other patients (60.87% vs. 39.13%). Conclusion: The mortality rate of COVID-19 patients was considerable in our study. Based on the present results, this infection can cause multiorgan damage. Therefore, intensive monitoring of these patients needs to be considered. [ABSTRACT FROM AUTHOR]

On March 11th 2020, the coronavirus outbreak was declared a pandemic by the WHO. One of the groups that is considered high risk in this pandemic are cancer patients as they are treated with a variety of immune system suppressor treatment modalities and this puts them in a great risk for infectious disease (including COVID-19). Therefore, cancer patients require higher level measures for preventing and treating infectious diseases. furthermore, cancer patients may bear additional risk due to the restriction of access to the routine diagnostic and therapeutic services during such epidemic. Since most of the attention of health systems is towards patients affected with COVID-19, the need for structured and unified approaches to COVID-19 prevention and care specific to cancer patients and cancer centers is felt more than ever. This article provides the recommendations and possible actions that should be considered by patients, their caregivers and families, physician, nurses, managers and staff of medical centers involved in cancer diagnosis and treatment. We pursued two major goals in our recommendations: first, limiting the exposure of cancer patients to medical environments and second, modifying the treatment modalities in a manner that reduces the probability of myelosuppression such as delaying elective diagnostic and therapeutic services, shortening the treatment course, or prolonging the interval between treatment courses. [ABSTRACT FROM AUTHOR]

Background: Sleep complaints are common problems in the general population and insomnia and sleep disorders place significant economic and social burdens on the community. Postmenopausal women are 2.6 to 3.5 times more likely to develop obstructive sleep apnea (OSA) compared to non-menopausal women. In this study, we evaluated sleep disorders and mental health in postmenopausal women. Materials and Methods: This study was a descriptive cross-sectional study and the samples were selected from postmenopausal women above 50 years who had participated in a survey entitled, "Evaluation of Sleep Disorders among Adults in Tehran" in 2017. Cluster sampling method was applied with proportional allocation. A total of 4021 samples were collected, 2075 of which belonged to women. In addition, 174 out of 2075 samples were related to postmenopausal women over the age of 50. The data were analyzed using the statistical package IBM SPSS version 22.0. P-values less than 0.05 were considered significant. Results: In this study, 118 (67.8%) women had insomnia for less than three months, and 23 (13.2%) women had insomnia for more than three months. The prevalence of STOPBANG parameters in this group of postmenopausal women was 37% and significantly related to Body mass index (BMI) and neck circumference at P < 0.001 and 0.006, respectively. There was no significant relationship between social dysfunction and insomnia. However, anxiety in General Health Questionnaire (GHQ) was significantly associated with insomnia, sleepiness, sadness, and irritability. Conclusion: Our results indicate that the impact of insomnia symptoms, OSA comorbidity and mental disorders could extend far beyond. The use of urgent health care and quality of life issues is essential for long-term mental and physical well-being; if there is no treatment in the menopause population, there will be serious mental and physical complications. [ABSTRACT FROM AUTHOR]

publisher‐imprint‐name Springer volume‐issue‐count 1 issue‐article‐count 0 issue‐toc‐levels 0 issue‐pricelist‐year 2019 issue‐copyright‐holder The Author(s) issue‐copyright‐year 2019 article‐contains‐esm No article‐numbering‐style Unnumbered article‐registration‐date‐year 2019 article‐registration‐date‐month 4 article‐registration‐date‐day 6 article‐toc‐levels 0 toc‐levels 0 volume‐type Regular journal‐product ArchiveJournal numbering‐style Unnumbered article‐grants‐type OpenChoice metadata‐grant OpenAccess abstract‐grant OpenAccess bodypdf‐grant OpenAccess bodyhtml‐grant OpenAccess bibliography‐grant OpenAccess esm‐grant OpenAccess online‐first false pdf‐file‐reference BodyRef/PDF/40169_2019_Article_229.pdf target‐type OnlinePDF issue‐type Regular article‐type OriginalPaper journal‐subject‐primary Medicine & Public Health journal‐subject‐secondary Medicine/Public Health, general journal‐subject‐collection Medicine --> Background: Plasma circulating cell‐free (cf) DNA is regarded as a source of tumor DNA. Based on availability of blood tissue for the purposes of early detection of cancer and patients' follow‐up, several studies have evaluated concentration of cf DNA in cancer patients in association with tumor features. In the present study, we assessed concentration of cf DNA in lung cancer patients with two commercial kits (MN and QIAGEN) to find whether it can be used as a prognostic biomarker. Results: Primary cf DNA concentrations as measured by QIAGEN kit was significantly higher in patients who died in the follow‐up period compared with alive patients (P = 0.007). Moreover, the concentrations as measured by both methods were higher in patients who experienced recurrence in the follow‐up period compared with patients without recurrence (P = 0.008 and 0.007 for MN and QIAGEN kits respectively). Significant associations were also found between cf DNA concentrations and tumor stage (P = 0.005 and 0.02 for MN and QIAGEN kits respectively). Notably, cf DNA concentration was higher in metastatic tumors compared with non‐metastatic tumors in association with number of involved organs. Based on the AUC values, both kits could differentiate metastatic cancers from non‐metastatic ones with accuracy of 98%. Conclusions: The current study highlights the accuracy of cf DNA concentrations for prediction of disease course in lung cancer patients. [ABSTRACT FROM AUTHOR]

