2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology.

OBJECTIVE: To update the 1997 clinical practice guidelines for the use of tumor marker tests in the prevention, screening, treatment, and surveillance of breast and colorectal cancers. These guidelines are intended for use in the care of patients outside of clinical trials. OPTIONS: Six tumor markers for colorectal cancer and eight for breast cancer were considered. They could be recommended or not for routine use or for special circumstances. In addition to carcinoembryonic antigen (CEA) and CA 15-3, CA 27.29 was also considered among the serum tumor markers for breast cancer. OUTCOMES: In general, the significant health outcomes identified for use in making clinical practice guidelines (overall survival, disease-free survival, quality of life, lesser toxicity, and cost-effectiveness) were used. EVIDENCE: A computerized literature search from 1994 to March 1999 was performed. VALUES: The same values for use, utility, and levels of evidence were used by the committee. BENEFITS, HARMS, AND COSTS: The same benefit, harms, and costs were used. RECOMMENDATION: Changes were recommended (see Appendix). VALIDATION: The updated recommendations were validated by external review by the American Society of Clinical Oncology's (ASCO's) Health Services Research Committee and by ASCO's Board of Directors. SPONSOR: American Society of Clinical Oncology.

Stress and coping research. Methodological challenges, theoretical advances, and clinical applications.

Coping is among the most widely studied topics in contemporary psychology. However, the explosion of interest in coping has yielded little and the field is in crisis. This section offers a survey of the state of the art in theory and research on stress and adaptational processes. The four core articles in the section take up, respectively, problems in research design, the neglect of unconscious reactions to stress, the selection of adaptational outcomes, and the link between research on adaptational processes and clinical practice. The final article by Richard S. Lazarus offers a commentary. The present introduction provides the historical backdrop for the section. Then, after a brief overview of research on adaptational processes, the authors summarize the scope and yield of coping research and preview the four core articles in the section. The strengths and limits of individual coping efforts and the need for realistic expectations and redoubled efforts are discussed.

Recommended colorectal cancer surveillance guidelines by the American Society of Clinical Oncology.

OBJECTIVE: To determine the most effective, evidence-based, postoperative surveillance strategy for the detection of recurrent colon and rectal cancer. Tests are to be recommended only if they have an impact on the outcomes listed below. POTENTIAL INTERVENTION: All tests described in the literature for postoperative monitoring were considered. In addition, the data were critically evaluated to determine the optimal frequency of monitoring. OUTCOMES: Outcomes of interest included overall and disease-free survival, quality of life, toxicity reduction, and cost-effectiveness. The American Society of Clinical Oncology (ASCO) Colorectal Cancer Surveillance Expert Panel was guided by the principle of cost minimization, ie, when two strategies were believed to be equally effective, the least expensive test was recommended. EVIDENCE: A complete MEDLINE search was performed of the past 20 years of the medical literature. Keywords included colorectal cancer, follow-up, and carcinoembryonic antigen, as well as the names of the specific tests. The search was broadened by articles from the tumor marker ASCO panel literature search, as well as from bibliographies of selected articles. VALUES: Levels of evidence and guideline grades were rated by a standard process. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. BENEFITS/HARMS/COSTS: The possible consequences of false-positive and false-negative tests were considered in evaluating a preference for one of two tests that provide similar information. Cost alone was not a determining factor. RECOMMENDATIONS: The expert panel's recommended postoperative monitoring schema is discussed in this article. VALIDATION: Five outside reviewers, the ASCO Health Services Research Committee, and the ASCO Board of Directors examined this document. SPONSOR: American Society of Clinical Oncology.

American Society of Clinical Oncology technology assessment on breast cancer risk reduction strategies: tamoxifen and raloxifene.

OBJECTIVE: To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. POTENTIAL INTERVENTION: Tamoxifen and raloxifene. OUTCOME: Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. EVIDENCE: A comprehensive, formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. VALUES: More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. CONCLUSIONS: For women with a defined 5-year projected risk of breast cancer of >/= 1.66%, tamoxifen (at 20 mg/d for up to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. At the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the current unanswered issues concerning the use of such interventions, especially when the influence on net health benefit remains to be determined. Breast cancer risk reduction is a rapidly evolving area. This technology assessment represents an ongoing process with existing plans to monitor and review data and to update recommendations in a timely matter. (See VALIDATION: The conclusions of the Working Group were evaluated by the ASCO Health Services Research Committee and by the ASCO Board of Directors. SPONSOR: American Society of Clinical Oncology.

Use of hematopoietic colony-stimulating factors: comparison of the 1994 and 1997 American Society of Clinical Oncology surveys regarding ASCO clinical practice guidelines. Health Services Research Committee of the American Society of Clinical Oncology.

