The reporting of confounding variables in gastric cancer surgery trials

The reporting of confounding variables in gastric cancer surgery trials

Poster Session, Saturday 28 January 2017 Abstracts S137 quantified by real-time RT-PCR in CRC tumoral and adjacent normal tissues. Results: Our resu...

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Poster Session, Saturday 28 January 2017

Abstracts

S137

quantified by real-time RT-PCR in CRC tumoral and adjacent normal tissues. Results: Our results indicated the expression pattern of FBXO39 gene was restricted to tumoral tissues and the gene expression was not observed in the adjacent normal tissues. The expression of this gene was detected in all stage-0 tumoral samples in our patients and there was a significant relation between FBXO39 gene expression and the lymph node involvement. Also there was a significant relation between ETS-1 gene expression with tumor size, lymph node involvement and metastasis. Our studies on H3F3B gene indicated that this gene significantly overexpressed in colorectal cancer tissue compare to adjacent normal tissue and there was a significant association between the expression level of H3F3B gene with the stage of colorectal cancer and lymph node involvement. Also according to our studies there is no association between BMI-1 and ETV-6 genes with colorectal cancer. Conclusion: Since the involvement of lymph nodes is an introduction to the occurrence of metastasis in patients, it is more possible that the expression of FBXO39, ETS-1 and H3F3B genes are an alarm for the occurrence of metastasis and as three candidate genes for prognostic marker for metastasis of colorectal cancer patients. No conflict of interest. 1332 POSTER The reporting of confounding variables in gastric cancer surgery trials C. Lo1 , R. Pinto1 , B. Alkhaffaf1 . 1 Central Manchester University Hospitals, Department of Oesophago-gastric surgery. Manchester Royal Infirmary, Manchester, United Kingdom Background: Surgery is the primary treatment for gastric cancer, however it is associated with a risk of significant short and long-term complications. Trials examining therapeutic surgical interventions aim to reduce these risks and improve long-term survival for patients. Understanding the external validity of these trials is essential prior to implementing new interventions into clinical practice. This can only be achieved if there is a clear understanding of the impact confounding variables may have on the outcomes reported. The aim of this study was to examine the reporting of confounding variables described in gastric cancer surgery trials. Material and Methods: Systematic literature searches of English-language RCTs examining therapeutic surgical interventions between 1996 and 2016 were undertaken. All variables not related to the interventions being examined (e.g. patient, treatment and tumour characteristics) were recorded independently by two researchers. Results: 50 publications were identified from 32 RCTs which had recruited a total of 8673 patients. In total, 144 unique potentially confounding variables were reported. Factor

1331A POSTER FBXO39, ETS-1 and H3F3B genes as three candidates for prognosis of colorectal cancer metastasis 1

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J. Motalebzadeh , F. Mahjoubi , E. Eskandari , S. Rezayati , N. Shakournia1 , H.A. Ayoubi1 . 1 National Research Institute for Genetic Engineering, Clinical Genetic, Tehran, Iran Background: Colorectal cancer (CRC) is one of the prevalent cancers worldwide. Despite recent progression in diagnosis and treatment of cancer, it is still one of the health problems in the world and therefore requires further studies. Many studies have shown many biomarkers for colorectal cancer and according to the presented study we want to report three genes with capability of prognostic markers for metastatic colorectal cancer. The aim of the present study was to investigate the FBXO39, ETS-1, ETV-6, H3F3B and BMI-1 genes expression in CRC patients as potential prognostic biomarkers to evaluate the risk of metastasis in CRC patients. Material and Methods: Thirty six patients with locally advanced colorectal cancer admitted to Hazrat-e-Rasoul Hospital, Tehran, were enrolled in this study. The expression pattern of FBXO39 and ETS-1 genes were investigated using RT-PCR and H3F3B, BMI-1 and ETV-6 genes were

Patient factors Age Sex BMI Weight Height ASA Co-morbidities ECOG PS Treatment factors Previous chemotherapy Previous radiotherapy Tumour factors Size Depth Location (anatomical) Location (by classification) Histological type Grade or TMN stage Grade TMN

Number of publications (%) 50 (100%) 50 (100%) 16 (32%) 9 (18%) 5 (10%) 5 (10%) 11 (22%) 6 (12%) 14 (28%) 16 (32%) 20 (40%) 9 (18%) 28 (56%) 2 (4%) 18 (36%) 27 (54%) 8 (16%) 21 (42%)

ECOG PS, Eastern Cooperative Oncology Group Performance Status. While patients’ age and gender were included in all publications, there were considerable variations in the reporting of other variables. Twentyone publications (42%) stated the patients’ BMI or weight. Seventeen publications (34%) provided information on the patients’ general health (ASA 10%, co-morbidities 22%, and performance status 12%). Fourteen and sixteen publications (28% and 32%) stated if patients had chemotherapy or radiotherapy previously for any malignancy respectively.

