Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial.

BACKGROUND: Breast cancer is the most frequently diagnosed cancer and the leading reason for cancer-related death among women. Neoadjuvant treatment with dual-HER2 (human epidermal growth factor receptor 2) blockade has shown promising effects in this regard. The present study aimed to compare the efficacy and safety of a proposed pertuzumab biosimilar with the reference pertuzumab. METHODS: This randomized, phase III, multicenter, equivalency clinical trial was conducted on chemotherapy-naive women with HER2-positive breast cancer. Patients were randomly assigned (1:1) to receive six cycles of either P013 (CinnaGen, Iran) or the originator product (Perjeta, Roche, Switzerland) along with trastuzumab, carboplatin, and docetaxel every 3 weeks. Patients were stratified by cancer type (operable, locally advanced, inflammatory) and hormone receptor status. The primary endpoint was breast pathologic complete response (bpCR). Secondary endpoints included comparisons of total pCR, overall response rate (ORR), breast-conserving surgery (BCS), safety, and immunogenicity. RESULTS: Two hundred fourteen patients were randomized to treatment groups. bpCR rate in the per-protocol population was 67.62% in the P013 and 71.57% in the reference drug groups. Based on bpCR, P013 was equivalent to the reference pertuzumab with a mean difference of - 0.04 (95% CI: - 0.16, 0.09). Secondary endpoints were also comparable between the two groups. CONCLUSIONS: The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.

Inflammatory Potential of Diet and Odds of Lung Cancer: A Case-Control Study.

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.

Evaluating the safety and effectiveness of PegaGen® (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study.

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.

Dietary Intake and Serum Level of Carotenoids in Lung Cancer Patients: A Case-Control Study.

The aim of this study was to compare the dietary intake and serum levels of some selected carotenoids of lung cancer patients with healthy subjects. Thirty-five lung cancer patients and 33 healthy people were enrolled into this case-control study. Daily intake of nutrients was estimated using a semiquantitative food frequency questionnaire and a 3-day 24-h food recall questionnaire. The concentration of serum beta-carotene and lycopene were analyzed using a high performance liquid chromatography method. Case and control groups did not differ by the means of age, gender, smoking habits, weight, body mass index, mean daily energy intake, mean daily fat intake, and the percentage of daily energy provided by fat to total daily energy intake. The beta-carotene and lycopene intake of the case subjects was 96% and 195% greater than that of the control subjects. Daily intake of fruits and vegetables in the cancer group was higher than the control group. However, the serum concentration of 118% beta-carotene and 60% lycopene were higher in the control group. Despite a higher daily dietary intake of beta-carotene and lycopene by lung cancer patients, serum beta-carotene and lycopene concentrations were significantly lower than the group without cancer.

Opium could be considered an independent risk factor for lung cancer: a case-control study.

BACKGROUND: Lung cancer is the leading cause of cancer-related death worldwide, and half of all incident lung cancers are believed to occur in the developing countries, including Iran. OBJECTIVE: We investigated the association of opium with the risk of lung cancer in a case-control study. METHODS: We enrolled 242 cases and 484 matched controls in this study. A questionnaire was developed, containing questions on basic demographic characteristics, as well as lifelong history of smoking cigarettes, exposure to passive smoking, opium use and alcohol consumption. For smoking cigarettes and opium and also oral opium intake frequency, duration and cumulative use were categorized into three groups: no use, low use and high use. Conditional logistic regression was used to calculate the odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Multivariate analysis in men showed that after adjusting for the effect of ethnicity, education and pack years of smoking cigarettes, smoking opium remained as a significant independent risk factor with an OR of 3.1 (95% CI 1.2-8.1). In addition, concomitant heavy smoking of cigarettes and opium dramatically increased the risk of lung cancer to an OR of 35.0 (95% CI 11.4-107.9). CONCLUSION: This study demonstrated that smoking opium is associated with a high risk of lung cancer as an independent risk factor.

Alvopem® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance.

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.

Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit.

BACKGROUND: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with  epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). METHODS: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients  with EGFR mutation received Erlova at 150 mg/day  as first line treatment. Primary endpoint was progression free survival (PFS). RESULTS: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were  occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about  88%. Most frequent treatment related adverse events was  skin rash. CONCLUSION: Our findings showed Erlova had remarkable effectiveness. In  mutation-positive patients with EGFR, Erlova can be used  safely instead of  other tyrosine-kinase inhibitors.

T790M and Acquired Resistance of Epidermal Growth Factor Receptor to Tyrosine Kinase Inhibitors in Patients with Lung Adenocarcinoma.

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 cfDNA-identified 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.

