ASPO Abstracts
Sulindac Improves Stiffness and Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer
Category: Survivorship & Health Outcomes/Comparative Effectiveness Research
Conference Year: 2020
Abstract Body:
a. Purpose: The purpose of this study was to evaluate the effect of sulindac, a non-selective, non-steroidal anti-inflammatory drug (NSAID), on aromatase inhibitor–associated arthralgia (AIA) and quality of life in breast cancer patients.
b. Methods: As a feasibility study, a total of 101 breast cancer patients stable on AI therapy were non-randomly enrolled to an open-label phase 2 clinical trial of sulindac 150 mg BID (n=51) or observation (n=50) for 12 months. Arthralgia, physical function, and pain measures were derived from the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and Brief Pain Inventory Short Form (BPI-SF). Quality of life was assessed using the Functional Assessment of Cancer Therapy – General form (FACT-G). Linear mixed models adjusted for age at baseline, BMI, time on AI, and use of pain medication were used to estimate the change in each outcome for each arm separately.
c. Results: Sulindac use for 12 months was associated with a significant decrease in mean Total WOMAC score (-129.5: 95% CI [-228.5, -30.5]; P = 0.010), and Stiffness (-20.3: 95% CI [-31.6, -8.9]; P < 0.001) and Physical Function subscales (-87.2: 95% CI [-158.6, -15.8]; P = 0.017), with a non-significant decrease in the WOMAC Pain subscale (-22.6: 95% CI [-50.1, -5.0]; P = 0.108) and no change in BPI-SF Worst Pain, Severity, or Interference. Sensitivity analysis supported stronger benefit in patients reporting higher baseline pain, physical dysfunction, and stiffness symptoms. With regard to quality of life, there was a significant mean increase in the Fact-G Total score (3.1: 95% CI [0.2, 5.9]; P = 0.035). In a sensitivity analysis, patients with lower baseline scores showed the greatest improvements in the FACT-G Total score and all four subscales (all P < 0.05). In contrast, observation-arm participants reported no change in WOMAC, BPI-SF, or FACT-G scales over 12 months.
d. Conclusions: While NSAIDs are frequently used to manage AIA in clinical practice, this is the first study to provide evidence demonstrating that sulindac at 150 mg BID improves AIA symptoms with positive effects on quality of life. Randomized trials are needed to determine the optimal NSAID dosing to reduce AIA symptoms and improve AI adherence.
Keywords: aromatase inhibitor arthralgias (AIA), breast cancer