S138

Abstracts

Among the publications that provided this information, no patients were given neo-adjuvant chemotherapy. Twenty-one publications (42%) reported if adjuvant chemotherapy was given to patients. Tumour size and depth were reported in twenty (40%) and nine (18%) publications respectively. Twenty-nine publications (58%) specified the location of the tumour. Tumour histological type was reported in eighteen publications (36%). Tumour grade or TMN stage were reported in twentyseven publications (54%). Conclusions: The reporting of baseline data in gastric cancer surgery trials is markedly inconsistent. A consensus-based approach is required to identify a standardised minimum set of baseline data which should be reported by all trials examining therapeutic surgical interventions for gastric cancer. No conflict of interest. 1332A POSTER The biological role of AKT serine/threonine kinase 2 in lung cancer M. Serilmez1 , S. Karaman2 , H. Oguz Soydinc1 , C. Tilgen Yasasever1 , E. Bilgin1 , D. Duranyildiz1 , V. Yasasever1 . 1 Istanbul University- Oncology Institute, basic oncology department of cancer biochemistry, Istanbul, Turkey; 2 Istanbul University- Oncology Institute, department of clinic oncology, Istanbul, Turkey Background: Lung cancer, also known as carcinoma of the lung or pulmonary carcinoma, is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. Primary lung cancers, are carcinomas that derive from epithelial cells. The main primary types are small-cell lung cancer (SCLC), and non-small-cell lung cancer (NSCLC). The closely follow-up of patients having the predisposing disorders can yield an increase in the rates of early diagnosis and curative treatment modalities. Protein kinase B (PKB), also known as Akt, is a serine/threonine-specific protein kinase that plays a key role in multiple cellular processes such as glucose metabolism, apoptosis, cell proliferation, transcription and cell migration. Akt2 is an important signaling molecule in the insulin signaling pathway. It is required to induce glucose transport. Akt isoforms are overexpressed in a variety of human tumors, and, at the genomic level, are amplified in gastric adenocarcinomas (Akt1), ovarian, lung, pancreatic and breast (Akt2) cancer. Emerging evidence confirms a central role of Akt in cancer. To evaluate the relative contribution of deregulated Akt and their clinicopathological significance in lung carcinomas, overexpression, activation of AKT gene increases were investigated. In the current study, we aim to determine the serum levels of AKT-2 verified lung cancer, healthy controls. The results are compared with the controls by using statistical tests. Material and Methods: The serum samples of the 60 consecutive patients with lung cancer who referred to Istanbul University Institute of Oncology from 2015 to 2016 were obtained. The healthy control group consisted of 20. AKT-2 protein assay employs ELISA. The colored reaction product was measured using an automated ELISA microplate reader at 450 nm. Results: Serum AKT-2 (P = 0.00) protein levels were significantly higher in patients with lung cancer than the healthy controls. However, known clinical variables including response to adjuvant chemotherapy were not found to be correlated with serum AKT-2 concentrations (P > 0.05). A significant relationship between other clinicopathologic variables including localization of lung (P = 0.04), presence of metastasis (P = 0.01), vascular invasion (P = 0.02). Discussion: We think this parameter will be important in serum samples of patients with lung cancer diagnosis and disease follow-up. AKT-2 is important in lung cancer targeted therapy. No conflict of interest. 1333 POSTER SPOTLIGHT Setting international standards in analyzing patient-reported outcomes and quality of life endpoints data for cancer clinical trials (SISAQOL consortium) M. Pe1 , for the SISAQOL Consortium. 1 EORTC, Brussels, Belgium Background: With patient-centered care garnering a more central role in oncology, patient-reported health-related quality of life (HRQL) is also increasingly being identified as an important source of data to help describe clinical benefit in cancer randomized controlled trials (RCTs). However, the various ways HRQL endpoints are currently defined, analyzed and interpreted make it difficult to compare results across cancer RCTs. To respond to this problem, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) initiative was established.

