Journal of Clinical Oncology, Vol 21, Issue 10
(May), 2003: 1937-1943
© 2003 American Society for Clinical Oncology
Fluoxetine Versus Placebo in Advanced Cancer Outpatients: A Double-Blinded Trial of the Hoosier Oncology Group
Michael J. Fisch,
Patrick J. Loehrer,
Jean Kristeller,
Steven Passik,
Sin-Ho Jung,
Jianzhao Shen,
Matthew A. Arquette,
Mary J. Brames,
Lawrence H. Einhorn
From the Department of Palliative Care and Rehabilitation, University of Texas M.D. Anderson Cancer Center, Houston, TX; Division of Hematology/Oncology, Indiana University; Walther Cancer Institute, and Division of Biostatistics, Indiana University School of Medicine, Indianapolis; Department of Psychology, Indiana State University, Terre Haute, IN; Department of Palliative Care, University of Kentucky, Lexington, KY; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC; and Division of Medical Oncology, Washington University, St Louis, MO.
Address reprint requests to Michael J. Fisch, MD, MPH, University of Texas M.D. Anderson Cancer Center, Box 008, Room P12.2911, 1515 Holcombe Blvd, Houston, TX 77030-4009; email: mfisch{at}mdanderson.org.
Purpose: To determine whether fluoxetine improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression revealed by a simple survey.
Patients and Methods: One hundred sixty-three patients with an advanced solid tumor and expected survival between 3 and 24 months were randomly assigned in a double-blinded fashion to receive either fluoxetine (20 mg daily) or placebo for 12 weeks. Patients were screened for at least minimal depressive symptoms and assessed every 3 to 6 weeks for QOL and depression. Patients with recent exposure to antidepressants were excluded.
Results: The groups were comparable at baseline in terms of age, sex, disease distribution, performance status, and level of depressive symptoms. One hundred twenty-nine patients (79%) completed at least one follow-up assessment. Analysis using generalized estimating equation modeling revealed that patients treated with fluoxetine exhibited a significant improvement in QOL as shown by the Functional Assessment of Cancer Therapy–General, compared with patients given placebo (P = .01). Specifically, the level of depressive symptoms expressed was lower in patients treated with fluoxetine (P = .0005), and the subgroup of patients showing higher levels of depressive symptoms on the two-question screening survey were the most likely to benefit from treatment.
Conclusion: In this mix of patients with advanced cancer who had symptoms of depression as determined by a two-question bedside survey, use of fluoxetine was well tolerated, overall QOL was improved, and depressive symptoms were reduced.
Supported in part by the Mary Margaret Walther Program for Cancer Care Research, Indianapolis, IN. Fluoxetine, placebo, and the study notebooks were provided by the Eli Lilly Company, Indianapolis, IN.
Presented in part at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12–15, 2001.
Related Correspondence
- Fluoxetine Versus Placebo in Advanced Cancer Outpatients
Carol Alliot
JCO 2004 22: 204-205
[Full Text]
- Prescribing Antidepressants to Advanced Cancer Patients With Mild Depressive Symptoms Is Not Justified
James C. Coyne, Steven C. Palmer, and Pamela J. Shapiro
JCO 2004 22: 205-206
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- Trial of Antidepressants for Mildly Depressed Cancer Patients Should Have Been Reported in a Manner Allowing Independent Evaluation of Investigators' Claims
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JCO 2004 22: 753-754
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Related Reply
- In Reply:
Michael J. Fisch, Jean L. Kristeller, Steven Passik, Patrick J. Loehrer, and Lawrence H. Einhorn
JCO 2004 22: 206-208
[Full Text]
- In Reply:
Michael J. Fisch, Jean L. Kristeller, Steven Passik, Patrick J. Loehrer, and Lawrence H. Einhorn
JCO 2004 22: 754-756
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