February 2005: Updates from St. Gallen

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Switch drugs after a year on tamoxifen?

Question from Marsha: I am a 45-year-old and post-menopausal. I currently take tamoxifen. My oncologist recommends it for five years before switching to something else. I started taking it a year ago January. What is the thought on changing drugs? And after how long?

Answers —Nicholas Robert, M.D.: There are now three trials that have shown convincingly that after two and one-half years of tamoxifen, the data supports changing to an aromatase inhibitor in postmenopausal women. There is a potential to use this strategy in premenopausal women, but then you have to eliminate ovarian function in order to use this new group of drugs.

Jennifer Griggs, M.D., M.P.H.: Could you comment on a woman who's at high risk of recurrence?

Nicholas Robert, M.D.: That's a great question, and one I was discussing with a colleague earlier today. We have two scenarios. You either start if you're postmenopausal and hormone- receptor-positive with an aromatase inhibitor, or you start with tamoxifen for two and one-half years and then switch to an aromatase inhibitor. Both strategies came out of clinical trials where the treatment is given for a five-year period.

If you start with an aromatase inhibitor at the beginning, the trial is dated for five years. If you switch after being started on tamoxifen for two and one-half years, then you take the aromatase inhibitor for another two and one-half years. But as Dr. Griggs said, we also have a trial that shows that if you take an aromatase inhibitor after five years of tamoxifen, you take that aromatase inhibitor for five years. However, the data on this isn't complete and we don't have experience for the full five years. So we think that continuing hormonal treatment beyond five years is a good idea.

But we have a dilemma— long do you continue the aromatase inhibitors? Personally, with patients I switch, I extrapolate the observation from the trial, and I recommend that the patients take it for five years so they'll end up with hormonal treatment that may last seven to eight years. The frustration we have is that there aren't any trials to guide us in terms of evidence-based medicine. We always feel more comfortable when we have evidence on how to treat our patients in a reasonable, rational way.

I'd emphasize the need and the utility of a group like Breastcancer.org in educating patients and survivors so they understand the issues. At the end of the day, they have to take this journey— walk— their care, hand in hand with their oncologist. If they understand the issues, they can make better decisions. We doctors can give opinions, but it's better if the patient can help make the decision. You end up making a trade-off between side effects and potential benefits. It's easier for someone to continue treatment if they're not having side effects, and maybe go beyond the clinical trials. But in my mind, it has to be a discussion with an emphasis on communication.

Jennifer Griggs, M.D., M.P.H.: It's such a personalized decision. If someone starts on an aromatase inhibitor and does have terrible joint pain, changing that patient to tamoxifen is not giving her inferior care. I think some of the media attention to the aromatase inhibitors might paint it that way. It would be so much better for a patient to get some treatment rather than none.

Nicholas Robert, M.D.: I agree. Tamoxifen has been the gold standard for two decades now, and tamoxifen is still a good and effective drug. To be honest, the difference between aromatase inhibitors and tamoxifen is real, but still small. If a patient cannot tolerate an aromatase inhibitor, I'll switch her back to tamoxifen. I think we should continue as long as the data supports, i.e. stopping after five years.

Jennifer Griggs, M.D., M.P.H.: Tamoxifen has some good side effects that the aromatase inhibitors do not, i.e. improvement in bone density and even lowering cholesterol. I've had several patients who were able to come off their cholesterol medication because they were on tamoxifen, and we don't have those results with aromatase inhibitors. On the other hand, the serious side effects of tamoxifen, like blood clots and cancer of the uterus, are not seen with the aromatase inhibitors. So again, it's very personalized.

Purpose of steroids in chemo?

Question from Lillian: Do steroids provide a treatment factor in chemo? Why use them since they affect bone density and there are other agents that can be used to help the patient have more energy?

Answers —Nicholas Robert, M.D.: The role of steroids in breast cancer is pretty much restricted as an anti-nausea medication and should be used in a limited fashion. It's not a medicine the patient should take on a daily basis, and certainly not for an extended period of time. It can be used to control nausea.

