The Abu Dhabi Declaration: Adapted Application of NCCN

55 Pages·2010·1.88 MB·English

S U P P L E M E N T
JNCCN
Volume 8 Supplement 3 Journal of the National Comprehensive Cancer Network
The Abu Dhabi Declaration: Adapted
Application of NCCN Clinical Practice
Guidelines in Oncology in the Middle East
and North Africa Region
The Process of NCCN Guidelines™ Adaptation to the Middle East
and North Africa Region
Abdul-Rahman Jazieh, Hamdy A. Azim, Joan McClure,
and Mohammad Jahanzeb
Also Featuring
Modification and Implementation of NCCN Guidelines™
in the Middle East and North Africa Region on:
Breast Cancer
Omalkhair Abulkhair, Nagi Saghir, Lobna Sedky, et al.
Non–Small Cell Lung Cancer
Abdul-Rahman Jazieh, Hanaa Bamefleh, Ahmet Demirkazik, et al.
Colon Cancer
Fikri İçli, Hakan Akbulut, Shouki Bazarbashi, et al.
The National Comprehensive Cancer
Network® (NCCN®) appreciates that
Prostate Cancer
supporting companies recognize NCCN®’s
Waleed A. Hassen, Farrok A. Karsan, Farhat Abbas, et al.
need for autonomy in the development
of the content of NCCN resources. All
Lymphomas
NCCN content is produced completely
Ali Bazarbachi, Hamdy A. Azim, Hussain Alizadeh, et al.
independently. NCCN GuidelinesTM are
not intended to promote any specific
Hepatobiliary Cancers
therapeutic modality. The distribution of
Muhammed Aasim Yusuf, Vinay Kumar Kapoor,
this task force report is supported by an
Refaat Refaat Kamel, et al.
educational grant from Roche.
Palliative Care
Omar Shamieh and Abdul-Rahman Jazieh
NCCN.org

JNCCN
Volume 8 Supplement 3 Journal of the National Comprehensive Cancer Network
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JNCCN
Volume 8 Supplement 3 Journal of the National Comprehensive Cancer Network
The Abu Dhabi Declaration: Adapted Application of NCCN Clinical Practice Guidelines in Oncology
in the Middle East and North Africa Region
Featured Articles
S-1 Welcome
William T. McGivney, PhD
S-2 Editorial: The Abu Dhabi Declaration: Why the Hustle?
Hamdy A. Azim, MD, PhD; Abdul-Rahman Jazieh, MD, MPH; and Mohammad Jahanzeb, MD
S-5 The Process of NCCN Guidelines™ Adaptation to the Middle East and North Africa Region
Abdul-Rahman Jazieh, MD, MPH; Hamdy A. Azim, MD, PhD; Joan McClure, MS; and Mohammad Jahanzeb, MD
NCCN Guidelines set the standard of cancer care in the United States. Because of wide acceptance of, need for, and interest in
standardized treatment practices across the world, NCCN launched initiatives to help international groups adapt these guidelines.
This article describes the initiative in the Middle East and North Africa region.
S-8 Modification and Implementation of NCCN Guidelines™ on Breast Cancer in the Middle East
and North Africa Region
Omalkhair Abulkhair, MD; Nagi Saghir, MD; Lobna Sedky, MD; Ahmed Saadedin, MD; Heba Elzahwary, MD;
Neelam Siddiqui, MD; Mervat Al Saleh, MD; Fady Geara, MD; Nuha Birido, MD; Nadia Al-Eissa, MD;
Sana Al Sukhun, MD; Huda Abdulkareem, MD; Menar Mohamed Ayoub, MD; Fawaz Deirawan, MD;
Salah Fayaz, MD; Alaa Kandil, MD; Sami Khatib, MD; Mufid El-Mistiri, MD; Dorria Salem, MD;
El Siah Hassan Sayd, MD; Mohammed Jaloudi, MD; Mohammad Jahanzeb, MD; and William I. Gradishar, MD
Published data from the Middle East and North Africa (MENA) region indicate suboptimal quality of cancer care, while the World
Health Organization predicts an increase in cancer cases in developing countries. Major advances in breast cancer management
mandate the development of guidelines to improve the quality and efficacy of oncology practice in the MENA region.
