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James Perkins, Patrick Boland, Steven J. Cohen, Anthony J. Olszanski, Yan Zhou, Paul Engstrom and Igor Astsaturov

Neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST) are believed to originate from the cells of Cajal that are randomly dispersed along the aerodigestive tract. Despite their distinct morphologic appearance, NET and GIST may share oncogenic mechanisms. Often presenting in the metastatic setting, treatment options for patients with NET are limited. This case report presents a patient with refractory metastatic NET that did not respond conventional chemotherapy. The patient was treated with a KIF11 inhibitor in a phase I clinical trial and experienced a prolonged and clinically meaningful partial response. On progression at 20 months, the patient’s tumor was sequenced to reveal a KIT exon 11 mutation. Institution of imatinib therapy achieved a rapid and sustained antitumor effect with profound clinical benefit. Despite previously reported KIT expression in NET, this is the first documented case of an activating KIT mutation in NET and of successful treatment with both a KIF11 inhibitor and imatinib, each of which was elucidated through molecular profiling of the patient’s tumor. Imatinib may be a valuable therapy in NET harboring activating KIT mutations.

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Marsha Reyngold, Joyce Niland, Anna ter Veer, Dana Milne, Tanios Bekaii-Saab, Steven J. Cohen, Lily Lai, Deborah Schrag, John M. Skibber, William Small Jr, Martin Weiser, Neal Wilkinson and Karyn A. Goodman

Based on randomized data, neoadjuvant chemoradiotherapy has been incorporated into the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for stage II-III rectal cancer. Factors associated with nonadherence to evidence-based guidelines for neoadjuvant radiotherapy (RT) were examined at dedicated cancer centers. The prospective NCCN Oncology Outcomes Database for Colorectal Cancers was queried for patients with stage II-III rectal cancer who underwent a transabdominal surgical resection between September 2005 and June 2012. Multivariable logistic regression was used to identify factors associated with omission of RT. Among 1199 identified patients, 1119 (93%) received neoadjuvant RT, 51 (4%) did not receive RT, and 29 (2%) received adjuvant RT. Among 51 patients not receiving RT, only 19 (37%) were referred and evaluated by a radiation oncologist. On multivariable analysis, clinical factors associated with not receiving RT included a history of prior pelvic RT (adjusted odds ratio [aOR], 23.9; P=.0003), ECOG performance status of 2 or greater (aOR, 11.1; P=.01), tumor distance from the anal verge greater than 10 cm (aOR, 5.4; P=.009), age at diagnosis of 75 years or older (aOR, 4.43; P=.002), body mass index of 25 to 30 kg/m2 and less than 25 kg/m2 (aOR, 5.22 and 4.23, respectively; P=.03), and clinical stage II (aOR, 2.27; P=.02). No significant change was seen in RT use according to diagnosis year, nor was any correlation seen with distance to the nearest RT facility. Concordance with NCCN Guidelines for neoadjuvant RT is high among NCCN Member Institutions. After adjusting for clinical characteristics that increase the risk for RT toxicity, including history of pelvic RT and high comorbidity burden/low functional status, the authors found that non-obese patients of advanced age or those with more favorable clinical features were more likely to not receive RT.

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Margaret A. O'Grady, Elena Gitelson, Ramona F. Swaby, Lori J. Goldstein, Elaine Sein, Patricia Keeley, Bonnie Miller, Tianyu Li, Alan Weinstein and Steven J. Cohen

Fox Chase Cancer Center Partners (FCCCP) is a community hospital/academic partnership consisting of 25 hospitals in the Delaware Valley. Originally created in 1986, FCCCP promotes quality community cancer care through education, quality assurance, and access to clinical trial research. An important aspect of quality assurance is a yearly medical oncology audit that benchmarks quality indicators and guidelines and provides a roadmap for quality improvement initiatives in the community oncology clinical office setting. Each year, the FCCCP team and the Partner Medical Oncologists build disease site- and stage-specific indicators based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Concordance with multiple indicators is assessed on 20 charts from each community practice. A report for each FCCCP medical oncology practice summarizes documentation, screening recommendations, new drug use, and research trends in a particular disease site. Descriptive statistics reflect indicators met, number of new cases seen per year, number of disease site cases from tumor registry information, and clinical trial accrual total. Education and documentation tools are provided to physicians and oncology office nursing staff. The FCCCP Clinical Operations Team, consisting of medical oncologists and oncology-certified nurses, has conducted quality audits in medical oncology offices for 7 years using NCCN-derived indicators. Successful audits comprising gastric, colorectal, and breast cancer have been the focus of recent evaluations. For the 2005 stage II/III breast cancer evaluation, mean compliance per parameter was 88%, with 15 of 16 practices achieving mean compliance greater than 80%. A large-scale quality assurance audit in a community cancer partner network is feasible. Recent evaluation of localized breast cancer shows high compliance with guidelines and identifies areas for focused education. Partnership between academic and community oncologists produces a quality review process that is broadly applicable and adaptable to changing medical knowledge.