The Frequency of Epidermal Growth Factor Receptor (EGFR) Mutation in Patients with Lung Adenocarcinoma Referred to a Lung Diseases Hospital; A Cross-Sectional Study from Iran.

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.

Comparing the Quality of Life and General Health Status in Thoracic Cancer Patients with their Family Caregivers in Iran.

Background: Cancer is one of the leading causes of morbidity and mortality around the world. Caregivers of these patients are affected by various physical, emotional, social, spiritual, and financial factors that can affect their quality of life (QoL). This study aimed to compare the QoL and general health status of thoracic cancer patients with their family caregivers in Iranian population. Materials and Methods: Using the City of Hope-Quality of Life (COH-QOL) questionnaire and the General Health Status (GHQ) questionnaire, this cross-sectional study compared the QoL and general health status in 71 thoracic cancer patients with their family members as the primary caregivers. The study was conducted in Masih Daneshvari Hospital of Tehran, Iran from 2017 to 2018. Demographic data and results of the questionnaires were analyzed using the Statistical Package for the Social Sciences (SPSS v.20). Student's t-test, Chi square test, and Pearson's correlation were used to compare the results. Results: In patients and their caregivers, 53.5% (N=38) and 36.6% (N=26) were male, respectively (P=0.043). While the average score of physical wellbeing was 6.12 ± 1.95 in caregivers, it was 5.32 ± 2.08 in patients (P=0.021). In case of psychological wellbeing, the average score in caregivers was 4.14 ± 1.50 and in patients was 5.7 ± 1.54 (P=0.000). We observed no significant difference between caregivers and patients regarding social concerns (4.62 ± 1.50 vs. 4.90 ± 1.74) and spiritual wellbeing (7.03 ± 1.17 vs. 7.2 ± 1.53). Also, the mean scores of GHQ-12 were 5.06 ± 2.5 and 4.17 ± 2.53 in caregivers and patients, respectively (P=0.04). A significant negative correlation was observed between GHQ-12 and QoL scores (r=-0.593, P<0.001). The probability of acquiring mental disorders in female caregivers was two times higher than male caregivers (P=0.05). Conclusion: Our findings demonstrated that family caregivers of thoracic cancer patients suffer from physical and psychological distress, sometimes even more than the patients. This highlights the important role of family caregivers in the process of approaching a patient with thoracic cancer.

Expression of miRNA1, miRNA133, miRNA191, and miRNA24, as Good Biomarkers, in Non-Small Cell Lung Cancer Using Real-Time PCR Method.

BACKGROUND: Lung cancer has recently shown the highest incidence among all cancers. microRNAs (miRNAs) are the molecules playing a role in regulating gene expression and contributing to many pathogenic mechanisms. Therefore, these molecules could be used as biomarkers for the detection, anticipation, and treatment of cancer. With this in mind, we decided to investigate and compare the expression of miR-1, miR-133, miR-191, and miR-24 and also the expression differences in these four RNA molecules between lung cancer patients and the controls. METHODS: A total of 50 patients with lung cancer participated in this study. In addition, 50 healthy blood samples were selected as the control group. Real-time PCR determined the expression levels of miRNA. The RNAs extracted from the patients' white blood cells were initially synthesized, and then cDNA was extracted. Finally, the synthesized cDNA was amplified using real-time PCR, and its expression was compared with the control group. RESULTS: The result indicated a low expression level of miR-1 and miR-133, and a high expression level of miR-191 and miR-24 in the blood of patients with lung cancer compared to the healthy subjects. CONCLUSION: Our findings revealed that miR-1, miR-133, miR-191, and miR-24 are oncogenes, and their expression could result in cancer. It appears that a therapy to overexpress miR-1 and miR-133 and downexpress miR-191 and miR-24 could contribute to the treatment of lung cancer.

EPA and DHA have selective toxicity for PBMCs from multiple myeloma patients in a partly caspase-dependent manner.

Poly-unsaturated fatty acids (PUFAs) have been shown to have cytotoxic effects in both solid and non-solid tumors. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are among the most studied PUFAs. The aim of the present study was to evaluate the cytotoxic effects of these two fatty acids (FAs) in the peripheral blood mononuclear cells (PBMCs) obtained from untreated patients (new cases) with confirmed symptomatic multiple myeloma (MM). Our results showed that EPA at the concentration of 100 µM and DHA at 50 and 100 µM induce potent apoptotic effects in the PBMCs of MM patients (P < 0.05) as evidenced by Annexin V and propidium iodide (PI) staining, while they have little or no effects on the PBMCs isolated from healthy donors (P > 0.05). The observed effects were concentration- and time-dependent and 72 h treatment with DHA at a concentration of 100 µM had the strongest effect (P < 0.01). CD138 + cells isolated from MM patients showed great sensitivity to EPA/DHA. EPA- and DHA-induced apoptosis was significantly inhibited by the pan-caspase inhibitor (Z-VAD-FMK), indicating that cell death was at least partly dependent on caspase activation. The results of the present study showed that EPA and DHA have selective toxicities for malignant human plasma cells from MM patients, but not for mononuclear cells of healthy donors. These results warrant further studies with larger study populations to investigate the usefulness of PUFAs as a promising adjunctive therapy in the treatment of MM.

