WEDNESDAY, NOVEMBER 11, 1998
"Treatments Old and New: What Works and What Doesn't"

How do we make decisions about therapy? How does one best understand some of the common treatment that we use like chemotherapy (AC, CMF) or hormone therapy (tamoxifen)? What are the benefits of a particular therapy, and how can that information be best conveyed? How does a person make a decision based on their own factors? These are critical questions to women who have been diagnosed with breast cancer. Preferences and values must be considered along with the tradeoffs of chemotherapy for a potentially very small benefit. The state of this process is currently very poor. A recent publication surveyed 500 members of the National Alliance for Breast Cancer who had been diagnosed with breast cancer. They found that only 30% of these women were given any qualitative or quantitative information on their risk after surgery for early stage breast cancer and how it would be modified by different adjuvant therapies. Most women also did not have a proper perception of the benefit of therapy. This was strongly overestimated by patients as well as their oncologists. We are looking at the best way to convey this benefit. Should we look at risk and how this is shifted by the various therapies, or should we look at time gained?

Over time we are going to have more and more ways to lower the risk of breast cancer. We have been stuck with chemo and hormone therapy for the last 20 years. In the last year we have Herceptin, a biological therapy, which has been helpful in some women with advanced breast cancer when added to adjuvant therapy (AC). Bisphosphonates (drugs that strengthen the bone mineral matrix) are showing some promise. The drug Clodronate may lower the risk of metastasis in some people with early stage breast cancer. Vaccines have not shown to be effective to date, but there is a whole new generation of vaccines which may have promise.

We have a very difficult dilemma when we talk about medical statistics. If you know that you have a 20% chance of having an accident if you drive on a rainy day, you might not drive to the mountains, or let your 16 year old drive, but you would not avoid driving completely. Basically we are using probabilities. But you will either have the accident or not--it is all or nothing. The same can be said for breast cancer. Someone can tell you that tamoxifen will cut your risk of recurrence in half, but you will either have a recurrence or not. At this point we cannot determine whether an individual's particular situation would lead to recurrence or not. There is no answer at this time. Statistics can only take you so far. They are good guidelines, but are difficult to apply to you as a person.

How is information about benefits of therapy best translated to the patient? How does the patient make decisions regarding their own personal illness? One patient with advanced cancer felt that her first oncologist used statistics to prepare her for death. She felt that physicians must be retrained to think of the individual, and not allow statistical bias to treat all patients the same way. She is frustrated by researchers who eliminate patients from studies because they have had too much chemo, she feels that she is being treated like she is already statistically dead.

Dr. Tripathy wanted to know if patients with early stage breast cancer who had a reasonably good prognosis statistically would consider using chemotherapy with side effects for potentially small decrease in risk of recurrence. Most people felt that they would consider it because describing the average benefit doesn't apply to everyone. If you do a large study on tamoxifen and find that 20% of women recur after 5 years without tamoxifen and only 12% recur with tamoxifen. This really means that the average risk is cut in half. Some people get a very small benefit and some get a large benefit. In fact most of the benefit from tamoxifen is derived by those patients who are ER/PR+, so dealing with a certain population, will increase the value of the drug. This may be true of even smaller subgroups. Of course patients don't want to embark on something with a small chance of success, but you cannot go strictly by statistics. The nature of biology is that it is chaotic, variable, so we cannot discard any option based solely on statistics.

WHAT PATIENTS WANT:

• Patients really want more written material which can be taken home. They don't think clearly at the time of the consultation; are too stressed. We would like to have patients look at our decision support tools and have feedback on their value. We will develop a list of people interested in this process. It is difficult to put together one universal packet. It is perhaps more important to give people access to the resource center where a large amount of information is available when the patient is ready to absorb it. Book entitled: "Evidence-based Medicine" had flow charts for breast cancer and was recommended by one patient.

