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Abstract 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.

Adherence to capecitabine, an effective oral chemotherapy agent, is essential in achieving treatment response in cancer. In this study, we aimed to investigate factors associated with non-adherence to capecitabine in a sample of patients with gastrointestinal cancer. We enrolled 98 patients with colon, rectal or gastric cancers who were undergoing treatment with capecitabine as part of their single or multi-agent chemotherapy regimen. The patients were followed during cohort time up to four consecutive cycles of their chemotherapy. For adherence measurement, the participants were asked to bring back the leftover medicines at the time of follow-up visits and were considered adherent if they had taken ≥95% of their prescribed dose. The mean adherence rate was 97.7%, and the patients were adherent to capecitabine in 93.1% of their cycles. The patients who underwent neoadjuvant chemotherapy were significantly less adherent to capecitabine (60%) as compared with adjuvant (95.2%) and palliative chemotherapy (94.6%) [P=0.004]. Multivariable logistic regression revealed that neoadjuvant chemotherapy and the presence of nausea and mucositis were inversely associated with adherence rate. We did not find any association between adherence and any of our laboratory findings. Our findings suggest a high adherence rate to capecitabine among patients with gastrointestinal cancers. Neoadjuvant chemotherapy and the presence of nausea and mucositis may play a significant role in non-adherence to capecitabine.

HER2-positive metastatic breast cancer is much less frequent than other subgroups of breast cancer. Treatment options for this cancer are mostly limited to systemic chemotherapy, which leads to moderate improvements. Targeted therapy against malignant breast cancer requires the identification of reliable biomarkers for personalized medicine to obtain the maximum benefit of this therapy. Any mutations in the TP53 signaling pathway can be considered as a significant causative factor of breast cancer, for which the identification of target genes plays an important role in selecting the appropriate treatment. The use of personalized gene expression profiling could be valuable to find the direct target of the treatment in this case. The present study assessed the genetic profile of an HER2-positive metastatic breast cancer patient (with a liver metastasis) and figured out a complete and sustained response to bevacizumab. According to the results of next-generation sequencing (NGS) analysis, the patient’s genetic profile showed an increased expression of p4EBP1 and PTEN and the activation of the mTOR signaling pathway with a mutation in the TP53 gene. Based on the common treatment of similar profiling, we administrated bevacizumab/Taxol/Gemzar chemotherapy up to six courses. Accordingly, as the response to treatment was revealed by reducing the volume of the liver metastasis from 4 to 1.4 cm, metastasectomy was performed as a complementary treatment. Hence, personalized gene expression profiling not only is useful for targeted therapy but also could be recommended to avoid prescription of non-responsive drugs.

Introduction: Communication skill (CS) has been regarded as one of the fundamental competencies for medical and other health care professionals. Student’s attitude toward learning CS is a key factor in designing educational interventions. The original CSAS, as positive and negative subscales, was developed in the UK; however, there is no scale to measure these attitudes in Iran. The aim of this study was to assess the psychometric characteristic of the Communication Skills Attitude Scale (CSAS), in an Iranian context and to understand if it is a valid tool to assess attitude toward learning communication skills among health care professionals. Methods: Psychometric characteristics of the CSAS were assessed by using a cross-sectional design. In the current study, 410 medical students were selected using stratified sampling framework. The face validity of the scale was estimated through students and experts’ opinion. Content validity of CSAS was assessed qualitatively and quantitatively. Reliability was examined through two methods including Chronbach’s alpha coefficient and Intra class Correlation of Coefficient (ICC). Construct validity of CSAS was assessed using confirmatory factor analysis (CFA) and explanatory factor analysis (PCA) followed by varimax rotation. Convergent and discriminant validity of the scale was measured through Spearman correlation. Statistical analysis was performed using SPSS 19 and EQS, 6.1. Results: The internal consistency and reproducibility of the total CSAS score were 0.84 (Cronbach’s alpha) and 0.81, which demonstrates an acceptable reliability of the questionnaire. The item-level content validity index (I-CVI) and the scale-level content validity index (S-CVI/ Ave) demonstrated appropriate results: 0.97 and 0.94, respectively. An exploratory factor analysis (EFA) on the 25 items of the CSAS revealed 4-factor structure that all together explained %55 of the variance. Results of the confirmatory factor analysis indicated an acceptable goodness-offit between the model and the observed data. [χ2/df=2.36, Comparative Fit Index (CFI)=0.95, the GFI=0.96, Root Mean Square Error of Approximation (RMSEA)=0.05]. Conclusion: The Persian version of CSAS is a multidimensional, valid and reliable tool for assessing attitudes towards communication skill among medical students.

