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Harold J. Burstein

Trend-spotters looking back at 2010 have noted it as a year of lament over clinical trials in the United States, particularly in oncology. A widely cited Institute of Medicine report1 called for reinvigorating cooperative groups. Documenting need for reform, a study of the activation of phase III clinical trials in the NCI system revealed over 750 separate steps, 36 approval stages, and median 2.5 years to activation.2 Clearly, that process will not encourage investigators, clinical cancer centers, or pharmaceutical or other sponsors to engage more actively in clinical research. Moving into 2011, plans are afoot for a dramatic overhaul and consolidation of the cooperative groups. In addition, gains in accrual to European-based clinical trials have been well publicized. Reports suggest superior accrual in Europe to clinical trials in lymphoma and stem cell therapies. On a population basis, European oncologists have been accruing better to clinical trials than have American oncologists. Reports at the 2010 San Antonio Breast Cancer Symposium brought home the power of that improved accrual. The major results were dominated by out-of-U.S. clinical trials. A series of large, provocative, biologically-based neoadjuvant studies (neoALTTO, neoSPHERE, GeparQuinto) were presented on behalf of European investigators. The negative AZURE study originated in the United Kingdom, and the negative MA27 study, which included the U.S. Intergroup, originated in NCI-Canada. Texas hosted a triumph for out-of-U.S. oncology. Part of the problem is an overly burdened study approval process in the United States. A recent study compared lung cancer clinical trial activation and accrual at...
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Harold J. Burstein

“There is no greater threat to the integrity of the clinical research enterprise than the appearance or reality of a conflict of interest—be it financial, academic, or scientific.”1 This is from the American Society for Clinical Oncology (ASCO) guideline on oversight of clinical research, and it would seem to apply also for the NCCN guidelines, which are created by experts from leading academic oncology centers and built on results of research and clinical judgment. Public scrutiny of conflict of interest in medicine is at an all-time high, fueled by expanding concerns over relationships between industry and physicians and ignited by reports of abuses. Ethicists note that conflict of interest rules are designed to maintain the “integrity of professional judgment” and to “minimize conditions” that would cause others to question that judgment.2 Rules center on disclosing, managing, and, when necessary, prohibiting conflicts. Yet research studies have shown tremendously variable practices, including how conflicts are classified and reported, monetary values permitted, and the management of potential conflicts.3,4 Greater transparency in conflict of interest management is important. In response to these evolving concerns, NCCN recently revised its conflict of interest practices (http://www.nccn. org/about/disclosure.asp). Instead of reporting the entire panel membership conflicts as an aggregate statement, NCCN has begun reporting individual disclosures for each panel member. Other oncology organizations, such as ASCO, are also revising conflict of interest policies for individuals on guideline committees. Furthermore, these steps are only part of a growing roster of probable changes in how potential conflicts are reported and...
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Harold J. Burstein

An October op-ed piece in The New York Times (http://www.nytimes.com/2009/10/10/opinion/10DeVries.html?_r=1&scp=1&sq=mammologist&st=cse) introduced a new term into the medical lexicon: Mammologist. This title refers to a multidisciplinary breast cancer specialist who would serve as a facilitator specifically for patients with newly diagnosed breast cancer. The concept proposed was timely, with October marking Breast Cancer Awareness Month, although the goal of a mammologist—to ease patients through the steps of cancer care by being involved in every step of their treatment—is very similar to that of patient navigators. The idea of a patient navigator is gaining currency at cancer centers around the country. Its rationale is based on recognition of the complicated layers cancer patients must negotiate from diagnosis through treatment and follow-up. Consider a “typical” woman with newly diagnosed breast cancer. She may already be under the care of a primary care physician and a gynecologist. She is sent for routine screening mammography and is told by the radiologist that she needs a biopsy based on the findings. Based on the biopsy results, she is referred to a breast surgeon and may also need to see a plastic surgeon, radiation oncologist, and medical oncologist. That's 7 doctors before even she gets to a second opinion! Anyone who has tried to negotiate the current health care system knows how vexing it can be. Care at a comprehensive center—where radiology, surgery, and oncology specialists all reside under one roof and may even work through one scheduling office—can minimize some of the hurdles. But many patients...
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Harold J. Burstein

In April, the National Academy of Science published its report, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program” (available at: www.nap.edu). The document is required reading for those interested in clinical trials in oncology, but the findings will not surprise those who have participated in cooperative groups trials. The groups deserve great credit for important clinical advances, conducting phase III trials that often define standards of care. At the same time, the processes that govern current development and administration of studies are too complicated and too slow, as well as highly inefficient and woefully underfunded. Some sobering statistics: • Only 60% of NCI-funded cooperative group trials reach their accrual goal; • The accrual of 25,000 patients per year requires the involvement of 3100 treating institutions, suggesting an average accrual of 8 patients per site per year; • The vast majority of patients at all cancer clinics are not treated on studies; • Funding for the cooperative groups in general has been stagnant for the past decade; • Per capita funding for cooperative group trials both lags industry-supported trials and is considered sufficient to cover only one third to one half of the costs of participating in a clinical study; • The slow development and accrual to studies limits the scientific value of many trials. The report calls for both intellectual and administrative changes to the cooperative groups process. It identifies goals of enhancing the speed and efficiency of trial development; identifying innovative science and trial designs; improving the...
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Harold J. Burstein