• The Breast Care Center is currently using a written consultation plan which can be given to the patient to take home. Patients are also entitled to a copy of the dictated report, this is not yet standard, but will be. Tape recorders are available to patients to tape the consultation with the oncologist.

• Patients want an ongoing education class on cancer, featuring terminology, how to read path report.

• The patient navigator program here has had a few roadblocks, but works quite successfully in other locations. Our original intention was to have a navigator program with a lot of training, but this may not be possible. Perhaps we could provide a list of women with similar problems who could be accessed at some time. We are trying to develop a program that matches the patients' needs. CPMC has an unsolicited patient visit by breast cancer survivor who come equipped with written information. Name and phone number are given to the patient who can use them if and when they want to. The name of a nurse is also given in case the patient has specific medical questions. There are seven trained volunteers who have had some part of their care at CPMC. Stanford has the same type of program.

The time after diagnosis is a very sensitive time, the patient is presented with a series of decisions and often a time limit for making these decisions. We would like to be able to provide the patient with some level of reassurance that the experience can be demystified, providing more tools to make the experience of decision making more comfortable.

• Most patients have had to go through a decision making process related to early stage breast cancer and either hormone or chemotherapy. Most felt that the information presented was clear and straightforward. Many felt it was hard to get a sense of what the risk is, although you need to know this in order to know what benefit you will derive from therapy.

• When statistics are presented, it is often a cold, confusing presentation, too much to comprehend when in a vulnerable state. Sometimes patients may get too much information. Some may just choose a doctor in whom they have confidence and let him/her decide, because the physician has so much more training and knowledge. The danger here is that the patient is subject to the physician's values, what they think is worthwhile.

• Patients should listen to their physician, evaluate all they have to say and then make their own decision based on information and intuition. Physicians must listen to the patient, see the responses of the patient. Often a patient will not ask a question that they are not prepared to hear the answer to. Or, the physician should understand that the patient is not just processing medical information, they may need help with social problems (childcare), financial problems (who will pay for this), etc. These issues may actually cloud the judgment of the patient as regards their immediate medical problem.

• There is a responsibility on the part of the physician to tell patients about benefits as well as side effects of specific therapies, and then perhaps lead the patient into making a decision as to what is the right thing to do. Often patients are not aware that the benefit might be quite small, it is the physician's duty to point this out. Some patients will think that more is better.

• Patients make decisions in one situation which they might not make in another. This may have to do with fear or feelings of being overwhelmed. Because they will have to deal with the consequences of these decisions, it is necessary to be sure that the decision is a reasoned one. One part of our shared decision making program will evaluate the satisfaction people feel with the decision they made over time. We will administer a questionaire a year after the fact and see how happy they were with the decision made. This will give us some idea if the manner in which we presented the information had some impact or gave the patient some sense of satisfaction with their decision.

• Certainly no amount of statistical analysis takes the place of being an advocate for yourself, being informed by reading books like Dr. Susan Love's Breast Book, or doing Internet searches. Although there is much value in standardizing information, patient interviews will always be different, the same information will be presented differently to different people. Maybe consistency should not be the goal. "When you are a hammer, don't treat everything as a nail".

• Because Dr. Tripathy is such a good communicator, maybe his patients might be agreeable to having their consultation taped and listened to by others who share a similar problem.

• It may be that a key set of questions needs to be developed to determine what is important to different individuals, a template that gives the physician a roadmap as to what are the important factors which need to be emphasized which will vary from one patient to another. Certainly the concept of statistics is mandatory if the physician is to be honest.

Early Breast Cancer Trialists' Collaborative Group, "Tamoxifen for early breast cancer: and overview of the randomized trials". The Lancet, Vol. 351, May, 1998, pp.1451-1467.

Early Breast Cancer Trialists' Collaborative Group, "Polychemotherapy for early breast cancer: an overview of the randomized trials". The Lancet, Vol. 352, September, 1998, pp. 930-942.