S-16 Modification and Implementation of NCCN Guidelines™ on Non–Small Cell Lung Cancer in the
Middle East and North Africa Region
Abdul-Rahman Jazieh, MD, MPH; Hanaa Bamefleh, MBchB, FRCPC; Ahmet Demirkazik, MD;
Rabab Mohamed Gaafar, MD; Fady B. Geara, MD, PhD; Mansur Javaid, MD, FCCP, FRCP; Jamal Khader, MD;
Kian Khodadad, MD; Walid Omar, MD; Ahmed Saadeddin, MD; Hassan Al Sabe, MD;
Mohammad Behgam Shadmehr, MD; Amgad El Sherif, MD, FCCP; Najam Uddin, FRCR; Mohammad Jahanzeb, MD;
and David Ettinger, MD
A lung cancer committee from the Middle East and North Africa region was established to modify the NCCN Guidelines on Lung
Cancer, to create a platform for standard care in the region.
S-22 Modification and Implementation of NCCN Guidelines™ on Colon Cancer in the Middle East
and North Africa Region
Fikri İçli, MD; Hakan Akbulut, MD; Shouki Bazarbashi, MD; Mehmet Ayhan Kuzu, MD; Mohandas K. Mallath, MD;
Kakil Ibrahim Rasul, FRCP Edin; Scott Strong, MD; Aamir Ali Syed, FRCS; Faruk Zorlu, MD; and Paul F. Engstrom, MD
Colorectal cancer is less common in the Middle East and South Asia than in western countries, with the rectum the most common
primary site, unlike in the United States. Major differences also exist in treatment preferences, as discussed in this article.
S-26 Modification and Implementation of NCCN Guidelines™ on Prostate Cancer in the Middle East
and North Africa Region
Waleed A. Hassen, MD; Farrok A. Karsan, MD; Farhat Abbas, MD; Yasar Beduk, MD; Ahmed El-Khodary, MD;
Marwan Ghosn, MD, MBA; Jamal Khader, MD; Raja Khauli, MD; Danny M. Rabah, MD; Ali Shamseddine, MD;
and Sandy Srinivas, MD
The treatment of prostate cancer in the Middle East and North Africa region has numerous challenges. The hope is that
this effort to modify the NCCN Guidelines on Prostate Cancer for practical use in the MENA region will improve regional
awareness and patient care.
JNCCN
Volume 8 Supplement 3 Journal of the National Comprehensive Cancer Network
Featured Articles
S-29 Modification and Implementation of NCCN Guidelines™ on Lymphomas in the Middle East
and North Africa Region
Ali Bazarbachi, MD, PhD; Hamdy A. Azim, MD, PhD; Hussain Alizadeh, MD, PhD; Mahmoud Aljurf, MD;
Ibrahim Barista, MD; Naeem A. Chaudhri, MD; Zahira Fahed, MD; Omar A. Fahmy, MD;
Ardeshir Ghavamzadeh, MD; Mohamed H. Khalaf, MD; Sami Khatib, MD; Aghiad Kutoubi, MD; Semra Paydas, MD;
Hanadi Rafii Elayoubi, MD; Ghazi Zaatari, MD; Hamdy M. Zawam, MD; and Andrew D. Zelenetz, MD, PhD
In the Middle East and North Africa (MENA) region, cancer has many epidemiologic and clinical features that are different
from those in the rest of the world. A critical need exists for regional guidelines for cancer care, including those for lymphoid
malignancies. This article presents the consensus recommendations from lymphoma experts from the MENA region on the NCCN
Guidelines on Non-Hodgkin’s Lymphoma.
