The Rise and Fall of the Radical Mastectomy

And the Clinical Trial that Led to Its Demise

For most newly diagnosed breast cancer patients, the option of breast conserving surgery (lumpectomy followed by radiation or simple mastectomy) is taken for granted. But that was not always the case. Forty years ago radical mastectomy was the standard of care. It took a controversial and landmark clinical trial to spare women from this unnecessary and disfiguring surgery.

William S. Halsted, an accomplished young surgeon at Johns Hopkins, first performed the “radical mastectomy,” also known as the Halsted procedure, in 1882. With surgery as a breast cancer patient’s only option, a woman treated by Halsted (and the many surgeons who followed his method) not only had her entire breast removed, but also the surrounding tissue, lymph nodes and the pectoral muscles. Halsted hypothesized that breast cancer grew in a slow, orderly way, spreading from the breast to the lymph nodes and finally to other parts of the body. Despite the resultant disfigurement, Halstead believed that the more extensive the surgery, the less likely the cancer would be to return.

Halsted’s procedure and his belief about the pathology of cancer persisted among physicians in the United States for a very long time. It was not until 1951 that another cancer surgeon seriously challenged Halsted’s underlying assumptions.  Ian MacDonald, a Canadian teaching in Los Angeles, argued that the relative aggressiveness of breast and other cancers was biologically determined and did not necessarily conform to Halsted’s “one size fits all” model of growth. That being the case, radical mastectomy might not be necessary for all women, especially those with slow-growing tumors.

Relatively few surgeons supported MacDonald’s theory. One of them was George “Barney” Crile, Jr., whose father, also a cancer surgeon, was renowned for describing in horrific detail the effects of radical mastectomies on his patients. In the early 1950s, Crile, Jr., became the first surgeon in the United States to offer women a choice – radical mastectomy or simple mastectomy. He performed his last radical mastectomy in 1954. Praised for his actions by a small but vocal group of patients, Crile’s less extensive simple mastectomy was vigorously attacked by his colleagues, some of whom considered it “equivalent to malpractice.”

By the 1960s, the lines were drawn: surgeons were either for or against radical mastectomy citing published case reports based on their own subjective clinical experience. At the same time, breast cancer patients increasingly began to question the efficacy of the Halsted procedure. Among the clamor, another group argued that the only way to objectively determine the effectiveness of radical mastectomy was through a randomized clinical trial, a relatively new concept at the time (Note: The first clinical trial was conducted in 1948 to evaluate the use of streptomycin for tuberculosis). But many physicians disagreed with the whole notion of gathering objective evidence: they didn’t support patients being randomly assigned to one surgical procedure or another nor would they trust the results, preferring to rely on their own experiences of working with patients and monitoring outcomes.

If ever there was a person to unite the contentious parties, it was Bernard Fisher, a prominent surgeon-scientist. Starting in 1958, Fisher pursued a life-long interest in breast cancer research straddling both the laboratory and clinic. From laboratory studies on tumor metastasis, he theorized that breast cancer was a systemic disease and that those women associated with poor survival outcomes were likely to have undetected tumor cells that had already spread to distant organs at the time of diagnosis. If this was true, then radical mastectomy was unlikely to improve outcomes over simple mastectomy.

Eager to apply scientific principles to his hypotheses, in 1967, Fisher became the first chair of National Adjuvant Breast and Bowel Project (NSAPB). Under his leadership NSABP launched NSABP-04 in 1971, the first randomized trial in America that compared radical mastectomy with simple mastectomy or simple mastectomy followed by radiation therapy. Published in 1974, its early results based on findings from 1,700 patients enrolled at 34 institutions, showed that the survival outcomes for patients were the same regardless of which type of treatment was performed.

Despite the mounting evidence to the contrary, many surgeons continued to advise their patients that the Halsted procedure was in their opinion the ‘safest’ treatment. But as later results from NSABP- O4 and other trials confirmed the efficacy of the simple mastectomy, the medical profession altered its standard treatment for breast cancer patients. In 1983, there were only 5,000 radical mastectomies performed in the country (down from 46,000 in 1974).

The controversy surrounding radical mastectomies has had far reaching consequences that continue to be felt. Not only did it pave the way for the acceptance of clinical trials as the standard by which all advances in breast cancer are evaluated (BreastCancerTrials.org currently lists over 500 U.S. breast cancer studies), but it also empowered women for the first time to talk openly about their experiences of breast cancer and to be actively involved in their care. With their “collective voice,” these women found a place at the table alongside health policy makers, funders, and research investigators. Breast cancer patient advocacy had been born.

Further Reading

The Breast Cancer Wars: Hope, Fear, and the Pursuit of a Cure in Twentieth-Century America Barron H. Lerner, Oxford University Press, 2001

Bernard Fisher Reflects on a Half-Century’s Worth of Breast Cancer Research Interview with Kate Travis, 2005

The Emperor of All Maladies: A Biography of Cancer, Siddhartha Mukherjee, Simon & Schuster, Inc., 2010