Background: A substitution of G to T at nucleotide 1849 in exon 14 of the Janus kinase2 (JAK2) gene is well recognized in myeloproliferative neoplastic disorders (MPNs). Based on WHO guidelines, detection of the mutation is very important to confirm the disease in suspected patients. Methods: Eighty-seven patients with different background diseases were tested for JAK2 V617F mutation by four different methods, including polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), amplification refractory mutation system (ARMS), polymerase chain reaction-high resolution melting (PCR-HRM), and two different commercial kits. Results: The mean age of patients was 53.38±17.43 years, 72.4% were males, and 37.6% were females. JAK2 mutation was detected in 16 patients (18.3%). Of those, 7 (43.75%) suffered from PV, 5 (31.25%) from ET, 3 (18.75%) from PMF, and 1 (6.15%) from unclassified neoplastic disorders. The frequency of JAK2 mutation was 71.4% (5/7) in PV, 80% (4/5) in ET, and 66.7% (2/3) in PMF patients. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and GE of PCR-HRM for detection of the JAK2 mutation was 86.7%, 100%, 100%, 97.3%, and 97.7%, respectively. While the sensitivity, specificity, PPV, NPV, and GE of PCR-RFLP were 93.3%, 80.5%, 50%, 98.3%, and 82.7%, respectively. On the other hand, the sensitivity, specificity, PPV, NPV, and GE of ARMS assays were evaluated by about 80%, 96%, 100%, 96%, and 96.5%, respectively. Conclusion: This study showed that PCR-HRM was a more sensitive assay to detect the JAK2 V617F mutation than the other assays. So, it can be used as a quick, easy, and effective method for screening the JAK2 V617F mutation in patients with MPNs disorders. PCR-RFLP must accompany it as a gold standard method for confirmation of the mutation of JAK2 V617F. [ABSTRACT FROM AUTHOR]

Objectives: To develop a diagnostic algorithm for positron emission tomography (PET)-detected incidental breast lesions using both breast imaging reporting and data system (BI-RADS) and maximum standardized uptake value (SUVmax) criteria.Methods: Fifty-six PET-detected incidental breast lesions from 51 patients, which were subsequently investigated by breast ultrasound within 1 month of the PET study, constituted the study cohort and they were finally verified by tissue diagnosis or a 2-year follow-up. Based on the maximum specificity with sensitivity > 60.0% and maximum sensitivity with specificity > 60.0%, two SUVmax cutoff values were calculated at 2 and 3.7. BI-RADS ≥ 4 was considered as highly suspicious for malignancy. The diagnostic accuracies were estimated for SUVmax levels above or below the cutoff points combined with the BI-RADS suspicion level.Results: Overall, 46 benign and 10 malignant lesions were studied. The diagnostic characteristics of SUVmax ≥ 2, SUVmax ≥ 3.7, and BI-RADS ≥ 4 were 80.0%, 60.0%, and 80.0% for sensitivity, 73.9%, 95.7%, and 92.7% for specificity, and 75.0%, 89.3%, and 90.2% for accuracy, respectively. When the SUVmax threshold was set at 2, combined with BI-RADS suspicion level, the sensitivity, specificity, and accuracy were 100.0%, 69.6%, and 75.0%, respectively. The results for SUVmax threshold set at 3.7 combined with BI-RADS were 90.0%, 91.3%, and 91.1% for the sensitivity, specificity, and accuracy, respectively. A diagnostic algorithm was accordingly generated.Conclusion: The need for biopsy should be justified in low BI-RADS lesions presenting with high SUVmax at 3.7 or higher. The biopsy of patients with high B-IRADS and low SUVmax could be preserved.Key Points: • A diagnostic algorithm was developed for PET-detected incidental breast lesions using both BI-RADS and SUVmax criteria. • Diagnostic performance was calculated separately and conjunctively for SUVmax ≥ 2, SUVmax ≥ 3.7, and BI-RADS ≥ 4. • The need for biopsy can be justified in BI-RADS < 4 lesions with SUVmax ≥ 3.7. Lesions with BI-RADS < 4 and indeterminate SUVmax (2 < SUVmax < 3.7) benefit from a short-interval follow-up. BI-RADS < 4 lesions with SUVmax < 2 may confidently be scheduled for routine screening. [ABSTRACT FROM AUTHOR]

