Day 1 :
Keynote Forum
Abdalla Abotaleb
World Health Organisation, Egypt
Keynote: Challenges facing payers towards biosimilars in cancer
Time : 10:00-11:00
Biography:
Abstract:
Background & Aim: With the presence of concept of biosimilar products at last decade which defined by WHO as a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Interchangeability concepts for Biosimilars were raised by the payers to develop multidisciplinary tools for policy analysis which is the main core of Health Technology Assessment (HTA). The main objective for this study is to determine the roles that can HTA body play for biosimilar products starting from regulatory step finished by decision for reimbursement.
Method: Integration between a systematic literature review and descriptive analysis of (FDA, WHO EMA, local guidelines and local data from regulatory body for efficacy, safety, quality) for biosimilars and ISPOR guidelines for HTA. Interviews was conducted with key stock holders for health system in Egypt, Tunisia, Jordan and Saudi Arabia, United Arab Emirates, Spain, Turkey, Germany and industry representative.
Results: A framework was proposed for biosimilars reimbursement decision making which included price and four non-price criteria. Pharmaceutical price (20% weight), quality module (33%), regulatory body approval for interchangeability (25%) post marketing studies (11%) clinical decision (11%).
Conclusion: Biosimilars should not be treated as generic products. In terms of HTA there is a need to conduct a selection criteria specialized for biosimilars; pricing process should be on case by case basis due to the nature of technology of biosimilars. The need for evidence base data for switching from innovator products to biosimilars should be mandatory during marketing authorization process. Integration between regulatory body and HTA should be initiated. As both bodies differ for their prospective and they need to integrate in order to minimize time consumption and unifying concepts for biosimilars. Effective assessment and evaluation for biosimilars, the comparator of HTA should be a different standard of care may and may not contain the reference product or second generation of Biosimilar.
Keynote Forum
Abdalla Abotaleb
World Health Organisation, Egypt
Keynote: Challenges facing payers towards biosimilars in cancer
Time : 10:00-11:00
Biography:
Abstract:
Background & Aim: With the presence of concept of biosimilar products at last decade which defined by WHO as a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Interchangeability concepts for Biosimilars were raised by the payers to develop multidisciplinary tools for policy analysis which is the main core of Health Technology Assessment (HTA). The main objective for this study is to determine the roles that can HTA body play for biosimilar products starting from regulatory step finished by decision for reimbursement.
Method: Integration between a systematic literature review and descriptive analysis of (FDA, WHO EMA, local guidelines and local data from regulatory body for efficacy, safety, quality) for biosimilars and ISPOR guidelines for HTA. Interviews was conducted with key stock holders for health system in Egypt, Tunisia, Jordan and Saudi Arabia, United Arab Emirates, Spain, Turkey, Germany and industry representative.
Results: A framework was proposed for biosimilars reimbursement decision making which included price and four non-price criteria. Pharmaceutical price (20% weight), quality module (33%), regulatory body approval for interchangeability (25%) post marketing studies (11%) clinical decision (11%).
Conclusion: Biosimilars should not be treated as generic products. In terms of HTA there is a need to conduct a selection criteria specialized for biosimilars; pricing process should be on case by case basis due to the nature of technology of biosimilars. The need for evidence base data for switching from innovator products to biosimilars should be mandatory during marketing authorization process. Integration between regulatory body and HTA should be initiated. As both bodies differ for their prospective and they need to integrate in order to minimize time consumption and unifying concepts for biosimilars. Effective assessment and evaluation for biosimilars, the comparator of HTA should be a different standard of care may and may not contain the reference product or second generation of Biosimilar.
- Special Session
Location: Abu Dhabi
Session Introduction
Ehab Al Rayyan
King Hussein Medical Center, Jordan
Title: Overview of the management of cervical cancer: A Jordanian experience
Biography:
Abstract:
Objective: The aim of our study was to analyze the clinical and pathological characteristics of women who were diagnosed with malignant cervical tumors and managed at King Hussein Medical Centre, Amman, Jordan.
Method: A retrospective study was conducted regarding the patients who were diagnosed with cervical cancer and received treatment at King Hussein medical center. Data were extracted from the patient’s files and reports from the period 2007 to 2017 (over ten years period). The collected data included patient’s characteristics for age, parity, presenting symptoms, marital and menopausal status. Tumor characteristics including the type, size and stage of disease at time of diagnosis. Other data included the types of primary treatment provided and different surgical operations performed. Data was revised, arranged in tables and statically analyzed. Results were extracted and conclusions were made.