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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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Mohamedtaki A. Tejani, Anna ter Veer, Dana Milne, Rebecca Ottesen, Tanios Bekaii-Saab, Al B. Benson III, Deborah Schrag, Stephen Shibata, John Skibber, Martin Weiser, Neal Wilkinson and Steven J. Cohen

Appendiceal malignancies are rare and represent 1% of intestinal tumors in the United States. The role and efficacy of modern systemic therapy in advanced appendiceal adenocarcinoma has not been established. This study analyzed patients with recurrent or metastatic appendiceal adenocarcinoma in the database for Colorectal Cancer (CRC; 2005-2012). This database tracks longitudinal care for patients treated at 8 specialty centers across the Unites States. Study objectives were to describe and evaluate the efficacy of systemic therapy and investigate relationships with clinicopathologic features. Cox regression analysis was performed to identify predictors of progression-free survival (PFS) and overall survival (OS). Of 248 patients with advanced appendiceal carcinoma, 112 (45%) received systemic therapy for measurable disease and are the focus of this report. The most common chemotherapy regimens included FOLFOX with or without bevacizumab (n=39 and n=37, respectively), FOLFIRI (n=15), and single-agent fluoro-pyrimidine (n=10). Among 99 patients evaluable for best response, 39 experienced a response (response rate [RR], 39%) and 36 (36%) had stable disease. The median PFS was 1.2 years (95% CI, 1.0-1.8) and median OS was 2.1 years (95% CI, 1.6-2.3). Patients with non-mucinous histology or high-grade tumors and those who underwent nondebulking surgery had worse PFS and OS. Treatment of advanced appendiceal adenocarcinoma at NCCN Member Institutions commonly incorporates agents used for CRC. RR, PFS, and OS are comparable to those achieved in the treatment of metastatic CRC. Poor prognostic factors include nonmucinous histology or high-grade tumors and history of nondebulking surgery.

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Sherif R. Z. Abdel-Misih, Lai Wei, Al B. Benson III, Steven Cohen, Lily Lai, John Skibber, Neal Wilkinson, Martin Weiser, Deborah Schrag and Tanios Bekaii-Saab

Background: Nodal status has long been considered pivotal to oncologic care, staging, and management. This has resulted in the establishment of rudimentary metrics regarding adequate lymph node yield in colon and rectal cancers for accurate cancer staging. In the era of neoadjuvant treatment, the implications of lymph node yield and status on patient outcomes remains unclear. Patient and Methods: This study included 1,680 patients with locally advanced rectal cancer from the NCCN prospective oncology database stratified into 3 groups based on preoperative therapy received: no neoadjuvant therapy, neoadjuvant chemoradiation, and neoadjuvant chemotherapy. Clinicopathologic characteristics and survival were compared between the groups, with univariate and multivariate analyses undertaken. Results: The clinicopathologic characteristics demonstrated statistically significant differences and heterogeneity among the 3 groups. The neoadjuvant chemoradiation group demonstrated the statistically lowest median lymph node yield (n=15) compared with 17 and 18 for no-neoadjuvant and neoadjuvant chemotherapy, respectively (P<.0001). Neoadjuvant treatment did impact survival, with chemoradiation demonstrating increased median overall survival of 42.7 compared with 37.3 and 26.6 months for neoadjuvant chemotherapy and no-neoadjuvant therapy, respectively (P<.0001). Patients with a yield of fewer than 12 lymph nodes had improved median overall survival of 43.3 months compared with 36.6 months in patients with 12 or more lymph nodes (P=.009). Multivariate analysis demonstrated that neither node yield nor status were predictors for overall survival. Discussion: This analysis reiterates that nodal yield in rectal cancer is multifactorial, with neoadjuvant therapy being a significant factor. Node yield and status were not significant predictors of overall survival. A nodal metric may not be clinically relevant in the era of neoadjuvant therapy, and guidelines for perioperative therapy may need reconsideration.

