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Harold J. Burstein

NCCN guidelines are notable for their comprehensive, maybe even exhaustive, nature. The goal of the guidelines is to create a template for most conceivable common clinical circumstances. Some nodal points in the guidelines are supported by high-quality evidence from randomized clinical trials. Others are supported by lesser data, expert opinion, or, in certain instances, the best guess of clinical experts. A great strength of the guidelines is that they patch together these decision points; those reinforced by strong ropes of data and those held by more tenuous lines of judgment. Such thoroughness is very useful in clinical practice, both in high-volume clinical situations in which clinicians are often quite experienced, and arguably even more so in low-volume clinical circumstances, that are often unfamiliar to practicing oncologists, who refer to guidelines for real guidance. This thoroughness creates somewhat of an illusion, however, that NCCN guidelines panel members always know the right thing to do next, that little uncertainty exists, or that things couldn't be done better. This is rarely the case in oncology, of course, which is why clinical trials are needed. NCCN guidelines always recommend consideration of clinical trials. In fact, the introduction to all the disease-based guidelines states: The NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Although these sentiments are widely accepted throughout the NCCN and larger oncology community, participation rates in clinical trials remain dismal. In the United States, fewer than 5% of...
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Harold J. Burstein

The most important recent publication on health care in the United States can be found in the June 1 The New Yorker magazine, in an article by Dr. Atul Gawande of Brigham & Women's Hospital (available at: http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande?yrail). Dr. Gawande spoke with locals about health care in McAllen, Texas—a town notable for spending more per capita on health care than the average resident earns in a year. He made a quick diagnosis: health care costs are high in McAllen because of the most expensive piece of medical equipment—the doctor's pen! That is, expenses are high because clinicians order and deliver a lot of health care services, many of which may not be needed. The result is not necessarily better health but simply higher costs. The White House is reportedly paying close attention to Dr. Gawande's article as the administration embarks on health care reform. Doctors may have several reasons for over-ordering medical services, including insecurity in medical judgment, misunderstanding proper care algorithms, patient demand, the desire to “do right” by patients, excess supply of available medical services, and personal financial gain. In light of this article, data in the paper by Foster et al. in this issue of JNCCN (page 712) are illuminating. The authors created a series of hypothetical case management questions and asked oncologists to state the next treatment or evaluation. The study reports that oncologists often made guideline-consistent choices but also suggests that these same oncologists frequently order unnecessary tests (such as staging PET, chest imaging, and...
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Harold J. Burstein

If you read articles about hereditary cancer syndromes, biological markers that predict risk and benefit from targeted therapies, optimizing adjuvant chemotherapy regimens, risk stratification based on tumor biology and stage considerations, emerging molecular diagnostic tests, and quality of life in cancer survivors, you would be forgiven for thinking that they are about breast cancer. So welcome to the new breast cancer: colon cancer. This issue of the Journal of the National Comprehensive Cancer Network highlights many of the new trends in colorectal cancer management. These trends epitomize the kind of changes that have redefined care in breast cancer and that are now being extended into other major tumor types. Heterogeneity that is a familiar part of the treatment dialogue in lymphoma and breast cancer is now also seen in colon cancer, promising a new wave of refinements in pathology, treatment selection, and tailored therapies. These are welcome changes. Colorectal cancer accounts for the second largest toll of cancer deaths in the United States, after lung cancer and before breast and prostate cancers. Recent years have shown real progress with the availability of new chemotherapy agents and biologically targeted drugs that seem to improve outcomes in both advanced and early stage disease. Insights into molecular subtypes of colon cancer may determine both risk and treatment. What can experts in colon cancer learn from breast cancer? First, guidelines may need to be restructured to accommodate various colon cancer subsets and provide recommendations for each tumor type, first in the metastatic, and eventually...
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Harold J. Burstein

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Harold J. Burstein

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Harold J. Burstein

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Harold J. Burstein

Although the calendar said “summer” and baseball season was in high gear, July seemed to be an early fall for Avastin in breast cancer. The Oncology Drugs Advisory Committee (ODAC) of the FDA voted 12 to 1 that the AVADO and RIBBON1 trials did not provide confirmatory evidence supporting the original ECOG 2100 study that had led to accelerated approval of bevacizumab in combination with paclitaxel for advanced breast cancer. The FDA will decide in September whether to withdraw the label for the agent. A previous ODAC vote, in 2007, was 5 to 4 against approval, a recommendation not honored in the subsequent FDA decision.To date, there have been no fewer than 5 randomized clinical trials of chemotherapy with or without bevacizumab. Of these, the first (capecitabine ± bevacizumab) showed no difference in progression-free survival (PFS). The second (ECOG 2100; paclitaxel ± bevacizumab) showed major improvement in PFS. The next 3 trials—all placebo-controlled—showed changes in PFS that were, though all statistically significant, arguably not clinically compelling, with improvements in PFS of 2 to 3 months. None of these studies, nor a meta-analysis, suggests a survival advantage for adding bevacizumab in advanced breast cancer.These results leave more questions than answers. The second most common, after the question of bevacizumab itself, is, “what should be the end points for oncology drug approval?” The FDA has offered guidance for clinical trial end points and approval of cancer drugs (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf). A variety of end points can lead to approval, including...