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Robert J. Morgan Jr

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Robert J. Morgan Jr.

Since the inception of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) around 15 years ago, the Ovarian Cancer Panel has seen major changes in treatment recommendations based on ever increasing knowledge of results and therapeutic developments. Nonetheless, significant controversies remain, and these controversies can cause major disagreement among experts. This issue of JNCCN proves this point and also illustrates the importance that we in the medical community must place on the information gathered through the clinical trials process. Major differences of opinion on what treatment is appropriate usually only occur in cases of insufficient information to generate uniform consensus. The articles in this issue on the appropriate use of chemosensitivity (chemoresistance) assays to help determine recommended chemotherapeutic management in recurrent ovarian cancer demonstrate this controversy, which has resulted in a category 3 level of consensus (meaning major disagreement among committee members) in the current NCCN Guidelines for Ovarian Cancer. The guidelines state, “Chemosensitivity/resistance assays are being used in some NCCN centers for decisions related to future chemotherapy in situations where there are multiple equivalent chemotherapy options available; the current level of evidence is not sufficient to supplant standard of care chemotherapy (category 3).” This issue also illustrates how strong clinical trial and meta-analysis data over the past 15 years has resulted in significant changes in recommendations. For example, data suggesting a correlation between patient survival and extent of initial surgical debulking resulted in strengthening recommendations. “Optimal” cytoreduction is defined as less than 1 centimeter residual disease at the...
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Benjamin E. Greer, Wui-Jin Koh, Nadeem Abu-Rustum, Michael A. Bookman, Robert E. Bristow, Susana M. Campos, Kathleen R. Cho, Larry Copeland, Marta Ann Crispens, Patricia J. Eifel, Warner K. Huh, Wainwright Jaggernauth, Daniel S. Kapp, John J. Kavanagh, John R. Lurain III, Mark Morgan, Robert J. Morgan Jr, C. Bethan Powell, Steven W. Remmenga, R. Kevin Reynolds, Angeles Alvarez Secord, William Small Jr and Nelson Teng

Uterine Neoplasms 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 lowerlevel evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lowerlevel 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. 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 Adenocarcinoma of the endometrium is the most common malignancy in the female genital tract in the United States. An estimated 40,100 new diagnoses of uterine cancer and 7470 deaths from this disease will occur in 2008.1 Uterine sarcomas are uncommon and account for approximately 1 in 12 of all uterine cancers.2 These guidelines describe epithelial carcinomas and uterine sarcomas; each of these major categories contains specific histologic groups that require different management (see page 500). By definition, these guidelines cannot incorporate all possible clinical variations and are not intended to replace good clinical judgment or individualization of treatments. Exceptions to the rule were discussed among panel members during the process of developing these guidelines. For patients with suspected uterine neoplasms, initial preoperative evaluation includes a history and physical examination, endometrial biopsy, chest radiograph, a CBC,...
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Donald A. Podoloff, Douglas W. Ball, Edgar Ben-Josef, Al B. Benson III, Steven J. Cohen, R. Edward Coleman, Dominique Delbeke, Maria Ho, David H. Ilson, Gregory P. Kalemkerian, Richard J. Lee, Jay S. Loeffler, Homer A. Macapinlac, Robert J. Morgan Jr., Barry Alan Siegel, Seema Singhal, Douglas S. Tyler and Richard J. Wong

Use of PET is widespread and increasing in the United States, mainly for oncologic applications. In November 2006, the National Comprehensive Cancer Network (NCCN) gathered a panel of experts to review the literature and develop clinical recommendations for using PET scans in lymphoma and non–small cell lung, breast, and colorectal cancers. However, because its use is not restricted to these diseases, and evidence is accumulating for its application in other types of cancers, NCCN convened a second meeting in December 2008 to expand on the initial report. A multidisciplinary panel met to discuss the current data on PET application for various tumor types, including genitourinary, gynecologic, pancreatic, hepatobiliary, thyroid, brain, small cell lung, gastric, and esophageal cancers, and sarcoma and myeloma. This report summarizes the proceedings of this meeting, including discussions of the background of PET, the role of PET in oncology, principles of PET use, emerging applications, and possible future developments.