Jennifer Griggs, M.D., M.P.H.: It can be used with some of the taxanes to prevent a serious reaction. But again, it's only for a short time.

Nicholas Robert, M.D.: If you're asking about chronic steroid use, it can affect bone density, but it's not an issue in the management of early breast cancer.

Why not continue chemo to prevent recurrence?

Question from Valerie: Why is chemotherapy not administered, say once a year, after the initial chemotherapy treatment to help prevent recurrence and/or metastatic breast cancer? Hormonal treatments continue for years after the initial treatment. Is it because of the harshness of the chemo?

Answers —Nicholas Robert, M.D.: I had a patient many years ago who asked to come in for a "boost" of chemo. Not to sound patronizing, but this is one of the wonderful things you get from patients who have this disease, because they ask questions that are out of the box. One study was done by the NSAB15 where, after chemo, they waited six months and then had more chemo, and it did not show any benefit. Another group, the International Breast Cancer Study group, tried chemo at three-month intervals, and that didn't work either. So although there is a theoretical basis for thinking it might work, you are right that the harshness of the treatment reduces any enthusiasm to do this kind of trial. It may be that ER-positive tumors don't seem to be as sensitive to chemo as ER-negative tumors, so endocrine treatments lend themselves better, and exposure to chemo later won't help. Given these two experiences, it is a strategy that would be difficult to test in clinical trials.

Jennifer Griggs, M.D., M.P.H.: Many of the patients to whom we give chemo don't need it, and to make someone a chronic patient would probably take away quality of life without the proven benefits. We're looking forward to determining who needs chemo, because the treatments will be more "worth it" in the patients who are at high risk of recurrence.

Which aromatase inhibitor is better?

Question from Bvodarka: Has there been a study that proves which aromatase inhibitor is better for the treatment of early stage breast cancer in post menopausal women after surgery and chemo, but no tamoxifen? Is there another drug that is even more effective in preventing recurrence? And what about after five years?

Answers —Nicholas Robert, M.D.: To the first part, no. There are three aromatase inhibitors, and the bottom line, in my opinion, is that they are all comparable. There is not one that is superior to the other two. The convention I've used is that there were three major clinical trials that looked at the three aromatase inhibitors, one at the beginning, which was Arimidex, one at the end, which was Femara, and one in the middle, which was Aromasin. When those three trials were reported, I used the aromatase inhibitor that was used in the clinical trial that was applicable to the patient's stage.

Life has become a bit more complicated, because now we have multiple trials showing that using an aromatase inhibitor up front was superior to tamoxifen. In this trial, they used Femara. The first trial to show this was the ATAC trial, which used Arimidex. So now for patients who are hormone positive, postmenopausal, we have trials that show if you use Arimidex that's also a good choice. We have these three aromatase inhibitors that have been used in different situations, so now we have options.

If a patient has musculoskeletal aches, I'll switch from one aromatase inhibitor to another. They are in two types— non-steroidal, which are Arimidex and Femara, and the steroidal, Aromasin. This refers to the chemical structure of the drug. I've had luck sometimes switching a patient from one kind to another. I'd like to ask Dr. Griggs, have you had the same experience?

Jennifer Griggs, M.D., M.P.H.: Instead of jumping right back to tamoxifen, especially if they've done their five years, I do switch them to another aromatase inhibitor with good success.

Change aromatase inhibitors before five years?

Question from Mbaldessarra: I am struggling with my oncologist's decision to leave me on tamoxifen until the second year mark. With all the studies now showing that Femara or Arimidex have proven themselves beyond the "gold standard" of years gone by, do you think I should just go ahead and ask to be switched over to one of these new drugs? I am 47, post-menopausal, diagnosed with Stage I in '03.

Answers —Nicholas Robert, M.D.: If I were a patient, and I walked into someone's office today, there's a good chance they'd say to take Arimidex or Femara, whereas if I'd done it a year ago, they would have put me on tamoxifen. The way I practice is a collaborative effort. I'd go through the trials, and say it's not unreasonable to switch if you feel more comfortable switching. I would certainly not be dogmatic and tell a patient she could not switch. I'd advise her of the pros and cons, but say I'd feel comfortable switching instead of waiting for two and one-half years.

