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Samuel W. Beenken and Marshall M. Urist

Merkel cell carcinoma (MCC) or neuroendocrine carcinoma of the skin is uncommon, often aggressive, and has a poor prognosis. Complete surgical excision with histologic documentation of clear resection margins is recommended for the primary cancer. Retrospective analysis of clinical data strongly suggests that adjuvant radiotherapy improves local control of MCC, but no evidence has been published that it prolongs survival. Sentinel lymph node biopsy is a useful method of determining the need for regional lymph node dissection in stage I patients. Chemotherapy regimens similar to those employed for small cell carcinoma of the lung have been recommended for advanced MCC. Patients often show an initial response to therapy, but it is usually short-lived. The three-year overall survival for patients with MCC is 31%. Before an improvement in long-term survival can be realized, early detection, appropriate use of surgery and radiation therapy, and the development of effective systemic chemotherapy are required.

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Daniel G. Coit, Robert Andtbacka, Christopher K. Bichakjian, Raza A. Dilawari, Dominick DiMaio, Valerie Guild, Allan C. Halpern, F. Stephen Hodi, Mohammed Kashani-Sabet, Julie R. Lange, Anne Lind, Lainie Martin, Mary C. Martini, Scott K. Pruitt, Merrick I. Ross, Stephen F. Sener, Susan M. Swetter, Kenneth K. Tanabe, John A. Thompson, Vijay Trisal, Marshall M. Urist, Jeffrey Weber and Michael K. Wong

Melanoma 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. In 2008, an estimated 62,480 new cases of melanoma will have been diagnosed and approximately 8420 patients will have died of the disease in the United States.1 However, these projections for new cases may represent a substantial underestimation, because many superficial and in situ melanomas treated in the outpatient setting are not reported. The incidence of melanoma continues to increase dramatically. Melanoma is increasing in men more rapidly than any other malignancy and more rapidly in women than any other malignancy except lung cancer. For someone born in the United States in 2005, the lifetime risk for developing melanoma may be as high as 1 in 55.2 Melanoma ranks second to adult leukemia in terms of loss of years of potential life, per death. The median age at diagnosis is 59 years. Risk factors for melanoma include...
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Stanley J. Miller, Murad Alam, James S. Andersen, Daniel Berg, Christopher K. Bichakjian, Glen M. Bowen, Richard T. Cheney, L. Frank Glass, Roy C. Grekin, Alan L. Ho, Anne Kessinger, Nanette Liegeois, Daniel D. Lydiatt, Jeff Michalski, William H. Morrison, Kishwer S. Nehal, Kelly C. Nelson, Paul Nghiem, Thomas Olencki, Clifford S. Perlis, Ashok R. Shaha, Malika Tuli, Marshall M. Urist, Linda C. Wang and John A. Zic

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Daniel G. Coit, Robert Andtbacka, Christopher J. Anker, Christopher K. Bichakjian, William E. Carson III, Adil Daud, Raza A. Dilawari, Dominick DiMaio, Valerie Guild, Allan C. Halpern, F. Stephen Hodi Jr., Mark C. Kelley, Nikhil I. Khushalani, Ragini R. Kudchadkar, Julie R. Lange, Anne Lind, Mary C. Martini, Anthony J. Olszanski, Scott K. Pruitt, Merrick I. Ross, Susan M. Swetter, Kenneth K. Tanabe, John A. Thompson, Vijay Trisal and Marshall M. Urist

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Stanley J. Miller, Murad Alam, James Andersen, Daniel Berg, Christopher K. Bichakjian, Glen Bowen, Richard T. Cheney, L. Frank Glass, Roy C. Grekin, Dennis E. Hallahan, Anne Kessinger, Nancy Y. Lee, Nanette Liegeois, Daniel D. Lydiatt, Jeff Michalski, William H. Morrison, Kishwer S. Nehal, Kelly C. Nelson, Paul Nghiem, Thomas Olencki, Allan R. Oseroff, Clifford S. Perlis, E. William Rosenberg, Ashok R. Shaha, Marshall M. Urist and Linda C. Wang