Results: One hundred twenty-seven (127) cases of cervical cancer were identified during the studded period. The median age of cases was 52.9 years (range 29-86) years. About 99% of the patients were above the age of 30 years at the time of diagnosis. The majority of the patients are grand multiparous (81%). More than half of the cases are at post-menopausal status (52%). Vaginal bleeding was the most common presenting symptom (86%). Squamous cell carcinoma formed 84% of all types. Chemo-radiotherapy was the most common modality of treatment provided (69%). Early stage disease (Stage I) formed only 9.5% compared to late stage disease (stage II-IV) 90.5%.
Conclusion: Cervical cancer among Jordanian women was most commonly diagnosed at locally advanced stage with no benefit of the surgery leaving the only option for radiotherapy. We recommend the application of more effective screening programs to detect and pre-cancer lesions or malignant lesions at earlier stages.
- Workshop
Location: Abu Dhabi
Session Introduction
Naglaa Mohamed Abdel Razek
Cairo University, Egypt
Title: Breast Intervention from basic to advanced
Biography:
Abstract:
Background: A biopsy remains the standard technique for diagnosing both palpable and non-palpable breast abnormalities and is the preferred initial method of evaluating almost all breast masses. Studies have shown that the combination of a physical examination, radiographic imaging and histopathological confirmation, also referred to as the triple-test, can produce accuracy levels of over 90% when all three components are concordant for benign or malignant disease. Under certain circumstances when a mass or radiographic abnormality is categorized as probably benign in the presence of high patient anxiety, family history of breast cancer or poor likelihood of compliance with recommended six-month follow-up imaging, a breast biopsy may be recommended for category three lesions. In National Comprehensive Cancer Network, a number of well-designed studies have demonstrated the safety and clinical utility of minimally invasive breast biopsy methods relative to open surgical biopsy. Advantages include less discomfort for the patient, a reduction in scarring and cosmetic defect, less invasive procedure, and quicker patient recovery.
Method: Large needle procedures:
BLES & VAB are two advanced automated large needle breast biopsy methods .To date , there is no clear international guide lines regarding the indications however we will try to put preferential indications of each technique based on the available international publications , NICE guideline (UK) as well as our experience in the two techniques ( 2000 VAB in 9 years and 300 BLES in 2yrs).
Conclusion:
BLES & VAB are used as the primary method for histopathology diagnosis of suspicious small & borderline lesions as well as the unclassified microcalcfications.
There are some limitations to BLES including; lactating females, patients with breast implants and patients presenting with a lesion close to the skin or in the axillary tail.
BLES is favored in high risk lesions & DCIS considering the relative high underestimation rate associated with VAB and not found with the BLES . Moreover BLES offers complete lesion removal with available margin evaluation.
- Positron Emission Tomography/Computed Tomography- PET/CT/X-ray | Breast care-Present Perspective | Cancer Awareness
Location: Abu Dhabi
Session Introduction
Ghazal Jameel
Pakistan Atomic Energy Commission General Hospital, Pakistan
Title: Determination of diagnostic accuracy of ACR (TI-RADS) in thyroid nodules on ultrasonography, keeping Bethesda cytological score at FNAC as gold standard
Biography:
Dr. Ghazal is currently working as a Consultant Radiologist at Pakistan Atomic Energy Commission General Hospital Islamabad for past five years. She specializes in radiology as well as in nuclear medicine. She has eight years of work experience in the field of nuclear medicine. Her interest is in interventional radiology and oncology.
Abstract:
Aim: Thyroid Imaging Reporting and Data System (TIRADS) is a risk stratification system for classifying thyroid lesions and were recently recognized by American College of Radiology (ACR) in 2017. TIRADS classification is now being used in daily routine categorization of sonographically visualized thyroid nodules. The aim of the study was to categorize all solid nodules of thyroid identified sonographically according to the TIRADS score and correlating the TIRADS score with Bethesda histopathological category of the same nodule after FNAC. This correlation if validated could help avoid many unnecessary aspirations and thyroid related surgical procedures in cases where both sonographic and histopathological grades are low and to warrant early intervention in case of high scores with increasing risk of malignancy.
Method: Ultrasound of thyroid was carried out on GE logic with linear transducer of 7.5–12 MHz frequency. 210 patients referred for sonography of thyroid nodules were included in the study from 1st January 2017 to 31st July 2018. Fine needle aspiration was carried out under ultrasound guidance and cytology was done of all nodules categorized according to TIRADS. TIRADS and Bethesda scores were correlated.