And after that, I'd support the patient's decision to switch. On the other hand, if a patient is happy and comfortable on tamoxifen, I'd let her stay on tamoxifen.

Jennifer Griggs, M.D., M.P.H.: I've had patients want to switch to the aromatase inhibitors, but then they have had trouble with side effects. The other reason I like to keep someone on tamoxifen a bit longer is that you deposit money in the bone bank, and you can withdraw your savings, and live off the interest instead of the principal, so there's less loss of bone density with tamoxifen than with the aromatase inhibitors.

If premenopausal, Femara okay after tamoxifen?

Question from Nancy: Has there been any work for premenopausal women and the use of Femara after taking tamoxifen for five years?

Answers —Nicholas Robert, M.D.: If a woman is still menstruating after five years of tamoxifen, we induce ovarian oblation or stop the ovaries from functioning, usually pharmacologically, with an RH analogue. There has not been any data yet on the early breast cancer study to address whether that's a good plan. I'm not aware of any clinical trials addressing that issue. There is one addressing the issue of taking patients upfront, where they have their ovarian function stopped and then take tamoxifen or an aromatase inhibitor.

However, if I had a high-risk patient who was premenopausal with multiple positive lymph nodes, was on tamoxifen at the five-year point, and still had evidence of ovarian function, I would have a serious discussion about exploring stopping her periods, inducing stoppage of ovarian function, and starting Femara. This is really a collaborative, interactive discussion, because we're extending the data that exists. But I think that's a reasonable discussion to have. That goes back to the personalized care we've been discussing.

Jennifer Griggs, M.D., M.P.H.: That's a big commitment, and not something you want to do lightly. But for a women who's in her late 40s and still menstruating, by stopping her periods by injection or surgery we're not shortening her menstrual life by much. I struggle more with a woman in her 30s. I don't want to take away her estrogen for quality of life and bone density issues. So I look at how likely she is to have a recurrence.

Hard to tolerate Arimedex, okay to stop?

Question from JR Sparkle: I had breast cancer surgery at the age of 78 (15 months ago). It was about 1cm in size and they removed two lymph nodes. They were clear and the margins were clear also. I had radiation and was put on Arimidex. I took it for one month and stopped because it didn't make me feel well. Did I make a big mistake in stopping the medication?

Answers —Nicholas Robert, M.D.: Categorically, no. I'd like to know a bit more about your tumor, but we know it's small and the lymph nodes were clear. Your chance of being alive in 10 years is excellent, and I'd suspect your chance of dying from breast cancer is less than two percent in 10 years.

I would go back to what Dr Griggs said: If you can't tolerate Arimidex, I'd wonder if you could tolerate another aromatase inhibitor or even tamoxifen, although I'm concerned with using tamoxifen in older patients because of the risk of blood clots, especially stroke, which is small but real.

But if a patient felt strongly about not having more intervention, I would not fight it. I'd support her decision if she decided not to pursue any further hormonal treatment. I'd also explore other strategies before giving up.

Jennifer Griggs, M.D., M.P.H.: That would be my approach as well. I have postmenopausal women who wonder if having their ovaries out will improve their breast cancer outcome. It won't. Ovaries in a postmenopausal woman are basically dormant and won't produce estrogen, so removing them won't help. The other thing I'd like to add is that a study was published recently saying there was no increase in the risk of stroke with tamoxifen. This is controversial, because these are rare events, but nonetheless real events that we take seriously. But I agree with you; at age 70 and over, I tend not to reach for tamoxifen first.

Explanation of genomic profiling?

Question from Leonora: Can you explain genomic profiling?

Answers —Nicholas Robert, M.D.: Genomic profiling has become the buzzword in oncology, especially in breast cancer. It's generated by the excitement and enthusiasm that we can identify tumors as individual tumors, which translates into individual treatment. We now have the technology to look at the 30,000+ genes that we have, and there's a potential to have a better understanding of what genes are abnormal. Knowing that may lead to a more effective treatment.

