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Philip J. Saylor and Matthew R. Smith

Androgen deprivation therapy (ADT) plays a central role in the management of men with locally advanced, recurrent, and metastatic prostate cancer. Because most men diagnosed with prostate cancer will die of something other than their cancer, treatment-related adverse effects are highly relevant to their long-term health. Benefits of ADT in each clinical setting must be weighed against ADT-related adverse effects. ADT is detrimental to several metabolic end points and to bone health. ADT has been prospectively shown to cause decreased lean muscle mass, increased fat mass, weight gain, increased cholesterol and triglycerides, insulin resistance, and loss of bone mineral density. In population-based analyses it has been associated with an increased incidence of diabetes, clinical fractures, and cardiovascular disease. Data-driven recommendations for managing these adverse effects are needed. Currently the authors advocate the use of adapted practice guidelines developed to prevent diabetes, fractures, and coronary heart disease in the general population.

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Allan Lipton, Robert Uzzo, Robert J. Amato, Georgiana K. Ellis, Behrooz Hakimian, G. David Roodman and Matthew R. Smith

Cancer and its treatment can compromise bone health, leading to fracture, pain, loss of mobility, and hypercalcemia of malignancy. Bone metastasis occurs frequently in advanced prostate and breast cancers, and bony manifestations are commonplace in multiple myeloma. Osteoporosis and osteopenia may be consequences of androgen-deprivation therapy for prostate cancer, aromatase inhibition for breast cancer, or chemotherapy-induced ovarian failure. Osteoporotic bone loss and bone metastasis ultimately share a pathophysiologic pathway that stimulates bone resorption by increasing the formation and activity of osteoclasts. Important mediators of pathologic bone metabolism include substances produced by osteoblasts, such as RANKL, the receptor activator of nuclear factor kappa B ligand, which spurs osteoclast differentiation from myeloid cells. Available therapies are targeted to various steps in cascade of bone metastasis.

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Julie R. Gralow, J. Sybil Biermann, Azeez Farooki, Monica N. Fornier, Robert F. Gagel, Rashmi N. Kumar, Charles L. Shapiro, Andrew Shields, Matthew R. Smith, Sandy Srinivas and Catherine H. Van Poznak

Bone health and maintenance of bone integrity are important components of comprehensive cancer care in both early and late stages of disease. Risk factors for osteoporosis are increased in patients with cancer, including women with chemotherapy-induced ovarian failure, those treated with aromatase inhibitors for breast cancer, men receiving androgen-deprivation therapy for prostate cancer, and patients undergoing glucocorticoid therapy. The skeleton is a common site of metastatic cancer recurrence, and skeletal-related events are the cause of significant morbidity. The National Comprehensive Cancer Network (NCCN) convened a multidisciplinary task force on Bone Health in Cancer Care to discuss the progress made in identifying effective screening and therapeutic options for management of treatment-related bone loss; understanding the factors that result in bone metastases; managing skeletal metastases; and evolving strategies to reduce bone recurrences. This report summarizes presentations made at the meeting.

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Doreen A. Ezeife, Sunil Parimi, Ellen R. Cusano, Matthew K. Smith, Tony H. Truong, Soundouss Raissouni, Yongtao Lin, Jose G. Monzon, Haocheng Li, Vincent C. Tam and Patricia A. Tang

Background: Phase III trials in metastatic colorectal cancer (mCRC) have collectively led to progressive advancements in patient outcomes over the past decades. This study characterizes the evolution of mCRC phase III trials through assessing the value of cancer therapy, as measured by the ASCO Value Framework. Methods: Phase III trial results of systemic therapy for mCRC published between 1980 and 2015 were identified, and their outcome, statistical significance, journal impact factor, and citation by the 2016 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for CRC were recorded. For each trial, the net health benefit (NHB) score was calculated using the June 2015 (original) and May 2016 (revised) ASCO Value Framework: Advanced Disease. Results: There were 114 mCRC phase III trials eligible for calculation of the NHB score. Using the revised framework, the median NHB score was 4.6 (range, −30 to 43.5); 12% of trials received bonus points. Trials with statistically significant results had higher NHB scores compared with nonsignificant trials (median NHB score, 21.6 vs 2.9; P<.0001). Clinical trials cited in the NCCN Guidelines had higher NHB scores than those not cited (median score, 8.0 vs 0.3; P=.02). In multivariate linear regression analysis, the only significant predictor of high NHB score was statistically significant studies. Conclusions: The median NHB score for mCRC phase III trials was 4.6. Higher NHB scores are associated with statistically significant studies and are cited in the NCCN Guidelines, a surrogate for practice-changing trials. The 2016 ASCO Value Framework may not fully capture the benefits on an individual patient level.

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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.3,4To 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...