Update on NSABP Protocol B-04

This is a clinical trial that began in 1971. It looked at comparison of the radical mastectomy created by Halsted to the total or simple mastectomy.

Follow up continued - a recent study published the following exerpts (as interpreted by Associated Press):

"A 25-year update of the first randomized clinical trial to ever look at this issue finds that a radical mastectomy is not more effective than a simple mastectomy, in which lymph nodes and muscles are left in place. In this latest follow-up, both procedures produced essentially the same survival rates.

The findings appear in tomorrow's issue of The New England Journal of Medicine. The "B-04" trial, as it is called, launched the trend towards less surgery to treat breast cancer.

The study involved 1,765 women who were randomly assigned to one of three groups. The first group received a radical mastectomy. The second got a simple mastectomy, plus radiation. The third received a simple mastectomy without radiation.

Twenty-five years later, the survival rate for all three groups was 14 percent if their lymph nodes tested positive for cancer at the time of surgery. The survival rate for all three groups was 23 percent, on average, if the lymph nodes tested negative for cancer at the time of surgery.

At the time the trial started, biopsies and mastectomies were done at the same time, while the woman was under general anesthesia."

Musa Mayer, advocate replies:

"Overall 25 year survival for women diagnosed and treated in 1975 is 50%, according to the SEER stats."

From the actual journal article:

"The cumulative incidence of death among the 1665 eligible patients was 80 percent during the 25 years of follow-up; 49 percent died after a recurrence or contralateral breast cancer, 31 percent died without a diagnosis of any breast-cancer–related event, and 20 percent were alive at last follow-up."


Radical Mastectomy Vs. Total Mastectomy

docguide.com on NSABP B-04 Report 8/02


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