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Rodger J. Winn

One of the pitches often used by the purveyors of cancer nostrums is that they work by “boosting the immune system.”1 The gist of this rose-colored presentation usually rests on a simplistic view that this system is one-dimensional and can be turned on or off by the simple flip of a switch, a switch such as the product being hyped. To many patients facing advanced cancer such as melanoma, supplementing conventional treatment with complementary or alternative medicine (CAM) is a way to take an active role in managing their disease and to ward off feelings of hopelessness.2 Although the need is understandable, with CAM, as with any medical intervention, treatment should only be rendered after fully informed consent has been obtained. A fine augmentation to this informed consent process might well be Antoni Ribas' article in this issue, which updates the status of immunotherapy for melanoma. Although undoubtedly beyond a patient's basic comprehension, the article provides a perspective on what the “immune system” means and how numerous and complex the underlying processes are. As someone new to the terms, a patient would undoubtedly be overwhelmed by just contemplating the number of approaches discussed: cytokines (including IL-2, IL-7, IL-12, IL-18, IL-21, and sargramostim), immunocytokines, whole tumor vaccines, gene-modified cells, cloned tumor antigen-specific T cells, tumor antigen naked DNA vectors, antagonistic (CTLA4,CD152) and activating (CD 40, CD 137) antibodies, heat shock proteins, recombinant virus, dentritic cell vaccines, costimulatory molecule modulation, and Toll-like receptor ligands. But what becomes truly awe-inspiring is the basic...
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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

This issue's Guidelines focus on small cell and non-small cell lung cancer and bring up an important issue, both for physicians and patients: compliance and barriers to it. Among the major barriers to physician compliance with the recommendations made in a clinical practice guideline are 1) how much the recommendations upset normal practice routines and 2) whether they require new clinical skills.1 Both the non-small cell and small cell lung cancer guidelines in this issue call for counseling patients with these tumors about the need to stop smoking. Counterintuitively, some lung cancer patients will continue to smoke even after treatment for tobacco-related tumors.2 The pernicious effects of persistent use of this noxious substance, both in decreasing the efficacy of therapy3 and promoting second primary tumors,4 is well documented. The guidelines impel oncologists to include smoking cessation as part of routine management of these diseases. Physicians are often well aware of their power to promote healthy change, especially in the “moment of opportunity” afforded by a dread diagnosis. But do we make the most of the opportunity? Unfortunately, in the crush of explaining complex therapies, not to mention administering them, this effort may be somewhat perfunctory and therefore not optimized. Importantly, a recent study has shown that a brief intervention by an oncologist is effective in increasing smoking abstinence rates at 12 months for patients with lung and head and neck cancers.5 The task is not trivial. Extra time must be allotted (routine is upset) and new, structured interventions must be...
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Rodger J. Winn

Oncologists take great pride in basing practice on the evidence that comes from well-designed trials. Critical appraisal of clinical data requires a firm grounding in the precepts of sound investigational methodology and a basic understanding of the underlying statistical analyses that lead to the conclusions drawn from a study. This knowledge base is further refined at professional meetings that facilitate critical commentaries. Clinical practice guidelines with texts that explain why a particular study did or did not change practice recommendations are another valuable means of developing analytic skills. This issue works to further sharpen these analytic skills, for example with the assessment from Rosenbaum et al. of the complex data surrounding the management of a post-therapeutic rising PSA and Ryan and Small's discussion of the multiple issues surrounding the use of hormonal therapy, including monotherapy or combined blockade, continuous or intermittent schedules, and the timing and duration of therapy. Moving on to some of the other articles, additional analytic skills are also necessary: – A solid understanding of the tools of clinical epidemiology are called into play in the article by Naya and Okihara on complexed PSA. Although the average oncologist may be comfortable with the definitions of sensitivity and specificity, the full implications of the positive predictive value of a test may be less clear, and the significance of a receiver operator curve (ROC) may be even more nebulous. – The Prostate Guideline is one of the first NCCN pathways to use a predictive nomogram1 in determining algorithm pathways...
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Rodger J. Winn