Introduction: The frequency of kidney disorders varies in pulmonary sarcoidosis patients. Since the prevalence of kidney disorders among Iranian sarcoidosis patients is uncertain, this study aimed to evaluate kidney disorders and associated manifestations in Iranian pulmonary sarcoidosis patients.Materials and Methods: One hundred patients with confirmed granuloma as pulmonary sarcoidosis were studied for renal disorders. Size of urinary tract and the presence of renal stones were checked via clinical examination and urinary organ ultrasonography. Patients' 24-hour urine sample was examined for pH, calcium, protein (over 250 mg) and creatinine (over 1.4 mg).Results: Thirty-three percent of the patients expressed renal disorders simultaneously.Uric acid in pulmonary sarcoidosis patients could be correlated with the probability of developing renal stone. In addition, 1,25-dihydroxyvitamin D levels above 30 ng/mL and uric acid levels above 7 mg/dL in urine were directly correlated with renal disorders in sarcoidosis patients.Conclusions: Urinalysis is an easy and reliable method for assessing renal disorders in sarcoidosis patients. The current study proposes inclusion of urinalysis in routine checkups of sarcoidosis individuals. [ABSTRACT FROM AUTHOR]

Background: Evolution of individualized radiosurgical therapeutic methods for brain metastasis as an ominous prognostic finding may encourage a more extensive application of neuroimaging in patients with extracerebral cancer. The aim of the present study was to investigate the added value of brain-included 18 F FDG PET/CT acquisition protocol based on primary cancer type and clinical indication. Materials and Methods: A retrospective review was performed on 3945 18 F FDG PET/CT reports of patients with extra-cerebral cancer underwent brain-included PET/CT study. Cerebral lesions suggestive of brain metastasis were subsequently verified by MRI, MRI+MRS, surgical pathology and a 1-year clinical formal follow up. The detection rate of new brain metastasis and related impact on disease status were then investigated in each cancer type based on clinical indication. Results: Of a total 3933 eligible patients, 44 (1.12%) were finally verified to have new cerebral metastasis. The most common primary sources were lung cancer (19/385, 4.93%), cancer of unknown primary (CUP) (5/168, 2.97%) and breast cancer (8/468, 1.71%). The most common clinical indications were initial staging (17/44, 43.1%) and restaging (19/44, 36.4%). Change in disease status occurred in 12 out of 44 patients (27.3%), more frequently occurred in lung cancer (n=4), in all indications and breast (n=3) cancers at restaging (n=7, 43.8%). Conclusion: PET/CT acquisition protocol study may be best optimized based on the type of primary cancer and timing of evaluation. Brain-included field of view may be recommended for lung cancer regardless the clinical indication, cancer of unknown primary and breast cancer at restaging. [ABSTRACT FROM AUTHOR]

Basal cell carcinoma is a common non-melanotic skin cancer with a prevalence of 74.5%-82.6% in the Iranian population. BCC rarely metastasizes. However, metastasis can cause significant morbidity. The prevalence of metastatic basal cell carcinoma varies between 0.0028% and 0.55% of all cases. We describe a case of lung metastasis of basal cell carcinoma of the scalp. [ABSTRACT FROM AUTHOR]

