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Mets fan in 2007 |
| Fluoxetine Versus Placebo in Advanced Cancer
Outpatients: A Double-Blinded Trial of the Hoosier Oncology Group Journal of Clinical Oncology, Vol 21, Issue 10 (May), 2003: 1937-1943 THE CARE of patients with advanced cancer is becoming increasingly challenging because of the growing numbers of patients living with cancer and the increasing expectations of patients and their families for effective palliative care. According to a recent report from the Institute of Medicine, "A major problem in palliative care is the underrecognition, underdiagnosis, and thus undertreatment of patients with significant distress ranging from existential anguish to anxiety and depression." Significant depressive symptoms occur in roughly 25% to 35% of cancer patients. However, there are several inherent difficulties in diagnosing depression in this population. The most obvious problem is that sadness and grief are normal responses to the changes associated with the diagnosis of cancer and at transitional points in the disease. In addition, the physical signs of depression may be caused by the malignancy or by medications commonly used for cancer patients. Furthermore, patients and their family caregivers often do not recognize or accept the diagnosis of depression. For patients who are treated for the syndrome of major depression, 50% to 60% respond to initial therapy with antidepressants, psychotherapy, or both. Compared with placebo, patients with subsyndromal depression or dysthymia also benefit from treatment with an antidepressant or psychotherapy with similar response rates. Fluoxetine (Prozac) is a familiar antidepressant to many oncologists, and it is the first and most widely studied selective serotonin-reuptake inhibitor. Uncontrolled trials published in the late 1980s and 1990s indicated that antidepressants might also be helpful in selected cancer patients. Only six published, randomized, placebo-controlled trials have compared an antidepressant drug (a tricyclic antidepressant or serotonin-reuptake inhibitor) with placebo for the treatment of depression in patients with cancer. The trend in these data shows a modest benefit of an antidepressant compared with placebo, but there is concern about the generalizability of the data because of patient dropout and the relative preponderance of women with breast or gynecologic malignancies in these studies. It is clear that patients with depressive disorders benefit from treatment, but it is also evident that there are major barriers to diagnosing depressive disorders in outpatients with advanced cancer. The purpose of this study was to explore the efficacy and feasibility of treating outpatients with advanced cancer with an antidepressant on the basis of the presence of at least minimal depressive symptoms. A randomized, placebo-control design was needed to obtain an accurate assessment of efficacy. The primary objective was to compare the change in quality of life (QOL) of these patients; the secondary objective was to compare the change in depressive symptoms.
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. |
