Practice Guidelines

American Urological Association Issues Guidelines on the Management of Bladder Cancer
Sharon Scott Morey

The American Urological Association (AUA) has issued guidelines for the management of nonmuscle invasive bladder cancer (Stages Ta, T1 and TIS). Developed by the AUA Bladder Cancer Clinical Guidelines Panel, the recommendations are based on outcomes data from randomized controlled trials and on expert opinion. The summary of the AUA report is published in the November 1999 issue of the Journal of Urology. The complete report can be obtained from the Guideline Division, American Urological Association, 1120 N. Charles St., Baltimore, MD 21201; telephone requests: 410-223-4367; fax requests: 410-223-4375.

The AUA Bladder Cancer Clinical Guidelines Panel analyzed 181 articles, published from 1966 to 1998, to collect data on the benefits and adverse effects of treatment and to derive estimates of the probability of tumor recurrence, tumor progression and complications of treatment. The results of transurethral resection of the bladder tumor alone were compared with those of resection plus adjuvant intravesical therapy with thiopeta, bacillus Calmette-Guérin (BCG), mitomycin C or doxorubicin.

According to the guidelines panel, the most important finding of the meta-analysis is that the use of intravesical agents after surgery lowers the probability of tumor recurrence but not the probability of tumor progression. This finding underscores the need for careful follow-up for the development of muscle invasive cancer.

With respect to the adverse effects of treatment, data revealed that the most common adverse outcomes of treatment are bladder symptoms. The most frequent immediate symptoms are dysuria, frequency and nocturia, urgency, pain and cramping, and passing of debris in the urine. Long-term adverse outcomes include bladder contracture.

Categories for the Recommendations

The AUA bladder cancer guidelines panel graded the treatment recommendations according to levels of flexibility as determined by the strength of evidence and the expected amount of variation in patient preferences. The recommendations are classified in three categories: a "standard," a "guideline" and an "option." A standard has the least flexibility, a guideline has significantly more flexibility, and an option is the most flexible of the recommendations. In the AUA guidelines, a policy is considered a standard if the outcomes of the alternative interventions are sufficiently well known to permit decisions and if there is unanimity about the preferred intervention. A policy is considered a guideline if the outcomes of the interventions are sufficiently well known to permit decisions and if there is appreciable but not unanimous agreement about the preferred intervention. A policy is considered an option if the outcomes of the interventions are not sufficiently well known to permit decisions, if preferences among the outcomes are not known and if patients' preferences are divided among the alternative interventions or patients are indifferent about alternative interventions.

Recognizing the differences in decisions that would be made according to the clinical setting, the guidelines panel developed recommendations for three clinical settings: (1) patients with an abnormal growth on the urothelium that has not yet been diagnosed as bladder cancer; (2) patients with bladder cancer of any grade, of stage Ta or T1, with or without carcinoma in situ, who have not received intravesical therapy; and (3) patients with carcinoma in situ or high-grade T1 cancer who have received at least one course of intravesical therapy.

Recommendations for All Patients

A discussion of the benefits and side effects of intravesical therapy is defined as a standard policy for all patients. The panel found that there is little information to define the optimal dose of adjuvant therapy, the number and timing of instillations and the influence of long-term maintenance therapy. Randomized studies that support the use of maintenance BCG therapy have been performed but they were excluded from analysis because the results are reported only in abstract form. Other trials also appear to support the role of maintenance therapy.

Undiagnosed Bladder Tumor

The recommendations state that the standard policy in patients presenting with a bladder tumor is the need to obtain a histologic diagnosis of the tumor. The report notes that intravesical therapy should not be used in the absence of a histologic diagnosis.

Stage Ta or T1 Cancer and No Prior Intravesical Therapy

Surgical Eradication. Complete surgical eradication of all visible tumors, if this is feasible, is the standard policy in patients with stage Ta or T1 bladder cancer of any grade not previously treated with intravesical therapy.

The method used to surgically eradicate the tumor is classified as an optional policy, with electrocautery resection, fulguration or laser ablation cited as optional methods. This recommendation is based on the panel's expert opinion.

Adjuvant Intravesical Therapy. An option in patients with low-grade Ta bladder cancer is the use of adjuvant intravesical chemotherapy or immunotherapy after endoscopic removal of the lesion. The panel states that a recommendation for adjuvant therapy stronger than an option for patients with bladder cancer of any grade, stage Ta or T1, with or without carcinoma in situ, cannot be supported on the basis of outcomes data. The panel found that outcomes data for patients with low-grade Ta cancer are difficult to obtain because most studies have combined patients with low-grade stage Ta tumors and patients with stage T1 bladder cancer and higher grade cancers.