Merkel Cell Carcinoma 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 Merkel cell carcinoma (MCC) is a rare, aggressive cutaneous tumor that combines the local recurrence rates of infiltrative non-melanoma skin cancer along with the regional and distant metastatic rates of thick melanoma.1–16 Several large reviews document the development of local recurrence in 25% to 30% of all cases of MCC, regional disease in 52% to 59%, and distant metastatic disease in 34% to 36%.1,16,17 MCC has a mortality rate that exceeds that of melanoma;18 overall 5-year survival rates range from 30% to 64%.3,19 A history of extensive sun exposure is a risk factor for MCC. Older white men (≥ 65 years) are at higher risk for MCC, which tends to occur on the areas of the skin that are exposed to sun.20 The NCCN Non-Melanoma Skin Cancer Panel has developed guidelines outlining treatment of...
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Stanley J. Miller, Murad Alam, James Andersen, Daniel Berg, Christopher K. Bichakjian, Glen Bowen, Richard T. Cheney, L. Frank Glass, Roy C. Grekin, Anne Kessinger, Nancy Y. Lee, Nanette Liegeois, Daniel D. Lydiatt, Jeff Michalski, William H. Morrison, Kishwer S. Nehal, Kelly C. Nelson, Paul Nghiem, Thomas Olencki, Clifford S. Perlis, E. William Rosenberg, Ashok R. Shaha, Marshall M. Urist, Linda C. Wang and John A. Zic

Overview Basal and squamous cell skin cancers, collectively known as non-melanoma skin cancers (NMSC), are the most common skin cancers.1,2 More than 1 million cases of NMSC are estimated to be diagnosed each year in the United States and their incidence is rising rapidly.3,4 Basal cell carcinomas are approximately 4 to 5 times more common than squamous cell carcinomas. Although rarely metastatic, basal and squamous cell cancers can produce substantial local destruction along with disfigurement, and may involve extensive areas of soft tissue, cartilage, and bone. The estimated annual cost of treating these 2 diseases in the United States Medicare population exceeds $400 million.5 However, NMSCs generally have a good prognosis. The most significant environmental carcinogen for NMSC is sunlight.6 Thus, individuals in Hawaii are at much greater risk than those in the northern parts of the United States. Fair-skinned individuals who have received too much sun exposure are at the greatest risk for these cancers. Most of these tumors develop on sun-exposed skin sites. The most common sites are on the head and neck area. According to a report from the Childhood Cancer Survivor Study, long-term survivors of childhood and adolescent cancers who have undergone prior radiation therapy are also at risk for developing NMSC.7 Actinic keratoses are sun-induced precancerous lesions.8,9 Bowen's disease is characterized by squamous cell carcinoma in situ lesions that occur predominantly in older persons.10 Both types of lesions, if untreated, can progress to invasive squamous cell carcinoma with the potential for metastasis. Skin cancer preventive...
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Daniel G. Coit, John A. Thompson, Alain Algazi, Robert Andtbacka, Christopher K. Bichakjian, William E. Carson III, Gregory A. Daniels, Dominick DiMaio, Marc Ernstoff, Ryan C. Fields, Martin D. Fleming, Rene Gonzalez, Valerie Guild, Allan C. Halpern, F. Stephen Hodi Jr, Richard W. Joseph, Julie R. Lange, Mary C. Martini, Miguel A. Materin, Anthony J. Olszanski, Merrick I. Ross, April K. Salama, Joseph Skitzki, Jeff Sosman, Susan M. Swetter, Kenneth K. Tanabe, Javier F. Torres-Roca, Vijay Trisal, Marshall M. Urist, Nicole McMillian and Anita Engh

This selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Melanoma focuses on adjuvant therapy and treatment of in-transit disease, because substantial changes were made to the recommendations for the 2016 update. Depending on the stage of the disease, options for adjuvant therapy now include biochemotherapy and high-dose ipilimumab. Treatment options for in-transit disease now include intralesional injection with talimogene laherparepvec (T-VEC), a new immunotherapy. These additions prompted re-assessment of the data supporting older recommended treatment options for adjuvant therapy and in-transit disease, resulting in extensive revisions to the supporting discussion sections.