Clinical Significance of Quantitative FDG PET/CT Parameters in Non-Small Cell Lung Cancer Patients.

BACKGROUND: An initial evaluation of non-small cell lung cancer (NSCLC) patients with 18F- fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) scan can modify treatment planning. We investigated the clinical significance of FDG PET/CT quantitative parameters (QPs) in NSCLC patients. MATERIALS AND METHODS: We included 125 NSCLC patients for initial staging FDG PET/CT scan. The primary tumor (T), regional lymph node metastases (N), and distant metastases (M) were evaluated on FDG PET/CT images. QPs, including standard uptake value (SUVmax), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were calculated separately for each T, N, and M lesion and also for the whole body. Statistical analysis through SPSS version 22 was used to evaluate the clinical significance of PET/CT QPs concerning primary tumor pathology characteristics, initial tumor stage, and patient's prognosis. RESULTS: We followed the patients for 19.28 (±11.42) months. Considering primary tumor pathology, there was a significant difference in FDG PET/CT QPs, including primary tumor SUVmax (p=0.00), metastases SUVmax (p=0.014), whole-body MTV (p=0.045), and whole-body TLG (p=0.002). There was also a significant difference in QPs, including primary tumor SUVmax (p=0.00) and regional lymph node metastases SUVmax (p=0.048) when accounting for tumor initial stage. There was a significant prognostic value for the whole-body TLG (p=0.01) and a cut-off point of 568 was reached to differentiate better versus worse survival outcome. CONCLUSION: We demonstrated a statistically significant difference in FDG PET/CT QPs when accounting for primary NSCLC pathology characteristics and initial stage, as well as patient's prognosis, and recommend incorporating QP values into clinical PET/CT reports.

Proteomic and genomic biomarkers for Non-Small Cell Lung Cancer: Peroxiredoxin, Haptoglobin, and Alpha-1 antitrypsin.

BACKGROUND: The development of lung cancer is a multifactorial process that involves the environmental and genetic factors. The mortality rate of this cancer is higher than breast, colorectal, and prostate cancers. In this study, we try to analyze the proteome of patients with Non-Small Cell Lung Cancer (NSCLC) and compare it with the healthy samples. METHODS: This study has compared 30 lung tissue samples from patients with NSCLC and 30 healthy samples using proteomics and RT-PCR. Hence, tissue samples were obtained from the surgical ward in sterile conditions, and then, protein extraction applied to them. At the next stage, two-dimensional electrophoresis and mass spectrometry LCMS/MS were performed for protein isolation and sequencing, respectively. RESULTS: The proteome analysis identified more than 40 differences in proteomic pattern of normal lung tissues compared to lung tissues with NSCLC. Peroxiredoxin, Haptoglobin, and Alpha-1 antitrypsin proteins were identified. Molecularly, it has also been shown that the two main proteins of Peroxiredoxin-2 and Alpha-1 antitrypsin were upregulated, and the expression of Haptoglobin protein was downregulated in cancer tissue. CONCLUSION: The results of this study showed that there are some differences in term of protein content between the normal and cancerous lung tissues. Further studies are needed to evaluate these proteins that investigate whether these proteins can candidate as biomarkers to use in the early diagnosis of patients with NSCLC.

Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial.

PURPOSE: The purpose of this study was to compare the efficacy and safety of a proposed bevacizumab biosimilar to those of the reference product in patients with metastatic colorectal cancer (mCRC). METHODS: This Phase III, multicenter, randomized, double-blind (patient- and assessor-blind), active-controlled, 2-armed, parallel-group, noninferiority trial was conducted in patients with histologically verified colorectal cancer with evidence of at least 1 metastasis. Patients with mCRC were randomized 2:1 to receive 5 mg/kg IV of either study drug plus FOLFIRI-3 (with repeated irinotecan 100 mg/m2 60-min infusion on day 3) or the reference drug plus FOLFIRI-3 every 2 weeks for 1 year. Progression-free survival (PFS) was the primary end point, and overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity were secondary end points. The population assessable for PFS was per protocol, and the intention-to-treat population was used for sensitivity analysis. Safety was assessed based on reports of adverse events, laboratory test results, and vital sign measurements. FINDINGS: A total of 126 patients were enrolled; PFS values in the biosimilar and reference arms were 232 days (7.7 months) and 210 days (7 months), respectively (P = 0.47). The hazard ratio of the biosimilar arm versus the reference arm was 0.79 in the per-protocol population (90% CI, 0.46-1.35; P = 0.47). The upper limit for the 2-sided 90% CI was lower than the margin of 1.44, indicating that the biosimilar drug was noninferior to the reference drug. The hazard ratio for overall survival in the intent-to-treat population was 0.99 (95% CI, 0.55-1.80; P = 0.99). The difference between other efficacy end points among the groups was not statistically significant. No significant difference was observed in the comparison of the two arms for safety. The antidrug antibody was positive in 1 patient in each arm. IMPLICATIONS: The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs. ClinicalTrials.gov identifier: NCT03288987.