The panel's expert opinion is that many patients with low-grade Ta tumors do not require adjuvant intravesical therapy. According to the recommendations, the risk of disease progression is low (less than 10 percent) in this group, and there is little evidence that adjuvant therapy affects disease progression.

In patients with carcinoma in situ or T1 or high-grade Ta tumors, the panel recommends as a guideline the use of intravesical instillation of BCG or mitomycin C. On the basis of the medical literature and the panel's opinion, BCG and mitomycin C are superior to doxorubicin or thiotepa for reducing recurrence of these tumors.

Cystectomy. Categorized as an optional policy, based on the panel's expert opinion, is the use of cystectomy as initial therapy in some patients with carcinoma in situ or T1 tumors. The recommendations explain that cystectomy is deemed to be an option because of the risk of progression to muscle invasive disease even after intravesical therapy. An increased risk of disease progression is associated with large tumor, high-grade tumor, location of the tumor at a site that is poorly accessible to complete resection, diffuse disease, infiltration of lymphatic or vascular spaces and prostatic urethral involvement.

Carcinoma in Situ or High-Grade T1 Cancer and Prior Intravesical Therapy

Cystectomy. Cystectomy is classified as an optional policy in patients with carcinoma in situ or high-grade T1 bladder cancer that has persisted or recurred after initial intravesical treatment. This recommendation is based on the panel's expert opinion rather than evidence from outcomes data. The recommendations note that data show a substantial risk of progression to muscle invasive cancer in patients with diffuse carcinoma in situ and high-grade T1 tumors. It is not known whether intravesical therapy alters this risk. As a result, the recommendations state, some patients with symptomatic disease or high-grade tumors may prefer to undergo cystectomy.

Intravesical Therapy. The recommendations state that additional intravesical therapy may be considered an option for patients with carcinoma in situ or high-grade T1 cancers that have persisted or recurred after initial intravesical therapy. This recommendation is based on the panel's expert opinion. While optimal dosing regimens have not been established, the recommendations state that six weekly instillations are used most often.

Recommendations for Future Research

The AUA guidelines panel notes that substratification of stage T1 bladder cancer based on depth of infiltration needs further clarification. Also, the risk and significance of urothelial carcinoma outside the bladder must be further determined. The report notes that the risk of urothelial cancer in the ureter or intrarenal collecting system in patients with carcinoma in situ may exceed the generally accepted rate of 5 percent. Another area that needs further elucidation is the role of treatment regimens using alternating or combined medications. In addition, the report states that randomized studies are needed to investigate the effects of early instillation of medications, sometimes immediately after transurethral resection of the bladder tumor.

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Surgeon General Releases Mental Health Report
Monica Preboth

The surgeon general of the Department of Health and Human Services, U.S. Public Health Service, has issued the first report on mental health and mental illness. The report takes a lifespan approach to its consideration of mental health and mental illness by discussing in detail the periods of childhood, adolescence, adulthood and later life.

In this report, the coverage of mental health and mental illness is comprehensive but not exhaustive. While the report considers mental health facets of some conditions that are not always associated with the mental disorders, it does not consider all conditions that are found in classifications of mental disorders such as the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV).

Mental Health: A Report of the Surgeon General (ISBN 0-16-050300-0) is available from the U.S. Government Printing Office, Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328.

Purpose of the Report

The purpose of the report is to convey several messages. First, mental health is fundamental to health. According to the report, Americans view the prevention of disease and promotion of personal well-being and public health as high-priority issues; the surgeon general stresses that we must also assign high priority to the promotion of mental health and the prevention of mental disorders. The second message of the report is that mental disorders are real health conditions that have a tremendous impact on persons and families throughout the world.

Definitions

The report defines the term "mental health" as: "the successful performance of mental function, resulting in productive activities, fulfilling relationships with other people, and the ability to adapt to change and to cope with adversity; from early childhood until late life, mental health is the springboard of thinking and communication skills, learning, emotional growth, resilience and self-esteem."

The report defines "mental illness" as: "the term that refers collectively to all mental disorders. Mental disorders are health conditions that are characterized by alterations in thinking, mood or behavior (or some combination thereof) associated with distress and/or impaired functioning."

Research Methods

The body of the report summarizes an extensive review of the scientific literature and consultations with mental health care professionals and consumers. More than 3,000 research articles and other materials, including first-person accounts from persons who have experienced mental disorders, were examined. The review of the research revealed two main findings: (1) the efficacy of mental health treatments is well documented and (2) a range of treatments exists for most mental disorders. Based on the strength of these findings, the main recommendation of the report is "to seek help if you have a mental health problem or think you have symptoms of a mental disorder."