PURPOSE: The American Society of Clinical Oncology (ASCO) Health Services Research Committee sought to assess whether more appropriate patterns of colony-stimulating factor (CSF) use occurred after the publication of ASCO evidence-based practice guidelines in 1994 and 1996 for patients with solid tumors or lymphoma. METHODS: In 1994 and 1997, questionnaires describing clinical scenarios were mailed to ASCO members who practiced medical oncology. Physicians were asked the extent to which they preferred to use a CSF for primary prophylaxis, secondary prophylaxis, or treatment of neutropenic complications. Multiple regression analyses were used to determine predictors of overall propensity to use CSFs and, when using a CSF, propensity to support longer schedules of CSF use. RESULTS: Decreased use of CSFs was shown in the following situations: (1) treatment for febrile neutropenia without localizing signs (39% in 1994 v 29% in 1997) or with a right lower lobe infiltrate (54% v 46%); (2) primary prophylaxis with paclitaxel for ovarian cancer (20% v 11%) or cyclophosphamide, doxorubicin, and vincristine chemotherapy for small-cell lung cancer (8.4% v 4.6%); and (3) secondary prophylaxis after afebrile neutropenia following chemotherapy for germ cell tumors (44.5% v 36.0%). One third fewer physicians supported the extended use of CSFs until an absolute neutrophil count >/= 10,000/mm(3) or a WBC count >/= 10,000/mm(3) was reached, both counts serving as criteria for stopping CSF therapy. However, we observed high rates of CSF use despite ASCO guideline recommendations against use in the following clinical situations: (1) primary prophylaxis in patients at low risk of febrile neutropenia (6% v 16%); (2) secondary prophylaxis late in the course of curative and palliative therapy (80% v 53%); and (3) treatment of afebrile and uncomplicated febrile neutropenia (30% v 60%). In 1994 and 1997, fee-for-service physicians were more likely than other physicians to prefer use of CSF support while maintaining treatment dose and schedule instead of using dose-reduction strategies, and, when using a CSF, they were more likely to support longer CSF treatment schedules (P <.05 for both scenarios). CONCLUSION: Decreased use and more appropriate use of CSFs in accordance with ASCO guideline recommendations occurred from 1994 to 1997, but there remain many opportunities to reduce CSF use with no clinical harm. Many oncologists continue to support the use of CSFs in scenarios and with scheduling criteria that the guidelines and evidence do not support. ASCO's evidence-based guidelines should be linked with formal continuous quality improvement initiatives to substantially improve the quality of supportive oncology care.

A systems model for adaptation to somatic distress among cancer survivors.

Applied coping research has generally failed to fulfill its goal of providing an empirical basis for clinical interventions, and research on coping with cancer is no exception. This can be attributed in large measure to the wide gap between coping theory and coping research. Theories of stress and adaptation are complex systems formulations that present conceptual and methodological challenges and thus make testing comprehensive models difficult. The present paper reviews arguments for a microanalytic strategy through which researchers can increase coverage of relevant variables from broad systems models of stress and coping by concentrating their resources on selected, high-frequency, high-stress problems. The utility of this approach for formulating problem-specific systems models is illustrated using the example of coping with somatic distress among cancer survivors.

Can 40 seconds of compassion reduce patient anxiety?

PURPOSE: To use a standardized videotape stimulus to assess the effect of physician compassion on viewers' anxiety, information recall, treatment decisions, and assessment of physician characteristics. PARTICIPANTS AND METHODS: One hundred twenty-three healthy female breast cancer survivors and 87 women without cancer were recruited for this study. A randomized pretest/posttest control group design with a standardized videotape intervention was used. Participants completed the State-Trait Anxiety Inventory (STAI), an information recall test, a compassion rating, and physician attribute rating scales. RESULTS: Women who saw an "enhanced compassion" videotape rated the physician as warmer and more caring, sensitive, and compassionate than did women who watched the "standard" videotape. Women who saw the enhanced compassion videotape were significantly less anxious after watching it than the women in the other group. Nevertheless, information recall was relatively low for both groups, and enhanced compassion did not influence patient decisions. Those who saw the enhanced compassion videotape rated the doctor significantly higher on other positive attributes, such as wanting what was best for the patient and encouraging the patient's questions and involvement in decisions. CONCLUSION: The enhanced compassion segment was short, simple, and effective in decreasing viewers' anxiety. Further research is needed to translate these findings to the clinical setting, where reducing patient anxiety is a therapeutic goal.

American Society of Clinical Oncology 1998 update of recommended breast cancer surveillance guidelines.