S-36 Modification and Implementation of NCCN Guidelines™ on Hepatobiliary Cancer in the
Middle East and North Africa Region
Muhammed Aasim Yusuf, FRCP Edin; Vinay Kumar Kapoor, MS, FRCS; Refaat Refaat Kamel, FRCS;
Ather Kazmi, MRCP, FRCR; Najam Uddin, FRCR; Nehal Masood, MD; and
Abdulmajeed Al-Abdulkareem, MD, FRCSC, FACS
Hepatocellular cancer incidence is higher in the Middle East and North Africa region than in the West, and hepatitis B and C
infections are particularly important. Regional problems discussed in this article include delay in diagnosis, shortage of trained
staff, and insufficient liver transplant facilities, and treatment cost is an ongoing concern.
S-41 Modification and Implementation of NCCN Guidelines™ on Palliative Care in the Middle East
and North Africa Region
Omar Shamieh, MD, and Abdul-Rahman Jazieh, MD, MPH
Advancing palliative care in the developing countries is essential to improving patient care. Palliative care is in its early stage of
evolution in the Middle East and North Africa region, and its practice encounters many challenges and barriers. Adaptation of
guidelines must consider the situation and conditions in the targeted region.
S-1
Journal of the National Comprehensive Cancer Network Welcome
The National Comprehensive Cancer Network (NCCN) and our 21 member
institutions are dedicated to improving the care available to patients around the world.
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the
attendant scientific, evaluative process has become the model for the development
and communication of clinical recommendations based on evidence review integrated
with expert judgment.
The NCCN is pleased to extend our scientific, clinical collaboration to thought
leaders in the Middle East and North Africa (MENA). The NCCN–MENA
Guidelines Congress held in Abu Dhabi, running from April 23 to 26, 2009, brought
together leading clinicians to review the NCCN Guidelines and supporting data
and to discuss the applicability of the NCCN Guidelines to patients in this part of
William T. McGivney, PhD
our world. As always, the clinical discussion highlighted areas for improvement and
William T. McGivney, PhD, is Chief
clarification in the NCCN Guidelines. As Drs. Azim, Jazieh, and Jahanzeb point out
Executive Officer of the NCCN,
in the accompanying introduction, the work has begun and the initial thinking is responsible for the development
of strategies and programs to
published is this “Abu Dhabi Declaration.” Much work remains as experts identify
improve the quality of care
issues for study in trials or through other research methods, issues that relate to possible available to cancer patients.
differences in genetic makeup and its expression, differences in the availability of Such programs include the
NCCN Clinical Practice Guidelines
technology across the 16 countries, and other factors. in Oncology, NCCN Oncology
Outcomes Database, NCCN
The NCCN thanks our colleagues in the Middle East and North Africa for their
Oncology Research Program,
willingness to share their knowledge, expertise, and experience as we work to improve and NCCN Drugs & Biologics
cancer care for patients whom we serve. Compendium. Strategically, Dr.
McGivney is responsible for the
growth of NCCN’s influence in
the oncology community and
for assuring the development of
partnerships with managed care
companies and employers, the
development of NCCN’s health
information capabilities, and the
expansion of centralized research
programs.
Before joining NCCN, Dr.
McGivney was Director of
the Division of Health Care
Technology at the American
Medical Association and then
Vice President for Clinical
and Coverage Policy at Aetna
Health Plans. While at Aetna, he
helped establish the first formal
independent outside review
process.
Dr. McGivney, a recognized
expert in coverage policy and
in drug and device regulatory
policy, was awarded the FDA
Commissioner’s Medal of
Appreciation in 1989. He has
served on numerous national
boards and committees including
as President of the Board of the
Patient Advocate Foundation
and National Patient Advocate
Foundation and as a member of
the UNOS Board of Directors and
the Medicare Coverage Advisory
Committee.
The ideas and viewpoints
expressed in this editorial are
those of the author and do not
necessarily represent any policy,
position, or program of the NCCN.
© Journal of the National Comprehensive Cancer Network | Volume 8 Supplement 3 | July 2010
S-2
Editorial Journal of the National Comprehensive Cancer Network
The Abu Dhabi Declaration: Why the Hustle?
