Remove breast or just lump?
That decision is deemed too close to called by many experts. It is for that reason a study that will once and for all give a definitive answer is being done at the National Cancer Institute (NCI). With a team of dedicated researchers, Dr. Peggie Findlay, breast-cancer radiology specialist for NCI, is undertaking an extensive research study that will randomly assign half of newly diagnosed female breast-cancer patients to lumpectomies with radiation and the other half to mastectomies.
For a newly diagnosed breast cancer patient participating in the program, the food, lodging and all medicine, doctor bills, treatments and travel expenses for follow-ups are paid for by the National Cancer Institute. If she meets the criteria and elects to participate in the study, all subsequent transportation is paid for, no matter if the patient is from Alaska or from Hawaii. "It's a small investment to know the truth about which treatment is most effective," says Dr. findlay.
We asked her to explain the randomized nature of the trial study.
Dr. findlay: Most of the information we have to date is not complete enough, and we need to know how to advise patients. There are many controversies in the treatment of all stages of breast cancer and certainly the early stages of breast cancer. Right now, a patient with early stage breast cancer will undergo the standard treatment in this country--modified radical mastectomy. That's a very good cancer treatment. We have a lot of experience with it. But we don't have as much experience with the lumpectomy and postoperative radiation therapy for the rest of the breast. What we are trying to do here at NCI is to determine in a scientific way if that procedure--removal of the lump and the administration of radiation therapy--is as good a cancer treatment as modified radical mastectomy.
Now in order to do that, we have to be very careful. It's possible for me, as a physician, knowing what I know about breast cancer, to take a patient and to look at certain characteristics and for me to make an estimate as to whether that person is going to do well. I can also look at another person and say, "O.K., I think this patient isn't going to do very well at all." If I have two treatments, I can say, "I'm going to give all the patients that I think are going to do well treatment A, and I'll give all the patients that I don't think are going to do well treatment B." Now, if I go back and look at the results of that treatment in five years or ten years, what happened? Treatment A--where all the patients who I've picked were going to do well--treatment A is going to look terrific. And treatment B is going to look awful. That doesn't say anything about the treatment, that just says something about my ability to pick patients. That's the objection that a lot of doctors have made about offering patients lumpectomy and radiation therapy. They say that treatment looks good because the physicians who give it have picked good patients. What we are doing here is picking all patients who are early-stae breast cancer, who we think are suitable for this trial, and then letting the computer pick out the treatment that patient will receive. In this way, we don't bias the outcome, and we'll have a true answer as to which treatment is better, if one is better than the other. I should mention to you that as part of the mastectomy treatment, we offer everyone breast reconstruction, and I encourage them to have that.
Clearly, there are women who know which treatment they want, and that's O.K. They can get that treatment. They can get good treatment. But there are patients who don't know which treatment is best. The decision is very difficult and those undecided patients do very well here. I think all of our patients feel very good because they know that they are contributing to what happens to all of the other American women, besides getting good medical treatment. We are very grateful to our patients for comping here and participating in this study. We feel that because they are contributing to our knowledge, we need to provide them with all of their medical care related to their breast cancer. Once someone comes here to the NCI, we provide their physicians and we furnish their tests, we provide their surgery, we provide their drugs and we bring them back for a follow-up. We put them up in a hotel if they need tests, or things like that.
Dr. SerVaas: How many women do you need to have statistically significant results?
Dr. Findlay: I think we would be very confident in the results that we get from the study if we had a minimum number of 250 patients in the trial. We'd like to have 300, but we can do it with 250.
Dr. SerVaas: Do you think that doctors in the past may have been giving patients the lumpectomy when they were young and attractive and still had a lot of sexual interest?
Dr. Findlay: It's interesting. I think that there are physicians who have said, "Well, people who are younger are more interested in preserving a breast than people who are older," but I had a number of experiences in treating patients 75 and 80 years old who were just as interested as people who were 20. I think that this may not be quite so well understood by a number of doctors--how important the body image is to women.