Background A number of complex and rare mutations in epidermal growth factor receptor (EGFR) gene have been identified and the clinical implication of serum EGFR ligands has also been reported. However, the prognostic significance of these mutations and also the serum EGFR and its ligands in Non-Small Cell Lung Carcinoma (NSCLC) has remained a challenging issue. This study is aimed at finding the prognostic importance of EGFR rare mutations and serum EGFR, amphiregulin (AR), and TGF-α (Transforming Growth Factor-alpha) in NSCLC. Materials and method NSCLC patients ( n = 98) with mean age of 59 ± 10.5 were enrolled (M/F: 75/23). DNA was extracted from formalin fixed paraffin embedded tissues. Exons 19 and 21 were amplified using polymerase chain reaction followed by direct sequencing for identification of mutations. Serum EGFR, AR, and TGF-α were measured by ELISA. Results EGFR mutation rate in patients was 37% (exon 19 deletions: 72.2%, exon 21 substitutions: 27.8%). The E872K in exon 21 mutation-positive cases was the most frequent rare mutation detected (90%; 9/10 samples). A significant relationship was found between EGFR exon 21mutations and serum EGFR and TGF-α ( P < 0.05). Increased serum AR (> 3 pg/ml) and TGF-α (> 10.5 pg/ml) were associated with shorter overall survival ( P < 0.05). Conclusions The data clearly show that elevation of serum TGF-α and AR are associated with poor prognosis of NSCLC. In addition to the close relationship between EGFR mutations and serum EGFR, serum TGF-α changes was associated with the gene mutations. These findings could be implicated in clinical decision making related to EGFR-TKIs. [ABSTRACT FROM AUTHOR]

CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic colon cancer. Oxaliplatin is also used in the off-label treatment of gastric cancer. FDA uses post-marketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. It is necessary to perform safety monitoring after marketing authorization is received; such monitoring can be done by means of characterizing the safety of drugs in patients being treated in real-world clinical practice settings. This Phase IV study aimed to evaluate the safety profile of a brand-name formulation of the generic drug oxaliplatin (AlvoxalⓇ, NanoAlvand, Tehran, Iran) in Iranian patients diagnosed with either colorectal or other, different types of cancer. Patients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational Phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers. A total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least 1 adverse event. Most of these adverse events were grade 1 or 2, and the most commonly reported adverse event was anemia (60.66%). During the study, 26 serious adverse events occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of adverse events in the system organ classes of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (ie, colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, postmarketing surveillance study demonstrated no unexpected safety findings from the use of this oxaliplatin product (AlvoxalⓇ) in Iranian patients diagnosed with different types of cancer. This Phase IV study provides data on the safety profile of a number of chemotherapy regimens containing an oxaliplatin product given to Iranian patients diagnosed with different types of cancer. [ABSTRACT FROM AUTHOR]

Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer. This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel. Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets. A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants' mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens. The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc. • Totally 411 patients were enrolled from 25 centers in Iran. • The most common adverse event was alopecia (41.12%). • Only 25 (6.08%) patients experienced serious adverse events. • Results of this study support the safety profile of Alvotere® in Iranian patients. [ABSTRACT FROM AUTHOR]

• The pathophysiology of SARS-CoV-2 infection may be attributed to cytokine release syndrome. • In this syndrome, interleukin 6 is released after the activation of the inflammatory cascade. • The mortality rate in the current study was 16%. • Tocilizumab may be a promising agent to decrease the mortality rate in severe or critical SARS-CoV-2 infection. The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection. In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software. Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients. Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage. [ABSTRACT FROM AUTHOR]

Background: Plasma circulating cell-free (cf) DNA is regarded as a source of tumor DNA. Based on availability of blood tissue for the purposes of early detection of cancer and patients' follow-up, several studies have evaluated concentration of cf DNA in cancer patients in association with tumor features. In the present study, we assessed concentration of cf DNA in lung cancer patients with two commercial kits (MN and QIAGEN) to find whether it can be used as a prognostic biomarker. Results: Primary cf DNA concentrations as measured by QIAGEN kit was significantly higher in patients who died in the follow-up period compared with alive patients (P = 0.007). Moreover, the concentrations as measured by both methods were higher in patients who experienced recurrence in the follow-up period compared with patients without recurrence (P = 0.008 and 0.007 for MN and QIAGEN kits respectively). Significant associations were also found between cf DNA concentrations and tumor stage (P = 0.005 and 0.02 for MN and QIAGEN kits respectively). Notably, cf DNA concentration was higher in metastatic tumors compared with non-metastatic tumors in association with number of involved organs. Based on the AUC values, both kits could differentiate metastatic cancers from non-metastatic ones with accuracy of 98%. Conclusions: The current study highlights the accuracy of cf DNA concentrations for prediction of disease course in lung cancer patients. [ABSTRACT FROM AUTHOR]