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Christopher G. Willett

The NCCN Guidelines for Rectal Cancer are now more closely aligned with those for colon cancer. A new MRI-based definition of the rectum has been included and the use of MRI in staging has been elevated in importance. There is a new emphasis on neoadjuvant therapy, especially the concurrent use of chemotherapy and radiotherapy. One of the biggest changes is more acceptance of an observational approach—“watch and wait, nonoperative management”—for select patients experiencing a complete clinical response with no evidence of residual disease after neoadjuvant therapy.

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Joseph M. Pepek, Christopher G. Willett and Brian G. Czito

Radiation therapy (RT) is established as the primary treatment of squamous cell carcinoma of the anus. Multiple randomized trials have shown that combined modality therapy with RT, 5-fluorouracil, and mitomycin-C results in high rates of local control, disease-free survival, and sphincter preservation. However, treatment-related toxicity using conventional radiation approaches remains high and may compromise therapeutic efficacy because of prolonged treatment breaks and inability to deliver adequate radiation dose. Recent developments, including the use of PET for staging, radiation planning, and response assessment, and advanced RT planning using intensity-modulated radiation therapy (IMRT), may decrease acute and late treatment-related toxicity, provide high-dose target conformality, and permit safe radiation dose escalation. This article reviews the basic principles of IMRT and highlights current literature on these recent advances and the application of new RT techniques.

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Swaminathan Murugappan, William P. Harris, Christopher G. Willett and Edward Lin

Although tumor biology and genomics of colon and rectal cancer are no different, patients with locally advanced rectal cancer (LARC) require neoadjuvant fluoropyrimidine-based chemoradiation and total mesorectal excision. In addition to known clinical risk factors, improved algorithms integrating molecular tools are needed to stratify patients with LARC to improve treatment outcomes and reduce acute and long-term toxicities. Simply combining newer systemic or targeted agents with standard treatment in all patients yielded little success but added toxicities. This article reviews the historical data, current standards of care, and ongoing research efforts regarding biomarkers, molecular imaging, and personalized genomic information.

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Paul F. Engstrom, Juan Pablo Arnoletti, Al B. Benson III, Jordan D. Berlin, J. Michael Berry, Yi-Jen Chen, Michael A. Choti, Harry S. Cooper, Raza A. Dilawari, Dayna S. Early, Peter C. Enzinger, Marwan G. Fakih, James Fleshman Jr., Charles Fuchs, Jean L. Grem, James A. Knol, Lucille A. Leong, Edward Lin, Mary F. Mulcahy, Eric Rohren, David P. Ryan, Leonard Saltz, David Shibata, John M. Skibber, William Small Jr., Constantinos Sofocleous, James Thomas, Alan P. Venook and Christopher Willett

OverviewAn estimated 5290 new cases (2100 men and 3190 women) of anal cancer (involving the anus, anal canal, or anorectum) will occur in the United States in 2009, accounting for approximately 1.9% of digestive system cancers, and an estimated 710 deaths due to anal cancer. Although considered to be a rare type of cancer, the incidence rate of invasive anal carcinoma in the United States increased by approximately 1.6-fold for men and 1.5-fold for women from 1973-1979 to 1994-2000 (see Risk Factors, facing page).This manuscript summarizes the NCCN Clinical Practice Guidelines in Oncology for managing squamous cell anal carcinoma, which represents the most common histologic form of the disease. Other types of cancers occurring in the anal region are addressed in other NCCN guidelines (i.e., anal adenocarcinoma and anal melanoma are managed according to the NCCN Clinical Practice Guidelines in Oncology on Rectal Cancer and Melanoma, respectively). Except where noted, the recommendations in these guidelines are classified as category 2A, meaning that uniform NCCN consensus was present among the panel based on lower-level evidence that the recommendation is appropriate. The panel unanimously endorses patient participation in a clinical trial over standard or accepted therapy.Risk FactorsAnal carcinoma has been associated with human papilloma virus (HPV) infection (anal-genital warts); history of receptive anal intercourse or sexually transmitted disease; history of cervical, vulvar, or vaginal cancer; immunosuppression after solid organ transplantation or HIV infection; and smoking. Currently, the association between anal carcinoma and persistent infection with a high-risk form...
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Paul F. Engstrom, Juan Pablo Arnoletti, Al B. Benson III, Yi-Jen Chen, Michael A. Choti, Harry S. Cooper, Anne Covey, Raza A. Dilawari, Dayna S. Early, Peter C. Enzinger, Marwan G. Fakih, James Fleshman Jr., Charles Fuchs, Jean L. Grem, Krystyna Kiel, James A. Knol, Lucille A. Leong, Edward Lin, Mary F. Mulcahy, Sujata Rao, David P. Ryan, Leonard Saltz, David Shibata, John M. Skibber, Constantinos Sofocleous, James Thomas, Alan P. Venook and Christopher Willett

