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 maximu m-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cyclopho sphamide (CY) in combination with granulocyte colony-stimulating facto r (G-CSF) and doxorubicin (DOX) given every 2 weeks for eight cycles a s outpatient adjuvant therapy for node-positive breast cancer. A pilot study to assess quality of life (QOL) was performed. Patients and Met hods: From March 1991 to April 1993, 19 patients were entered, patient s 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 c ycles. QOL was measured by the Profile of Mood States (POMS), the Psyc hosocial Adjustment to illness Scale-Self Report (PAIS-SR), and a 27-i tem QOL scale. Results: The CY dose of 2,500 mg/m(2) every 2 weeks eli cited toxicities that required dose reductions secondary to a combinat ion of thrombocytopenia, hematuria, and anemia that required transfusi on. The dose of 2,000 mg/m(2) resulted in an acceptable toxicity profi le. Ninety-two percent of cycles at the 2,000-mg/m(2) dose were delive red on schedule and 77% without hospitalization. QOL assessments indic ated high levels of distress measured by POMS in 47%, poor overall qua lity of life in 40%, and significant problems with physical symptoms i n less than 27% of all patients for any given cycle. Conclusion: A dos e of CY at 2,000 mg/m(2) can be administered every 2 weeks with DOX an d G-CSF for eight cycles in the outpatient setting with manageable tox icity. The majority of women described levels of physical symptoms and emotional distress as tolerable during treatment. (C) 1996 by America n Society of Clinical Oncology.