Dr. SerVaas: How long will the study go on? Until the NCI has something to say to women?
Dr. Findlay: Well, certainly we are planning on continuing to follow those women who are entered into the study for a long period of time. Hopefull, longer than ten years. This doesn't mean that it would have to be ten years before we could get some meaningful results as to which treatment is better.
Dr. SerVaas: So you're saying that you might be able to release some information about the study sooner?
Dr. Findlay: Oh yes. Ideally, we would like to have an average follow-up of patients in the study of about four years. We could really make some substantive statements at that point about the results.
Dr. SerVaas: You'd probably like to get the entire 250 to 300 women under treatment as soon as possible so that you wouldn't have a long time between the first one begun and the last one to enroll.
Dr. findlay: Exactly.
Dr. SerVaas: Could you give as any criteria for participation? Are there andy women turned down because their cancer is too advanced?
Dr. Findlay: This specific study is addressing women with stage-one and -two breast cancer. That is, lumps that are five centimeters [about two inches] or smaller without skin involvement or skin ulceration and without lymph nodes that we can feel underneath the arm or that, if we can feel, are freely movable and not very large. There can be no other evidence of disease elsewhere or of cancer elsewhere in the body. Those are the people suitable for this particular trial. However, patients with just about every stage of cancer are being studied here, so that if we get a patient inquiring about this study who we discover has a bigger lump, other studies that we are currently conducting here are suitable for those patients.
If we look at the National Cancer Institute as a whole, ever since its inception, it has attracted physicians who were interested in breast cancer research.
Dr. SerVaas: Could you describe what happens when the newly diagnosed patient first arrives at the Institute?
Dr. Findlay: Typically, the patient is interviewed by the radiation, medical and surgical oncologists. There are a number of tests and physical examinations and other clinical studies carried out. We go over all those studies and findings with the patient and again discuss the differences in treatment and alternatives offered on the study. Then the computer picks a number and tells us which treatment the patient will get. Usually the surgery is going to be scheduled for several days following that randomization procedure.
SerVaas: Is there much difference in the length of hospitalization for the two options?
Dr. Findlay: No. One option is the lumpectomy with axillary node [underarm lymph node] dissection. Most of the surgery in that option is the axillary node dissection, and the patients are generally in the hospital recovering from that surgical procedure for about seven to ten days. The other patients, who receive a modified radical mastectomy, have the lymph nodes under the arm removed and the breast removed, but again, the major recovery time is involved in recovering from removal of axillary lymph nodes. Those patients are also in the hospital for about seven to ten days, maybe a little bit longer. If a mastectomy is administered and if the patient does not have positive axillary lymph nodes and does not require any chemotherapy, that's the end of treatment, and the patient starts on a follow-up schedule.
Dr. SerVass: In this country, would you hazard a guess as to how many women are currently getting lumpectomies versus mastectomies?
Dr. Findlay: I think that varies a great deal depending on the part of the country where a person resides. If the patient lives in an area near a major medical center where there's a lot of interest in doing lumpectomies, I think that 10 percent, and in some hospitals mabye even 20 percent, of the patients who have early-stage breast cancer now undergo lumpectomy/radiation breast-conserving procedures. In other areas of the country, it's just not available, so I think it depends a lot on which section of the country you're looking at.
Dr. SerVaas: It's not available because the surgeons are afraid of missing part of the tumor in their surgery?
Dr. Findlay: Yes, it's a technique that's been done with a lot of experience in only a few centers. I think that's one issue, and I think the other issue is people are awaiting a scientific answer.
Dr. SerVaas: Yes. And while they're waiting they're doing the conservative mastectomy?
Dr. Findlay: Exactly.
Dr. SerVaas: What is the averag age of your group?
Dr. Findlay: It's pretty comparable to the rest of the country and in the general incidence of breast cancer. I think the last time I looked, it was about age 48.
