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Jeffrey Allen and Mohammad Jahanzeb

Edited by Kerrin G. Robinson

Non-small cell lung cancer (NSCLC) continues to be the leading cause of cancer-related mortality in the United States. Current standard care for treating NSCLC is surgical resection, when feasible, followed by adjuvant chemotherapy in stages II and III. Neoadjuvant or induction chemotherapy may have several potential advantages compared with adjuvant chemotherapy and has been evaluated in randomized and nonrandomized clinical trials in NSCLC. This article reviews the data for neoadjuvant chemotherapy in NSCLC with a particular focus on regionally advanced disease (stage III) that is still amenable to surgical resection.

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Hamdy A. Azim, Abdul-Rahman Jazieh and Mohammad Jahanzeb

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 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 into practical medical decisions that may offer a better and more consistent treatment outcome for patients. The NCCN recently launched the NCCN–Middle East and North Africa (NCCN–MENA) Guidelines Congress in an attempt to provide versions of the original NCCN Guidelines tailored for cancer management in this region. However, one may ask whether it is really important to have a revised set of Guidelines specifically dedicated to a certain geographical region, when the original NCCN guidelines are satisfactory and comprehensive. We believe the answer is “YES” for 3 main reasons: differences in race, genetic, and environmental factors; differences in presenting features and stage; and differences in access to technology and drugs. Differences in Racial, Genetic, and Environmental Factors The NCCN Guidelines have been generated based on high-level evidence provided by...
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Abdul-Rahman Jazieh, Hamdy A. Azim, Joan McClure and Mohammad Jahanzeb

The NCCN developed clinical practice guidelines for oncology that 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 (MENA) region. A group of oncology experts and key opinion leaders were assembled into 7 specific committees to develop treatment guidelines for breast cancer, lung cancer, colon cancer, prostate cancer, hepatobiliary cancer, lymphoma, and palliative care. The committees reviewed the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to identify any modifications required for them to be more applicable to the MENA region based on available evidence and regional experience. These modifications were discussed with NCCN experts and summarized for each specific area. The development of these guidelines generated a strong interest in the region to develop more evidence-based practice and create further networking and collaboration.

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Abdul-Rahman Jazieh, Hanaa Bamefleh, Ahmet Demirkazik, Rabab Mohamed Gaafar, Fady B. Geara, Mansur Javaid, Jamal Khader, Kian Khodadad, Walid Omar, Ahmed Saadeddin, Hassan Al Sabe, Mohammad Behgam Shadmehr, Amgad El Sherif, Najam Uddin, Mohammad Jahanzeb and David Ettinger

A lung cancer committee from the Middle East and North Africa (MENA) region was established to modify the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) on Non–Small Cell Lung Cancer to create a platform for standard care in the region. The committee comprised different experts in thoracic oncology from the region, including the disciplines of medical and clinical oncology, radiation oncology, thoracic surgery, pulmonary medicine, radiology, and pathology. The committee reviewed version 2 of the 2009 NCCN Guidelines on Non–Small Cell Lung Cancer and identified recommendations requiring modification for the region using published evidence and relevant experience. These suggested modifications were discussed among the group and with a United States–based NCCN expert for approval. The recommended modifications, with justification and references, were categorized based on the NCCN Guidelines flow. This article describes these recommended modifications. The process of adapting the first NCCN-based guidelines in the region is a step toward helping to improve lung cancer care in the region and encouraging networking and collaboration.

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Omalkhair Abulkhair, Nagi Saghir, Lobna Sedky, Ahmed Saadedin, Heba Elzahwary, Neelam Siddiqui, Mervat Al Saleh, Fady Geara, Nuha Birido, Nadia Al-Eissa, Sana Al Sukhun, Huda Abdulkareem, Menar Mohamed Ayoub, Fawaz Deirawan, Salah Fayaz, Alaa Kandil, Sami Khatib, Mufid El-Mistiri, Dorria Salem, El Siah Hassan Sayd, Mohammed Jaloudi, Mohammad Jahanzeb and William I. Gradishar

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. A Breast Cancer Regional Guidelines Committee was organized and activated, comprising experts from various regional cancer institutions. The multidisciplinary team included 12 medical oncologists, 3 radiation oncologists, 2 radiologists, 2 surgeons, and 1 pathologist. The committee members agreed on adapting the current NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) on Breast Cancer for use in the MENA region to achieve common practice standards for treating patients. The members suggested several modifications to the guidelines, especially those related to risk factor profiles. United States–based NCCN experts reviewed these recommendations before final approval. The MENA–NCCN Breast Cancer Guidelines modification process was the first initiative in the development of common practice guidelines in the region. This project may serve as a foundation for the development of evidence-based practice standards, and improve collaborative projects and initiatives.

