Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy.

BACKGROUND: The need to dissect axillary nodes in patients with early breast cancer and clinically negative axilla remains controversial. The aim of the study was to assess the role of axillary radiotherapy (RT) in reducing axillary metastases in patients with early breast cancer who did not receive axillary dissection. PATIENTS AND METHODS: From 1995 to 1998, 435 patients over 45 years old with breast cancer up to 1.2 cm and no palpable axillary nodes were randomized 214 to breast conservation without axillary treatment and 221 to breast conservation plus axillary RT. RESULTS: After a median follow-up of 63 months, overt axillary metastases were fewer than expected: three cases in the no axillary treatment group (1.5%) and one in the RT group (0.5%). Expected cases were 43 in the no axillary treatment group and 10 in the RT group. Rates of distant metastases and local failures were low, and 5-year disease free survival was 96.0% (95% confidence interval, 94.1%-97.9%) without significant differences between the two arms. CONCLUSIONS: This study suggests that occult axillary metastases might never become clinically overt and axillary dissection might be avoided in patients with small carcinomas and a clinically negative axilla. Axillary RT seems to protect the patients from axillary recurrence almost completely.

Single-agent epirubicin as primary chemotherapy in T2-T3, N0-N2, M0 breast carcinoma: 6-year follow-up.

OBJECTIVE: Single-agent epirubicin was tested as primary chemotherapy treatment in patients with early breast cancer >3 cm. METHODS: 100 women with locally advanced breast cancer >3 cm were treated with three cycles of single-agent epirubicin at a dose of 120 mg/m2. All patients showing tumor shrinkage to less than 3 cm were considered candidates for conservative surgery (quadrantectomy); in the remaining patients modified radical mastectomy was carried out. Postsurgical treatment consisted of CMF chemotherapy except for postmenopausal node-positive, estrogen-positive patients who were assigned to hormonal treatment with tamoxifen and postmenopausal node-negative, estrogen-positive ones who did not receive any treatment. RESULTS: Quadrantectomy was carried out in 71 patients. At the median follow-up time of 69 months, the relapse rate was 29.6% among patients who underwent quadrantectomy (21 out of 71) and 58.6% among patients who underwent modified radical mastectomy (17 out of 29). CONCLUSIONS: Single-agent chemotherapy with anthracyclines could appear to be an effective treatment in inducing a tumor downstaging in patients with early breast cancer >3 cm. This treatment can be administered outside clinical trials in patients who desire to preserve their body integrity. Further prospective, randomized trials are needed in order to validate and better define the role of epirubicin in the neoadjuvant strategy of breast cancer patients.