Duloxetine treatment is superior to placebo for managing aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) among postmenopausal women with stage I-III early-stage breast cancer taking AIs for at least 3 weeks, according to study findings presented at the 2016 San Antonio Breast Cancer Symposium.1

“Duloxetine was relatively well-tolerated, consistent with trials for other indications,” said lead study author N. Lynn Henry, MD, PhD, of the University of Michigan Comprehensive Cancer Center in Ann Arbor. “In addition to improvements in pain, duloxetine was associated with modest improvements in quality of life.”

Improved joint pain was noted in both the treatment and the placebo-control group.

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While duloxetine outperformed placebo between 2 and 12 weeks after initiation of therapy, those differences disappeared at 24 weeks, after the end of treatment.

Among 150 women treated with duloxetine and 149 given placebo, 127 and 128 women were evaluable by the end of the study. Pain ratings and quality of life assessments (FACT-ES questionnaire) were collected at baseline and weeks 2, 6, 12 and 24.

Average joint pain declined more among patients on treatment than placebo (P = 0.0002). Worst joint pain, pain interference, WOMAC (knee/hip) and M-SACRAH (hand) scores all improved with duloxetine.

Mean Global Rating of Change Scale Pain and Stiffness scores were also improved.

The most frequent adverse events affecting more than 10% of patients in the duloxetine study group included dry mouth (25%), fatigue (32%), nausea (30%), headache (21%), hot flashes (15%), diarrhea (13%), dizziness (13%), and constipation (12%).

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Grade 3/4 toxicities were rare, with insomnia affecting 4 (2.9%) patients on duloxetine and extremity pain affecting 2 (1.4%). Overall, 12 (8.7%) patients on duloxetine had grade 3/4 adverse events, Dr Henry said.  


  1. Henry NL, Unger JM, Schott AF, et al. Randomized, placebo-controlled trial of duloxetine for aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in early stage breast cancer (SWOG S1202). Paper presented at: 39th San Antonio Breast Cancer Symposium; Dec 2016; San Antonio, TX.