OBJECTIVE: To determine an effective, evidence-based, postoperative surveillance strategy for the detection and treatment of recurrent breast cancer. Tests are recommended only if they have an impact on the outcomes specified by American Society of Clinical Oncology (ASCO) for clinical practice guidelines. POTENTIAL INTERVENTION: All tests described in the literature for postoperative monitoring were considered. In addition, the data were critically evaluated to determine the optimal frequency of monitoring. OUTCOME: Outcomes of interest include overall and disease-free survival, quality of life, toxicity reduction, and secondarily cost-effectiveness. EVIDENCE: A search was performed to determine all relevant articles published over the past 20 years on the efficacy of surveillance testing for breast cancer recurrence. These publications comprised both retrospective and prospective studies. VALUES: Levels of evidence and guideline grades were rated by a standard process. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. BENEFITS, HARMS, AND COSTS: The possible consequences of false-positive and -negative tests were considered in evaluating a preference for one of two tests providing similar information. Cost alone was not a determining factor. RECOMMENDATIONS: The attached guidelines and text summarize the updated recommendations of the ASCO breast cancer expert panel. Data are sufficient to recommend monthly breast self-examination, annual mammography of the preserved and contralateral breast, and a careful history and physical examination every 3 to 6 months for 3 years, then every 6 to 12 months for 2 years, then annually. Data are not sufficient to recommend routine bone scans, chest radiographs, hematologic blood counts, tumor markers (carcinoembryonic antigen, cancer antigen [CA] 15-5, and CA 27.29), liver ultrasonograms, or computed tomography scans. VALIDATION: The recommendations of the breast cancer expert panel were evaluated and supported by the ASCO Health Services Research Committee reviewers and the ASCO Board of Directors.

The association between physician reimbursement in the US and use of hematopoietic colony stimulating factors as adjunct therapy for older patients with acute myeloid leukemia: results from the 1997 American Society of Clinical Oncology survey. Health Services Research Committee of the American Society of Clinical Oncology.

BACKGROUND/OBJECTIVES: Financial considerations play an important role in the delivery of medical care in the US. In 1996, revised guidelines from the American Society of Clinical Oncology (ASCO) indicated that granulocyte colony-stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF) were unlikely to be harmful for older acute myeloid leukemia (AML) patients and suggested that physicians could consider their use in this setting. In 1997, the ASCO health services research committee evaluated whether physician reimbursement was a primary determinant in the decision to use G-CSF and GM-CSF in this clinical situation. PATIENTS AND METHODS: A questionnaire describing clinical scenarios for a 67-year-old man with newly diagnosed de novo AML was mailed to 1500 ASCO members who practiced medical oncology and hematology. Physicians were queried about their preferences for adjunctive CSF use following induction and consolidation chemotherapy. RESULTS: Of 1020 potentially eligible respondents, returned surveys were received from 672. Following induction chemotherapy, support for CSF use was 40%, similar in magnitude for that for non-use of these agents. The most important determinant of support for CSF use was being in a fee-for-service practice (P < 0.001). CONCLUSIONS: Physicians in the US are mixed in their support for CSFs for older AML patients. Support was high in settings where CSF use was accompanied by financial profit to the physician practice, and support was low otherwise.

The utility of systems models of stress and coping for applied research: the case of cancer adaptation.

Contemporary conceptual models of stress and coping are intricate systems formulations that depict adaptation as a dynamic, interactional process. The inherent complexity of these models presents conceptual and methodological challenges that make testing a complete model difficult. This article makes the case for a more microanalytic strategy for applied coping research that, by centering attention and available resources on selected high-frequency, high-stress problems, permits more conceptually sophisticated and clinically informative analyses. In this context, the prevailing conceptual models have heuristic value for organizing the holistic study of adaptational processes. The utility of the proposed strategy for the development of problem-specific systems models is illustrated using the example of treatment-induced sterility from research on cancer adaptation.

The future of coping research as we know it: a response to commentaries.

The author responds to commentaries by J. C. Coyne, S. Folkman, S. E. Hobfoll and J. D. Wells, R. S. Lazarus, H. Leventhal, T. L. Patterson and R. M. Kaplan, T. A. Revenson, C. A. Smith and K. A. Wallston, J. Spicer, D. Spiegel, and H. Weber concerning his target article on the utility of systems models of stress and adaptation for applied coping research. The author addresses the pragmatic advantages of targeted, programmatic applied coping research; the potential contributions of coping research on specific stressors to basic stress and coping research; measurement, design, and analysis issues in coping research; the value of systems concepts and methods for stress and coping research; the integration of dispositional and situational coping approaches; and the future of coping research.