Patient safety research – how important?

If you are working on oncology studies, have you noticed that complete radical mastectomy is usually reported pre-1980 for breast cancer patients. Have you thought about the reason?

Radical mastectomy used to be a norm in America after Halsted first established the procedure in 1894. This Surgery entailed removal of breast, chest muscles, and all of the lymph nodes under the arm, and this was thought to be the only option to treat breast cancer. Halsted based his surgery on centrifugal theory. In Emperor of all maladies, Siddhartha Mukherjee explains this as – cancer like a malevolent pinwheel, tended to spread in ever-growing arcs from a single central focus in the body. A surgeon’s job was to arrest the centrifugal speed by cutting every piece of it out of the body, as if to catch and break the wheel in midspin. The more a surgeon cut, the more it cured. However, morbidity after the operation was great, because the large wounds were left to heal by granulation, lymphedema was near universal, and arm movement was severely restricted (due to pectoralis muscle removal and damage to axilla nerves). For these reasons, chronic pain was also an important sequela. 

Another oncologist Geofferey Keynes was not so convinced about Halsted’s theory. 1n 1924, from experience with his patients, he saw that a lumpectomy, a much less invasive procedure along with radiation, worked just as well but with much less morbidity. The relapse rates were almost equal as with Radical mastectomy but the quality of life for the patients was much better. He presented his data but his ideas were not taken seriously as the surgeons of that time were completely sold to the centrifugal theory. 

In 1953 (almost 30 years later), George Crile, a follower of Halsted theory started having his doubts about radical mastectomy. His research and studies revealed that the cancer spread was more erratic and unpredictable. The patients treated with radical mastectomy also relapsed and died due to metastasis. He came to understand that either the breast cancer is a highly localised disease – thus curable by a smaller mastectomy – or an inherently systemic disease – thus uncurable event by the most exhaustive surgery. He gave up radical mastectomy altogether and started following the Keynes’s procedure and saw that the survival rate of patients in the two surgeries had no difference. Separated by 40 years of clinical practice, both Keynes and Crile had seemingly stumbled on the same clinical truth.

However, it took another twenty years, and dedicated efforts and clinical trials by another great oncologist Bernard Fisher to establish the futility and danger of a complete radical mastectomy. It will also be interesting to note that the withdrawal of radical mastectomy was also sped up due to the thalidomide disaster in 1960s. Fallibilities in the medical discipline surfaced and patients recognized that one of the most common and disfiguring operations was never tested in a trial, women refused radical mastectomies. Clinical trials were conducted by Fisher to prove his findings! However, they were not without obstacles. It took him around 10 years to gather all data.

Meanwhile, more mutilating and invasive procedures liked extended radical mastectomy were also tried and abandoned due to high mortality rates! 

A radical mastectomy is rarely performed now and has been replaced by less invasive procedures. I wonder if medical fraternity at that time was more accepting of the new ideas and theories, would it have taken as much as almost a century to reach this decision?

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