We have already seen that this is beginning to have an effect on how we think about cancer. We're starting to divide them into groups beyond the traditional categories we're familiar with. I think we need to be careful that our enthusiasm doesn't ignore the complexity of genomic analysis. It's going to take some time for us to understand. It's a pretty complex situation. But what's exciting is that there's a hope that once we unravel some of the mysteries of genomic analysis, we'll be more intelligent about our treatment choices.

Jennifer Griggs, M.D., M.P.H.: Amen!

Nicholas Robert, M.D.: It's very, very exciting. We've already seen, in one very select area, women who are node-negative and estrogen-receptor-positive where we may be able to omit chemotherapy. This is a small subset of patients, but hopefully is the beginning of how to use this for treatment. So stay tuned; this is not ready for prime time yet.

Jennifer Griggs, M.D., M.P.H.: For the last decade and a half that I've been practicing breast cancer, the majority of articles that look at prognosis in breast cancer goes something like this, "Such-and-such on breast cancer cells is associated with the worst prognosis." Since we're already treating women as aggressively as we are, it's a relief to see something that will help us tailor treatment to women who don't need chemo. We haven't had such an important piece of information for years.

HR negative advances?

Question from Jams: What advances, if any, are there for women who are hormone- receptor-negative, especially in terms of recurrence?

Answer —Nicholas Robert, M.D.: A woman who's truly estrogen-receptor-negative and zero progesterone-receptor-negative, and HER2-negative (a gene that in 20-30 percent of patients increases the numbers, and they're HER2-positive), they're candidates for treatment with Herceptin. But to make it difficult for us, what do you do with a patient who is "triple negative," with metastasized disease? We realize this is a separate group of patients. We may need drugs we don't use as often in breast cancer treatment, like platinun or carboplatinum, or VP.

There may be potential roles to use some of the newer oral drugs that affect growth factors.

Advice on clinical study with Herceptin?

Question from Clare B: After chemo and radiation, I will be starting a clinical study with Herceptin. What are your thoughts on this drug?

Answers —Nicholas Robert, M.D.: This is a very exciting approach, and it's important that patients participate in the clinical trials and stay on them. There's reason to think Herceptin will produce a better outcome, but we're concerned that Herceptin has side effects, especially congestive heart failure. So we need to know the potential benefits of Herceptin, but also that it's safe, and we'll only know that by women participating in these clinical trials. So my recommendation is strongly to stay on the trial.

Jennifer Griggs, M.D., M.P.H.: I don't recommend Herceptin in women who don't have metastatic disease unless they're on a trial like this one. Do you use this drug in a woman who's not on a clinical trial, and who does not have metastatic disease?

Nicholas Robert, M.D.: No, I don't. I think we need to be a little bit rigorous here. Although there is some exciting information that Herceptin would be valuable in the management of early breast cancer, there is concern about the toxicity to the heart. We've learned from prior experiences where there's been excitement, as in stem cell treatment, where we actually found in randomized trial that the benefit was not there. So it's a balancing act— of us taking care of patients and also involved in clinical trials— separate the enthusiasm of doing a clinical trial with being patient to wait for the evidence. We need to make sure an approach is valuable, especially in the adjuvant area. Treatment may not be necessary, but we don't know for which patients it won't be necessary.

Jennifer Griggs, M.D., M.P.H.: In America, we seem to think that more treatment and more expensive is better. And we've all learned from the high profile study results that unexpected side effects are more common than we think. Our first rule is, "Do no harm." We're not just being sticks-in-the-mud.

Stop meds to prevent bone loss?

Question from Donna A: I developed lymphedema after my mastectomy. I took tamoxifen for almost one and one-half years before developing a blood clot in my right arm. My doctor then took me off tamoxifen and put me on Coumadin. My oncologist wants me to start Arimidex, but I had a bone density test two weeks ago that has showed moderate osteopenia. What are the statistics of developing another cancer if I don't take anything further at this point? I am an RN.

Answers —Nicholas Robert, M.D.: We need more information about your tumor size, node involvement, etc., but if tamoxifen was recommended, it's likely to reduce your risk. In the old days before aromatase inhibitors, the option was to stop tamoxifen and start Coumadin. But now what I would do is walk through and talk about the risk of recurrence. I'm confident that using an aromatase inhibitor will not increase your chance of getting another clot.