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Benjamin E. Greer, Wui-Jin Koh, Nadeem R. Abu-Rustum, Sachin M. Apte, Susana M. Campos, John Chan, Kathleen R. Cho, Larry Copeland, Marta Ann Crispens, Nefertiti DuPont, Patricia J. Eifel, David K. Gaffney, Warner K. Huh, Daniel S. Kapp, John R. Lurain III, Lainie Martin, Mark A. Morgan, Robert J. Morgan Jr., David Mutch, Steven W. Remmenga, R. Kevin Reynolds, William Small Jr., Nelson Teng and Fidel A. Valea

Overview An estimated 12,200 new cases of cervical cancer will be diagnosed in the United States in 2010, and 4200 people will die of the disease.1 Cervical cancer rates are decreasing among women in the United States, although incidence remains high among Hispanic/Latino, black, and Asian women.2–5 However, cervical cancer is a major world health problem for women. The global yearly incidence of cervical cancer for 2002 was 493,200; the annual death rate was 273,500. It is the third most common cancer in women worldwide,6,7 with 78% of cases occurring in developing countries, where cervical cancer is the second most frequent cause of cancer death in women. Persistent human papillomavirus (HPV) infection is regarded as the most important factor contributing to the development of cervical cancer. A relationship seems to exist between the incidence of cervical cancer and the prevalence of HPV in the population. The prevalence of chronic HPV in countries with a high incidence of cervical cancer is 10% to 20%, whereas its prevalence in low-incidence countries is 5% to 10%.6 Immunization against HPV prevents infection with certain types of HPV and, thus, is expected to prevent specific HPV cancer in women (see NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines] for Cervical Cancer Screening, in this issue; to view the most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org).8–12 Other epidemiologic risk factors associated with cervical cancer are a history of smoking, parity, contraceptive use, early age at onset of coitus, larger number...
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Robert J. Morgan Jr., Ronald D. Alvarez, Deborah K. Armstrong, Barry Boston, Robert A. Burger, Lee-may Chen, Larry Copeland, Marta Ann Crispens, David Gershenson, Heidi J. Gray, Perry W. Grigsby, Ardeshir Hakam, Laura J. Havrilesky, Carolyn Johnston, Shashikant Lele, Ursula A. Matulonis, David M. O'Malley, Richard T. Penson, Steven W. Remmenga, Paul Sabbatini, Russell J. Schilder, Julian C. Schink, Nelson Teng and Theresa L. Werner

Ovarian neoplasms consist of several histopathologic entities, and treatment depends on the specific tumor type. Epithelial ovarian cancer comprises most malignant ovarian neoplasms (∼ 80%)1; however, other less-common pathologic subtypes must be considered in treatment guidelines. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Ovarian Cancer discuss epithelial ovarian cancer (including borderline or low malignant potential) and less-common histopathologies, including malignant germ cell neoplasms, carcinosarcomas (malignant mixed Müllerian tumors of the ovary [MMMT]), and sex cord-stromal tumors. The guidelines also discuss fallopian tube and primary peritoneal cancers, which are less-common neoplasms that are managed similarly to epithelial ovarian cancer. However, the less-common histologies of ovarian cancer are managed differently. Information on the less-common ovarian histopathologies are not published in this issue of JNCCN, but can be found online at www.NCCN.org. Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the country's fifth most common cause of cancer mortality in women. In 2010, an estimated 21,900 new diagnoses and 13,900 deaths will occur from this neoplasm in the United States; fewer than 40% of women with ovarian cancer are cured.2,3 The incidence of ovarian cancer increases with age and is most prevalent in the eighth decade of life, with a rate of 57 per 100,000 women. The median age at diagnosis is 63 years, and 70% of patients present with advanced disease.4 Epidemiologic studies have identified risk factors for ovarian cancer. A 30% to 60% decreased risk of cancer is associated...
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Razelle Kurzrock, A. Dimitrios Colevas, Anthony Olszanski, Wallace Akerley, Carlos L. Arteaga, William E. Carson III, Jeffrey W. Clark, John F. DiPersio, David S. Ettinger, Robert J. Morgan Jr, Lee S. Schwartzberg, Alan P. Venook, Christopher D. Gocke, Jonathan Tait and F. Marc Stewart