Colon Cancer Clinical Practice Guidelines in OncologyNCCN Categories of Evidence and ConsensusCategory 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.OverviewColorectal cancer is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States. In 2009, an estimated 106,100 new cases of colon and 40,870 cases of rectal cancer will occur. During the same year, it is estimated that 49,920 people will die from colon and rectal cancer.1 Despite these statistics, mortality from colon cancer has decreased slightly over the past 30 years, possibly due to earlier diagnosis through screening and better treatment modalities.This manuscript summarizes the NCCN Clinical Practice Guidelines in Oncology for managing colon cancer. The guidelines begin with clinical presentation to the primary care physician or gastroenterologist and address diagnosis, pathologic staging, surgical management, adjuvant treatment, management of recurrent and metastatic disease, and patient surveillance. When reviewing these guidelines, clinicians should be aware of...
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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

OverviewAn 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 PredispositionAlthough 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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Paul F. Engstrom, Juan Pablo Arnoletti, Al B. Benson III, Yi-Jen Chen, Michael A. Choti, Harry S. Cooper, Anne Covey, Raza A. Dilawari, Dayna S. Early, Peter C. Enzinger, Marwan G. Fakih, James Fleshman Jr., Charles Fuchs, Jean L. Grem, Krystyna Kiel, James A. Knol, Lucille A. Leong, Edward Lin, Mary F. Mulcahy, Sujata Rao, David P. Ryan, Leonard Saltz, David Shibata, John M. Skibber, Constantinos Sofocleous, James Thomas, Alan P. Venook and Christopher Willett

Rectal 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. 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 In 2009 an estimated 40,870 new cases of rectal cancer will occur in the United States (23,580 cases in men; 17,290 cases in women). During the same year, an estimated 49,920 people will die from rectal and colon cancers.1 Although colorectal cancer is ranked as the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States, mortality from colorectal cancer has decreased during the past 30 years. This decrease may be due to earlier diagnosis through screening and better treatment modalities. The recommendations in these clinical practice guidelines are classified as category 2A except where noted, meaning that there is uniform NCCN consensus, based on lower-level evidence (including...
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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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Metastatic Colon Cancer, Version 3.2013

Featured Updates to the NCCN Guidelines

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, Moon J. Fenton, Charles S. Fuchs, Jean L. Grem, Steven Hunt, Ahmed Kamel, Lucille A. Leong, Edward Lin, 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, Kristina M. Gregory and Deborah A. Freedman-Cass

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer begin with the clinical presentation of the patient to the primary care physician or gastroenterologist and address diagnosis, pathologic staging, surgical management, perioperative treatment, patient surveillance, management of recurrent and metastatic disease, and survivorship. The NCCN Colon Cancer Panel meets annually to review comments from reviewers within their institutions and to reevaluate and update their recommendations. In addition, the panel has interim conferences as new data necessitate. These NCCN Guidelines Insights summarize the NCCN Colon Cancer Panel's discussions surrounding metastatic colorectal cancer for the 2013 update of the guidelines. Importantly, changes were made to the continuum of care for patients with advanced or metastatic disease, including new drugs and an additional line of therapy.

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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, Moon J. Fenton, Charles S. Fuchs, Jean L. Grem, Steven Hunt, Ahmed Kamel, Lucille A. Leong, Edward Lin, 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, Kristina M. Gregory and Deborah A. Freedman-Cass

The NCCN Clinical Practice Guidelines in Oncology for Colon Cancer begin with the clinical presentation of the patient to the primary care physician or gastroenterologist and address diagnosis, pathologic staging, surgical management, perioperative treatment, patient surveillance, management of recurrent and metastatic disease, and survivorship. The NCCN Colon Cancer Panel meets annually to review comments from reviewers within their institutions and to reevaluate and update their recommendations. In addition, the panel has interim conferences as new data necessitate. These NCCN Guidelines Insights summarize the NCCN Colon Cancer Panel’s discussions regarding the treatment of localized disease for the 2013 update of the guidelines.