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Christopher K. Bichakjian, Thomas Olencki, Sumaira Z. Aasi, Murad Alam, James S. Andersen, Daniel Berg, Glen M. Bowen, Richard T. Cheney, Gregory A. Daniels, L. Frank Glass, Roy C. Grekin, Kenneth Grossman, Susan A. Higgins, Alan L. Ho, Karl D. Lewis, Daniel D. Lydiatt, Kishwer S. Nehal, Paul Nghiem, Elise A. Olsen, Chrysalyne D. Schmults, Aleksandar Sekulic, Ashok R. Shaha, Wade L. Thorstad, Malika Tuli, Marshall M. Urist, Timothy S. Wang, Sandra L. Wong, John A. Zic, Karin G. Hoffmann and Anita Engh

Basal cell carcinoma (BCC) of the skin is the most common cancer, with a higher incidence than all other malignancies combined. Although it is rare to metastasize, patients with multiple or frequently recurring BCC can suffer substantial comorbidity and be difficult to manage. Assessment of risk is a key element of management needed to inform treatment selection. The overall management of BCC primarily consists of surgical approaches, with radiation therapy as an alternate or adjuvant option. Many superficial therapies for BCC have been explored and continue to be developed, including topicals, cryosurgery, and photodynamic therapy. Two hedgehog pathway inhibitors were recently approved by the FDA for systemic treatment of advanced and metastatic BCC, and others are in development. The NCCN Guidelines for Basal Cell Skin Cancer, published in full herein, include recommendations for selecting among the various surgical approaches based on patient-, lesion-, and disease-specific factors, as well as guidance on when to use radiation therapy, superficial therapies, and hedgehog pathway inhibitors.

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Daniel G. Coit, John A. Thompson, Alain Algazi, Robert Andtbacka, Christopher K. Bichakjian, William E. Carson III, Gregory A. Daniels, Dominick DiMaio, Ryan C. Fields, Martin D. Fleming, Brian Gastman, Rene Gonzalez, Valerie Guild, Douglas Johnson, Richard W. Joseph, Julie R. Lange, Mary C. Martini, Miguel A. Materin, Anthony J. Olszanski, Patrick Ott, Aparna Priyanath Gupta, Merrick I. Ross, April K. Salama, Joseph Skitzki, Susan M. Swetter, Kenneth K. Tanabe, Javier F. Torres-Roca, Vijay Trisal, Marshall M. Urist, Nicole McMillian and Anita Engh

The NCCN Guidelines for Melanoma have been significantly revised over the past few years in response to emerging data on a number of novel agents and treatment regimens. These NCCN Guidelines Insights summarize the data and rationale supporting extensive changes to the recommendations for systemic therapy in patients with metastatic or unresectable melanoma.

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Melanoma, Version 2.2013

Featured Updates to the NCCN Guidelines

Daniel G. Coit, Robert Andtbacka, Christopher J. Anker, Christopher K. Bichakjian, William E. Carson III, Adil Daud, Dominick DiMaio, Martin D. Fleming, Valerie Guild, Allan C. Halpern, F. Stephen Hodi Jr., Mark C. Kelley, Nikhil I. Khushalani, Ragini R. Kudchadkar, Julie R. Lange, Anne Lind, Mary C. Martini, Anthony J. Olszanski, Scott K. Pruitt, Merrick I. Ross, Susan M. Swetter, Kenneth K. Tanabe, John A. Thompson, Vijay Trisal, Marshall M. Urist, Nicole McMillian and Maria Ho

The NCCN Guidelines for Melanoma provide multidisciplinary recommendations on the clinical management of patients with melanoma. This NCCN Guidelines Insights report highlights notable recent updates. Foremost of these is the exciting addition of the novel agents ipilimumab and vemurafenib for treatment of advanced melanoma. The NCCN panel also included imatinib as a treatment for KIT-mutated tumors and pegylated interferon alfa-2b as an option for adjuvant therapy. Also important are revisions to the initial stratification of early-stage lesions based on the risk of sentinel lymph node metastases, and revised recommendations on the use of sentinel lymph node biopsy for low-risk groups. Finally, the NCCN panel reached clinical consensus on clarifying the role of imaging in the workup of patients with melanoma.