Poster Session, Saturday 28 January 2017 This; international multidisciplinary Consortium steered by the European Organization for Research and Treatment of Cancer (EORTC) was assembled to standardize the analysis of HRQL data from RCTs. Methods: We present the steps undertaken to form the SISAQOL initiative: an open discussion among various stakeholders regarding current needs, the assembly of an international and multidisciplinary Consortium, the preparation of a work plan and planning of future steps. Results: The Consortium is composed of over 40 leading international experts including: HRQL researchers and statisticians, key individuals from various international oncology and medical societies, pharmaceutical industry, regulatory and advisory bodies (US Food and Drug Administration, European Medicines Agency, Health Canada, Institute for Quality and Efficiency in Health Care), academic societies (International Society for Pharmacoeconomics and Outcomes Research, International Society for Quality of Life Research, Multinational Association of Supportive Care in Cancer), cancer institutes (National Cancer Institute, Mayo Clinic, EORTC) and patient organizations (International Brain Tumour Alliance). We met and listened to the diverse views of the members. There was a clear consensus that a standardized way of analyzing HRQL data is urgently needed. A work plan was developed to a) examine current statistical methods and challenges in interpreting HRQL in cancer RCTs, and b) consider general methodological guidelines proposed by different regulatory bodies and academic societies. These reports will be collated and a formal consensus will be set-up to deliberate on how to resolve these issues. Conclusions: RCTs cost time, money and effort; and patients, in the interest of improving their situations and helping others, voluntarily give their time to complete HRQL questionnaires for these trials. Therefore, the data from these trials must be exploited to the full, with appropriate and standardized statistical analyses. The aim of SISAQOL is to develop clear, international standards for the analysis of HRQL data in cancer RCTs. We anticipate that the availability of guidelines will lead to more reliable findings, stemming from use of higher quality statistical methods. Conflict of interest: Other Substantive Relationships: An unrestricted education grant was received from Boehringer Ingelheim GmbH to initiate this work. 1334 POSTER Development of biosensor for non-invasive oral cancer detection B.K. Yadav1 , S. Kumar2 , S. Kumar2 , D.C. Doval3 , B.D. Malhotra2 . 1 Rajiv Gandhi Cancer Institute & Research Center, Research, Delhi, India; 2 Delhi Technological University, Department of Biotechnology, Delhi, India; 3 Rajiv Gandhi Cancer Institute & Research Center, Medical Oncology- Research, Delhi, India Background: Oral cancer occurs due to uncontrolled growth of cells in the mouth and is currently the sixth most common cancer. If undetected at an early stage, it can metastasizes in the whole body leading to death. The conventional methods currently used for detection and monitoring of the oral cancer are time consuming, labour-intensive, expensive and require serum/blood. Therefor, an urgent need for the availability of a suitable technique that can be used for rapid detection of oral cancer. In this context, biosensors are considered to be attractive and cost-effective technique that can be used for detection of oral cancer. Recently, There are several biomarkers such as IL-8, IL-6, VEGF, HER2, TPA and EGFR etc. have been used in the oral cancer detection But these biomarkers are secreated in in very low concentration (~pg mL−1 ) in biological fluids. So it require ultrasensitive technique for its detection, that make the whole process very complex. Besides this, these biomarkers are secreted in serum/ blood samples and hence the detection is invasive. Detection via salivary biomarker is a promising non-invasive approach for detection of oral cancer. Interstingly, the CYFRA-21-1 antigen is known to be over-secreated in saliva. In normal subjects, the CYFRA-21-1 level is found to be 3.8 ng mL−1 whereas in oral cancer patients it increases to 17.46±1.46 ng mL−1 . The aim of this study was to fabricate nHfO2 based efficient, that cover the whole physiological range of CYFRA-21−1 biomarker secreted in saliva sample of oral cancer patients. Material and Methods: The nHfO2 was synthesized through one step hydrothermal process and further functionalized with 3-aminopropyl triethoxy silane (APTES) via low temperature silanization process. Indium tin oxide (ITO) coated glass electrode was used as a substrate for fabrication of biosensing platform. Functionalized nHfO2 (APTES/nHfO2 ) was electrophoretically deposited onto ITO electrode. Next, antri-CYFRA-21-1 biomolecules was further immobilized onto APTES/nHfO2 /ITO electrode through EDC-NHS chemistry. BSA was used for the blocking of non-specific binding sites. Unstimulated saliva of ten patients were used to diagnosed oral cancer. Results: Fabtricated immunoelectrode i.e. BSA/anti-CYFRA-21-1/APTES/ nHfO2 /ITO shows longlinearity range 2 to 18 ng mL−1 (with regression