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Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breastcancer: European organization for research and treatment of cancer breast cancer group, Investigational drug branch for breast cancer and the New drug development group study
Bottomley, Andrew ...
Purpose To compare health-related quality of life (HROOL) in patients with metastatic breast cancer receiving the combination of doxorubicin and paclitaxel (AT) or doxorubicin and cyclophosphamide ...(AC) as first-line chemotherapy treatment. Patients and Methods Eligible patients (n = 275) with anthracycline-naive measurable metastatic breast cancer were randomly assignedto AT (doxorubicin 60 mg/m2 as an intravenous bolus plus paclitaxel 175 mg/m2 as a 3-hour infusion) or AC (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2) every 3 weeks for a maximum of six cycles. Dose escalation of paclitaxel (200 mg/m2) and cyclophosphamide (750 mg/m2) was planned at cycle 2 to reach equivalent myelosuppression in the two groups. HROOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and the EORTC Breast Module at baseline and the start of cycles 2, 4, and 6, and 3 months after thelast cycle. Results Seventy-nine percent of the patients (n = 219) completed a baseline measure. However, there were no statistically significantdifferences in HROOL between the two treatment groups. In both groups, selected aspects of HROOL were impaired over time, with increased fatigue, although some clinically significant improvements in emotional functioning were seen, as well as a reduction in pain over time. Overall, global quality of life was maintained in both treatment groups. Conclusion This information is important when advising women patients of the expected HROOL consequences of treatment regimens and should help clinicians and their patients make informed treatment decisions.
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