Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study

The aim of this trial was to study the value of adding post-operative radio therapy to lumpectomy in a subgroup of breast cancer patients with favourab le patient-, tumour-, and treatment-related prognostic features. 152 women aged over 40 with unifocal breast cancer seen in preoperative mammography w ere randomly assigned to lumpectomy alone (no-XRT group) or to lumpectomy f ollowed by radiotherapy to the ipsilateral breast (50 Gy given within 5 wee ks, XRT group). All cancers were required to be invasive node-negative, sma ller than 2 cm in diameter and well or moderately differentiated, to contai n no extensive intraductal component, to be progesterone receptor-positive, DNA diploid, have S-phase fraction less than or equal to7 and be excised w ith at least 1 cm margin. During a mean follow-up time of 6.7 years, 13 (18 .1%) cancers recurred locally in the no-XRT and 6 (7.5%) in the XRT group ( P = 0.03). There was no difference between the groups in the ultimate breas t preservation rate (95.0% vs. 94.4% in XRT and no-XRT, respectively, P = 0 .88), distant metastasis-free survival (P = 0.36), or 5-year cancer-specifi c survival (97.1% in XRT and 98.6 in no-XRT). Radiation therapy given after lumpectomy reduces the frequency of ipsilateral breast recurrences even in women with small breast cancer with several favourable clinical and biolog ical features. However, the breast preservation rate may not increase due t o more frequent use of salvage mastectomies in patients treated with postop erative radiotherapy. (C) 2001 Cancer Research Campaign.