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Philip E. Johnson, George Dahlman, Kirby Eng, Rekha Garg, Scott Gottlieb, James M. Hoffman, Peyton Howell, Mohammad Jahanzeb, Shirley Johnson, Emily Mackler, Mark Rubino, Brenda Sarokhan, F. Marc Stewart, Tim Tyler, Julie M. Vose, Sharon Weinstein, Edward C. Li and Jessica DeMartino

REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologics will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.

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Robert W. Carlson, Susan Moench, Arti Hurria, Lodovico Balducci, Harold J. Burstein, Lori J. Goldstein, William J. Gradishar, Kevin S. Hughes, Mohammad Jahanzeb, Stuart M. Lichtman, Lawrence B. Marks, Joan S. McClure, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Mary Lou Smith, Neal S. Topham, Tiffany A. Traina, John H. Ward and Eric P. Winer

Breast cancer is common in older women, and the segment of the U.S. population aged 65 years and older is growing rapidly. Consequently, awareness is increasing of the need to identify breast cancer treatment recommendations to assure optimal, individualized treatment of older women with breast cancer. However, the development of these recommendations is limited by the heterogeneous nature of this population with respect to functional status, social support, life expectancy, and the presence of comorbidities, and by the underrepresentation of older patients with breast cancer in randomized clinical trials. The NCCN Breast Cancer in the Older Woman Task Force was convened to provide a forum for framing relevant questions on topics that impact older women with early-stage, locally advanced, and metastatic breast cancer. The task force is a multidisciplinary panel of 18 experts in breast cancer representing medical oncology, radiation oncology, surgical oncology, geriatric oncology, geriatrics, plastic surgery, and patient advocacy. All task force members were from NCCN institutions and were identified and invited solely by NCCN. Members were charged with identifying evidence relevant to their specific expertise. During a 2-day meeting, individual members provided didactic presentations; these presentations were followed by extensive discussions during which areas of consensus and controversy were identified on topics such as defining the “older” breast cancer patient; geriatric assessment tools in the oncology setting; attitudes of older patients with breast cancer and their physicians; tumor biology in older versus younger women with breast cancer; implementation of specific interventions in older patients with breast cancer, such as curative surgery, surgical axillary staging, radiation therapy, reconstructive surgery, endocrine therapy, chemotherapy, HER2-directed therapy, and supportive therapies; and areas requiring future studies. (JNCCN 2008;6[Suppl 4]:S1–S25)

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Robert W. Carlson, Susan J. Moench, M. Elizabeth H. Hammond, Edith A. Perez, Harold J. Burstein, D. Craig Allred, Charles L. Vogel, Lori J. Goldstein, George Somlo, William J. Gradishar, Clifford A. Hudis, Mohammad Jahanzeb, Azadeh Stark, Antonio C. Wolff, Michael F. Press, Eric P. Winer, Soonmyung Paik, Britt-Marie Ljung and for the NCCN HER2 Testing in Breast Cancer Task Force

The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically evaluate the ability of the level of HER2 expression or gene amplification in breast cancer tumors to serve as a prognostic and a predictive factor in the metastatic and adjuvant settings, to assess the reliability of the methods of measuring HER2 expression or gene amplification in the laboratory, and to make recommendations regarding the interpretation of test results. The Task Force is a multidisciplinary panel of 24 experts in breast cancer representing the disciplines of medical oncology, pathology, radiation oncology, surgical oncology, epidemiology, and patient advocacy. Invited members included members of the NCCN Breast Cancer Panel and other needed experts selected solely by the NCCN. During a 2-day meeting, individual task force members provided didactic presentations critically evaluating important aspects of HER2 biology and epidemiology: HER2 as a prognostic and predictive factor; results from clinical trials in which trastuzumab was used as a targeted therapy against HER2 in the adjuvant and metastatic settings; the available testing methodologies for HER2, including sensitivity, specificity, and ability to provide prognostic and predictive information; and the principles on which HER2 testing should be based. Each task force member was charged with identifying evidence relevant to their specific expertise and presentation. Following the presentations, an evidence-based consensus approach was used to formulate recommendations relating to the pathologic and clinical application of the evidence to breast cancer patient evaluation and care. In areas of controversy, this process extended beyond the meeting to achieve consensus. The Task Force concluded that accurate assignment of the HER2 status of invasive breast cancer is essential to clinical decision making in the treatment of breast cancer in both adjuvant and metastatic settings. Formal validation and concordance testing should be performed and reported by laboratories performing HER2 testing for clinical purposes. If appropriate quality control/ assurance procedures are in place, either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods may be used. A tumor with an IHC score of 0 or1+, an average HER2 gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or greater is considered HER2 positive. A tumor with an IHC score of 2+ should be further tested using FISH, with HER2 status determined by the FISH result. Tumor samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are considered to be borderline, and strategies to assign the HER2 status of such samples are proposed. (JNCCN 2006;4(Suppl 3):S1–S22)