BACKGROUND AND OBJECTIVE: Applying the Best Evidence Medical Education (BEME) in real educational arena is a necessity in medical education. As to the literature, there are enough evidence; however, their application by educators and policymakers has been still failed. Therefore, this study conducted to explore the experience of educators about applying BEME in Iranian context. MATERIALS AND METHODS: Qualitative approach using content analysis method was utilized for exploring 25 participants involved with medical education in different levels, introduced the study using purposeful sampling. Data were collected through a semi-structured interview by which they answered to researcher's questions in around 45 min about how they apply evidence in their educational setting. To make more clarification, probing questions were used. Interviews were recorded and transcribed and then analyzed by coding paradigm immediately. RESULTS: Three categories were emerged as: applying different levels of evidence, substitution of evidence-based medicine for BEME, and variation of understanding BEME. The first category includes subcategories of using personal experience, textbooks, and filtered papers. The second contains lack of knowledge about BEME elements, time and motivation as well as no priority for applying available medical education evidence; and third, using different terminology and having some problems in applying process, based on individual understanding and using papers with or without modification. DISCUSSION: For effective evidence application, it is necessary to operationalize BEME terminology and overcome any ambiguity surrounded it. It is also important to suggest educators to apply the appraised evidence as well as teach them how they search and appraise evidence independently. Certainly, in the first steps, supervision and providing a proper context for BEME applications are crucial.

Background and Aim: Micro RNAs are a group of small non-coding RNAs which play an important role in multiple processes such as proliferation, differentiation, apoptosis, and cancer. Recent studies indicate that mir-210 is overexpressed into erythroid linage during the differentiation of hematopoietic precursor. The main goal of the present study is to investigate the influence of mir-210 on the pattern of expression in hemoglobin gamma chain. Materials and Methods: First, K562 cell line was cultured in RPMI1640 media. Then, pre-miR-210 was transferred into K562 cell line by lipofectamin. Finally, the alterations in the pattern of gamma chain expression were analyzed in days 7 and 14 by RT-PCR and real time PCR technique. Results: It was demonstrated that the overexpression of mir-210 in K562 cell line would lead to a 25-fold increase in the expression of gamma chain in comparison with the control group. Data analysis revealed that the change in the pattern of hemoglobin gamma chain expression was meaningful (p

Background and Aim: Micro RNAs are a group of small non-coding RNAs which play an important role in multiple processes such as proliferation, differentiation, apoptosis, and cancer. Recent studies indicate that mir-210 is overexpressed into erythroid linage during the differentiation of hematopoietic precursor. The main goal of the present study is to investigate the influence of mir-210 on the pattern of expression in hemoglobin gamma chain. Materials and Methods: First, K562 cell line was cultured in RPMI1640 media. Then, pre-miR-210 was transferred into K562 cell line by lipofectamin. Finally, the alterations in the pattern of gamma chain expression were analyzed in days 7 and 14 by RT-PCR and real time PCR technique. Results: It was demonstrated that the overexpression of mir-210 in K562 cell line would lead to a 25-fold increase in the expression of gamma chain in comparison with the control group. Data analysis revealed that the change in the pattern of hemoglobin gamma chain expression was meaningful (p