Dr. SerVaas: So you do have some senior citizens coming too?
Dr. Findlay: Oh, yes, and they're perfectly welcome. I think the youngest person is 26 years old. Part of mastectomy treatment that we give to people on the study includes breast reconstruction. That's very important. We include, as part of the mastectomy treatment package, breast reconstruction, and I encourage people to have it. That doesn't mean that you absolutely must have breast reconstruction, but I think that that's an important part of the treatment that we make available to people.
Dr. SerVaas: What could we tell our readers about your staff and the quality of care they'll be getting should they join your study?
Dr Findlay: First of all, our staff at the Cancer institute is here because they are specifically interested in breast cancer and breast cancer patients. The people who are here for the breast study have been working together for quite a long period of time. We work very well as a team. We have a program that I think really addresses not just the tumor, not just the disease, but also the patient. We're very concerned about our patients and we're grateful to them for helping us answer this question. We all feel it's very important. I think with that level of interest and certainly with the level of expertise here, the actual medical treatment that's administered to people is superb. Also, I think that the psychological support is just outstanding.
After interviewing some of the women who are participating in the study, I came away from Bethesda with the distinct feeling that, should I be unfortunate lump diagnosed in the near future, I would opt to be part of the study.
The National Cancer Institute needs more volunteers to participate. If you are one of the 315 United States women who are diagnosed daily as having a malignant breast lump, there is a 70 percent chance that your lump will qualify you for participation.
If you aren't already convinced that you would want a lumpectomy or a mastectomy, you might want to join the program.
A phone call to Dr. Peggie Findlay will get you all the additional information you need before traveling to Washington, D.C. The telephone number is 1-301-496-5457.
The best route available to women is to do everything possible to avoid cancer in the first place. With that in mind, I spoke with Dr. William DeWys, who is conducting an interesting project at the NCI that will put 3,000 women with a high breast cancer risk on a low-fat diet (20 percent).
"One of the important areas that we are looking at is the role of diet as a factor in determining risks for developing cancer," Dr. DeWys explained. "We are giving dietary fat particular emphasis in our studies. The types of cancer that have been associated with high intake of dietary fat include cancer of the breast, cancer of the colon, cancer of the prostate and cancer of the endometrium [lining of the uterus]. We think that if we can reduce the dietary fat intake in the population, we can significantly reduce the incidence of these cancers. At the present time, I would say that the evidence is perhaps 99 percent certain of these associations that I've mentioned. We're in the process of conducting research projects which will, at least theoretically, bring us from 99 percent certainty up to 100 percent certainty."
He explained that his study would use women at high risk for contracting cancer. The risk factors include having a first-degree relative with breast cancer, previous biopsies or benign disease of the breast and a benign disease of the breast and a late age at first pregnancy (over 30). "We have evidence from other studies that women who have two or more of these risk factors have a significantly increased risk for breast cancer," Dr. DeWys explained. "One of the starting groups for this will be women who have participated in breast cancer detection projects that we have funded in the past. These women came periodically to have breast examinations and mammographies. They filled out a questionnaire that includes their family history; whether they had previous biopsies; and their age at their first pregnancy. We can just take these questionnaires through the computer, and it will sort out those women who meet the criteria. We will then invite those women to come in and participate in the study. We will, in addition, accept any high-risk women who volunteer.
"Our tentative sample size calculation now is 6,000. But we will modify that based on the degree of adherence to the diet and how many people drop out," the doctor said.
I then asked Dr. DeWys to explain the diet that this study is going to prescribe for the women. "This is our first study in which we are deliberately trying to intervene our diet," he replied, "and we have deliberately attempted to emphasize the fat, because we feel that is most important. We are not going to emphasize any other change in diet, simply because we don't want to fail by making it too complex. We are then going to ask half of the women in the study to go on a low-fat diet, while the other half are asked to simply continue their usual diet. Forty percent of the calories in the U.S. diet are dervied from fat. In the experimental diet we will aim for 20 percent of the calories to be derived from fat.