The osteopenia issue in my mind is not an absolute contraindication for using an aromatase inhibitor. It is a concern, but in the past we've under diagnosed bone loss and now we're more aware of it. It's important to recognize it and intervene, but I think it's important to separate the indication of using a drug to prevent recurrence from the issue of bone loss.

In the past, when we gave tamoxifen, we thought we were helping patients to reduce bone loss, but now we have a better group of drugs to help prevent recurrence, and these groups are separate.

Jennifer Griggs, M.D., M.P.H.: I agree that you need to address your bone health separately from your adjuvant hormonal therapy. This is a great time to start an adjuvant hormonal therapy if there is some benefit there to you.

Trials for duration of aromatase inhibitors?

Question from Beth: How can one volunteer for trials on the length of taking AI's?

Answer —Nicholas Robert, M.D.: It would be nice if we had a trial addressing this question. There is only one that I'm aware of addressing the length of aromatase inhibitor, where after five years of tamoxifen, patients were randomized to take Femara for five years. Now the women who took the Femara are going to be randomized again, to either continue or stop the Femara. But I'm not aware of any studies that look at taking tamoxifen for two and one-half years and then switching to aromatase inhibitors. I suspect that taking aromatase inhibitors for more than five years is going to be a good strategy, but there is no data to support that that is actually true. It would be great to have a trial like that.

Sentinel node biopsy accurate for implants?

Question from Louise: I have implants and was just diagnosed with breast cancer. Will the sentinel node biopsy yield accurate results for me?

Answers —Nicholas Robert, M.D.: As a non-surgeon, I'm going to jump in, but as a former pathologist who's looked at lots of lymph node dissections, I think if the standard procedure is successful in identifying a sentinel lymph node, that should provide good information. I'd have to defer to a surgeon to know whether technically it's difficult to identify sentinel lymph nodes with an implant.

Jennifer Griggs, M.D., M.P.H.: If the implants were not as part of a mastectomy but were just for augmentation, there should be no trouble. There are some people for whom we would not recommend a sentinel lymph node procedure, for example, a woman who had clearly involved lymph nodes at diagnosis that has palpable nodes in the armpit.

Nicholas Robert, M.D.: The group we're probably overboard with are those with ductal carcinoma in situ (DCIS). There is a group that has extensive DCIS that may even end up with a mastectomy, but there are women with low grade DCIS who are doing some lymph nodes.

Jennifer Griggs, M.D., M.P.H.: The other group of women I would not recommend lymph node procedure would be one with a large tumor, such as 5cm or more. For those patients, the accuracy of the sentinel lymph node procedure falls because our suspicion of lymph node involvement is so high. I would be uncomfortable trusting a sentinel lymph node result.

Accuracy of Oncotype Diagnosis?

Question from Cwik: How accurate are the results of the new molecular test that can be done to determine recurrence risk?

Answers —Nicholas Robert, M.D.: The test being referred to is the Oncotype DX provided by Genomic Health. This group should be complimented, because they have developed a technology that depends on tissue in paraffin or wax, which is how it's usually kept after it's been removed, and is preserved in this way.

They first evaluated this test in patients who were estrogen-receptor-positive who were treated with tamoxifen, and suggested they could identify which women would do well, and who would not do well. They further tested women with tamoxifen or tamoxifen and chemo, and they found some women did not benefit as much from chemo.

At this point, at best, I'd feel it should be restricted to lymph-node-positive, hormone-negative patients. For some people who have been enthusiastic about using chemo, this may indicate using just hormonal therapy. I think we overuse chemotherapy. So for patients with small low grade tumors who are highly estrogen receptor positive, I think we can make a good case for using hormonal therapy.

We may have more confidence that if a patient is designated as low risk, we can omit chemotherapy. I need more information to see where this test is going in terms of its everyday use, but I'd underscore that this approach is very exciting and, in time, will probably have an effect on how we evaluate patients and recommend treatment. This kind of work should be encouraged.