Results: A total of 210 patients with 233 nodules of mean size 2.5±1.5 cm were included. The risk of malignancy of the TIRADS categories were as follows: TIRADS 2 0%, TIRADS 3 2.2%, TIRADS 4A 5.9%, TIRADS 4B 57.9%, TIRADS 5 100%
Conclusion: TIRADS is a useful diagnostic classification in predicting malignancy and with FNAC using Bethesda classification, unnecessary surgical procedures can be avoided.
Abhimanyu Pradhan
Manipal Academy of Higher Education, India
Title: Diagnostic reference level: A phantom study to investigate the fisibility of dose reduction stratigies in Computed Tomography Angiography
Biography:
Mr. Abhimanyu Pradhan is pursuing his Ph.D. in Manipal Academy of Higher Education, Manipal, India and has completed her Under Graduate and Post-Graduation in Medical Imaging Technology from Manipal Academy of Higher Education, Manipal, India. He is Currently working as an Assistant Professor (Senior Scale) in the Dept. of Medical Imaging Technology, Manipal Academy of Higher Education, Manipal, India. (An Institute of Eminences). He has also completed a certificate course in “Biostatistics and Research Methodology” and also in “Bioethics in Clinical Trials” conducted by Manipal Academy of Higher Education. He has published more than 8 research papers in reputed journals.
Abstract:
Background & Aim: Diagnostic reference level (DRL) is a tool which mainly focuses on dose optimization, keeping the adequate image quality for diagnostic interpretation intact. The concept of DRL, initially suggested by International Commission on Radiological Protection (ICRP) publication 73, is a process to identify the situation where the radiation dose to the patient is high and the need of optimization. DRL on the other hand does not recommended an ideal dose for a specific procedure, but it’s a dose level at which an examination should be initiated. Since computed tomography (CT) is a most commonly used modality to investigate the cross sectional anatomy of the patient. The advancement in technology, reduced scan time significantly increasing the demand of contrast enhanced for differential diagnosis of the diseases.
Method: For the purpose of optimizing the radiation dose in CT Angiography examination a set of dose optimization technique was initiation which includes the strategies to reduce dose incurred to the patient. While combining different tube voltage (kVp) and tube current with time (mAs), three different low dose protocols was developed and tested the feasibility of the strategies in phantom. A head phantom measuring 16mm and body phantom measuring 32mm was used in this study with pencil ionization chamber to calculate the radiation dose.
Result and Conclusion: The result of the dose reduction strategies with various combinations of kVp and mAs showed a very significant reduction in the radiation dose, hence concluding that the use of the purposed strategies is feasible and can be initiated in clinical research.
Maamar Boukabcha
University Center Hassiba Benbouali, Algeria
Title: Perpectives of the application of epidemiological methods of study breast cancer in Algeria
Biography:
Maamar Boukabcha has pursued Radiation Physics at University of Science and Technology Houari Boumediene in Algeria. In 1996, he began teaching in Physical Sciences with all levels of students from middle school and up to the university at the level of Chlef region, Algeria. After receiving his Magister degree in Biophysics-Mathematics and Simulation in 2010, he was Education Advisor and Assistant Professor in Biophysics at Hassiba Benbouali University of Chlef (HBUC), Algeria.
Abstract:
Algeria is a regional and middle power; Algeria is the largest country in North Africa and is estimated to have a population of around 40 million people. Breast cancer starts when cells in the breast begin to grow out of control, these cells usually form a tumor that can often be seen on an x-ray or felt as a lump, among eight women, one's breast cancer will develop according to several studies. The cause of breast cancer is multifactorial and includes hormonal, genetic and environmental cause and others risk factors. After the collaboration with the oncology service of the Chlef region and other service of epidemiology in Algeria for more four years from 2014 and until today to study and treat the different medicals files of breast cancer patients, either for estimate the incidence or some statistical and epidemiological parameters or to discover the different risk factors for breast cancer disease. The region of Chlef is a sample of the country of Algeria either for these studied patients or the general population. In this work, epidemiological, statistical and other computer methods play a very important role in analyzing and studying medicals files. From January 2014 until the end of December 2017, in the Chlef region of Algeria, more than 845 breast cancer cases have been collected and it is expected about 210 cases during the year 2018. The number of female population in the study area at the end of the study period is about 616876 women, but the total number of Algerian population is about 42,2 million inhabitants and breast cancer are more than 11000 a year for the last five years. Breast cancer incidence rate of the Algerian population is 28,45 cases per 100000 populations, but the incidence rate of Chlef region is 34 cases of breast cancer per 100000 woman. The incidence rate is very low for men compared to women about 1% of women. Breast cancer is a major public health problem, the first cancer in women in Algeria, very rare in men and the leading cause of death in women. To reduce this disease, prevention and early diagnosis are needed.
