WEDNESDAY, February 14, 2001

Quality of Life After Breast Cancer: How Do We Measure It and Use the Information Effectively?

Tonightís topic is a rather nebulous one, revolving around symptoms that arise from having cancer or the treatments of cancer which have a lot of side effects. Historically this area has been very poorly studied and is only recently getting any attention. It is critically important to the patient, involving decisions on therapies which may make small differences in risk of recurrence, but cause impact on everyday life. These are difficult decisions for patients to make and physicians have a hard time counselling them. Advocates and survivors have lobbied for more studies in this area, and it is beginning to bear some fruit.

Quality of life can be measured in many ways. The functional domains are the practical aspects of how one feels and gets around through the day (interference with work, household activities, social activities, etc.). Questionnaires have been designed to look at these activities. In order for the answers to be used in research, they have to undergo a process known as validation: is the material understandable, will the question be answered the same way at two different points in time? The questions are subjected to statistical analysis and asked in various ways to a large group of people. There are now several questionnaires which have been validated and are tailored specifically for breast cancer. Most new clinical trials looking at new chemotherapy drugs will use one of these questionnaires so that when the results of the trial are analyzed they can report not only on the safety and efficacy of the drug but also on how patients lives are impacted by its use. Other aspects of measuring quality of life have more to do with analyzing emotional states like depression or anxiety as well as spirituality and sexuality.

The design of clinical trials has been hampered because this information has not been available to the researcher in the past. The studies using Taxol for early stage breast cancer which began in 1993 did include some of this information. They found that the neuropathies which developed on the drug usually disappeared fully over time. The gathering of this information has enriched the research, but there is a trade-off. Patients sometimes tire of answering lengthy questionnaires which take up to an hour of their time, so the accuracy of the responses sometimes tails off toward the end of the questionnaire.

Case Study. 30 year old woman who was struggling with idea of taking chemotherapy, thought it preferable to have an oophrectomy (surgical removal of the ovaries to eliminate the source of estrongen) to reduce the risk of recurrence of her cancer. The literature suggests that oophrectomy might be as good as chemotherapy to reduce risk, although not as good as chemotherapy plus tamoxifen. After the surgical treatment she developed menopausal symptoms that were quite severe for a long time, much longer than would be anticipated. Because there was no research on this issue, she could not be counselled as to whether significant menopausal symptoms were experienced by many women in her age group. She could not therefore make a considered judgment before deciding on the oophrectomy.

Making decisions for treatment in advanced breast cancer reflect a balance of improving longevity and symptoms against the side effects of treatment. This is an area that oncologists handle least well. They often prescribe therapies as a matter of course without making sure of what is happening with the patientósome almost "stop living" while on treatment. Office visits are focused on tests, what scans show, etc. What is needed is a method to quickly assess lifestyle and behavior in the office, as part of the medical history. What the patient can do is make a priority list (so fatigued, had to cancel social engagement, canít go to sleep) that relates to quality of life. The physician is then required to problem solve to determine whether the treatment is the cause of the problem or it has another source. This must be an ongoing dialogue between the patient and the oncologist. The goal of treatment should be to improve both the quality and quantity of life.

Do quality of life issues affect prognosis? There is a good bit of evidence that functional measures affect prognosis. People functioning at a higher level do better. In terms of emotional and psychological indices, the data are mixed. There are no controlled studies, but the retrospective studies show that the more socially connected you are, the better you handle stress, the better your longevity. Dr. David Spiegelís retrospective study concluded that people with group support tended to live longer than those without it.

In low risk cancers, the benefits to taking Tamoxifen may be so small that quality of life has to come into play. Younger patients may take it without the risk of significant side effects, but as you grow older, with smaller impacts on outcome, you may want to consider quality of life.

Can you actually tell if the effect on breast cancer is from Tamoxifen? The biggest predictive factor in the efficacy of Tamoxifen is hormone receptor status. If the tumor makes the estrogen receptor, your chances of response with hormone therapy are probably equal to chemotherapy.

What about tumor markers? Tumor markers are imprecise estimates of what is going on in the body. People often tend to overreact, and want to use treatment options before they are necessary. They may prompt getting scans sooner.

Define "early stage" breast cancer? Non-metastatic, Stage I through IIIb, meaning it is curable. This includes inflammatory, even though these patients may be at higher risk for recurrence. But it is in these higher risk patients that we can influence outcome the most with therapy.

Cancer has become the "snake behind the sofa", have I become a hypochondriac? Fear and anxiety can be great with cancer, but this is not necessarily directly related to someoneís risk. Often it is the uncertainty, the not being in control. A difficult transition time can be when a patient comes off therapyóand needs to get on with their life. Over time people do get preoccupied with other things and the time they spend thinking about their cancer diminishes. Not thinking about cancer may actually be worse for some patients. It is here that support groups play a very useful role. Patients donít feel that they are alone, sharing fear makes it seem more rational as it is happening to everyone. The most important thing seems to be reaching a level of acceptance, taking one day at a time, and determining what you can do something about and what you canít.

What can you do? There are two general ways to look at this. One is the scientific way, using controlled clinical trials to determine benefits. This approach has not proven too useful as there are few clinical trials in this area. Another is the individual way. Certain behaviors and treatments might help some people and not others. Chinese medicine, acupuncture, meditation, etc. fall into this category. This will be hard to study and hard to counsel people about. Individuals should design a program that feels right for them (tai chi, meditation, etc.) and work with someone experienced in that area. It should be a program that is simple, affordable and fits your lifestyle. Then use yourself as your own experiment by being attentive to what the program is doing for you. Keep what makes you feel better and eliminate what doesnít work.

How do you counsel patients on supplements? One should be cautious of suggestions in the literature to take megadoses of anything that is harmful or potentially harmful. Try to find out what the data is based on. Some common sense approaches include being aware of how herbs interact with medication and letting your physician know what you are taking. To date there is no definitive information on whether vitamins help.

What about soy for people with diagnosed breast cancer? Soy has a lot of compounds in it that have estrogenic potential, some have pro-estrongenic effect and some have anti-estrogenic effect. There are about ten large studies in the literature on this topic, the results are mixed, but with soy consumption there seems to be a slightly lower risk of breast cancer in premenopausal women. This effect is not seen in postmenopausal women. If you decide to take soy, it should be from natural products, not from extracts.

What is co-enzyme Q10? It is an antioxidant. In a series of Dutch papers, the author seemed to think it was protective, but the patient population was women with DCIS and small early stage breast cancers who all did well. Another antioxidant, selenium, has been found to decrease the amount of esophageal and breast cancer.

Some of the problems that affect oneís quality of life in the medical setting:

• Dealing with the logistics of appointments. Trying to work and make an 11:00 appointment can be impossible.
• Paying attention to patient history. Reporting walking two miles a day can be a cause for concern if you are used to walking five miles, it may mean fatigue.
• Scheduling tests. The number of tests has gone up dramatically in recent years. Both patients and physicians are usually impatient to have them, but many times the urgency is not really there.
• Waiting for test results. Biopsies results are usually given quickly because of the high anxiety nature of the procedure. For scans and blood work, patients are usually contacted if there is a change. Abnormal results should always be given with a plan for dealing with them.
• Losing files.
• Phone calls and messages not returned.
• Results not given to patients. As a practical matter, results canít be given to the patient on the phone from the testing facility. You should call your clinic two days after the test to get the result.