Jennifer Griggs, M.D., M.P.H.: Having just returned from Europe, what do you notice about the way European women with breast cancer are treated?

Nicholas Robert, M.D.: Traditionally, they've been much more conservative about chemotherapy in that they don't use as much as we do, and they've been more comfortable with hormonal treatment. I think it's beginning to have an effect on American oncologists.

There was a trial at San Antonio that was referred to at St. Gallen that showed if the tumor was estrogen-receptor-positive, even though you may have up to three positive lymph nodes, chemotherapy did not add to tamoxifen. It was a good trial, very credible, and certainly fit the biases of a lot of European colleagues. I hope it will stimulate some rethinking among American colleagues, especially for older premenopausal women, that maybe they can benefit from endocrinal therapy alone. And if you see someone in her 60s who has high estrogen-receptor-positive, you could use only an aromatase inhibitor. This is something we'll hear more about in the future.

Jennifer Griggs, M.D., M.P.H.: Chemo vs. hormonal therapy, in women with stage II cancer, the research is done mostly in Europe.

Nicholas Robert, M.D.: A couple of years ago, I was involved in a trial of tamoxifen vs. tamoxifen with ovarian oblation. We were only able to get 350 women, and I think today a lot of us would want to know the answer to that question. We see a lot of low-risk premenopausal women that we think a lot about whether we can just get away with endocrinal treatment, but we don't have that information.

A/C chemo vs. A/C plus Taxol?

Question from Lilian: Which are the important factors to consider for my daughter who has been given a choice of A/C chemo or A/C plus Taxol?

Answers —Nicholas Robert, M.D.: A/C is usually given every three weeks and was the standard for years. But Taxol or the taxanes have improved the outcome of patients. Taxanes have been used in lymph node positive patients. It's been further refined that if you give the regimen every two weeks, it's well tolerated. So in many patients today that I would have considered A/C alone, I'd now give A/C with Taxol. If the patient has decided that chemo is a good course of action, then I think adding Taxol is an attractive option for those patients.

Jennifer Griggs, M.D., M.P.H.: Also reassuring is recent data suggesting that delaying radiation and increasing the number of chemotherapy treatments does not appear to have a sizeable impact on the value of radiation.

Take taxane to ensure clear nodes?

Question from Franny Sue: I had neo-adjuvant chemo and my nodal status is unknown. A sentinel node biopsy showed they were clear, but that was after A/C chemo. Should I have a taxane to be safe? My oncologist is not giving me much information. He just says, "Well, they are clear now, so don't worry about it." But I do!

Answers —Nicholas Robert, M.D.: Lymph nodes were negative? It would be nice to know what the breast tumor was. There was a recent trial— B-27 trial— pathological complete remission, regardless of how you got there, does well. But in someone who received adjuvant therapy (and again, in my practice if someone gets chemotherapy prior to surgery, they tend to be high risk patients), my preference is to follow with four cycles of taxanes.

Jennifer Griggs, M.D., M.P.H.: I agree. My preference is to offer a taxane, because the stakes are high. The tumor was probably large or estrogen receptor negative. It's encouraging if someone has negative nodes after chemo, but clearly you're committed to getting high quality, aggressive treatment.

Frequency of Dr. visits during hormonal treatment?

Question from Stanza: I had a mastectomy followed by radiation. I'm considering hormonal treatment after that. How often should I be seeing my various doctors over the next five years?

Answers —Nicholas Robert, M.D.: This raises the follow-up strategy. In my practice, we use a multi-disciplinary approach. In the first two years, they're seen every three months by a member of the team— or oncologist. At two to three years, we see the patient every six months. The surgeon has an important role, because at that time the risk is of local recurrence. In my opinion, the breast cancer surgeon is best equipped for follow-up.

One of the things that have changed for estrogen-receptor-positive tumors is adjuvant. For patients who take Femara after five years, I find myself having a role in their care for five more years. One of the things that have happened in medical oncology is that we're getting more knowledge about bone health, like DEXA scans and strategies for bone loss. We know we need to monitor that, which has been an interesting change in my practice.