- Workshop
Location: Abu Dhabi
Session Introduction
Abdalla Abotaleb
World Health Organisation, Egypt
Title: Impact of CETUXIMAB on enhancing patient out come & resource utilization for head and neck cancer treatment: Cost utility study
Biography:
Abstract:
- Cancer Prevention & Research | Breast Cancer-Present Perspective | Medical Imaging Technology
Location: Abu Dhabi, UAE
Session Introduction
Abdelmohsen R Hussien
SUNY Upstate Medical University, USA
Title: Early breast cancer: Improve your ability to find it
Biography:
Abdelmohsen R Hussien is an American Board Certified Radiologist. He has his graduation in Bachelor of Medicine from Cairo University Medical School. He also had his Radiology Residency in Egypt.
Abstract:
About 1 in 8 U.S. women (about 12.4%) will develop invasive breast cancer over the course of her lifetime. In 2018, an estimated 266,120 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 63,960 new cases of non-invasive (in situ) breast cancer. Detection of early invasive breast cancer is important, as patient survival is high when the cancer is 2 cm or smaller. Radiologists’ mission is to be able to detect breast cancer when it is very small, which is important in reducing breast cancer mortality. Women with invasive cancers of 1cm or smaller have a 95% chance of survival at 10 years, while those with invasive cancers 1–2 cm and 2–5 cm in size have, respectively, 85% and 60% survival at 10 years
There are many factors that govern the radiologists’ ability to detect breast cancer including their experience, number of hours per week reading screening mammogram, quality of imaging, availability of comparison, quality of the prior mammograms, distraction in the workplace, dedication to breast imaging, retrospective evaluation of the newly discovered cancers, awareness of the ACR updated regulations, and availability of the new technology such as tomosynthesis and high-resolution ultrasound.
Properly managed breast imaging center is of similar importance to the aforementioned factors.
Comprehensive breast cancer center staff should be aware that their ultimate goal is to help finding breast cancer and managing the diagnosed cancers, which requires a qualified leadership, a team spirit, dedication of each team member to what they do; from being careful how receptionists talk to the patient on the phone, how technologists get the best mammographic views, how a trained MR technologist can get the best MRI image possible to what is the exact job description of the nurse should be.
Winniecia Dkhar
Manipal Academy of Higher Education, India
Title: Evaluation of the effect of breast density in breast tumor conspicuity in Diffussion Weighted MRI
Biography:
Mrs. Winniecia Dkhar is pursuing her Ph.D. in the Department of Medical Imaging Technology, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, India and has completed her Post Graduation in Medical Imaging Technology from School of Allied Health Sciences Manipal Academy of Higher Education, Manipal, India. She is Currently working as an Assistant Professor( Senior Scale) in the Dept of Medical Imaging Technology, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, India. She has also completed a certificate course in “Biostatistics and Research Methodology” and also in “Bioethics in Clinical Trails” conducted by Manipal Academy of Higher Education. She has published more than 15 research papers in reputed journals.
Abstract:
Introduction and Aim: A sensitive and acceptable screening regimen for breast cancer is essential. Magnetic resonance imaging (MRI) of the breast is highly sensitive for the diagnosis of breast lesions irrespective of the breast density. MR imaging of the breast is increasingly used as an adjunct to mammography and ultrasonography to improve the detection and characterization of primary and recurrent breast cancers and for evaluation of the response to therapy. DWI sequence derives quantitative and qualitative data reflecting changes at the cellular level and information on the tumor cellularity. DWI heighten the sensitivity and thereby improve diagnostic accuracy. The purpose of this study was to find out the effect of breast density on breast tumor conspicuity detected in Diffusion Weighted MRI. Bilateral MRI breast scan was conducted with DWI pulse sequences.
Method: Bilateral MRI breast scan was conducted with DWI pulse sequences. For quantitative analysis, ROIs was drawn manually in the tissues and the average ADC will be acquired for quantitatively evaluating the differential diagnosis. The breast density was categorized according to ACR, under the category A, B, C, D. Quantify the tumor conspicuity on ADC maps, the contrast to noise ratio (CNR) was calculated for each lesion detection.
Result and Conclusion: The ADC cut off values were found to be higher for benign lesions than malignant lesions and DWI increases the lesion conspicuity without altering the detection rate. While benign lesions exhibited a CNR that was higher than malignant lesions. DWI sequences have a promising application in diagnosing of breast lesions especially in the dense breast which is often missed in mammography and in women at high genetic risk for breast cancer.