Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

OBJECTIVES:

Primary

• Determine the independence of older women with resected stage I, II, or III breast cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide.

Secondary

• Determine the impact of this regimen on other aspects of the patient's life, utilizing the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment, the Folstein Mini-Mental State Exam, the Geriatric Depression Scale, and the Cumulative Illness Rating Scale-Geriatrics.
• Determine the quality of life of patients treated with this regimen.
• Determine the acceptability of this regimen in these patients.
• Determine the toxicity of this regimen, in terms of cardiac issues and anemia, in these patients.
• Determine recurrence-free survival, event-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a pilot, nonrandomized, multicenter study.

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires at baseline and after completion of chemotherapy. Questionnaires include the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment (malnutrition), the Folstein Mini-Mental State Exam (cognitive function), the Geriatric Depression Scale (depression), the Cumulative Illness Rating Scale - Geriatrics (comorbidities), and the EORTC Quality of Life Questionnaire Core 30 (quality of life).

After completion of study therapy, patients are followed every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the breast

• Stage I, II or III disease

• pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)
• No metastatic disease
• Must have undergone prior conservative or radical surgery that included axillary lymph node or sentinel node dissection

• No residual tumor
• Negative margins
• Hormone receptor status:

• Estrogen receptor and progesterone receptor negative

PATIENT CHARACTERISTICS:

• Female
• Postmenopausal
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 10 g/dL
• Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
• Bilirubin < 1.25 times ULN
• AST and ALT < 2.5 times ULN
• Creatinine clearance ≥ 40 mL/min
• No contraindication to receiving anthracyclines or alkalizing agents
• FEV normal
• Activities of Daily Living (ADL) score ≥ 5

• No decrease of ≥ 1 point within the past 3 months
• None of the following at baseline:

• Cognitive deficiency (Folstein Mini-Mental State < 25)
• Severe depression (Geriatric Depression Scale ≥ 20)
• Severe malnutrition (Mini-Nutritional Assessment ≤ 17)
• No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics grade 3-4), including any of the following:

• Cardiac insufficiency
• Unstable angina
• Myocardiopathy
• Myocardial infarction within the past year
• Uncontrolled hypertension
• Uncontrolled high-risk arrhythmia
• Severe medullary insufficiency
• Neurological or psychological condition that would preclude study consent
• Uncontrolled or active infection
• Severe urinary tract infection
• Preexisting hematuria
• Active ulcer
• Uncontrolled diabetes
• No other cancer within the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
• No familial, geographical, social, or psychological condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 60 days since prior therapeutic surgery
• At least 4 weeks since prior investigational drugs