Langerhans cell histiocytosis of the lung and thyroid, co-existing with papillary thyroid cancer.

A 24-year-old man presented to our center with a huge goiter compressing his airway. He had a previous diagnosis of Langerhans cell histiocytosis (LCH) of the lung. Core needle biopsy was consistent with histiocytosis. Thyroidectomy was performed. A very invasive mass was encountered at the time of surgery. Histopathology result was consistent with an invasive papillary cancer of thyroid co-occurring with LCH. Although association of LCH with different malignancies has been reported, co-existing invasive papillary thyroid cancer and LCH is a rare combination.

Thymoma Recurrence and its Predisposing Factors in Iranian Population: a Single Center Study.

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 case-control studies may be required for better evaluation of risk factors.

Cell Free Tumoral DNA Versus Paraffin Block Epidermal Growth Factor Receptor Mutation Detection in Patients with Non-Small Cell Lung Cancer.

Increasing knowledge about the molecular profile of tumors has led to personalized treatment for achieving better outcomes in patients with nonsmall cell lung cancer (NSCLC). Currently, finding exact somatic genomic changes of tumor has gained great importance. On the other hand, crescendoing needs to actual tumor tissue at different time points during cancer treatment may produce major discomfort for NSCLC patients. Tumor genomes can be reconstructed by information obtained from circulating cell-free deoxyribonucleic acid (cfDNA) of peripheral blood. cfDNA may be represented as a suitable alternative test  for epidermal growth factor receptor (EGFR) mutation detection in these patients. This study aimed to assess validity of cfDNA in somatic EGFR mutation identification in Iranian NSCLC cases. METHODS: Somatic mutation of EGFR gene was studied in both tissue specimens and plasma. Then, mutations were detected by polymerase chain reaction(PCR) and sequencing. RESULTS: We observed a high concordance (90%) between tissue samples and cfDNA for EGFR gene mutation.  The sensitivity, accuracy, and positive precision value were 90%, 90% and 100%, respectively. A false negative rate of 10% was also demonstrated in this study. CONCLUSION: We established sensitive methods for detecting EGFR gene mutation which may be very useful in clinical practice.
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Serum Interleukin-27 Level in Different Clinical Stages of Lung Cancer.

BACKGROUND: Advanced lung cancer is indicated with rapid disease development. Interleukin 27 (IL-27) is regarded as a cytokine with anti-tumour activities. AIM: Since, the impact of type of lung cancer on the level of IL-27 in patient's serum has not yet been investigated; current study evaluated the clinical stages according to American Joint Committee on Cancer (AJCC) criteria, Tumor-Node-Metastasis (TNM) stage and the lung cancer spread (localized or widespread) and it's correlation with serum IL-27.MATERIAL AND METHODS: Thirty patients with confirmed histopathological lung cancer and 30 cancer-free healthy individuals as the control group were included in the current study. Patients group were assigned to either small cell lung cancer group (SCLC) or non-small cell lung cancer (NSCLC) according to the clinical features and the results of lung biopsy specimens. Level of IL-27 was quantified with enzyme-linked immunosorbent assay (ELISA) test in serum samples. RESULTS: A significant increase in serum IL-27 level was noticed in individuals with lung cancer in comparison with the control group. The level of serum IL-27 in the NSCL squamous carcinoma (NSCLC-Sc) type was significantly greater than in the NSCLC adenocarcinoma (NSCLC-Ad) type, and in both groups, this variable was more than the control group. The serum IL-27 content level was greater in stage III versus stage IV. CONCLUSION: The current research confirmed the existence of the anti-tumour components in patients with NSCLC. IL-27 can be utilised in diagnosis and screening in early stages of lung cancer along with the management of patients. Different levels of IL-27 in different types of lung cancers in the current study can lead to design more comprehensive studies in the future.