Abstract P6-11-01: Final results of the randomized trial of exercise intervention vs. usual care for breast cancer patients with aromatase inhibitor to prevent and improve the aromatase inhibitor induced arthralgia

Aromatase inhibitors (AIs) have been used in the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer as a consequence of the significant benefit in DFS and OS when compared with tamoxifen. However the patients who receive AIs have an increased risk of arthralgia, at most 50% of patients did not take AIs and the 20% of the discontinued patients were within the first year of use. The HOPE study demonstrated that exercise was effective in improving AI-induced arthralgia. We conducted the AIAI (Arthralgia Improvement for the patients with Aromatase Inhibitors) study using wider eligibility criteria that the HOPE study to assess the impact on AI induced arthralgia in breast cancer patients. Patients were randomly assigned, in a 3:1 ratio, to exercise intervention or usual care. Following randomization participants could choose from 3 types of exercise including group 1 (120-150 minutes per week of walking or running), group 2 (daily NIPPON HOSO KYOKAI: NHK broadcast exercise in Japan) and group 3 (going up the stairs- frequency, etc). The primary endpoint was the arthralgia change at 6 and 12 months, which was assessed using the BPI (Brief Pain Inventory). Secondary endpoints included the BPI according to the completion rate of exercise (70% and more or less than 70%), the BPI change of the patients with arthralgia (the patients who had arthralgia at the time they enrolled this study; BPI worst pain 3≤), the BPI of the each exercise group, the BPI according to the duration of AIs therapy (24 months and more or less than 24 months), the correlation between the BMI change and the BPI change, adherence of AIs and safety. 102 were randomly assigned to exercise intervention group (22 patients dropped out of this study) and 37 to usual care group (9 patients dropped out of this study). Trends for differentiations of pain interference at 12 months was detected between exercise intervention group and usual care group, but the differences did not reach statistical significance (p = .067). There was statistically better pain interference of the 70% and more exercise completion group than the usual care group at 12 months (-0.29±1.22 for exercise intervention group and 0.33±0.88 for usual care group, p= .002). The change of pain interference was statistically better for the exercise intervention group than the usual care group at 12 months (p= .017, -0.61±0.69 for exercise intervention group and 1.14±1.56 for usual care group). There was statistically significant difference of pain interference between group 1 exercise intervention group and the usual care group at 12 months (-0.14±0.68 for group 1 exercise intervention group and 0.33±0.88 for the usual care group, p= .009). Tendencies were detected in the AIs therapy less than 24 months group. Trends for the correlation between BPI and BMI were detected in worst pain at 6 month, pain severity at 6 month and pain interference at 12 month. There was a statistically significant difference of AIs adherence between the exercise intervention group (99%) and the usual care group (92%) (P=0.03). Exercise may be effective in improving and preventing AI-induced arthralgia. Citation Format: Tamaki K, Takaesu M, Nagamine S, Terukina S, Kamada Y, Uehara K, Takigami N, Arakaki M, Yamashiro K, Miyashita M, Ishida T, McNamara KM, Tamaki N, Sasano H. Final results of the randomized trial of exercise intervention vs. usual care for breast cancer patients with aromatase inhibitor to prevent and improve the aromatase inhibitor induced arthralgia [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-01.