Background: With advances such as next-generation sequencing (NGS) increasing understanding of the basis of cancer and its response to treatment, NCCN believes it is important to understand how molecular profiling/diagnostic testing is being performed and used at NCCN Member Institutions and their community affiliates. Methods: The NCCN Oncology Research Program's Investigator Steering Committee and the NCCN Best Practices Committee gathered baseline information on the use of cancer-related molecular testing at NCCN Member Institutions and community members of the NCCN Affiliate Research Consortium through 2 separate surveys distributed in December 2013 and September 2014, respectively. Results: A total of 24 NCCN Member Institutions and 8 affiliate sites provided quantitative and qualitative data. In the context of these surveys, “molecular profiling/diagnostics” was defined as a panel of at least 10 genes examined as a diagnostic DNA test in a Clinical Laboratory Improvement Amendments (CLIA)–certified laboratory. Conclusions: Results indicated that molecular profiling/diagnostics are used at 100% of survey respondents' institutions to make patient care decisions. However, challenges relating to reimbursement, lack of data regarding actionable targets and targeted therapies, and access to drugs on or off clinical trials were cited as barriers to integration of molecular profiling into patient care. Frameworks for using molecular diagnostic results based on levels of evidence, alongside continued research into the predictive value of biomarkers and targeted therapies, are recommended to advance understanding of the role of genomic biomarkers. Greater evidence and consensus regarding the clinical and cost-effectiveness of molecular profiling may lead to broader insurance coverage and increased integration into patient care.

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Wui-Jin Koh, Benjamin E. Greer, Nadeem R. Abu-Rustum, Sachin M. Apte, Susana M. Campos, John Chan, Kathleen R. Cho, David Cohn, Marta Ann Crispens, Nefertiti DuPont, Patricia J. Eifel, David K. Gaffney, Robert L. Giuntoli II, Ernest Han, Warner K. Huh, John R. Lurain III, Lainie Martin, Mark A. Morgan, David Mutch, Steven W. Remmenga, R. Kevin Reynolds, William Small Jr, Nelson Teng, Todd Tillmanns, Fidel A. Valea, Nicole R. McMillian and Miranda Hughes

These NCCN Clinical Practice Guidelines in Oncology for Cervical Cancer focus on early-stage disease, because it occurs more frequently in the United States. After careful clinical evaluation and staging, the primary treatment of early-stage cervical cancer is either surgery or radiotherapy. These guidelines include fertility-sparing and non-fertility-sparing treatment for those with early-stage disease, which is disease confined to the uterus. A new fertility-sparing algorithm was added for select patients with stage IA and IB1 disease..

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Robert J. Morgan, Ronald D. Alvarez, Deborah K. Armstrong, Robert A. Burger, Mariana Castells, Lee-may Chen, Larry Copeland, Marta Ann Crispens, David Gershenson, Heidi Gray, Ardeshir Hakam, Laura J. Havrilesky, Carolyn Johnston, Shashikant Lele, Lainie Martin, Ursula A. Matulonis, David M. O’Malley, Richard T. Penson, Steven W. Remmenga, Paul Sabbatini, Joseph T. Santoso, Russell J. Schilder, Julian Schink, Nelson Teng, Theresa L. Werner, Miranda Hughes and Mary A. Dwyer

These NCCN Guidelines Insights focus on the major updates for the 2012 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Ovarian Cancer by describing how and why the new recommendations were made. The 6 update topics were selected based on recent important updates in the guidelines and on debate among panel members about recent clinical trials, and include: 1) screening, 2) diagnostic tests for assessing pelvic masses, 3) primary treatment using neoadjuvant chemotherapy, 4) primary adjuvant treatment using bevacizumab in combination with chemotherapy, 5) therapy for recurrent disease, and 6) management of drug/hypersensitivity reactions. These NCCN Guidelines Insights also discuss why some recommendations were not made (eg, panel members did not feel the new data warranted changing the guideline). See “Updates” in the NCCN Guidelines for Ovarian Cancer for a complete list of all the recent revisions.