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Kenneth C. Anderson, Melissa Alsina, William Bensinger, J. Sybil Biermann, Asher Chanan-Khan, Adam D. Cohen, Steven Devine, Benjamin Djulbegovic, Cristina Gasparetto, Carol Ann Huff, Madan Jagasia, Bruno C. Medeiros, Ruby Meredith, Noopur Raje, Jeffrey Schriber, Seema Singhal, George Somlo, Keith Stockerl-Goldstein, Guido Tricot, Julie M. Vose, Donna Weber, Joachim Yahalom and Furhan Yunus

Multiple Myeloma 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. 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 Multiple myeloma (MM) is a malignant neoplasm of plasma cells that accumulate in bone marrow, leading to bone destruction and marrow failure. The American Cancer Society estimates that 20,580 new cases of MM will occur in the United States in 2009, including 11,680 in men and 8900 in women, with an estimated 10,580 deaths.1 The mean age of affected individuals is 62 years for men (75% > 70 years) and 61 years for women (79% > 70 years). The treatment of MM has dramatically improved over the past decade. The 5-year survival rate reported in the Surveillance Epidemiology and End Results database has increased from 25% in 1975 to 34% in 2003 because of the availability of newer and more effective treatment options.2,3 MM is typically sensitive to various cytotoxic drugs, both as initial treatment...
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Kenneth C. Anderson, Melissa Alsina, William Bensinger, J. Sybil Biermann, Asher Chanan-Khan, Adam D. Cohen, Steven Devine, Benjamin Djulbegovic, Edward A. Faber Jr., Cristina Gasparetto, Carol Ann Huff, Adetola Kassim, Bruno C. Medeiros, Ruby Meredith, Noopur Raje, Jeffrey Schriber, Seema Singhal, George Somlo, Keith Stockerl-Goldstein, Steven P. Treon, Guido Tricot, Donna M. Weber, Joachim Yahalom and Furhan Yunus

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Margaret A. Tempero, J. Pablo Arnoletti, Stephen Behrman, Edgar Ben-Josef, Al B. Benson III, Jordan D. Berlin, John L. Cameron, Ephraim S. Casper, Steven J. Cohen, Michelle Duff, Joshua D.I. Ellenhorn, William G. Hawkins, John P. Hoffman, Boris W. Kuvshinoff II, Mokenge P. Malafa, Peter Muscarella II, Eric K. Nakakura, Aaron R. Sasson, Sarah P. Thayer, Douglas S. Tyler, Robert S. Warren, Samuel Whiting, Christopher Willett and Robert A. Wolff

Overview An estimated 36,800 people will die of pancreatic cancer in the United States in 2010.1 This disease is the fourth most common cause of cancer-related death among men and women in the United States.1 Its peak incidence occurs in the seventh and eighth decades of life. Although incidence is roughly equal for the sexes, African Americans seem to have a higher incidence of pancreatic cancer than white Americans.2 These guidelines only discuss tumors of the exocrine pancreas; neuroendocrine tumors are not included. By definition, these NCCN 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 the panel members during development of these guidelines. A 5% rule (omitting clinical scenarios that constitute fewer than 5% of all cases) was used to eliminate uncommon clinical occurrences or conditions from these guidelines. The panel unanimously endorses participation in a clinical trial as the preferred option over standard or accepted therapy. Risk Factors and Genetic Predisposition Although the associated increase in risk is small, the development of pancreatic cancer is firmly linked to cigarette smoking.3–5 Some evidence shows that increased consumption of red meat and dairy products is associated with an elevation in pancreatic cancer risk,6 although other studies have failed to identify dietary risk factors.4 An increased body mass index is also associated with increased risk.7–9 Occupational exposure to chemicals, such as beta-naphthylamine and benzidine, is also associated with an increased risk of pancreatic...
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Pancreatic Adenocarcinoma, Version 2.2012

Featured Updates to the NCCN Guidelines

Margaret A. Tempero, J. Pablo Arnoletti, Stephen W. Behrman, Edgar Ben-Josef, Al B. Benson III, Ephraim S. Casper, Steven J. Cohen, Brian Czito, Joshua D. I. Ellenhorn, William G. Hawkins, Joseph Herman, John P. Hoffman, Andrew Ko, Srinadh Komanduri, Albert Koong, Wen Wee Ma, Mokenge P. Malafa, Nipun B. Merchant, Sean J. Mulvihill, Peter Muscarella II, Eric K. Nakakura, Jorge Obando, Martha B. Pitman, Aaron R. Sasson, Anitra Tally, Sarah P. Thayer, Samuel Whiting, Robert A. Wolff, Brian M. Wolpin, Deborah A. Freedman-Cass and Dorothy A. Shead

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pancreatic Adenocarcinoma discuss the workup and management of tumors of the exocrine pancreas. These NCCN Guidelines Insights provide a summary and explanation of major changes to the 2012 NCCN Guidelines for Pancreatic Adenocarcinoma. The panel made 3 significant updates to the guidelines: 1) more detail was added regarding multiphase CT techniques for diagnosis and staging of pancreatic cancer, and pancreas protocol MRI was added as an emerging alternative to CT; 2) the use of a fluoropyrimidine plus oxaliplatin (e.g., 5-FU/leucovorin/oxaliplatin or capecitabine/oxaliplatin) was added as an acceptable chemotherapy combination for patients with advanced or metastatic disease and good performance status as a category 2B recommendation; and 3) the panel developed new recommendations concerning surgical technique and pathologic analysis and reporting.