One of the hallmarks of the oncology scientific community has been a general reluctance to sensationalize advances. Although the news media tends to blare forth with the breakthrough of the week, or even du jour, investigators reporting results usually cloak them with caution and almost always point to the need for further studies. This is not to say, however, that the oncology community is shrouded in a pall of pessimism. The willingness to treat these devastating diseases and provide compassionate support and hope, grounded in realistic expectations, has earned the specialty the (sometimes begrudging) admiration of non-oncology practitioners. And for many years, one of the precepts that enabled oncologists to provide honest succor to patients was the well-grounded belief that progress was being made, if slowly, in small but well-defined increments. Thus, the breathtaking change in pace we see now in understanding the underlying mechanisms of carcinogenesis and introducing innovative approaches to therapy based on this understanding that now confronts (blesses) the oncology world evokes almost a sense of disbelief. I would guess that, for the past decade, no clinician has left a major meeting thinking, “nothing really new is happening.” Multiple myeloma, highlighted in this issue, may well serve as the cover disease for this remarkable change of pace. When first published, the NCCN Multiple Myeloma Clinical Practice Guidelines rested squarely on standard alkylating agents and corticosteroid treatment or well-tested regimens such as VAD that had been the mainstay of treatment for more than 30 years. Since this initial...
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Rodger J. Winn

One of the major premises supporting the development of clinical practice guidelines is that they promote increased consistency in health care practices.1 A decrease in random variation in this care, we reason, will, in turn, lead to better patient outcomes, increased patient confidence and satisfaction, and more efficient use of resources.2 Is this premise correct? In a review of 59 non-cancer guidelines, Grimshaw and Russell3 reported that 55 led to a change in medical practice, and 9 of 11 showed an improvement in patient outcomes. In a review of oncology-related guideline studies, Smith and Hillner4 noted some evidence of the effect of guidelines and critical care pathways on decreasing costs, but pointed out the need for more data about other outcomes. In attempting to answer the question of whether oncology guidelines “work,” we can assess a multiplicity of end-points: • Have oncologists accepted the basic premise that guidelines are useful? • Are oncologists aware that guidelines exist, and do they access them? • Do the practice patterns of oncologists conform to standard guidelines recommendations? • Does the implementation of guidelines change oncology practice behavior? • Does the use of guidelines lead to better patient outcomes? Oncologist Acceptance of the Concept In line with other specialties,5 modern oncologists seem to acknowledge the utility of clinical practice guidelines. In a survey of Canadian oncologists,6 86% agreed with a statement that guidelines were a useful educational tool, and 83% believed they were a good source of advice, whereas only 4% of those surveyed...
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Rodger J. Winn

It is axiomatic that state-of-the art antineoplastic therapy calls for a multi-pronged strategy with an emphasis on integrating complementary and, hopefully, synergistic modalities. With the advent of more-precise molecular and genetic typing and the identification of responsive and resistant subgroups, this therapy is also becoming more customized; one size no longer fits all. The net result of this heterogeneous approach is a greater burden on the oncologist caregiver. The field has progressed far beyond the cookbook stage, when once we knew the tumor type, the treatment choice flowed somewhat automatically. What is not so readily apparent, however, is that this complexity of management decisions also extends to the use of supportive care agents. In the not too distant past, the practicing oncologist had only a limited repertoire of interventions to manage such incapacitating and even limiting events as intractable chemotherapy-induced vomiting, but today a much broader array of interventions is available. This array of treatment options, in turn, has led to the increasing need to characterize the clinical aspects of the syndromes, to apply individualized treatments. The science of emesis continues to evolve. Introduction of the 5-HT3 receptor inhibitors were a significant advance in managing the acute vomiting that follows closely after the administration of highly emetogenic agents, but control was certainly not complete. Two articles in this issue address the further refinements in the management of post-chemotherapy vomiting. Stoutenberg and Raftopoulos review the physiology and clinical effectiveness of a new class of antiemetic agents, the NK1 receptor antagonists, as...
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Rodger J. Winn

