Effect of Trastuzumab on Health-Related Quality of Life in Patients With HER2-Positive Metastatic Breast Cancer: Data From Three Clinical Trials

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Background: Trastuzumab (Herceptin (R); Genentech, Inc.; South San Francisco, CA) provides clinical benefit when combined with chemotherapy or as monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Given the demonstrated improvement in standard outcomes, it is important to assess this therapy's effect on patients' health-related quality of life (HRQOL). Patients and Methods: The QLQ-C30 and BR-23 questionnaires were used to assess global HRQOL; physical, social, and role functioning; and fatigue as secondary endpoints in trials of trastuzumab monotherapy (H0649g and H0650g) or in combination with chemotherapy (H0648g). Patients completed assessments at baseline, week 8 (H0648g only), and at 12-week intervals until disease progression. Results: In H0648g (n = 400), more patients exhibited improved global QOL in the chemotherapy-plus-trastuzumab versus chemotherapy arms (51% vs. 36%; P

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