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Jeffrey A. Gilreath, Daniel S. Sageser, James A. Jorgenson and George M. Rodgers

Erythropoietic-stimulating agent (ESA) therapy has significantly impacted the management of chemotherapy-induced anemia (CIA) by decreasing the number of red blood cell transfusions required by patients with cancer. However, managing these patients with ESA therapy has become increasingly difficult since the release of the Centers for Medicare & Medicaid Services' new National Coverage Determination document because of the disparities between this document and recommendations from expert-reviewed national clinical guidelines on the treatment of anemia. This article describes a collaborative practice agreement between pharmacists and physicians as one approach to managing CIA in hematology-oncology patients in an anemia clinic. The goal of the pharmacist-managed anemia clinic is to improve patient satisfaction and clinical outcomes associated with the treatment of CIA. This article describes the rationale for the clinic and discusses its design and implementation in managing ESA, iron, folate, and vitamin B12 therapy for CIA in hematology-oncology patients. The pharmacist's role is justified in this clinic model through increased adherence to evidence-based practice guidelines and decreased costs associated with ESA therapy.

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Paul F. Engstrom, Mara G. Bloom, George Daniel Demetri, Phillip G. Febbo, William Goeckeler, Marc Ladanyi, Bryan Loy, Kate Murphy, Michael Nerenberg, Paul Papagni, Mark Robson, Robert W. Sweetman, Sean Tunis, Jessica DeMartino and Jonathan K. Larsen

Personalized medicine in oncology is maturing and evolving rapidly, and the use of molecular biomarkers in clinical decision-making is growing. This raises important issues regarding the safe, effective, and efficient deployment of molecular tests to guide appropriate care, specifically regarding laboratory-developed tests and companion diagnostics. In May 2011, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify challenges and provide guidance regarding molecular testing in oncology and its corresponding utility from clinical, scientific, and coverage policy standpoints. The NCCN Molecular Testing Work Group identified challenges surrounding molecular testing, including health care provider knowledge, determining clinical utility, coding and billing for molecular tests, maintaining clinical and analytic validity of molecular tests, efficient use of specimens, and building clinical evidence.

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Peter F. Coccia, Jessica Altman, Smita Bhatia, Scott C. Borinstein, Joseph Flynn, Suzanne George, Robert Goldsby, Robert Hayashi, Mary S. Huang, Rebecca H. Johnson, Lynda Kwon Beaupin, Michael P. Link, Kevin C. Oeffinger, Kathleen M. Orr, Alberto S. Pappo, Damon Reed, Holly L. Spraker, Deborah A. Thomas, Margaret von Mehren, Daniel S. Wechsler, Kimberly F. Whelan, Bradley J. Zebrack, Hema Sundar and Dorothy A. Shead

Cancer is the leading cause of death among the adolescent and young adult (AYA) population, excluding homicide, suicide, or unintentional injury. AYA patients should be managed by a multidisciplinary team of health care professionals who are well-versed in the specific developmental issues relevant to this patient population. The recommendations for age-appropriate care outlined in these NCCN Guidelines include psychosocial assessment, a discussion of infertility risks associated with treatment and options for fertility preservation, genetic and familial risk assessment for all patients after diagnosis, screening and monitoring of late effects in AYA cancer survivors after successful completion of therapy, and palliative care and end-of-life considerations for patients for whom curative therapy fails.

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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, David A. Mankoff, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Jasgit Sachdev, Mary Lou Smith, George Somlo, John H. Ward, Antonio C. Wolff and Richard Zellars

OverviewThese NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer are the work of the members of the NCCN Breast Cancer Panel. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the NCCN Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.NCCN.org.The American Cancer Society estimated that 209,060 new cases of invasive breast cancer were diagnosed and 40,230 people died of breast cancer in the United States in 2010.1 In addition, approximately 54,010 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death.The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment.The cause of most breast cancer cases is unknown. However, numerous risk factors for the disease have been established, including female gender, increasing patient age, family history of breast cancer at a young age, early menarche, late menopause, older age at first live birth, prolonged hormone replacement therapy, previous exposure to therapeutic chest...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Mohammad Jahanzeb, Krystyna Kiel, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Richard L. Theriault, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Breast 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.The Breast Cancer Clinical Practice Guidelines presented here are the work of the members of the NCCN Breast Cancer Clinical Practice Guidelines Panel. Categories of evidence were assessed and are noted on the algorithms and in the text. Although not explicitly stated at every decision point of the Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.nccn.org.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.OverviewThe American Cancer Society estimated that 184,450 new cases of invasive breast cancer would be diagnosed and 40,930 patients would die of the disease in the United States in 2008.1 In addition, approximately 67,770 women will be diagnosed with carcinoma in situ of the breast during the same...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

OverviewThe NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer: Noninvasive and Special Situations presented here are the work of the NCCN Breast Cancer panel members. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. These NCCN Guidelines focus on noninvasive breast cancer and special situations, such as Paget's disease, phyllodes tumor, breast cancer during pregnancy, and axillary breast cancer. Another NCCN guideline addresses invasive breast cancer (see NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines] for Breast Cancer: Invasive and Inflammatory; to view the complete and most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org).The American Cancer Society estimates that 194,280 new cases of invasive breast cancer were diagnosed and 40,610 died of the disease in the United States in 2009.1 In addition, approximately 62,280 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death.The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment.The origin of most breast cancer...
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James Mohler, Robert R. Bahnson, Barry Boston, J. Erik Busby, Anthony D'Amico, James A. Eastham, Charles A. Enke, Daniel George, Eric Mark Horwitz, Robert P. Huben, Philip Kantoff, Mark Kawachi, Michael Kuettel, Paul H. Lange, Gary MacVicar, Elizabeth R. Plimack, Julio M. Pow-Sang, Mack Roach III, Eric Rohren, Bruce J. Roth, Dennis C. Shrieve, Matthew R. Smith, Sandy Srinivas, Przemyslaw Twardowski and Patrick C. Walsh

