Originally published as JCO Early Release 10.1200/JCO.2004.07.139 on September 7 2004

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Cancer Prevention and the American Society of Clinical Oncology

The University of Texas M. D. Anderson Cancer Center, Houston, TX
University of Michigan, Ann Arbor, MI
Abbott Laboratories, Abbott Park, IL
Cancer Prevention and Research Foundation of America, Alexandria, VA
National Institutes of Health, Department of Health and Human Services, Bethesda, MD
Dana-Farber Cancer Institute, Boston, MA
National Cancer Institute, Department of Health and Human Services, Bethesda, MD
UCLA Schools of Medicine and Public Health, Los Angeles, CA
American Society of Clinical Oncology, Alexandria, VA

As cancer prevention has matured and deepened its role in the science and practice of oncology, the American Society of Clinical Oncology (ASCO) has strengthened its commitment to cancer prevention. After a year of intensive planning initiated by former ASCO President Dr Larry Norton, ASCO established its standing Cancer Prevention Committee (CAPC) in November 2002. The CAPC will develop cancer prevention as an emerging subdiscipline of oncology and a core component of ASCO's mission and 2004-2007 Strategic Plan. A recent mark of cancer prevention's increasing national prominence was the publication of the comprehensive Institute of Medicine report entitled "Fulfilling the Potential of Cancer Prevention and Early Detection." This report offers recommendations to "increase the rates of adoption, the reach, and the impact of evidence-based cancer prevention and early detection interventions." These recommendations are synonymous with the prevention interests of ASCO and the ASCO CAPC, which are highlighted in this article.

Working Definition of Cancer Prevention

Until recently, the practice of oncology has focused principally on intervening to slow or reverse cancer. Insights from molecular biology and molecular and population epidemiology justify interventions within a broadened definition of carcinogenesis that includes the continuum of events from the initial genetic or epigenetic "hit" to the terminal events. It is now recognized that cancer can be a preventable, late stage of the often lengthy disease continuum of carcinogenesis, which has reversible early, premalignant phases that provide further opportunities for intervention. This process involves mutations in key tumor-suppressor genes and/or oncogenes, epigenetic changes (via aberrations of DNA methylation), genetic instability, signal transduction defects, and clonal expansion, all contributing to the disruption of cellular function and loss of cellular differentiation. The invasive end stage of this process is an abnormal cellular clone that has a selective growth advantage due to the loss of many physiologic controls of proliferation, apoptosis (programmed cell death), hormonal homeostasis, motility, and vascular supply. A wave of new technology (eg, multiplex gene expression/protein arrays, laser-capture microdissection, high-resolution endoscopy, and molecular imaging) is rapidly refining the definition of carcinogenesis and transformation.

These important molecular advances coupled with others in our understanding of cancer susceptibility create opportunities for developing novel, multidisciplinary approaches for preventing cancer. Cancer management has grown to encompass new tools and concepts (ie, managing lesions at increasingly early stages) that will help shape the future role of oncologists in patient care. Oncologists have already gained substantial experience in randomized controlled trials designed to reduce the risk of primary and second primary tumors, such as the Cooperative Oncology Group–sponsored Breast Cancer Prevention Trial (BCPT) and Prostate Cancer Prevention Trial (PCPT), the Head and Neck and Lung Intergroup trials, and in treating or preventing premalignant conditions such as oral leukoplakia, prostatic intraepithelial neoplasia, and adenomatous polyps.

The ASCO CAPC has adopted the following working definition of cancer prevention: a reduction in the risk of developing clinically evident cancer, whether first or second primary cancer, or of developing intraepithelial neoplasia (IEN), a frequent cancer precursor. Inherent in this definition is the early detection and treatment of IEN. Earlier definitions included the classical terms "primary" prevention (intervention for relatively healthy individuals with no invasive cancer and an average risk for developing cancer), "secondary" prevention (intervention for patients determined by early detection to have asymptomatic, subclinical cancer), and "tertiary" prevention (symptom control, rehabilitation, or other issues in patients with clinical cancer). Because our understanding of risk and disease has evolved (and is evolving) from purely observational/epidemiologic (risk) and histopathologic (disease) models to more comprehensive models incorporating molecular data, the classical prevention terms may not be as helpful as they once were in defining this dynamic field. For example, these terms do not explicitly account for IEN patients and individuals at extremely high risk for germ-line mutations. The improved ability to identify individuals at a high risk of cancer justifies adding surgical and medical interventions to the less-invasive classical preventive interventions of dietary change, smoking cessation, and other lifestyle modifications.

Implications for Oncologic Disciplines

Cancer prevention spans a wide range of disciplines, including population, behavioral, and social sciences; diagnostics; and clinical therapeutics (chemoprevention, risk reduction). Therefore, diverse training and skills are required to fully address the spectrum of carcinogenesis and its control. ASCO members generally focus on cancer treatment or managing patients with established malignancy. The CAPC is committed to encouraging ASCO members to expand their clinical focus to include cancer prevention, or intervening before malignant transformation can occur.

