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Study Using the NCCN Guidelines for Palliative Care to Screen Patients for Palliative Care Needs and Referral to Palliative Care Specialists

Paul Glare, Kathy Plakovic, Anna Schloms, Barbara Egan, Andrew S. Epstein, David Kelsen, and Leonard Saltz

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Palliative Care recommend screening all patients for palliative care (PC) needs and to call a PC consult when referral criteria are met. The goal of this pilot project was to evaluate the feasibility of implementing the screening and referral components of the NCCN Guidelines for Palliative Care in patients admitted to the Gastrointestinal Oncology Service (GIOS) at a comprehensive cancer center (CCC). Floor nurses performed the initial screening of all patients admitted to the 2 teams—Team A and Team B—of the GIOS on one floor of Memorial Hospital for 3 months. In addition, only the patients admitted to Team A were evaluated according to the referral criteria, triggering a PC consult if results were positive. Nurses were surveyed regarding satisfaction with and the acceptability of screening. During the study period, 229 (90%) total admissions were screened, with 169 (73%) having positive results. Of the Team A admissions, 72 (64%) met the referral criteria. More consults occurred for patients in Team A (47 vs 15; P=.001). In 30% of the referral criteria-triggered consults, the PC needs were manageable by the primary team. Nurses reported screening to be easy and quick (<5 minutes per patient) but only somewhat helpful. Being unfamiliar with many patients and families, floor nurses often felt unable to screen them accurately for some issues. In conclusion, screening was feasible, increasing access to PC, but accuracy and usefulness are concerns. With a consult indicated in 64% patients, yet with 30% being manageable by the primary team, the current criteria may be too sensitive for the inpatient environment of a CCC. More evaluation is needed before widespread implementation can be recommended.

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Frequency, Morbidity, and Mortality of Bone Metastases in Advanced Hepatocellular Carcinoma

James J. Harding, Ghaith Abu-Zeinah, Joanne F. Chou, Dwight Hall Owen, Michele Ly, Maeve Aine Lowery, Marinela Capanu, Richard Do, Nancy E. Kemeny, Eileen M. O'Reilly, Leonard B. Saltz, and Ghassan K. Abou-Alfa

Background: Bone metastases are common in hepatocellular carcinoma (HCC), but their incidence, morbidity, and mortality are not well defined. Methods: The Memorial Sloan Kettering Cancer Center database was queried for all patients with HCC and metastases seen from 2002 to 2014. The prevalence of bone metastasis was determined and cumulative incidence function was used to estimate the probability of developing a bone metastasis. Regression models were created to identify risk factors for osseous metastasis. The frequency of skeletal-related events (SREs), defined as pathologic fracture, spinal cord compression, need for radiation therapy to bone, and/or surgical resection of bone, was determined and cumulative incidence function was used to estimate the probability of SRE development. Regression models were created to identify SRE risk factors. Correlation of clinicopathologic parameters, including bone metastases and SREs, with overall survival was analyzed using Kaplan-Meier methodology. Results: A total of 459 patients with HCC and extrahepatic metastases were identified; 151 patients (32.9%) had or developed bone metastases: 128 (27.9%) as a primary site and 23 (4.6%) as a secondary site of extrahepatic disease. Among the 331 patients without bone metastasis at presentation, the yearly incidence of bone metastasis was 6.4% (95% CI, 3.6%–9.2%). Hepatitis B virus (HBV) infection increased the chance of developing a bone metastasis (P=.02). The cumulative incidence of SREs was 50% at 6 months. Univariate analysis showed that patients with HBV-related HCC had a significantly higher incidence of SREs (P=.02). Sorafenib and bisphosphonates each protected against SREs. The presence of SREs was independently associated with a worse overall survival (hazard ratio, 2.13; 95% CI, 1.52–2.97; P<.01) in the multivariable model. Conclusions: Patients with AJCC stage IV HCC and bone metastases that are clinically evident on routine radiography or on clinical examination at presentation are apt to develop frequent, morbid, and mortal SREs, whereas those without evident bone metastasis at presentation are unlikely to develop these complications.

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Neoadjuvant Chemotherapy First, Followed by Chemoradiation and Then Surgery, in the Management of Locally Advanced Rectal Cancer

Andrea Cercek, Karyn A. Goodman, Carla Hajj, Emily Weisberger, Neil H. Segal, Diane L. Reidy-Lagunes, Zsofia K. Stadler, Abraham J. Wu, Martin R. Weiser, Philip B. Paty, Jose G. Guillem, Garrett M. Nash, Larissa K. Temple, Julio Garcia-Aguilar, and Leonard B. Saltz

