Lumpectomy or Radical Mastectomy?

Summarized by Robert W. Griffith, MD
November 4, 2002 (Reviewed: November 13, 2004)

Introduction

About 100 years ago Halstead introduced his technique for radical mastectomy, which soon became the treatment of choice for almost any breast cancer, regardless of the size, type, or the patient's age. It is a severely invasive procedure, which instinctively would seem to prevent local recurrence to a greater degree than any less aggressive approach. However, about 30 years ago surgeons started to employ breast-conserving techniques, variously known as quadrantectomy or lumpectomy, which were accompanied by axillary node removal. In 1973 and 1976 two major randomized studies were begun, comparing breast-conserving surgery with mastectomy. The 20-year follow-up results have just been published in the New England Journal, and are summarized here.

The first study

This study was initiated in 1973 in Milan, Italy, comparing radical mastectomy with breast-conserving surgery in women up to 70 years of age who had a breast cancer with a diameter of 2 cm or less, and no palpable axillary nodes. After excisional biopsy under general anesthesia, leading to tumor confirmation and sizing on frozen section, patients were randomized to undergo either radical (Halstead) mastectomy alone, or quadrantectomy combined with complete axillary dissection and postoperative radiotherapy to the ipsilateral mammary tissue. For the first 3 years of the study enrollment, half those patients with positive axillary nodes were given additional radiotherapy to the supraclavicular and internal mammary nodes. From 1976 to 1980, all those with positive axillary nodes received 12 monthly cycles of chemotherapy (cyclophosphamide, methotrexate, and fluoruracil).

The median follow-up period was 20 years. Times from the day of surgery to local recurrence, contralateral breast carcinomas, regional or distant metastases, and cancer-specific deaths, were the major endpoints for analysis.

There were 701 women enrolled in the study - 349 who had radical mastectomies, and 352 who had quadrantectomies. Their mean age was 50.5 years, and 55% were premenopausal. Axillary node metastases were found in 24.6% of those who had radical mastectomies, and in 27% of those with quadrantectomies.

After 20 years, a significantly greater proportion of women had experienced local recurrences in the breast-conserving group (8.8%) than in the radical mastectomy group (2.3%). However, there were no differences in the rates of contralateral breast carcinomas, distant metastases, or fresh primary cancers.

The overall death rates (all causes) were 41.7% and 41.2% for the breast-conserving and the radical mastectomy groups, respectively. Death rates attributed to breast cancer were 26.1% and 24.3% for these groups, respectively.

The second study

The National Surgical Adjuvant Breast and Bowel Project (NSABP) initiated this study in 1976. It was designed to compare outcomes in women who had lumpectomy alone, lumpectomy with irradiation, or total mastectomy. During the first 7 years of the study 2,163 women with invasive breast tumors 4 cm or less in diameter were randomly assigned one of these three treatments. All of them had axillary nodes removal - the lower two levels of nodes for the groups receiving lumpectomies, and total clearance in those having total mastectomies. The group treated with irradiation had radiation to the breast, but not to the axilla. All those with any positive axillary node received adjuvant chemotherapy (melphalan and fluoruracil). Women who had lumpectomy whose resection specimen margins showed incomplete removal (about 10%) underwent total mastectomy.

There were 1,851 women whose nodal results were known, and formed the basis for the published analysis - 589 had total mastectomies, 634 had lumpectomies alone, and 628 had lumpectomies plus irradiation. About 60% of them were 50 or older, and 62% had negative nodes.

Over the 20-year follow-up period, local recurrences were reported in 14.3% of the lumpectomy plus irradiation group, compared with 39.2% in the lumpectomy-alone women (p<0.001). This finding was independent of node status. There were no differences between the three groups with respect to the rates of contralateral breast carcinomas, distant metastases, or fresh primary cancers.

The overall 20-year death rates (all causes) were similar for all three groups - 52.8% for total mastectomy, and 54% for both lumpectomy alone and lumpectomy with irradiation. The death rate attributed to breast cancer for the whole collective was 40.4%, without significant differences between the groups.

Conclusions

The results of these two pivotal studies are similar. There is no evidence that mastectomy has a significant 20-year survival advantage over breast conservation.

The types of conservative surgery employed - quadrantectomy and lumpectomy - differ in the degree of invasiveness. In quadrantectomy, the tumor is removed with a 2 to 3 cm cuff of tissue, together with skin, pectoral fascia and pectoralis minor muscle; there is a total axillary dissection. Lumpectomy involves removal of the tumor and sufficient normal tissue to ensure the margins are free of tumor; nodal dissection is limited to the lower two levels of the axilla. Obviously, quadrantectomy is less likely to provide a cosmetically satisfactory result.

Death rates ranging from 42% to 54% may seem alarming, but they should not be - the average age of survivors at the end of the follow-up period was about 70 years of age. Absence of an increase in contralateral breast cancer in irradiated patients indicates that the dose of radiation was not carcinogenic.

An increased rate of local recurrence with breast-conserving surgery (as seen in both studies) has also been a concern in the past. However, the absence of any differences in breast-cancer related deaths after 20 years indicates that death was due to occult distant foci of cancer cells, rather than the extent of local surgery.

It is clear that every woman with breast cancer should be fully informed of the availability of breast-conserving therapy, and whether it's a suitable option in her particular situation. This is not, at present, the case. In 1999, almost 30% of women with breast cancer in one metropolitan USA area were only offered the option of total mastectomy at their first consultation. We must hope this state of affairs will change, based on the findings from these two studies.

Sources

• Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. U. Veronesi, N. Cascinelli, L. Mariani,  et al., N Engl J Med, 2002, vol. 347, pp. 1227--1232



• Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. B. Fisher, S. Anderson, J. Bryant,  et al., N Engl J Med, 2002, vol. 347, pp. 1233--1241

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