One of the cancer-related Healthy People 2010 goals is to decrease deaths from cancer of the cervix in the U.S. from 3/100,000 to 2/100,000. The basis for this goal is the tremendous impact of the Papanicolaou (Pap) test in reducing mortality from this once common and devastating cancer. Over the past 50 years, U.S. death rates have dropped by 75%, and the target is certainly possible if screening and appropriate follow-up can be extended to all women. Given the remarkable effectiveness of cervical screening in lowering mortality, we must still recognize that the Pap test is only moderately accurate. Fortunately, the long preinvasive phase of cervical cancer and the successful public health initiatives that foster regular follow-up examinations lead to repeated opportunities to discover the neoplasm when it is curable. The NCCN Cervical Screening Clinical Practice Guidelines in Oncology provide a valuable roadmap for ensuring that appropriate steps are taken when routine examination shows abnormalities. A third factor leading to success has been the concerted educational and quality assurance programs to minimize laboratory variation and error. Therefore, noting the two major advances in the science of cervical screening in the past several years is gratifying: the use liquid-based cytology (LBC) to process Pap specimens and the use of human papillomavirus (HPV) testing to help guide the interpretation abnormal tests. In his review of the extensive trials comparing conventional Pap and LBC preparations, Cox notes that the new modality appears to be more sensitive in finding both low- and high-grade squamous...
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Rodger J. Winn

The standard definition of clinical practice guidelines explicitly states their aim as “to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”.1 Over the past several years, the goal of allowing patients direct involvement in managing their health care has been pushed to the forefront, with the emphasis on shared decision-making2 and patient-centered care.3 The old paternalistic model of unassailable physician-directed recommendations is no longer a tenable approach.4 Patients are expected to understand the reasons for and consequences of the procedures they undergo and the care they receive to be able to decide between alternatives when available. Therefore, clinical practice guidelines, especially versions specifically designed for patient understanding, serve a valuable function in providing the information required for this informed decision-making.5 The implications of using guidelines recommendations as a vehicle for shared decision-making between caregiver and patient are both subtle and profound. If the guideline recommendations reflect only the judgments of a set of expert professionals, do they reflect the sum of the factors that should be considered in advancing those recommendations? Although the goal of any experts developing guidelines is to use the best available evidence in deriving recommendations, physicians recognize that the results of even high-powered clinical trials must be subjected to expert evaluation to ensure proper interpretation and that the results are congruent with other values and practical considerations.6 In the Ottawa Practice Guidelines Development Cycle, evidence-based recommendations derived by a panel of experts are sent to a broad range of practitioners for...
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Rodger J. Winn

This issue features a paper by Porter and Lange, “Controversies in the Surgical Management of Renal Cancer,” that highlights a major role for the oncology journal: examining the significant changes in treatment brought on by new technology. Taking on this task entails more than just describing the new procedure or device. To be of practical use to the clinician, the report must contain careful analysis of the multiple ramifications of introducing the new method or procedure. Radical nephrectomy has long been considered the appropriate management for renal cell cancer. Over recent years, increased use of partial nephrectomy and the introduction of laparoscopic techniques for performing radical nephrectomy have expanded the urologic oncologist's options. As one might suspect, the first consideration must be whether the new procedure is as good as the old in controlling the disease. In the case of the nephron-sparing procedure, observations in more than 2,600 patients indicate that for tumors less than 4 cm (and perhaps for tumors 4–7 cm), the control rates are the same as those achieved with the total organ excision. Similarly, multiple studies indicate that laparoscopic removal of the kidney achieves equivalent disease control to open approaches. If the cancer outcome is the same, how then should use of these new procedures be determined? In this instance, secondary outcomes become important. For partial nephrectomy, major postoperative morbidity is not increased despite the longer and more complex surgical procedure. What about the advantages? Studies suggest that overall renal function, as measured by creatinine levels,...