Lynne I Wagner1, Fengmin Zhao2, Paul E Goss3, Judith-Anne W Chapman4, Lois E Shepherd4, Timothy J Whelan4,5, Bassam I Mattar6, Jose A Bufill7, William C Schultz8, Irving E LaFrancis9, Gauri G Nagargoje10, Radhakrishna Vemuri11, Daniel A Nikcevich12, George W Sledge13, David Cella14. 1. Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston Salem, NC, 27151, USA. lywagner@wakehealth.edu. 2. Dana Farber Cancer Institute, Boston, MA, USA. 3. Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. 4. Canadian Cancer Trials Group (CCTG), Kingston, Canada. 5. McMaster University, Hamilton, ON, Canada. 6. Wichita NCORP, Wichita, KA, USA. 7. Michiana Hematology-Oncology, P.C., Mishawaka, IN, USA. 8. Swedish American Regional Cancer Center, Rockford, IL, USA. 9. Mercy Hospital-Joplin, Joplin, MO, USA. 10. Mercy Hospital, Coon Rapids, MN, USA. 11. West Michigan Cancer Center, Kalamazoo, MI, USA. 12. Essentia Health Cancer Center, Duluth, MN, USA. 13. Stanford University, Stanford, CA, USA. 14. Northwestern University, Chicago, IL, USA.
Abstract
PURPOSE:Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized toanastrozole or exemestane. METHODS:MA.27 participants (N = 686, of 7576) randomized to 5 years ofanastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. RESULTS: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08-1.55, p = 0.01). CONCLUSIONS:TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.
RCT Entities:
PURPOSE:Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treatment-related symptoms (TRS) and health-related quality of life (HRQL) among postmenopausal women randomized to anastrozole or exemestane. METHODS: MA.27 participants (N = 686, of 7576) randomized to 5 years of anastrozole (1 mg/day, n = 371, Arm A) or exemestane (25 mg/day, n = 315, Arm E) completed the 56-item Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire to assess TRS and HRQL. The FACT-ES was completed at baseline, 3, 6, 12, and 24 months. RESULTS: No significant differences in FACT-ES median scores measuring TRS and HRQL were observed between treatment arms at any time point. Change in TRS from baseline was statistically significant at 3, 6, 12, and 24 months. HRQL was stable over time in both arms. Greater TRS burden was associated with poorer HRQL (coefficient = 0.57, p < 0.001). Twenty percent of patients discontinued AI therapy by month 24 and 32% discontinued AIs at 4 years. In both arms, patients reporting more side effect bother prior to initiating study treatment had a higher risk of discontinuing treatment before completing protocol therapy (hazard ratio [HR] 1.29, 95% CI 1.08-1.55, p = 0.01). CONCLUSIONS: TRS and HRQL were comparable between anastrozole and exemestane. TRS negatively affect HRQL. Women who report being bothered by treatment side effects prior to initiating an AI are at increased risk for early treatment discontinuation.
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