Risk-based management is the process of determining the best cancer prevention approaches for specific cancer risks. Risk-based cancer prevention includes behavioral as well as surgical and systemic interventions in the individuals at increased or very high risk, such as tobacco cessation in smokers, prophylactic mastectomy in women with BRCA1 or BRCA2 germ-line mutations, and molecular-targeting agents in patients with aneuploid oral leukoplakia. These latter scenarios exemplify the convergence of prevention with therapy. Cross-sectionally and prospectively validated molecular alterations in neoplastic transformation can be used as (1) markers of cancer risk and susceptibility; (2) targets for developing novel preventive interventions; and (3) markers of intervention efficacy, including intermediate measures of response, that can help in identifying new cancer preventive agents.

Implications for ASCO

The formation of the CAPC reflects the importance ASCO has placed on the emerging field of cancer prevention. ASCO formalized its commitment to implementing a strong prevention agenda by incorporating cancer prevention into the 2004-2007 ASCO Strategic Plan (Table 1, goal 6 and accompanying objectives). With this encouragement and support from the Society leadership, the CAPC has developed the plans outlined below for integrating and promoting prevention science and practice into the programs and policies of ASCO.

Tools and interventions to identify and reduce environmental risk.
The CAPC will encourage methods to discover and reduce environmental exposures that initiate or accelerate carcinogenesis. Individual risk is based on interactions between inherited genetic risks and exogenous exposures (including diet and lifestyle factors). ASCO supports the development, testing, and implementation of clinical interventions that will reduce the risk of carcinogenesis in individuals and families at risk because of exposures to known or suspected carcinogens. High priorities include tobacco control, human nutrition (especially the control of obesity), and other preventable risk factors, such as ultraviolet radiation, infection, and environmental carcinogens, in certain populations.

Tools and interventions to identify and interrupt carcinogenesis defined by detectable clinical, molecular, and/or biochemical events in humans.
The CAPC will encourage efforts to discover and rigorously validate surrogate markers for cancer end points, as well as markers that detect relevant molecular events in morphologically normal cells, cells with germ line-genetic mutations, and clonally expanded cell masses that predict for increased risk of developing cancer. ASCO supports efforts to develop and implement clinical strategies targeting valid surrogate end points, potentially including IEN, for establishing the efficacy of biologically active and clinically sound combinations of behavioral, pharmacologic, nutritional, or nutraceutical interventions in preventing or delaying the onset of malignant transformation. ASCO also supports the development of innovative, well-designed clinical prevention trials with cancer end points such as the BCPT in high-risk individuals.

Support for health policy and regulation.
The CAPC will encourage efforts to apply the scientific data collected and analyzed from cancer-prevention and clinical-outcomes research to the development of policies and regulations for good health that will have an impact on all phases of the cancer continuum. For example, tobacco control will remain central to these efforts.

Cancer Prevention and Clinical Oncology: Refining Priorities

The CAPC advocates an integral role for cancer prevention in the science and practice of oncology and the activities of ASCO and its members. The Committee acknowledges that the challenge of reducing the incidence of cancer is complex and that solutions will require a diverse array of interventions, some of which, at present, are not within the scope of the clinical oncologist. Third-party reimbursement for these activities will be highly relevant to their success, and ASCO must play a leading role in facilitating the development of appropriate charge codes. Determining effectiveness will provide important support for the validity of prevention approaches for saving lives and improving quality of life.

Strategies and Tactics for Implementing the ASCO CAPC Agenda

The CAPC followed two overarching principles in developing its goals and priorities: (1) set an agenda that is highly relevant to the membership of the Society, who, primarily, are practicing oncologists; and (2) avoid duplicating well-managed efforts of other components of ASCO or the medical community at large. Toward these ends, the CAPC recently fielded a survey of the ASCO membership to help in refining our activities to meet the needs of members in the area of cancer prevention and control. The second principle of action has practical implications for the focus, strategies, and tactics of the Committee. For example, members of the CAPC agreed to carefully weigh the need to enter the already crowded arena of issuing or endorsing cancer-screening guidelines, a plethora of which, from numerous organizations, already exists. The CAPC determined that ASCO should avoid issuing new guidelines unless a compelling need for such is identified with respect to a specific organ site. The CAPC further determined that ASCO should focus on providing comprehensive assessments of existing cancer-screening guidelines, as well as other educational tools, that can help ASCO members to objectively weigh the validity of varying guidelines as they make screening recommendations to patients and their families.

The CAPC, therefore, will devote substantial energy to disseminating the evidence that supports effective prevention interventions in the clinical practice setting. It will also work toward earning recognition for the Society as a highly credible source of cancer prevention information. Success in this concentration of effort should lead to an enhanced ability to inform public policy in areas of the most relevance to Society members.

