Abstract PD08-06: Duloxetine for Treatment of Aromatase Inhibitor (AI)-Associated Musculoskeletal Syndrome (AIMSS)
| Autor: | Df. Hayes, C. Van Poznak, Max S. Wicha, D Blossom, Jeffrey B. Smerage, Mousumi Banerjee, Norah Lynn Henry, JG Griggs, Anne F. Schott |
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| Rok vydání: | 2010 |
| Předmět: |
Cancer Research
medicine.medical_specialty Aromatase inhibitor business.industry medicine.drug_class Visual analogue scale Chronic pain Phases of clinical research medicine.disease chemistry.chemical_compound Breast cancer Oncology chemistry Internal medicine Cohort Physical therapy Medicine Duloxetine Brief Pain Inventory business |
| Zdroj: | Cancer Research. 70:PD08-06 |
| ISSN: | 1538-7445 0008-5472 |
| DOI: | 10.1158/0008-5472.sabcs10-pd08-06 |
| Popis: | Background: Approximately 50% of postmenopausal women with hormone receptor positive early stage breast cancer treated with an aromatase inhibitor (AI) develop arthralgias. Standard analgesics are relatively ineffective. Duloxetine is a serotonin and norepinephrine receptor inhibitor with proven efficacy for treatment of multiple chronic pain states. We investigated the hypothesis that duloxetine would be efficacious for treatment of AIMSS. Methods: We performed a single-arm, open-label phase II study of duloxetine in 35 postmenopausal women who had been treated with AI therapy for at least 2 weeks and who developed new or worsening pain after starting AI therapy that was rated at least 4 on a 10 point Visual Analog Scale. Enrollment was completed in June 2010. Subjects were treated with duloxetine 30 mg daily for one week, and then 60 mg daily for 3 weeks. Depending on patient-perceived response to therapy, patients had the option of continuing duloxetine 60 mg daily or increasing the dose to 60 mg twice daily for the subsequent 4 weeks. Change in patient-reported pain was assessed. Outcome measures included the Brief Pain Inventory (BPI) and modified Health Assessment Questionnaire (HAQ). Benefit from therapy was defined as a 30% decrease in average pain score from baseline to 8 weeks. Paired t tests were used for statistical analysis. Results: Of the 35 enrolled subjects, 20 subjects completed the 8-week study period, 6 subjects discontinued therapy early because of duloxetine-associated toxicity, and 9 subjects had been enrolled less than 8 weeks at the time of this analysis and were therefore not evaluable. In an intent-to-treat analysis, 16 of 26 evaluable subjects (61.5%) experienced at least a 30% decrease in average pain, and 14 of 20 subjects (70%) who completed all 8 weeks of protocol-directed treatment chose to continue duloxetine therapy. There were statistically significant reductions in average pain severity (p < 0.0001) and maximum pain severity (p < 0.0001) from baseline to 8 weeks. The mean percent reduction in average pain severity between baseline and 8 weeks was 56.1% (95% CI 37.9%-74.2%) and in maximum pain severity was 55.7% (95% CI 37.3%-74.1%). No grade 3 or 4 adverse events were reported. The most common adverse events were fatigue and drowsiness, xerostomia, nausea, and headache. Conclusions: Duloxetine appears to be effective and well-tolerated for treatment of AIMSS. Final results from the entire cohort will be presented. Future randomized, placebo-controlled studies are warranted. Clinicaltrials. gov NCT01028352. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD08-06. |
| Databáze: | OpenAIRE |
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