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Rodger J. Winn

The Myeloid Growth Factors guidelines in this month's issue are in some ways a paradigm for successful guidelines—guidelines that support clinical decision-making. The algorithm comes down to the level of actual administration, with specific thresholds for beginning, dosages, and stopping. This granularity is possible, of course, because of the extraordinary number of trials meticulously designed to answer specific drug-related questions. For example, Frankfurt and Tallman's article on using these agents in leukemia describes trials that have investigated not only the efficacy of these stimulating factors but also their potential deleterious effects. I'm reassured to learn from Lyman and Kleiner of the consistency found across 3 well-known guidelines for these agents. A major recommendation in all 3 guidelines is that growth factors be initiated for primary prophylaxis if the expected rate of febrile neutropenia is 20%. This new threshold varies considerably from the initial American Society of Clinical Oncology (ASCO) guidelines in 1994, which used a 40% threshold. The new mark is based on results from several randomized clinical trials and meta-analyses that confirm the efficacy of these agents in significantly diminishing the incidence of febrile neutropenia at this level. In what will likely become a major issue for guidelines developers in the future, economic considerations emerged in these discussions. Although NCCN and ASCO state that decisions were based on proven clinical benefit, both groups acknowledge the potentially large economic impact that using these agents may have—both their capacity to save in-hospital expenses and the financial burden they could impose if...
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Rodger J. Winn

Despite the increasing use of clinical practice guidelines to aid clinical decision-making, obstacles to the potential full use of guidelines still exist. Interestingly, 2 major barriers in the clinical context balance at opposite ends of the implementation spectrum. The first obstacle is clinical inertia1—the failure to intensify treatment to achieve optimal targets. An oft-cited example in oncology is the finding that a substantial number (30%) of patients across a broad spectrum of clinical practices receive therapy with a relative dose intensity less than 85%. Perhaps even more puzzling, more than half of the under-treated patients are started at doses below those established in clinical trials.2 Hopefully the judicious use of quality improvement methods, including system and computerized checks, can overcome some of this inertia. At the other end of the spectrum is what might be called the “My Big Fat Greek Wedding Windex phenomenon,” after the belief of one of the characters in that film that the cleaning product Windex could be used for almost everything. In oncology, the phenomenon suggests that once a modality is found useful in one situation, its use is indiscriminately disseminated to many other applications. Certainly, some of these applications are based on science, but others rest on more tenuous theoretic rationales. In light of this obstacle, I found it refreshing that Mayer et al., in their paper on use of the new agent lapatinib in breast cancer, strike a cautionary note. They propose that lapatinib be used in patient groups for whom its efficacy...
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Rodger J. Winn

It is easy to measure the loss of Dr. Christopher Desch by recounting his considerable accomplishments: the seminal studies in cancer-related health services research during his early years at the Medical College of Virginia, the clinical research programs he began in the Community Clinical Oncology Program (CCOP) and private practice venues, the leadership position he held in an exemplary oncology practice, the pre-eminent positions he held in ASCO. If I had to point to one achievement that epitomized his career, it would be the rural oncology program he initiated and still staffed, bringing expert oncologic care to all reaches of country-side Virginia. We at NCCN can especially single out the benefits we accrued from Chris's all-too-short tenure as medical director: launching a quality measure program, strengthening the guidelines process, and helping refine JNCCN itself. But, professional accomplishments aside, it is the man we miss and mourn. Chris, the man, brought to each of his endeavors a quality we see too infrequently in today's hard-edged, increasingly corporate world of oncology practice—zeal. And it was zeal committed to one principle, one goal: getting better care for cancer patients. Although his manner was soft-spoken and self-effacing, Chris' passion shone forth. He had an underlying steely determination to raise standards at all levels of care. His probing questions, often astonishing insights, and outside-the-box thinking forced discussions to higher levels. His remarkable people skills allowed him to simultaneously ruffle and smooth feathers, ultimately driving his colleagues to accept his principles and become co-aspirers. Quality of...
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Rodger J. Winn