Scope of the Report and General Conclusions

The surgeon general's report is divided into eight chapters. The following is a summary of each chapter and the surgeon general's recommendations:

Chapter One: Introduction and Themes. This chapter gives an introduction to the report and lists the key conclusions drawn from each of the succeeding chapters.

Chapter Two: The Fundamentals of Mental Health and Mental Illness. Chapter two discusses several defining trends in the mental health field during the past 25 years. These include the following:

• The impressive pace and productivity of scientific research on human behavior and the brain.
• The introduction of a range of effective treatments for most mental disorders.
• The transformation of society's approaches to the organization and financing of mental health care.
• The emergence of powerful consumer and family movements.

This chapter was written to provide background information to help persons outside the field of mental health to better understand this report.

Chapter Three: Children and Mental Health. According to chapter three, childhood is characterized by periods of transition, making it necessary to assess the mental health of children and adolescents in the context of familial, social and cultural expectations about age-appropriate thoughts, emotions and behavior. Young persons can and do develop mental disorders that are more severe than the typical "ups and downs" of development.

About 20 percent of young persons experience the signs and symptoms of a DSM-IV disorder during any given year, but only about 5 percent of all children experience "extreme functional impairment."

Mental health problems and disorders can affect persons of any social class or background. The children at greatest risk are those with physical problems, intellectual disabilities, low birth weight, family history of mental and addictive disorders, multigenerational poverty and caregiver separation or abuse and neglect.

Preventive interventions have been effective in reducing the impact of risk factors for mental disorders, and improving social and emotional development. A range of psychosocial and pharmacologic treatments also exist for many mental disorders in children, including attention-deficit/hyperactivity disorder, depression and disruptive disorders.

Primary care and schools are ideal settings for the potential recognition of mental disorders in young persons, but trained staff are limited. Family members have also become essential partners in the recognition and delivery of mental health services for children and adolescents.

Chapter Four: Adults and Mental Health. As persons move into adulthood, untreated mental disorders can lead to lost productivity, unsuccessful relationships and significant distress and dysfunction. Mental illness in adults can have a significant impact on children in their care. Also, stressful life events or the manifestation of mental illness can disrupt life balance and result in distress and dysfunction.

Research has improved our understanding of mental disorders in the adult stage of life. It has also contributed to our ability to recognize, diagnose and treat each of these conditions effectively in terms of symptom control and behavior management.

Certain common events in midlife, such as divorce or other stressful life events, can cause mental health problems that may be addressed through a range of interventions. Substance abuse is a common co-occurring problem for adults with mental disorders.

The report also emphasizes that sensitivity to culture, race, gender, disability, poverty and the need for patient involvement are important considerations for treatment and care.

Chapter Five: Older Adults and Mental Health. Chapter five states that continued intellectual, social and physical activity throughout life are important for maintaining mental health in late life.

Stressful life events, such as declining health or the loss of mates, family members or friends, will often increase with age. Persistent bereavement or serious depression is not "normal" and should be treated. Normal aging is not characterized by mental or cognitive disorders. Mental or substance use disorders that present alone or co-occur should be recognized and treated as illnesses.

Disability caused by mental illness in persons older than 65 years will become a major public health problem in the near future. Particularly, dementia, depression and schizophrenia, among other conditions, will present special problems in this age group.

There are effective interventions for most mental disorders and many mental health problems, such as bereavement, that affect older persons. The treatment of older adults with mental disorders can improve the interest and ability of persons to care for themselves and follow their physician's directions and advice. The report states that primary care physicians are a critical link in identifying and addressing mental disorders in older adults.

Chapter Six: Organization and Financing of Mental Health Services. Chapter six gives an overview of the current system of mental health services. It describes where persons receive care and how they use mental health services. The chapter also provides information on the costs of care and trends in mental health spending.

Chapter Seven: Confidentiality of Mental Health Information: Ethical, Legal and Policy Issues. This chapter emphasizes the critical need for confidentiality in the treatment of mental health conditions because of the extremely personal nature of the material shared. If patients trust that their condition not be disclosed without their consent, they are more likely to seek treatment for mental health problems.

Chapter Eight: A Vision for the Future--Actions for Mental Health in the New Millennium. The final chapter of the report recommends the following courses of action:

• Continue to build the science base for new treatment opportunities and the prevention of mental illness.
• Overcome stigma that prevents persons from acknowledging their own mental health problems.
• Improve public awareness of effective treatment.
• Ensure the supply of mental health services and providers.
• Ensure delivery of state-of-the-art treatments.
• Tailor treatment to age, gender, race and culture.
• Facilitate entry into treatment.
• Reduce financial barriers to treatment.

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