In the late 1980s and early 1990s, the number of newly diagnosed prostate cancers in the United States increased dramatically, surpassing lung cancer as the most common cancer in men. 1 Experts generally believe that these changes resulted from prostate-specific antigen (PSA) screening that detected many early-stage prostate cancers. For example, the percentage of patients with low-risk disease has increased (45.3% in 1999–2001 vs. 29.8% in 1989–1992; P < .0001). 2 The incidence of prostate cancer increased 2.0% annually from 1995 to 2001 and has since declined. In 2009, an estimated 192,280 new cases were diagnosed and prostate cancer was expected to account for 25% of new cancer cases in men. 1 Fortunately, the age-adjusted death rates from prostate cancer have also declined (–4.1% annually from 1994 to 2001). 1 Researchers expect prostate cancer to account for 27,360 deaths in 2009. 1 This comparatively low death rate suggests that, unless prostate cancer is becoming biologically less aggressive, increased public awareness with earlier detection and treatment of prostate cancer has begun to affect mortality from this prevalent cancer. However, early detection and treatment of prostate cancers that do not threaten life expectancy cause unnecessary side effects that impair quality of life, increase health care expenses, and decrease the value of PSA and digital rectal examination (DRE) as early detection tests. 3,4 To properly identify and manage patients with prostate cancer or any other malignancy, physicians must have an in-depth understanding of the natural history and diagnostic, staging, and treatment options. To this end, every year the NCCN...
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William J. Gradishar, Benjamin O. Anderson, Sarah L. Blair, Harold J. Burstein, Amy Cyr, Anthony D. Elias, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, Daniel F. Hayes, Clifford A. Hudis, Steven J. Isakoff, Britt-Marie E. Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Robert S. Miller, Mark Pegram, Lori J. Pierce, Elizabeth C. Reed, Kilian E. Salerno, Lee S. Schwartzberg, Mary Lou Smith, Hatem Soliman, George Somlo, John H. Ward, Antonio C. Wolff, Richard Zellars, Dorothy A. Shead and Rashmi Kumar

Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The overall management of breast cancer includes the treatment of local disease with surgery, radiation therapy, or both, and the treatment of systemic disease with cytotoxic chemotherapy, endocrine therapy, biologic therapy, or combinations of these. The NCCN Guidelines specific to management of large clinical stage II and III tumors are discussed in this article. These guidelines are the work of the members of the NCCN Breast Cancer Panel. Expert medical clinical judgment is required to apply these guidelines in the context of an individual patient to provide optimal care. Although not stated at every decision point of the guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer.

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Peter F. Coccia, Alberto S. Pappo, Jessica Altman, Smita Bhatia, Scott C. Borinstein, Joseph Flynn, A. Lindsay Frazier, Suzanne George, Robert Goldsby, Robert Hayashi, Mary S. Huang, Rebecca H. Johnson, Lynda Kwon Beaupin, Michael P. Link, Kevin C. Oeffinger, Kathleen M. Orr, Damon Reed, Holly L. Spraker, Deborah A. Thomas, Margaret von Mehren, Daniel S. Wechsler, Kimberly F. Whelan, Brad Zebrack, Dorothy A. Shead and Hema Sundar

The NCCN Guidelines Insights on Adolescent and Young Adult (AYA) Oncology discuss the fertility and endocrine issues that are relevant to the management of AYA patients with cancer. Fertility preservation should be an essential part in the treatment of AYA patients with cancer. The NCCN Guidelines recommend discussion of fertility preservation and contraception before the start of treatment. Oophoropexy and embryo cryopreservation are the 2 established options for fertility preservation in women. Semen cryopreservation before the start of treatment is the most reliable and well-established method of preserving fertility in men. AYA women with cancer also have unique contraception needs, depending on the type of cancer, its treatment, and treatment-related complications. Management of cancer during pregnancy poses significant diagnostic and therapeutic challenges for both the patient and the physician. AYA women diagnosed with cancer during pregnancy require individualized treatment from a multidisciplinary team involving medical, surgical, radiation, and gynecologic oncologists; obstetricians; and perinatologists.

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Peter R. Carroll, J. Kellogg Parsons, Gerald Andriole, Robert R. Bahnson, Daniel A. Barocas, Erik P. Castle, William J. Catalona, Douglas M. Dahl, John W. Davis, Jonathan I. Epstein, Ruth B. Etzioni, Thomas Farrington, George P. Hemstreet III, Mark H. Kawachi, Paul H. Lange, Kevin R. Loughlin, William Lowrance, Paul Maroni, James Mohler, Todd M. Morgan, Robert B. Nadler, Michael Poch, Chuck Scales, Terrence M. Shaneyfelt, Marc C. Smaldone, Geoffrey Sonn, Preston Sprenke, Andrew J. Vickers, Robert Wake, Dorothy A. Shead and Deborah Freedman-Cass

Prostate cancer represents a spectrum of disease that ranges from nonaggressive, slow-growing disease that may not require treatment to aggressive, fast-growing disease that does. The NCCN Guidelines for Prostate Cancer Early Detection provide a set of sequential recommendations detailing a screening and evaluation strategy for maximizing the detection of prostate cancer that is potentially curable and that, if left undetected, represents a risk to the patient. The guidelines were developed for healthy men who have elected to participate in the early detection of prostate cancer, and they focus on minimizing unnecessary procedures and limiting the detection of indolent disease.