Over the past decade, the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines) have emerged as a very useful tool for supporting and improving the
quality of decision-making for oncologists worldwide. Considering that approximately
12 million cancer patients were registered by the WHO during 2008 and that the
NCCN Web site (www.NCCN.org) attracts more than 150,000 visitors per month,
one can conclude that the NCCN Guidelines program has potentially influenced the
management of approximately 15% of all cancer patients worldwide. Although this
example shows its far-reaching benefit, it also shows that there is plenty of room for
Hamdy A. Azim, MD, PhD expanding its application. A real need exists within the oncology community to have
a reliable evidence-based tool to translate the rapidly accumulating scientific research
Dr. Azim is Professor of Clinical
Oncology at Cairo University into practical medical decisions that may offer a better and more consistent treatment
in Egypt. His interests lie in outcome for patients.
lymphoma, breast cancer, bone
The NCCN recently launched the NCCN–Middle East and North Africa
metastases, and translational
research, and has published (NCCN–MENA) Guidelines Congress in an attempt to provide versions of the
more than 50 papers and 100 original NCCN Guidelines tailored for cancer management in this region. However,
abstracts. Dr. Azim is a member
one may ask whether it is really important to have a revised set of Guidelines
of numerous societies, including
specifically dedicated to a certain geographical region, when the original NCCN
ASCO and ASH. He sits on
several scientific committees guidelines are satisfactory and comprehensive. We believe the answer is “YES” for 3
and has been an invited speaker main reasons: differences in race, genetic, and environmental factors; differences in
to more than 100 regional
presenting features and stage; and differences in access to technology and drugs.
and international conferences
in the Middle East, Europe,
United States, and Asia, and has
published more than 50 papers
Differences in Racial, Genetic, and Environmental Factors
and 100 abstracts.
The NCCN Guidelines have been generated based on high-level evidence provided by
large trials conducted mainly in the United States and Europe (hence predominantly
enrolling a Western population) with a limited contribution from the rest of the
world, including the Middle East.
Racial and genetic factors are known to play a vital role in the development
of cancer. For example, in Europe, the United States, and Australia, people have
a higher risk of developing skin cancer because they have fair skin, a characteristic
that is uncommonly witnessed in other regions. Although guidelines for prevention
and early detection of skin cancer are needed in these countries, they are of lesser
importance in the Middle East.1
Racial and genetic factors are not only relevant in cancer epidemiology but also
can have significant influence on treatment strategies because of varying sensitivities
to, and metabolism of, different drugs, resulting in a different prioritization of these
Abdul-Rahman Jazieh, MD,
approaches. For example, studies recently showed that Asian patients with advanced
MPH
non–small cell lung cancer have a higher incidence of epidermal growth factor receptor
Dr. Abdul-Rahman Jazieh, (EGFR) mutations, and therefore experienced a greater benefit from treatment with
MD, MPH, is Chairman of the
EGFR inhibitors such as gefitinib and erlotinib.2,3 As a result of these findings, these
Department of Oncology at the
King Abdulaziz Medical City agents were established as first-line therapies for these patients, before platinum-based
in Riyadh, Kingdom of Saudi chemotherapy, unlike in patients with non–small cell lung cancer in Europe and the
Arabia. He is also a Professor
United States.4 This raises an important question: can the results from large studies
at the King Saud bin Abdulaziz
conducted mainly in Caucasian patient populations be accurately applied to the non-
University for Health Sciences
and a volunteer professor at the Caucasian majority in the rest of the world?
University of Cincinnati in Ohio.
