SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial

OBJECTIVES:

• Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin, and fluorouracil on protocol SWOG-8897.
• Estimate the frequency of late cardiac effects (congestive heart failure, cardiac ischemic events, and clinical symptoms) in these patients treated with these regimens.
• Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens.

OUTLINE: This is a multicenter study.

The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897. The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study, and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial accrual is completed, approximately 50 additional patients will be accrued at 10 years.

DISEASE CHARACTERISTICS:

• Women registered on Arm I, II, III, or IV of protocol SWOG-8897 who have completed at least 1 course of assigned chemotherapy

• Completion of tamoxifen therapy not required
• Registration to current study required between 5.25-8 years or 10-11 years after randomization to protocol SWOG-8897
• Patients must be diagnosed disease-free with no prior recurrence after registration on protocol SWOG-8897
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Pre- and postmenopausal

Performance status:

• Not specified

Life Expectancy:

• At least 5 years

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Pregnant or nursing women not eligible for nuclear medicine (MUGA) portion of study
• Fertile patients must use effective contraception during and for 1 month after MUGA

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior chemotherapy for second primary malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for second primary malignancy

Surgery:

• Not specified