Breast Cancer Update
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CHARLAYNE HUNTER-GAULT: A 1985 study first showed that limited surgery combined with radiation therapy works just as well as extensive surgery as a treatment for small breast tumors. The smaller operation is known as a lumpectomy. Removal of the entire breast is known as mastectomy. But last year, fraud charges against one of the researchers raised doubts about the study. Today, the “New England Journal of Medicine” has published the latest findings, upholding the study. Here to tell us what it all means is Dr. Christine Berg, the director of the Breast Radiation Oncology Section at Georgetown University Medical Center. And Dr. Berg, tell us about first the original study and its conclusions and then what led to the controversy.
DR. CHRISTINE BERG, Georgetown University Medical Center: I’d be very happy to, Charlayne. The study was conceived quite a number of years ago to look at the best treatment for the breast for women with early-stage breast cancer. And the goal was to find out which types of treatments would be most appropriate. There were three groups of women, one group treated with mastectomy, the removal of the whole breast, another treated with lumpectomy alone, and then a third group treated with lumpectomy with radiation. The study was first published in 1985, and then updated in 1989, and then the results at that time indicated that the treatment arms were identical in terms of long-term survival.
CHARLAYNE HUNTER-GAULT: All three of them.
DR. CHRISTINE BERG: All three of them. As, as you mentioned–
CHARLAYNE HUNTER-GAULT: So that, in other words, a woman didn’t have to go to the radical step of having her whole breast removed, but could have the lumpectomy or just, or the lumpectomy with radiation, the lesser?
DR. CHRISTINE BERG: A woman could opt to have both lumpectomy with the radiation, or the mastectomy. The lumpectomy alone arm is showing a higher in-breast recurrence rate, and so we’re advocating treatment either with the lumpectomy with radiation or the mastectomy.
CHARLAYNE HUNTER-GAULT: But then a controversy arose because there were suggestions that the study was tainted, right?
DR. CHRISTINE BERG: Yes. The controversy arose because the group that did the study, the National Surgical Adjuvant Breast Project, NSABP, noticed that some of the data from one investigator in Montreal was tainted, and they found that out of the over three hundred patients that he had enrolled six of those patients had data that was not accurate.
CHARLAYNE HUNTER-GAULT: How bad was it? I mean, how tainted was it?
DR. CHRISTINE BERG: Well, it–what he had done was, you know, for like a date of surgery, he had–in order to ensure that the woman met the entry criteria, he might have modified the date by a few days. And so it–you know–it didn’t all–and he knew that he was modifying the date.
CHARLAYNE HUNTER-GAULT: Modifying what date?
DR. CHRISTINE BERG: The date that the woman would have originally had the surgery.
CHARLAYNE HUNTER-GAULT: Oh, I see.
DR. CHRISTINE BERG: You have to start the treatment, you know, the radiation with a certain number of days, you know, to meet the study entry criteria. And in order to ensure that a woman might be still eligible, he would push the date of the surgery up a little bit–
CHARLAYNE HUNTER-GAULT: And that–
DR. CHRISTINE BERG: Well—
CHARLAYNE HUNTER-GAULT: And that could affect the outcome?
DR. CHRISTINE BERG: Well, one would then wonder about is he accurately reporting all of the information about the women in terms of their results.
CHARLAYNE HUNTER-GAULT: Okay. So what does today’s audit show?
DR. CHRISTINE BERG: Today’s audit went back and investigated all of the charts from the major institutions that participated in the trial. The National Cancer Institute sent out a team of 76 investigators to pull these records, look over all the important details regarding the dates of treatment, the results of treatment, to confirm the validity of the information; they went to the charts individually and pulled those and looked at them. And they verified that the data that had been entered into the analysis was accurate.
CHARLAYNE HUNTER-GAULT: And so now the conclusion takes us back to the original study.
DR. CHRISTINE BERG: The conclusion–in parallel with the audit, the “New England Journal of Medicine” published a–the update, the 12-year update of the NSABP results, confirming that lumpectomy and radiation when compared directly to mastectomy is identical in terms of long-term disease-free survival for women.
CHARLAYNE HUNTER-GAULT: So in terms of the women out there, I think the incidence now is about 180,000, is that right?
DR. CHRISTINE BERG: That’s correct, in 1995.
CHARLAYNE HUNTER-GAULT: What should they be thinking now, and what would you be telling them?
DR. CHRISTINE BERG: Yes. I deal with this every day. I mean, I see a lot of women with breast cancer. I think the most important thing for them to do is to gather information about the particulars of their situation, discuss with their physician, or even better, a group of physicians to find out what’s best for them.
CHARLAYNE HUNTER-GAULT: All right. Well, Dr. Berg, thank you for joining us.
DR. CHRISTINE BERG: Thank you very much.