Of course, the pharmacogenomic preferential benefit of EGFR inhibitors reported
He is board certified in internal
in the above-mentioned studies does not necessarily exist in the same magnitude
medicine, hematology, and
medical oncology. in other races or with other types of anticancer drugs. However, one may assume
© Journal of the National Comprehensive Cancer Network | Volume 8 Supplement 3 | July 2010
Editorial S-3
The Abu Dhabi Declaration
that certain differences are likely to emerge from the integrated efforts of experts
in the region. The same concept may also be applied to the differences in some
environmental factors that may also play a role in the process of carcinogenesis and
response to treatment. For example, in contrast to the West, where hepatocellular
carcinoma (HCC) is less common and mainly secondary to alcoholic hepatitis and
hepatitis B virus,7 in many Middle East countries, HCC is one of the most common
cancers and usually secondary to hepatitis C virus (HCV).8 In a subgroup analysis
of a pivotal sorafenib study, a greater benefit of this drug was seen among patients
with HCV-associated HCC. Another example is bladder cancer, which is usually
of transitional cell histology in Europe and the United States, but is commonly of
squamous cell histology in several countries in the Middle East where schistosomiasis
is rampant.9 These differences may limit the applicability of “West-centric” guidelines
Mohammad Jahanzeb, MD,
in the clinical practice of oncology in other regions of the world.
FACP
These issues presented significant challenges for our diverse team while setting the
Dr. Jahanzeb is an international
objectives of the NCCN–MENA project, because the geography of our loosely defined
lecturer on issues related to
region stretches from the west of Morocco to the eastern part of India. Therefore, the breast and lung cancers. He
so-called MENA cancer patients according to this geographic definition are in fact a is currently National Director
large population of racially and environmentally heterogeneous people among whom for Quality Improvement in
the Aptium Oncology network
one might elicit differences rather than similarities. Still, in the current project of
and a Professor of Medicine
NCCN–MENA, we made a thorough review of the available literature generated from at University of Tennessee. He
cancer patients in our region, seeking any convincing evidence that may suggest a has served as a member of the
unique therapeutic feature attributable to racial, genetic, or environmental factors. National Comprehensive Cancer
Network (NCCN) Board of
Directors, the NCCN Guidelines
Steering and Investigators
Differences in Presenting Features and Stage Steering Committees, and the
Breast Cancer and Non-Small
In the Middle East and in other developing regions of the world, cancer is often Cell Lung Cancer Panels. He is
diagnosed at a younger age and tends to be of more advanced-stage compared with currently the Medical Advisor on
cases reported among the Western populations.5 For example, in the Middle East, the Global Initiatives. Dr. Jahanzeb
is board certified in Internal
median age of breast cancer diagnosis is younger 50 years (with 25% of patients < 40
Medicine with subspecialties
years) compared with older than 60 years in the West. The lack of early detection in Hematology and Medical
programs in the Middle East has resulted in most breast cancer and other solid tumors Oncology.
presenting at stages III/IV compared with in Western countries. Taken together, the
screening policy adopted in the West would certainly miss early detection of breast
cancer in many young women, who represent a good proportion of cases in the region.
Differences in Access to Technology and Drugs
The Middle East is composed mostly of developing nations with restricted access to
advanced technology and novel agents incorporated in current oncology practice.
Cost–benefit analysis studies conducted in the West are difficult to apply to this region
because of the differences in health systems among the developing and developed
nations. Guidelines taking into account these limitations would help optimize the
application of novel strategies to best use the limited resources available. Current
NCCN Guidelines are cost-blind and do not address these issues, and therefore fall
short in a resource-restricted setting.
Despite these limitations, we believe that this project will provide better
guidance for oncologists in the MENA region. These regionally targeted projects
are likely to stimulate oncologists in the region to not only practice more evidence-
based medicine but also conduct local epidemiologic studies and clinical trials to The ideas and viewpoints
better define the magnitude of the problem and customize solutions for their part of expressed in this commentary are
those of the author and do not
the world. We believe that the MENA region would benefit greatly if they invested
necessarily represent any policy,
in the area of predictive and prognostic biomarkers.10 Expensive and sophisticated position, or program of the NCCN.
© Journal of the National Comprehensive Cancer Network | Volume 8 Supplement 3 | July 2010
Editorial
S-4
The Abu Dhabi Declaration
technologies can then be channelled to the subsets of small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129–
patients who are really likely to benefit from them. 2139.
Finally, we would like to invite all oncologists in the 4. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-
paclitaxel in pulmonary adenocarcinoma. N Engl J Med
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© Journal of the National Comprehensive Cancer Network | Volume 7 Supplement 1 | February 2010