WEDNESDAY, Aug. 21, 2002 (HealthDayNews) -- When it comes to mastectomies, new research shows that more is not better.
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.
"This was one of the most important trials ever in breast cancer," says Dr. Alan J. Stolier, medical director of the Lieselotte Tansey Breast Center at the Ochsner Clinic Foundation in New Orleans. "It told us that what we thought might be true intuitively was not true, that more was not better. The cure was the same whether we did a more simple procedure versus a more radical procedure. This trial was one that was given credit for doing away with most radical breast surgery."
"This opened the door for what we are now doing," says Dr. Bernard Fisher, the study's author and scientific director of the National Surgical Adjuvant Breast and Bowel Project (NSABP), which conducted the trial. "This was the turning point in the story of the surgical management of breast cancer, plus it led to the understanding that you weren't going to cure more people by bigger operations, and that you needed systemic therapy in order to do that. And that opened the door for chemotherapy."
In 1971, when the study first started enrolling women, radical mastectomy -- in which the entire breast, muscles of the chest wall and nearby lymph nodes are all removed -- was the norm.
However, not all doctors agreed and they pushed for less invasive procedures. To resolve the controversy, the NSABP started the B-04 trial.
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.
"There was no difference in the outcome by any of the three methods," Fisher says.
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.
Stolier, then a resident, operated on some of the women in the trial and remembers waiting in the operating room with the whole surgical team for the biopsy results to come back. If the diagnosis was cancer, Stolier was handed a white envelope that contained which of the three procedures he was to perform on the woman, still asleep on the operating table.
Part of the significance of the trial is its sheer length.
"I don't know of anything else that long," Fisher says. "It provides the first real solid natural-history information to what happens to these women."
A substantial proportion of women had recurrences of breast cancer after the watershed five-year mark, indicating the need for long-term follow-up, even when the patient has a good prognosis.
Because none of the women in the study received chemotherapy, the trial also serves as a good baseline for what is accomplished with the addition of chemotherapy, Fisher says.
"I don't know of any other studies that really have that information," he adds.
What To Do
For more information on cancer trials, visit the National Surgical Adjuvant Breast and Bowel Project.
Here is a primer on the different types of mastectomies.