This month's issue provides the journal reader with an elegant analysis of the clinical evidence substantiating the use of aromatase inhibitors (AIs) in the adjuvant treatment of breast cancer in postmenopausal women. Based on the data from 6 randomized studies, women may be treated with an AI alone, with 2 or 3 years of tamoxifen followed by an AI, or with 5 years of tamoxifen followed by another extended period of an AI. As this issue's special feature by Carlson et al. points out, the NCCN guidelines, the ASCO Technology Assessment, and the St Gallen consensus statement all recommend these 3 options. All 3 documents also state that existing data do not allow a choice among these approaches because they have not been compared head-to-head. In the broadest sense, all 3 panels agree that AIs offer a benefit, but the recommendations are not identical. The St Gallen recommendations also present a fourth option, the use of standard tamoxifen in patients at minimal or intermediate risk. The NCCN, in turn, does not recommend adjuvant treatment for very small lesions. As Baum and Ravdin1 previously observed, patients in the same clinical category could potentially be treated differently based on which clinical guideline their practitioner consulted. Why this disparity? Several differences in the guideline development process may account for it. The first and most obvious reason is that the panels can interpret data differently or attribute differing validity to the studies.2 This does not appear to be the case in this instance. A...
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Rodger J. Winn

Liver cancer occurs relatively infrequently in the United States. As Arciero and Sigurdson (in this issue) point out, only 18,000 cases are expected this year. The important fact to remember, though, is that, worldwide, hepatocellular cancer ranks as one of the most devastating tumors. In China, for instance, with its estimated 130 million cases of chronic heptatis B infection, more than 300,000 deaths occur a year from liver cancer. The reasons for this high prevalence worldwide are multiple, including hepatitis B and C virus infection, aflatoxins, and chemical exposures, so improvement in preventative rather than therapeutic measures may ultimately be the step that eradicates the morbidity and mortality from the disease. This month's article by Kulik explores the possible role of interferon-based therapy in halting the progression of hepatitis C disease to its malignant phase. Meanwhile, the asymmetric international distribution of liver cancers raises an interesting problem for guideline users—are the NCCN guidelines usable as they are promulgated or can they be modified to accommodate local practices and cultural preferences? This question was brought home vividly at an NCCN conference in India. The attendees pointed out that the NCCN cervix screening guideline recommendations based on PAP test findings are irrelevant in many local sites, because annual PAP testing would far exceed the economic resources of many villages. In addition, the cervix treatment guidelines were believed to be unnecessarily nuanced for early stage disease, which was not relevant there, because only stage 3 and 4 disease was seen in these settings...
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Rodger J. Winn

One of the strengths of clinical practice guidelines is their dynamic nature. Rather than representing absolute truths, they reflect the best evidence available when they are produced. Periodic review is, therefore, mandatory. Given the prodigious outpouring of new data in oncology, NCCN has determined that guidelines must be reviewed at least annually to remain valid, with interim modifications for important information emerging within the cycle. This pursuit of change is at the core of guidelines utility: to provide a basis for physician and patient decision-making, they must be as up-to-date as the data. For the most part, innovations—new technology advances, either in the diagnostic or therapeutic realms—lead to changes. Often these changes are incremental, such as replacing previously recommended adjuvant regimens with new combinations reported in well-conducted randomized trials. In some instances, new technologies can change the entire approach to a disease, as seen in how GIST tumors are managed now that responsiveness to imatinib mesylate and subsequent agents was demonstrated. In this case, GIST was separated from a group of sarcomas for which relatively similar care had been recommended. In this issue, Andersen et al. address the current management of lobular neoplasia of the breast. As they note, for the past 20 years, lobular carcinoma in situ (LCIS) was considered a risk marker for subsequent breast cancer but not a malignant lesion itself. The therapeutic implications of this idea were that no further treatment other than biopsy was required, even if margins were positive. What Anderson et al. elegantly...
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Rodger J. Winn