Standard therapy for locally advanced rectal cancer (LARC) is preoperative chemoradiotherapy and postoperative chemotherapy. At Memorial Sloan-Kettering Cancer Center (MSKCC) the authors began offering FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) as initial treatment for patients with high-risk LARC to target micrometastases while treating the primary tumor. The purpose of this study is to report the safety and efficacy of initial FOLFOX given before chemoradiotherapy on tumor downsizing and pathologic complete response (pathCR) in LARC. The records of patients with stage II/III rectal cancer treated at MSKCC between 2007 and 2012 were reviewed. Of approximately 300 patients with LARC treated at MSKCC, 61 received FOLFOX as initial therapy. Of these 61 patients, 57 received induction FOLFOX (median 7 cycles) followed by chemoradiation, and 4 experienced an excellent response, declined chemoradiation, and underwent total mesorectal excision (TME). Twelve of the 61 patients did not undergo TME: 9 had a complete clinical response (CCR), 1 declined despite persistent tumor, 1 declined because of comorbidities, and 1 developed metastatic disease. Among the 61 patients receiving initial FOLFOX, 22 (36%) had either a pathCR (n=13) or a CCR (n=9). Of the 49 patients who underwent TME, all had R0 resections and 23 (47%) had tumor response greater than 90%, including 13 (27%) who experienced a pathCR. Of the 28 patients who received all 8 cycles of FOLFOX, 8 experienced a pathCR (29%) and 3 a CCR (11%). No serious adverse events occurred that required a delay in treatment during FOLFOX or chemoradiation. FOLFOX and chemoradiation before planned TME results in tumor regression, a high rate of delivery of planned therapy, and a substantial rate of pathCRs, and offers a good platform for nonoperative management in select patients.

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False-Positive Elevations of Carcinoembryonic Antigen in Patients With a History of Resected Colorectal Cancer

Anya Litvak, Andrea Cercek, Neil Segal, Diane Reidy-Lagunes, Zsofia K. Stadler, Rona D. Yaeger, Nancy E. Kemeny, Martin R. Weiser, Melissa S. Pessin, and Leonard Saltz

Routine monitoring of carcinoembryonic antigen (CEA) levels is standard in patients with resected colorectal cancer (CRC). The incidence of false-positives and the upper limits of false-positive elevations have not been previously well characterized. A search of medical records at Memorial Sloan-Kettering Cancer Center identified 728 patients who underwent an R0 resection of locoregional CRC between January 2003 and December 2012 and who had an increase in CEA level above the normal range after a normal perioperative CEA level. Of these, 358 had a false-positive elevation of CEA level, 335 had a true-positive elevation indicative of recurrent CRC, and 35 had a true-positive elevation indicative of the development of a new, non-CRC malignancy. Of those with false elevations, 111 had a single isolated CEA level elevation (median highest CEA level of 5.5 ng/mL) with no further abnormal measurements, whereas 247 had elevations on 2 or more readings, with a median highest level of 6.7 ng/mL. Of these 247 patients with confirmed false-positive CEA level elevations, only 5 (2%) had measurements greater than 15 ng/mL, and no confirmed elevation greater than 35 ng/mL was a false-positive. False-positive CEA test results in the range of 5 to 15 ng/mL are common. Confirmation of CEA elevation in this range before initiating imaging studies may be appropriate. False-positive results greater than 15 ng/mL are rare, and all confirmed CEA levels greater than 35 ng/mL were associated with cancer recurrence.

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NCCN Task Force Report: Oral Chemotherapy

Saul N. Weingart, Elizabeth Brown, Peter B. Bach, Kirby Eng, Shirley A. Johnson, Timothy M. Kuzel, Terry S. Langbaum, R. Donald Leedy, Raymond J. Muller, Lee N. Newcomer, Susan O’Brien, Denise Reinke, Mark Rubino, Leonard Saltz, and Ronald S. Walters

Oral chemotherapy is emerging as a new option for well-selected patients who can manage potentially complex oral regimens and self-monitor for potential complications. If a choice between oral and parenteral therapy is available, patients may opt for oral chemotherapy because it is more convenient to administer, allows them to avoid multiple office visits, and gives them a sense of control over their own cancer care. Whether these potential advantages are maintained in regimens that combine oral and parenteral drugs is less clear. The use of oral chemotherapeutic agents profoundly affects all aspects of oncology, including creating significant safety and adherence issues, shifting some traditional roles and responsibilities of oncologists, nurses, and pharmacists to patients and caregivers. The financing of chemotherapy is also affected. To address these issues, the NCCN convened a multidisciplinary task force consisting of oncologists, nurses, pharmacists, and payor representatives to discuss the impact of the increasing use of oral chemotherapy. (JNCCN 2008;6[Suppl 3]:S1–S14)

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Occult Primary

David S. Ettinger, Mark Agulnik, Justin M. M. Cates, Mihaela Cristea, Crystal S. Denlinger, Keith D. Eaton, Panagiotis M. Fidias, David Gierada, Jon P. Gockerman, Charles R. Handorf, Renuka Iyer, Renato Lenzi, John Phay, Asif Rashid, Leonard Saltz, Lawrence N. Shulman, Jeffrey B. Smerage, Gauri R. Varadhachary, Jonathan S. Zager, and Weining (Ken) Zhen

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Occult Primary, Version 3.2014