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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Mohammad Jahanzeb, Krystyna Kiel, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Richard L. Theriault, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Breast Cancer Clinical Practice Guidelines in Oncology NCCN Categories of Evidence and Consensus Category 1: The recommendation is based on high-level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus. Category 2A: The recommendation is based on lower-level evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lower-level evidence and there is nonuniform NCCN consensus (but no major disagreement). Category 3: The recommendation is based on any level of evidence but reflects major disagreement. All recommendations are category 2A unless otherwise noted. The Breast Cancer Clinical Practice Guidelines presented here are the work of the members of the NCCN Breast Cancer Clinical Practice Guidelines Panel. Categories of evidence were assessed and are noted on the algorithms and in the text. Although not explicitly stated at every decision point of the Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.nccn.org. Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Overview The American Cancer Society estimated that 184,450 new cases of invasive breast cancer would be diagnosed and 40,930 patients would die of the disease in the United States in 2008.1 In addition, approximately 67,770 women will be diagnosed with carcinoma in situ of the breast during the same...
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David S. Ettinger, Wallace Akerley, Gerold Bepler, Matthew G. Blum, Andrew Chang, Richard T. Cheney, Lucian R. Chirieac, Thomas A. D'Amico, Todd L. Demmy, Apar Kishor P. Ganti, Ramaswamy Govindan, Frederic W. Grannis Jr., Thierry Jahan, Mohammad Jahanzeb, David H. Johnson, Anne Kessinger, Ritsuko Komaki, Feng-Ming Kong, Mark G. Kris, Lee M. Krug, Quynh-Thu Le, Inga T. Lennes, Renato Martins, Janis O'Malley, Raymond U. Osarogiagbon, Gregory A. Otterson, Jyoti D. Patel, Katherine M. Pisters, Karen Reckamp, Gregory J. Riely, Eric Rohren, George R. Simon, Scott J. Swanson, Douglas E. Wood and Stephen C. Yang

OverviewLung cancer is the leading cause of cancer-related death in the United States. An estimated 219,440 new cases (116,090 men; 103,350 women) of lung and bronchus cancer were diagnosed in 2009, and 159,390 deaths (88,900 men; 70,490 women) occurred from the disease.1 Only 15% of all lung cancer patients are alive 5 years or more after diagnosis (http://seer.cancer.gov/statfacts/html/lungb.html). Common symptoms of lung cancer include cough, dyspnea, weight loss, and chest pain; symptomatic patients are more likely to have chronic obstructive pulmonary disease.The primary risk factor for lung cancer is smoking, which accounts for more than 85% of all lung cancer-related deaths.2 The risk for lung cancer increases with the number of cigarettes smoked per day and the number of years spent smoking. In addition to the hazard of first-hand smoke, exposed nonsmokers have an increased relative risk for developing lung cancer.3 Radon gas, a radioactive gas that is produced by the decay of radium 226, is the second leading cause of lung cancer.4 The decay of this isotope leads to the production of substances that emit alpha-particles, which may cause cell damage and therefore increase the potential for malignant transformation. Data suggest that postmenopausal women who smoke or are former smokers should not undergo hormone replacement therapy, because it increases the risk for death from non–small cell lung cancer (NSCLC).5Asbestos, a mineral compound that breaks into small airborne shards, is a known carcinogen that increases the risk for lung cancer in people exposed to the airborne fibers,...