Publication Year: 2000 Visited: 34

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Health Related Quality of Life (HRQL) of Patients Treated with First-Line, Single Agent, Trastuzumab (Herceptin) for Metastatic Her-2 Overexpressing Breast Cancer (MBC). David Osoba, Michael J Burchmore, Maureen Ash, Debu Tripathy, Charles Vogel, QOL Consulting, West Vancouver, Canada; Genentech, South San Francisco, CA; Univ of CA, San Francisco, CA; Aventura Comprehensive Cancer Ctr, Aventura, FL.

An open-label study of single agent trastuzumab (4 mg/kg loading dose then 2 mg/kg weekly IV or 8 mg/kg loading dose then 4 mg/kg IV weekly until disease progression) was conducted in 114 women as a first line treatment for MBC. The overall (combined dose groups) objective response rate as determined by the investigators was 26.3% (95% CI 18.2-34.4) with a median survival of 24.4 months (95% CI 16.9-31.7). Most adverse events were mild to moderate. Two patients experienced cardiac dysfunction. HRQL was measured with the EORTC-QLQ-C30, self-administered at baseline and then every 12 weeks. Five prospectively identified domains were chosen for analysis. Evaluable patients (n=74) completed the baseline and at least one subsequent questionnaire. Results are expressed as 0-100 points. The prespecified analysis compared baseline to subsequent timepoints using an ANOVA carrying forward the last observation at progression. Statistically significant improvements were observed in GQL and fatigue. Another way of interpreting the data is to group the patients using clinically important changes as described by Osoba, et al (JCO, 1998). Most patients had either no change or improvements in scale scores.{table}Patients with CR or PR had improvements in HRQL compared to non-responders. Overall, trastuzumab does not adversely affect HRQL when used as a first line single agent for MBC. This report supports previous results showing the maintenance of HRQL when trastuzumab is used as a treatment for MBC.