David S. Ettinger, Charles R. Handorf, Mark Agulnik, Daniel W. Bowles, Justin M. Cates, Mihaela Cristea, Efrat Dotan, Keith D. Eaton, Panagiotis M. Fidias, David Gierada, G. Weldon Gilcrease, Kelly Godby, Renuka Iyer, Renato Lenzi, John Phay, Asif Rashid, Leonard Saltz, Richard B. Schwab, Lawrence N. Shulman, Jeffrey B. Smerage, Marvaretta M. Stevenson, Gauri R. Varadhachary, Jonathan S. Zager, Weining (Ken) Zhen, Mary Anne Bergman, and Deborah A. Freedman-Cass

The NCCN Guidelines for Occult Primary tumors provide recommendations for the evaluation, workup, management, and follow-up of patients with occult primary tumors (cancers of unknown primary). These NCCN Guidelines Insights summarize major discussion points of the 2014 NCCN Occult Primary panel meeting. The panel discussed gene expression profiling (GEP) for the identification of the tissue of origin and concluded that, although GEP has a diagnostic benefit, a clinical benefit has not been demonstrated. The panel recommends against GEP as standard management, although 20% of the panel believes the diagnostic benefit of GEP warrants its routine use. In addition, the panel discussed testing for actionable mutations (eg, ALK) to help guide choice of therapy, but declined to add this recommendation.

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Rectal Cancer

Al B. Benson III, Tanios Bekaii-Saab, Emily Chan, Yi-Jen Chen, Michael A. Choti, Harry S. Cooper, Paul F. Engstrom, Peter C. Enzinger, Marwan G. Fakih, Charles S. Fuchs, Jean L. Grem, Steven Hunt, Lucille A. Leong, Edward Lin, Michael G. Martin, Kilian Salerno May, Mary F. Mulcahy, Kate Murphy, Eric Rohren, David P. Ryan, Leonard Saltz, Sunil Sharma, David Shibata, John M. Skibber, William Small Jr, Constantinos T. Sofocleous, Alan P. Venook, Christopher G. Willett, Deborah A. Freedman-Cass, and Kristina M. Gregory

These NCCN Clinical Practice Guidelines in Oncology provide recommendations for the management of rectal cancer, beginning with the clinical presentation of the patient to the primary care physician or gastroenterologist through diagnosis, pathologic staging, neoadjuvant treatment, surgical management, adjuvant treatment, surveillance, management of recurrent and metastatic disease, and survivorship. This discussion focuses on localized disease. The NCCN Rectal Cancer Panel believes that a multidisciplinary approach, including representation from gastroenterology, medical oncology, surgical oncology, radiation oncology, and radiology, is necessary for treating patients with rectal cancer.

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Neuroendocrine Tumors, Version 1.2015

Matthew H. Kulke, Manisha H. Shah, Al B. Benson III, Emily Bergsland, Jordan D. Berlin, Lawrence S. Blaszkowsky, Lyska Emerson, Paul F. Engstrom, Paul Fanta, Thomas Giordano, Whitney S. Goldner, Thorvardur R. Halfdanarson, Martin J. Heslin, Fouad Kandeel, Pamela L. Kunz, Boris W. Kuvshinoff II, Christopher Lieu, Jeffrey F. Moley, Gitonga Munene, Venu G. Pillarisetty, Leonard Saltz, Julie Ann Sosa, Jonathan R. Strosberg, Jean-Nicolas Vauthey, Christopher Wolfgang, James C. Yao, Jennifer Burns, and Deborah Freedman-Cass

Neuroendocrine tumors (NETs) comprise a broad family of tumors that may or may not be associated with symptoms attributable to hormonal hypersecretion. The NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine Tumors discuss the diagnosis and management of both sporadic and hereditary NETs. This selection from the guidelines focuses on sporadic NETs of the pancreas, gastrointestinal tract, lung, and thymus.

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Neuroendocrine Tumors

Matthew H. Kulke, Al B. Benson III, Emily Bergsland, Jordan D. Berlin, Lawrence S. Blaszkowsky, Michael A. Choti, Orlo H. Clark, Gerard M. Doherty, James Eason, Lyska Emerson, Paul F. Engstrom, Whitney S. Goldner, Martin J. Heslin, Fouad Kandeel, Pamela L. Kunz, Boris W. Kuvshinoff II, Jeffrey F. Moley, Venu G. Pillarisetty, Leonard Saltz, David E. Schteingart, Manisha H. Shah, Stephen Shibata, Jonathan R. Strosberg, Jean-Nicolas Vauthey, Rebekah White, James C. Yao, Deborah A. Freedman-Cass, and Mary A. Dwyer

Neuroendocrine tumors comprise a broad family of tumors, the most common of which are carcinoid and pancreatic neuroendocrine tumors. The NCCN Neuroendocrine Tumors Guidelines discuss the diagnosis and management of both sporadic and hereditary neuroendocrine tumors. Most of the recommendations pertain to well-differentiated, low- to intermediate-grade tumors. This updated version of the NCCN Guidelines includes a new section on pathology for diagnosis and reporting and revised recommendations for the surgical management of neuroendocrine tumors of the pancreas.