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Material comprising 569 cancer patients in clinical stages I-III is presented; recurrence, factors influencing recurrence and survival after recurrence have been studied. The 10-year recurrence rate for the whole material was 52%. Frequency of recurrence correlated with the clinical stage, the axillary biopsy finding and with the malignancy grade of infiltrating ductogenic carcinoma. The incidence ratio of local recurrence and distant metastases was 1:2; the most common site of the former being the chest wall and of the latter the viscera. After diagnosis of the first local recurrence, subsequent 5- and 10-year survival rates were 42% and 24% and after diagnosis of the first distant metastasis correspondingly 15% and 13%. Survival after the detection of axillary and supraclavicular metastases was better than after the detection of chest wall recurrences. Prognosis for distant metastases was best for soft tissue metastases and poorest for visceral and multiple metastases.

Four hundred forty-one women with operable breast cancer with histologically positive axillary nodes were randomized to receive either combination cyclophosphamide (60 mg/m2 orally everyday for 1 year); fluorouracil (300 mg/m2 intravenously [IV] weekly for 1 year); methotrexate (15 mg/m2 IV weekly for 1 year); vincristine (0.625 mg/m2 IV for 10 weeks); prednisone (30 mg/m2 orally days 1 to 14, 20 mg/m2 days 15 to 28, 10 mg/m2 days 29 to 42) (CMFVP) or single-agent melphalan (L-PAM) (5 mg/m2 orally every day for 5 days every 6 weeks for 2 years) chemotherapy after a modified or radical mastectomy between January 1975 and February 1978. Patients were stratified according to menopausal status and number of positive nodes (one to three, more than three nodes) before randomization. Seventy-eight patients were ineligible, most (56) because they were registered more than 42 days from surgery. Maximum duration of follow-up is 12 years, with a median of 9.8 years. The treatment arms were balanced with respect to age, menopausal status, and number of positive nodes. Among eligible patients, disease-free survival and survival were superior with CMFVP (P = .002, .005, respectively). At 10 years, 48% of patients treated with CMFVP remain alive and disease-free and 56% remain alive, compared with 35% alive and disease-free and 43% alive on the L-PAM arm. Disease-free survival and survival were significantly better with CMFVP compared with L-PAM only in premenopausal patients and patients with four or more positive nodes. Both regimens were well tolerated, although toxicity was more severe and more frequent with CMFVP. We conclude that after 10 years of follow-up, adjuvant combination chemotherapy with CMFVP is superior to single-agent L-PAM in patients with axillary node-positive primary breast cancer. The major advantage is in premenopausal women and in patients with more than three positive axillary nodes.

The most important discriminant in staging carcinoma of the breast is the presence of positive axillary lymph nodes. In this study, we determined if 45 female breast cancer patients originally classified as lymph node-negative by standard light microscopy (SLM) could be more accurately classified by immunohistochemical (IH) examination of their lymph nodes with an anticytokeratin monoclonal antibody cocktail. Identical sections of lymph nodes were sequentially examined by SLM and IH. Eight nodes (1%) in a total of five patients (11%) were positive by SLM. In comparison, 12 nodes (1.5%) in a total of nine patients (20%) were positive by IH. Five nodes were positive by IH and negative by SLM. There was no correlation between IH-detected metastases and tumor size or patient age. The survival curve for patients with IH-detected metastases was significantly worse than that of patients without IH-detected metastases. IH detection methods may be an important adjunct in staging breast cancer patients.

Metastases to the axillary nodes, the internal mammary nodes, or both, define a group of patients at very high risk of having systemic micrometastases leading to recurrent disease and death if surgical therapy alone is used. In our review of 7,070 patients with breast cancer in whom both axillary nodes and internal mammary nodes were examined histologically, 5% to 10% had internal mammary node metastases in the absence of axillary node metastases. With the availability of effective systemic therapy that can improve the survival of patients with operable breast cancer who have lymph node metastases, information obtained from internal mammary node biopsies assumes practical significance. Our current policy is to perform internal mammary node biopsies on patients with operable breast cancer who have medial and central primary tumors of any size and lateral primary tumors 2 cm or greater in diameter if a frozen section of the most suspicious node in the axillary dissection shows no histologic evidence of metastasis.