Fluoxetine Versus Placebo In Advanced Cancer Outpatients: A Placebo-Controlled, Double-Masked Trial Of The Hoosier Oncology Group

Heather Jones, MD

University of Pennsylvania Cancer
Last Modified: May 14, 2001

Presenter: Michael Jordan Fisch
Affiliation: UT/MD Anderson Cancer Center, Houston, TX


    Depressive symptoms are prevalent in advanced cancer patients, and no standard of care exists regarding assessment and management of this clinical problem. Studies have demonstrated that Serotonin reuptake inhibitors such as fluoxetine are effective for major depression and well tolerated in the medically ill. In addition, there is no controlled data on the efficacy of a simple screening tool for depressive symptoms in a cancer population. This study evaluates the use of a simple screening instrument and the use of fluoxetine as an antidepressant in patients with advanced cancer.

Materials and Methods:

  • Advanced cancer outpatients were routinely screened with a two-question screening survey that assessed depressed mood and anhedonia.
  • Patients with at least minimal depressive symptoms and no current or recent exposure to antidepressants were eligible for study inclusion regardless of their primary disease site or concurrent anti-cancer treatment.
  • 163 patients with an advanced cancer and an expected survival between 3-24 months were randomized in a double-blind fashion to receive either fluoxetine 20 mg daily or placebo for a total of 12 weeks.
  • Assessments were performed every 3-6 weeks including analysis of quality of life (QOL), depression, and spiritual well-being.
  • The primary objective was to compare the change in QOL (using the FACT-G) of patients treated with fluoxetine versus placebo. Secondary endpoints included assessment of depression and spiritual well-being.


  • The placebo and fluoxetine group did not differ significantly in age, or PS.
  • The median overall survival in both groups was 38 weeks indicating that both consisted of patients with advanced stage cancer.
  • There was a significant improvement in the FACT-G score of the fluoxetine group vs placebo group even after adjusting for age and gender (p = .001).
  • There was no significant difference between the two groups in terms of spiritual well being.
  • Post Hoc subset analysis demonstrated that the most distressed group benefited the most from the use of fluoxetine.
  • Toxicity was mild and included slight increase in nausea and vomiting.

Authors' Conclusions

    Fluoxetine is well tolerated and its administration is able to improve the overall quality of life and depressive symptoms in a group of patients with a broad mix of advanced stage tumors.

Clinical/Scientific Implications:

    Patients with advanced cancer face many challenges that can impair their QOL. This study demonstrates that using an effective screening tool, we can target the patients most at risk for depression and successfully treat them with serotonin reuptake inhibitor.

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OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen