Randomized clinical trial to assess the effectiveness of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer.

BACKGROUND: Although the conservation management of breast cancer has become a routine method of treatment in most centers, there is still considerable controversy surrounding the ultimate minimum treatment required for node-negative breast cancer to achieve adequate local control. PURPOSE: Our purpose was to assess the value of breast irradiation in reducing breast relapse following conservation surgery for node-negative breast cancer. We attempted to define low-risk groups of women for breast and distant site relapse (i.e., recurrence outside the breast) who might be spared breast irradiation or adjuvant systemic therapy. METHODS: Eight hundred thirty-seven patients were randomly assigned to receive radiation therapy or no radiation therapy following lumpectomy and axillary dissection for node-negative breast cancer. RESULTS: Breast irradiation reduced relapse in the breast from 25.7% in the controls to 5.5% in the irradiated patients. There was no difference in survival between the two groups (median follow-up, 43 months). A low-risk group (less than 5% chance of relapse in the breast without irradiation) could not be defined. Tumor size (greater than 2 cm), age (less than 40 years), and poor nuclear grade were important predictors for breast relapse. Age (less than 50 years) and poor nuclear grade were important predictors for mortality. The presence of ductal carcinoma in situ did not predict breast relapse. CONCLUSIONS: Breast irradiation significantly reduces breast relapse, but it does not influence survival. Important predictors of breast relapse are age, tumor size, and nuclear grade, but not the presence of ductal carcinoma in situ. Age and, in particular, nuclear grade predict survival. IMPLICATIONS: Further follow-up may define an acceptable low-risk group for breast relapse. Until then, we recommend that all patients receive breast irradiation. Systemic adjuvant therapy should be considered for patients with poor nuclear grade tumors.

Intracavitary radiation for rectal carcinoma.

Thirty-five patients with low-lying rectal adenocarcinoma have been treated with intracavitary radiation (Papillon's technique). Twenty-three were treated for cure and 12 for palliation. The indications for curative intracavitary radiation were mobile polypoid tumors, less than 3 cm in diameter, with Broder's Grades I and 2 differentiation lying less than 11 cm from the anal verge. Doses between 2 000 and 4 000 cGy were delivered to a total of 7 000 to 20 000 cGy with complete resolution of the tumors. Eighty-seven per cent in the curative group are alive and well up to 42 months after treatment with a minimum follow-up of six months. Of the 23 patients treated for cure, three patients had recurrences within 18 months of therapy. Two of the three patients are alive following surgery. The third patient died in the postoperative period. The results of intracavitary radiation are comparable to ablative surgery and avoid a permanent colostomy. Age, frailty, or other medical conditions do not preclude this treatment. Anesthesia and hospitalization are not required. This method can also be used for palliation of recurrent tumors and in patients who are unsuitable for surgery.