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Journal of Clinical Oncology, Vol 22, No 1 (January 1), 2004: pp. 205-206 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.221
Prescribing Antidepressants to Advanced Cancer Patients With Mild Depressive Symptoms Is Not JustifiedAbramson Cancer Center, University of Pennsylvania Health System, Philadelphia, PA To the Editor: Investigators have an ethical responsibility to launch a clinical trial only when the existing literature does not indicate that a treatment will be ineffective. They have a similar responsibility to conduct trials in a way that will allow specification of the larger population of patients to whom results can be generalized. Not only do Fisch et al [1] fail to meet these conditions, they make the unwarranted proposal that their results "may broaden the comfort zone of oncologists for prescribing antidepressants" to cancer patients whose depressive symptoms do not meet criteria for major depression. Although there is little guidance from well-controlled trials of antidepressants with advanced cancer patients, a large literature concerning the efficacy of antidepressants and their effectiveness with primary care and general medical patients may prove instructive. A number of clinical trials have demonstrated the efficacy of antidepressants as treatment for major depression and dysthymia, and there now are established practice guidelines for the delivery of such treatment [2]. However, efficacy has not been established for the use of antidepressants in the treatment of depressive symptoms that do not meet diagnostic criteria for major depression or dysthymia [3], and guideline congruent treatment for depression has proven difficult to achieve in general medical settings [4]. Although efficacy studies demonstrate 50% to 70% of patients with major depression improve with antidepressant medication [2], the rate of improvement for depressed patients identified and treated in general medical settings is considerably lower, at about 20% to 40% [5,6]. This rate approximates the improvement of patients receiving placebo in well-managed clinical trials, and is much lower than the 50% to 60% cited by Fisch et al. A major reason for poorer outcomes in routine medical care is that adequate management and follow-up are provided to only a minority of patients, perhaps as few as 10% to 20% of patients who receive their care for depression exclusively in these settings [7,8]. Although up to 50% of depressed patients will require a change in dosage or medication before experiencing a benefit from antidepressant treatment [9], among depressed patients seen exclusively in general medical settings, most do not receive follow-up care adequate for medication monitoring [7-9]. Except when there have been ambitious efforts to modify the basic structure of clinical practice, efforts to improve the management of depression in general medical settings have had only modest sustained effects [10]. Rather than ascertaining that patients entering their study met the diagnostic criteria for which the efficacy of antidepressants has been established, Fisch et al [1] used unvalidated criteria to exclude patients not having at least minimal depressive symptoms. Exceedingly broad entry criteria and an effort to recruit all patients who met them yielded an unknown, but small proportion of eligible patients who were recruited and retained. This indicates that unspecified factors, such as decision making and gate keeping by clinicians, were crucial in determining inclusion into the study and inhibits our ability to generalize results. In addition, data were available from only a minority of patients during the single assessment point after baseline, at which the treatment and control groups seem to differ on the outcome measures. Our most confident interpretation of the project is that the investigators met overwhelming obstacles to enlist cancer clinicians and patients in a clinical trial involving minimal selection criteria, free treatment for mild depressive symptoms, and clinical management that did not meet established guidelines. We are concerned that clinical practice may be influenced by the incorrect assumptions that guided the design of the study and by the investigators' unsupported conclusions. Namely, that cancer clinicians can ignore both diagnostic criteria and established practice guidelines and still expect that the prescription of antidepressants will yield improvements in depression and quality of life among patients with advanced cancer. There are formidable barriers to providing appropriate mental health and psychosocial care to cancer patients, especially those with advanced disease. Aside from the urgent and competing demands of treating a life-threatening illness, crises in health care and its reimbursement make it difficult to marshal the resources to address depression and quality of life. It would be a pity if anyone, particularly policy makers, found aid and comfort from Fisch et al for dismissing the need to address these issues with appropriate evaluation and supportive services. We object to the suggestion that instructing cancer clinicians to dispense antidepressants without regard for diagnosis, and without ensuring patient education, management, and follow-up care dictated by established guidelines, can substitute for assembling the resources necessary to provide informed and thoughtful supportive care for patients with advanced cancer. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest. REFERENCES
1. Fisch MJ, Loehrer PJ, Kristeller J, et al: Fluoxetine versus placebo in advanced cancer outpatients: A double-blinded trial of the Hoosier Oncology Group. J Clin Oncol 21:1937-1943, 2003 2. Depression Guideline Panel: Depression in Primary Care, Volume 1: Detection and Diagnosis—Clinical Practice Guideline No. 5. Rockville, MD, US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, AHCPR publication 93-0550, 1993. 3. Lavretsky H, Kumar A: Clinically significant non-major depression: Old concepts, new insights. Am J Geriatr Psychiatry 10:239-255, 2002[CrossRef][Medline]
4. Young AS, Klap R, Sherbourne CD, et al: The quality of care for depressive and anxiety disorders in the United States. Arch Gen Psychiatry 58:55-61, 2001 5. Ormel J, Kempen GI, Deeg DJ, et al: Functioning, well-being, and health perception in late middle-aged, and older people: Comparing the effects of depressive symptoms and chronic medical symptoms. J Am Geriatr Soc 46:39-48, 1998[Medline]
6. Rost K, Nutting P, Smith JL, et al: Managing depression as a chronic disease: A randomized trial of ongoing treatment in primary care. BMJ 325:934-937, 2002
7. Unutzer J, Katon W, Callahan CM, et al: Collaborative care management of late-life depression in the primary care setting: A randomized controlled trial. JAMA 288:2836-2845, 2002
8. Kessler RC, Berglund P, Demler O, et al: The epidemiology of major depressive disorder: Results from the National Comorbidity Survey replication. JAMA 289:3095-3105, 2003 9. Simon GE: Evidence review: Efficacy and effectiveness of antidepressant treatment in primary care. Gen Hosp Psychiatry 24:213-224, 2002[CrossRef][Medline]
10. Wells KB, Sherbourne C, Schoenbaum M, et al: Impact of disseminating quality improvement programs for depression in managed primary care: A randomized controlled trial. JAMA 283:212-220, 2000
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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