The March issue of JNCCN detailed moving from the “good to the perfect” in managing Hodgkin disease, one of the more treatable and curable cancers. The articles in this issue, such as the one by Das et al. (Combined modality therapy of localized gastric and esophageal cancer), vividly highlight the painstaking steps involved in making headway against some of the more resistant tumors, such as esophageal tumors. The encouraging news is that the oncology disciplines are coming together in their attack on the disease. Surgical, radiation, and medical oncology are collaborating in designing new strategies and are submitting these strategies to the scrutiny of laborious clinical trials. Progress, albeit slow, is being made. A major step appears to be confirmation that combined modality therapy can lead to pathological complete response, which appears to translate into a survival advantage. Thus, in a recent analysis, the 22% of patients undergoing chemoradiation who experienced complete response at esophagectomy had a 3-year survival rate of 64%, compared with 34% for patients with residual tumor.1 And yet, we are really just beginning. For example, as the Das et al. article points out, “Our inability to individualize therapy for localized upper gastrointestinal cancer patients remains a major setback.” Are types I, II, and III tumors of the gastroesophageal region the same or does each require a different approach? Do squamous and adenocarcinomas behave the same? Are the treatment strategies for stage II disease the same as should be used in stage IVa disease? Furthermore, each of...
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Rodger J. Winn

Although it is certainly true that each step in any NCCN algorithm must receive due consideration, sometimes it is the most obvious things that need restating, lest the eye skip over something that might, on superficial reading, appear perfunctory. A case in point is the carefully worded Genetics/Familial High Risk Assessment Clinical Practice Guideline. In keeping with the formula for NCCN supportive care guidelines, the algorithm proposes screening as the first step, followed by a detailed risk assessment if the screening result is positive. What must not be glossed over, however, is the important recommendation joining these clinical decision nodes: “Referral to cancer genetics professional recommended.” The geneticist is the health care professional who can perform the sophisticated pedigree analysis that determines whether genetic screening is warranted. If the patient decides to undergo testing, the geneticist's role becomes even more involved, with a mandate to “provide counseling, including psychosocial support and assessment, risk counseling, education, and discussion of genetic testing, and obtain informed consent.” This mandate is a far cry from a well-meaning but inadequately trained oncologist taking a cursory family history and ordering a blood test, the results of which might be delivered by a member of the office staff. Special attention should be given to the components of a meaningful informed consent. The American Society for Clinical Oncology Special Article on Genetic Testing for Cancer Susceptibility1 details 12 basic elements needed for truly informed consent for cancer susceptibility testing: information on the specific test; implications of a positive...
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Rodger J. Winn

For most of us, acquiring knowledge has been a fairly linear, unidirectional process—monolithic (and increasingly heavy) textbooks; graphically sophisticated, slide-supported lectures; journal articles multiplying logarithmically—we absorb and then apply. Certainly our patients have benefited from the avalanche of data and evidence that threatens to overwhelm us. Technology transfer is rapid, and thanks to the Internet and the post office, the results of carefully designed and meticulously implemented clinical trials are widely available and are easily accessed. Unfortunately, the slightly darker side of this process comes in the finding of health services researchers that education per se does not necessarily lead to the adoption of new standards and the “tell them you have built it and they will come” approach frequently does not attract players to the field. Fortunately, communications and education experts have stepped in and the new by-word in effective teaching has become “interactive.” Unlike the passive acquisition of information that we may be used to, interactive learning calls on us to inform educators of our needs, examine our deficiencies, receive an instant evaluation of our educational accomplishments, and provide feedback to our mentors so that they too can benefit from the process. The result is that new information is not only noted; it becomes incorporated into practice. The reason: Buy-in. The question then becomes: why a new journal? Is JNCCN bucking the future by delivering a paperbound, linear, unidirectional teaching tool—attractive and oncologically interesting but still a relic of an outdated approach? We hope not. In each issue...
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Rodger J. Winn and Joan McClure

Guidelines are becoming increasingly important as potential tools in improving clinical decision making. Because oncology practice encompasses a large number of tumors and their variants and because each tumor is characterized by heterogeneous presentations and clinical evolutions, an oncology guidelines program must be large in scope. Oncology practice is slowly moving toward evidence-based status, but guideline developers still must rely on less than perfect information to achieve this scope. By formalizing the consensus process, the NCCN program relies on the expertise of a broad range of cancer specialists to interpret the major clinical studies and apply their evaluative skills in assessing the relevance of these studies to clinical practice. In areas in which data are meager or contradictory, these experts are still charged with making recommendations if they believe their collective clinical experience points to a reasonable approach to disease management. It follows, therefore, that guidelines represent one of the most dynamic areas in medicine. The annual review process is designed to incorporate change as new evidence or innovative therapies become available. Therefore, the guidelines should be a true reflection of the state-of-the-art in oncology. The ultimate goal, as always, is improving care for the cancer patient.