Jennifer Griggs, M.D., M.P.H.: I see my patients for many years after their treatment, and I agree we're taking more responsibility for things like bone loss and sexuality. What Dr. Robert outlined in terms of follow-up is consistent with the American Society of Clinical Oncologist guidelines, and most groups do something similar. You want to make sure you don't spend your years after breast cancer treatment in a doctor's office.

Nicholas Robert, M.D.: I see patients struggle with the emphasis on early diagnosis and detection. They're diagnosed with breast cancer, and they ask about tests and scans, like PET scans. It must be very frustrating for someone to go through treatment and ask how they're doing, but now there is no data to support giving patients lots of blood tests, no tumor markers, nor using scans outside of a mammogram. It's a difficult discussion to have with someone, but diagnosing early metastatic breast cancer does not change survival. I'm not sure that will remain the same. There may come a day when we will want to look at patients a bit more carefully and follow up with tests, but right now there is no data to support that.

Jennifer Griggs, M.D., M.P.H.: Prompt evaluation of symptoms is very important. For example, if someone develops bone pain in a rib or hip, calling your physician and getting evaluated is important, compared to testing people with no symptoms.

Results of 1-98 trial?

Question from Jay Bee: Could you please discuss the results of the BIG 1-98 trial on Femara and tamoxifen?

Answer —Nicholas Robert, M.D.: This was one of the things that was breaking news at the St. Gallen meeting, although there were many overviews, There was an opportunity to hear the initial presentation of the trial of Femara vs. tamoxifen in premenopausal patients who were estrogen-positive.

This trial showed there was improvement in outcome, with a 30-month follow-up. This is consistent with the other trial that had a similar design, but used a different aromatase inhibitor instead, Arimidex. So now we have two trials that show superior benefits to tamoxifen with a toxicity profile that is more favorable than tamoxifen. Both show you need to monitor for bone loss, but I think this was encouraging information that will have an effect on groups in the use of aromatase inhibitors.

If you go back to the ATAC trial, there was some reluctance to wait for more data before saying that tamoxifen is no longer the gold standard. I think now we can say for sure that five years of tamoxifen alone is not the gold standard. It's still an open question whether to start with an aromatase inhibitor first, or to start with tamoxifen for two to three years and then switch to an aromatase inhibitor. Both strategies are reasonable until we get more data.

Double mastectomy common with DCIS?

Question from Lynda L: I have recently had a lumpectomy, only to find out I have more calcifications elsewhere in this breast and also in the opposite breast. I have asked for a mastectomy, and the doctor thinks I should have both breasts removed. Is this common with DCIS?

Answers —Nicholas Robert, M.D.: No, it's not common. DCIS tends to be a local process with an area of suspicious calcification. A woman can have calcification elsewhere in her breast that can be benign, but some patients have extensive calcification, usually in one breast. Having it in both breasts is pretty uncommon.

So the idea of doing bilateral mastectomy is an option. There are some women who would like to avoid mastectomy, and for her I'd make sure it was necessary to do this type of surgery. There is another group of women who are disturbed about being followed with uncertainty and would prefer the mastectomy. It's an even greater concern for women with a family history. Earlier we talked about personalized care. This is an area where the patient plays an important part in deciding what kind of surgical care she wants. This is a process that needs to be interactive between the patient and her doctor.

Jennifer Griggs, M.D., M.P.H.: Getting a second opinion is a good way to deal with uncertainty. Sometimes, hearing another doctor making a recommendation, even if it's the same one, can be helpful even if it's not phrased the same way. With breast cancer, you have the time to make a thoughtful decision that's right for you.

Nicholas Robert, M.D.: Breast cancer can take years to develop, so there's time to collect your thoughts, collect opinions, and make a thoughtful deliberate decision.

Jennifer Griggs, M.D., M.P.H.: And you could investigate whether there's a clinical trial for you.

Nicholas Robert, M.D.: I think Dr. Griggs and I agree that breast cancer is a multidisciplinary disease, and I think our patients end up getting three different opportunities to ask questions. And at the end of the day, they have a much better grasp as to what the questions are.