"The three main categories of foods that are richest in fat include the meats, dairy products and what we call fats and oils," he continued. "The fats-and-oils category is probably the largest source of fat in the U.S. diet and in many ways is the one that can be adjusted with the least adverse effect on your overall diet. This category includes butter and margarine, salad dressings and oils that are used in baking.
"Turning next to the meat category, we have a series of suggestions to reduce the fat content drawn from meat. One suggestion is to select more fish and poultry and make fewer choices from the red-meat category. Second, we suggest that, prior to any cooking, people remove all visible fat from beef or pork, and if they're using poultry, that they remove the skin, because in poultry much of the fat is associated with the skin. Also, the cooking method is important. We recommend cooking the meat on a rack so that any fat released by the cooking process can drip off from the meat and not be eaten with the meat. We particularly, discourage use of frying because frying actually adds fat to the meat.
When I asked Dr. DeWys about the wok he replied, "I have reservations about the use of a wok. The temperature that is employed there may be higher than is advantageous. The temperature at which the food is prepared is another factor that we have some concern about. There is evidence that preparation of foods at very high temperatures will cause the formation of certain chemicals that have been shown to have mutagenic activity. Mutagenic activity means that this chemical will damage the DNA, which is the genetic information in a cell. The mutagents may also be carcinogens and could cause cancer. The evidence is incomplete as to whether these chemicals formed by cooking at high temperatures can cause cancer. We recommend cooking foods at moderate rather than high temperatures.
"The other large portion of the diet having fat is the dairy foods. There you simply need to suggest that people go to fat-free or low-fat products instead of the whole milk and regular cottage cheese, etc."
Even though you follow all of Dr. DeWys' suggestions for the prevention of cancer, there's still the possibility of developing a lump. The bottom line is: by catching a small lump before the lymph nodes become positive, you have the option of a mastectomy or a lumpectomy with radiation. Once your lymph nodes are positive, the specter of chemotherapy comes into the picture. And laymen as well as oncologists know that to avoid the necessity of chemotherapy is a plus.
How can you avoid it? A technique that can be employed by all women is self-examination. This method can be demonstrated by your personal physician. When done routinely, self-examination is an effective first line of defense. Another weapon in this war against cancer is the mammogram.
Most authorities believe that women under 50 should not be given breast X-rays yearly, on the theory that during their remaining life they might receive radiation. Women over 50, however, are in a higher cancer-risk category, and most physicians believe they should be screened annually because they are not likely to received enough radiation in their remaining years to threaten their health.
Other guidelines include:
* annual palpation of the breasts by qualified medical personnel;
* between 35 and 39, annual mammorgraphy if you have a personal history of breast cancer; and
* between ages 40 and 49, annual mammograph if there is history of breast cancer in immediate relatives or a personal history of breast cancer.
When your doctor prescribes an X-ray, it is a good idea to ask where you can go to get the least amount of radiation--a particularly important consideration for women over 50 who are having a yearly mammogram. The cumulative effects of radiation will be significantly decreased with low-dose, state-of-the-art X-ray mammogram equipment. Newer equipment uses one-third as much radiation as xeromammography and 100 times less than the older X-ray equipment still in use at some hospitals, says Dr. Patricia Harper, a radiologist who operates the breast clinic where I go for low-dosage mammograms.
Japanese women, who eat far less fat than U.S. women, have about one-third as much breast cancer as American women; in Japan older women have far less breast cancer than younger women. Japanese women are screened for early detection. If the Japanese can screen their women, shouldn't we be trying harder, since we have three times Japan's incidence of breast cancer?
We would like to know what percentage of our female readers over 50 fail to have annual mammograms. To help us find out, we are hopeful that you will fill out and return to us the survey printed on pages 57-58.
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|Publication:||Saturday Evening Post|
|Date:||Jul 1, 1984|
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