Duloxetine may be an effective means of managing aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) among patients with early-stage breast cancer, according to a study published in the Journal of Clinical Oncology.
The standard of care for postmenopausal women with early-stage hormone receptor-positive breast cancer is AIs, but common treatment-associated adverse events such joint pain and musculoskeletal symptoms often lead to discontinuation.
For this phase 3 study, researchers randomly assigned 299 postmenopausal patients with AI-treated early-stage breast cancer experiencing AIMSS to receive duloxetine or placebo for 13 weeks. Study patients had an average joint pain score greater than 4 on a 10-point pain scale that developed or worsened since the initiation of AI treatment. At the time of analysis, 127 patients in the duloxetine arm and 128 in the placebo arm were evaluable.
After 12 weeks, patients who received duloxetine had an average joint pain score that was 0.82 points lower compared with patients who received placebo (95% CI, –1.24 to –0.40; P =.0002). Improvements for the duloxetine group were also noted for measurements of joint stiffness, worst joint pain, pain interference, and functioning.
Although improvements in AIMSS were noted for patients who received duloxetine, this patient group also reported higher rates of adverse events of any grade compared with the placebo group: 78% vs 50%, respectively. There were low rates of grade 3 toxicities, however.
The authors noted that despite the increased rate of toxicity, duloxetine significantly improved the quality of life of this patient population, and concluded, “identifying ways to control symptoms and increase adherence with AI therapy while maintaining quality of life could lead to improvements in breast cancer disease-related outcomes.”
Henry NL, Unger JM, Schott AF, et al. Randomized, multicenter, placebo-controlled clinical trial of duloxetine versus placebo for aromatase inhibitor-associated arthralgias in early-stage breast cancer: SWOG 1202 [published online November 14, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.74.6651