title: Intensive outpatient adjuvant therapy for breast cancer: results of dose escalation and quality of life.
abstract: OBJECTIVE
  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-CSF0 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.
  
  
  METHODS
  From March 1991 to April 1993, 19 patients were entered. Patients received escalating doses of CY intravenously (i.v.) (1,000 mg/m2, 1,500 mg/m2, 2,000 mg/m2, or 2,500 mg/m2) with DOX 40 mg/m2, G-CSF 10 micrograms/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/m2 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/m2 resulted in an acceptable toxicity profile. Ninety-two percent of cycles at the 2,000-mg/m2 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.
  
  
  CONCLUSIONS
  A dose of CY at 2,000 mg/m2 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.
authors.affiliation: Vincent T. Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Swain
authors.forename: J
authors.initials: J
authors.lastname: Rowland
authors.forename: K
authors.initials: K
authors.lastname: Weinfurt
authors.forename: C
authors.initials: C
authors.lastname: Berg
authors.forename: M E
authors.initials: ME
authors.lastname: Lippman
authors.forename: L
authors.initials: L
authors.lastname: Walton
authors.forename: E
authors.initials: E
authors.lastname: Egan
authors.forename: D
authors.initials: D
authors.lastname: King
authors.forename: I
authors.initials: I
authors.lastname: Spertus
authors.forename: S F
authors.initials: SF
authors.lastname: Honig
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D004317:Doxorubicin; D003520:Cyclophosphamide