Intensive outpatient adjuvant therapy for breast cancer: Results of dose escalation and quality of life

Purpose: A dose-escalation study was conducted to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cyclophosphamide (CY) in combination with granulocyte colony-stimulating factor (G-CSF) and doxorubicin (DOX) given every 2 weeks for eight cycles as outpatient adjuvant therapy for node-positive breast cancer. A pilot study to assess quality of life (QOL) was performed. Patients and Methods: From March 1991 to April 1993, 19 patients were entered, patients received escalating doses of CY intravenously (IV) (1,000 mg/m(2), 1,500 mg/m(2), 2,000 mg/m(2), or 2,500 mg/m(2)) with DOX 40 mg/m(2), G-CSF 10 mu g/kg/d on days 2 to 12, and mesna, every 2 weeks for eight cycles. QOL was measured by the Profile of Mood States (POMS), the Psychosocial Adjustment to illness Scale-Self Report (PAIS-SR), and a 27-item QOL scale. Results: The CY dose of 2,500 mg/m(2) every 2 weeks elicited toxicities that required dose reductions secondary to a combination of thrombocytopenia, hematuria, and anemia that required transfusion. The dose of 2,000 mg/m(2) resulted in an acceptable toxicity profile. Ninety-two percent of cycles at the 2,000-mg/m(2) dose were delivered on schedule and 77% without hospitalization. QOL assessments indicated high levels of distress measured by POMS in 47%, poor overall quality of life in 40%, and significant problems with physical symptoms in less than 27% of all patients for any given cycle. Conclusion: A dose of CY at 2,000 mg/m(2) can be administered every 2 weeks with DOX and G-CSF for eight cycles in the outpatient setting with manageable toxicity. The majority of women described levels of physical symptoms and emotional distress as tolerable during treatment. (C) 1996 by American Society of Clinical Oncology.