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Harold J. Burstein

JNCCN – The Journal of the National Comprehensive Cancer Network is committed to publishing the world's most authoritative and comprehensive cancer treatment guidelines, the NCCN Clinical Practice Guidelines in Oncology. These invaluable, evolving, state-of-the-art documents articulate best known treatment based on evidence from the literature and collected wisdom of experts. To enhance its value, JNCCN also publishes timely reviews and commentaries that expand on important themes or emerging practices. However, guidelines are not the end of determining quality health care. How are guidelines interpreted and applied? What trends emerge? To what extent should and do cost considerations affect both recommendations and treatments? What important benchmarks should define our best practices? In a vast and varied world, what can different cultures and perspectives teach us about optimal care? How can societies with fewer resources access appropriate innovations, and what lessons can we learn from medical care in places without the resources available here? Although these questions are not unique to cancer care, they are particularly important in oncology. Cancer is a global health burden and a growing problem. Cancer care is also a high stakes game—the pairing of lethal disease and toxic treatment demands high-quality decisions executed correctly. Cancer treatments are expensive, and cancer care is complicated. For all these reasons, JNCCN is issuing a call for papers on excellence in cancer care, from both academic and community perspectives. We are particularly seeking original research and insightful commentary on the best ways to use resources and improve outcomes for patients. Examples of...
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Harold J. Burstein

Friday, 4:36 pm—ASCO is huge. Nearly official estimates can be found in a weekly newsletter, Farecast, distributed to taxi drivers in Orlando, which estimates 30,000 ASCO attendees at the Orange County Convention Center. That seems large, but perspective is also important: next week is a beauty products show for which they expect 41,000 attendees. Apparently, that crowd is more likely to use cabs. Saturday, 9:36 am—Major changes reflect global trends. First, exhibitors no longer hand out “freebies”: no more pens, note pads, key chains, squishy balls, calendars, paper dispensers, or pocket flashlights with company logos. The absence of the usual enormous, brightly colored tote bags changes the complexion of the whole crowd. Mercifully, one can still get a slug of espresso and a small cup of frozen yogurt, gratis. Second, the fear of swine flu has prompted a new must-have accessory: small bottles of hand sanitizer, free for the taking from big tubs in the registration hall. Saturday, 5:49 pm—As day 2 comes to an end, the chattering masses are exhilarating, in part because of the large international contingent. Oncology is truly a worldwide enterprise, and doctors, researchers, and pharmaceutical representatives are here from all over the globe. The reach of meetings like this is exciting. New findings will radiate out, and I realize that patients all over the world might have their treatments, and thus their lives, affected by what is presented here. Sunday, 11:02 am—I visit the booth of Cold Spring Publishing, JNCCN's new publisher, where computers are...
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Harold J. Burstein

In November 2008, the journal Nature published 2 extraordinary articles revealing the potential utility for genomics. Each contribution was a gargantuan task and technical tour de force. One article described the reconstruction of the woolly mammoth genome, using ancient DNA salvaged from the hair of an extinct mammoth frozen in permafrost for over 100,000 years. The other described the first complete sequencing of a cancer cell—a cytogenetically “normal” acute leukemia cell. Each of these contributions was reported on by major media outlets, and these reports led to grandiose, futuristic predictions of what to make of this vast if repetitive genetic information. In the case of the mammoth, the frequently voiced hope was that the DNA sequence could lead to regeneration of a living woolly mammoth—presumably for research purposes and not to serve as the ultimate fur coat. For the cancer cell, the hope was that the full coding DNA sequence of the malignant cell could tell clinicians how to uniquely treat each patient with cancer. For now, both those dreams are science fiction, but the latter scheme seems far more approachable than the former. In probing more than 2.5 million single nucleotide variants, investigators found more than 97% concordance with the “normal” genome of the same individual, based on sequencing DNA from healthy skin. In fact, leukemic cells had acquired mutations in only 10 named genes across the human genome, a new standard for needle-in-the-haystack searches. Intriguingly, 2 of the mutated genes were FLT3 and NPM1, loci implicated in previous...
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Harold J. Burstein

This year marks the sixth volume of JNCCN—The Journal of the National Comprehensive Cancer Network. What began as a quarterly publication has expanded to 10 issues per year with multiple additional supplements, with a subscription base of more than 20,000 oncologists and other health care practitioners per issue. JNCCN has been accepted for indexing in PubMed/MEDLINE since 2005, making the NCCN guidelines and original articles published in it available worldwide in the leading databases of medical research. I am honored to serve as the next editor-in-chief of JNCCN. The NCCN includes 21 of the leading cancer centers in the United States, bringing together the multidisciplinary expertise of all types of cancer specialists. The “jewels in the crown” are the NCCN Clinical Practice Guidelines in Oncology, the most comprehensive, up-to-date guides for managing cancers of all types. These guidelines are authored by panels composed of experts from all cancer-related disciplines—pathologists, radiologists, surgeons, medical oncologists, radiation oncologists, cancer survivors, and other clinicians focused on cancer care and prevention. The breadth, depth, and timeliness of the NCCN guidelines, along with their origin from the outstanding cancer clinics in this country, give them unique authority in defining treatment standards. JNCCN is committed to publishing these essential and scholarly cancer care documents and seeks additionally to create “value added” for the reader interested in understanding the evolving nature of cancer treatment. In the issues to come, we hope to expand the commentary that accompanies the guidelines, highlighting areas of disagreement or controversy or pointing to...