Background: Trastuzumab (Herceptin; 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 < .05). In the chemotherapy-plus-trastuzumab arm, fatigue was significantly improved at week 32 (chemotherapy completed at week 20) compared with baseline in both study arms (P < .05); more patients in the chemotherapy-plus-trastuzumab arm also showed improved physical and role functioning. Subscale scores in H0649g (n = 154) and H0650g (n = 74) were similar at all time points. In H0649g, clinical responders showed meaningful improvements (>or= 10 points) in all 5 subscales by week 12 through week 36. Nonresponders had meaningful decreases in all subscale scores. In H0650g, clinical responders exhibited meaningful increases in social and role functioning and global QOL by week 12; nonresponder scores worsened for all subscales.
Conclusion: Trastuzumab has a beneficial effect on HRQOL in patients with HER2-positive MBC, particularly those with responsive disease.