Education

The CAPC feels that prevention should be integrated more fully into the national Annual Meeting, thus enhancing the education of the ASCO membership about this relatively young discipline and its growing importance to scientific inquiry and clinical care. We propose strong representation of prevention on the Program Committee to develop prominent sessions on the science and practice of cancer prevention, such as sessions that address new prevention research results. Since there are limited, if any, resources available for the systematic education of medical students, postgraduate residents, oncology trainees, and practicing physicians in cancer prevention, curricular materials in this area are urgently needed. The target audiences/collaborators in the development of a curricular effort would include family and internal medicine physicians; specialists in all areas of oncology; and specialists in gynecology, gastroenterology, pulmonology, dermatology, and urology. An important function of this curriculum would be to educate physicians on how to judge the strength of evidence provided by the growing number of cancer prevention and early-detection studies and on integrating the definitive findings of such studies into standard practice. ASCO should take the lead in developing a prevention curriculum but should also invite the participation of other professional societies that could use the curriculum in their educational efforts. Practicing oncologists would benefit from learning about the nuances of conducting and analyzing prevention studies, which sometimes differ in important ways from classic cancer treatment studies. An important objective of ASCO, which should dovetail with the overall educational program outlined, is to work with the American Board of Internal Medicine to integrate cancer prevention material into the Board's examination.

Reimbursement

The CAPC recognizes that putting prevention into clinical practice can also be accelerated greatly by appropriate reimbursement models that support proven prevention interventions. Developing the evidence base and disseminating research results of prevention are unlikely to translate into daily practice if reimbursement patterns do not recognize the value of such interventions. In order that the cancer prevention agenda be effectively implemented, ASCO needs to engage the support of community hospital systems and third-party payors for giving appropriate populations (eg, minority and medically underserved populations) access to prevention and for financial coverage for these services. Influencing reimbursement patterns toward prevention is an important proposed collaboration between the CAPC and the ASCO Clinical Practice Committee (CPC). The CAPC recommends that the CPC have adequate representation by prevention scientists who would ensure consideration of the full spectrum of modern oncology practice during CPC deliberations. Furthermore, as national standards of quality of care are developed, ASCO and the CAPC, in concert with the CPC, will advocate that prevention interventions with strong evidence of benefit belong on an equal footing with therapy for consideration for reimbursement.

Conclusion

The CAPC and ASCO have embarked on a bold program of implementing the science and practice of cancer prevention as an emerging subdiscipline and core component of the Society's mission. Major components of this program are as follows: proactive commitment to cancer prevention; recognition of the expanding clinical application of the science of IEN; formalized initiatives to promote risk- and evidence-based prevention management in oncology practices; support for multidisciplinary prevention research.

Major objectives of the CAPC are to improve preventive interventions; to expand global efforts for tobacco control; to implement other preventive efforts, such as controlling obesity, UV radiation exposure, and (in relevant populations) cancer-causing infections (eg, hepatitis C and B, the latter controllable with a vaccine) and environmental carcinogens; and to advance the appropriate climate of reimbursement needed to accomplish these goals. ASCO also has an increasing role in working with the US Food and Drug Administration on regulatory issues involved with preventive drug development.

Cancer prevention science and practice are just beginning to gain public, academic, government and industry recognition as a major aspect of oncology. The prevention program outlined in this editorial signifies the hard work of ASCO in sustaining and increasing this acceptance.

Authors' Disclosures of Potential Conflicts of Interest

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Employment: Gary B. Gordon, Abbott Laboratories. Consultant/Advisory Role: Judy E. Garber, Pfizer. Stock Ownership: Gary B. Gordon, Pfizer. Honoraria: Judy E. Garber, Pfizer. For a detailed description of these categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration form and the "Disclosures of Potential Conflicts of Interest" section of Information for Contributors found in the front of every issue.

Acknowledgment

The authors gratefully acknowledge the invaluable insights and contributions of our ASCO Cancer Prevention Committee colleagues David S. Alberts, MD (Arizona Cancer Center), Monica M. Bertagnolli, MD (Brigham and Women's Hospital), Otis W. Brawley, MD (Emory University), Alan S. Coates, MD, FRACP, Astat (The Cancer Council of Australia), Leslie G. Ford, MD (National Cancer Institute), Arlene A. Forastiere, MD (The Sidney Kimmel Cancer Center, Johns Hopkins University), Karen Kelly, MD (University of Colorado Health Sciences Center), James L. Mulshine, MD (National Cancer Institute, Center for Cancer Research), Kenneth Offit, MD, MPH (Memorial Sloan-Kettering Cancer Center), Richard Pazdur, MD (Food and Drug Administration), and Robin Zon, MD (Michiana Hem Onc), and of Charles M. Balch, MD, Executive Vice President and CEO of the American Society of Clinical Oncology.

NOTES

These authors collaborated on this article as a Writing Committee of the ASCO Cancer Prevention Committee.

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