The unique approach involved in age-specific concerns surrounding young patients with breast cancer

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This transcript has been edited for clarity.

Dr. Partridge: We’re here today to have a conversation about the unique or age-specific issues that face our young patients and survivors with breast cancer.

Olivia, let’s get started. What kinds of things do we need to think about when we’re seeing a young patient in clinic, beyond the usual things we think about for patients with breast cancer?

Dr. Pagani: The idea of selecting age as a determinant of care of young women is because they have specific issues, which are different from older, premenopausal patients but also older patients in general. We need to take care of many things, which can go from their job, family, fertility, and all these things are specific to these women and can impact their treatment, survivorship issues, side effects, and long-term problems. It’s a different world, compared with other patients with breast cancer.

Dr. Partridge: One of the areas that you and I have been very deep in the weeds in is the fertility issues. That’s obviously one of the things that’s pretty age-specific. There are some new data around that that we’re excited about. What do we think about when we think about trying to have a pregnancy or not after a breast cancer diagnosis?

Dr. Pagani: Yeah. I think it’s great times for that because we succeeded in building up a very important trial, which broke a taboo that was there for many, many decades: You had breast cancer so forget your pregnancy desire.

Despite many retrospective data from many groups that suggested pregnancy after breast cancer was not detrimental, there were so many obstacles for these women to address their pregnancy desire. I think we succeeded in explaining and showing in a quite solid way that if you desire a baby after breast cancer, you can try to have him or her.

Dr. Partridge: This was called the POSITIVE trial, with early findings published in the New England Journal of Medicine this past year, which was very exciting. Let’s dig a little deeper into that. Is this relevant for all patients with breast cancer or select patients with breast cancer who want to get pregnant?

Dr. Pagani: The accrual of the trial was open to all patients with stage I-III disease, but the majority of the patients were low risk, which means that the majority were node negative with small tumors. I think, so far, we can say that in low-risk women, pregnancy after breast cancer can be discussed and planned.

Summarizing, I think the evidence is for low-risk patients with early breast cancer. A minority had huge tumors or node-positive disease.

Dr. Partridge: It’s nice to be able to have these data to say a temporary interruption of endocrine therapy – not coming off forever, getting back on – was not associated with any worsening in terms of their breast cancer events in the future, which is great news for the women who are diagnosed when they’re trying to get pregnant and build their families or not having completed their families. It’s been fantastic.

What about for our patients with advanced disease who come in, and we’re treating them more to try and manage the cancer and improve their survival and quality of life, but cure may not be the goal. How do we manage the fertility issues for them?

Dr. Pagani: This is, I think, still an open issue despite overall survival for many women with advanced disease, especially HER2 positive or endocrine responsive; it is improving and it’s getting better and better. There are few women with oligometastatic disease that can be cured.

We are not yet there. At the Advanced Breast Cancer conference, we started to open the door to say that fertility should be discussed with patients with advanced breast cancer as well. We cannot recommend to patients with advanced breast cancer to pursue a pregnancy.

We have no data. For sure, this needs to be taken into account and discussed openly with all the patients who desire to discuss this.

Dr. Partridge: Yes. To help people to either grieve their losses or find alternative ways to build their family, I think, is something that we focus on.

How to optimize the plan of care for young patients

Dr. Partridge: Shifting gears into the psychosocial, we know that our young women of all stages have a harder time adjusting to a breast cancer diagnosis for good reason. It’s not normative at all to be dealing with a lot of the slings and arrows that our young women deal with at the age that they do. How do you manage that in your clinic, Olivia?

Dr. Pagani: Well, I think it’s always tough. One of the problems, which is also true for early breast cancer in general, which I think is common to you as well, is that in our society many women get breast cancer before even having thought of their family planning. That’s many of them in our reality.

In other countries, maybe they have already two to three children. In our countries, they are aged 30-35 years with no children, no stable relationship, and then are faced with all these things, and their pregnancy desire can be blown up because they understand there is no time, especially if they are metastatic. This can be devastating.

We are not very good at that yet. I think we need to develop better tools, better competence, and knowledge to support them to this extent as well.

Dr. Partridge: I know that whether people want kids or not, the diagnosis of breast cancer has financial toxicity and the inconvenience of going through this kind of experience while managing a busy life. Many of our patients, especially our young patients, are trying to develop their careers, to graduate from schools, and to grow a nest egg. They’re not retired yet, on average.

I agree that we have a large amount of work to do. The one thing I try and do is always bring in our social workers and our psychosocial supportive care providers for our young patients; not that I don’t bring them in for everybody that needs them, but our young patients on average seem to need them a little bit more just because it can be just so hard on them from a psychosocial and emotional standpoint, don’t you think?

 

 

Dr. Pagani: Yes, I think so. Do you have any specific program going on at Harvard?

Dr. Partridge: We do. We’ve built a program for young women that focuses on their unique and specific needs that capitalizes on groups that are already there. We have a social work department. We just have smoothed the pathway, and we send our young people in there more quickly and have some dedicated support groups and one-to-one interventions where patients can guide other young patients. We’ve built out the supportive care for these young patients and programming.

The other big area we’ve developed that’s not unique to young age but certainly enhanced in our young patients is genetics. We have a big genetic component at our cancer center. The young patients, more so than any other group, need to have the genetic counseling and the genetic testing not only to know about future risks and about their families but also to inform their treatment decisions these days. Do you want to comment on that?

Dr. Pagani: Yes, of course. Genetic counseling, especially for the most common BRCA1 and BRCA2, can change their local treatment (e.g., bilateral mastectomy instead of conservative surgery) but they have also to take care of their ovaries. They need to think of prophylactic oophorectomy, which makes fertility and pregnancy even more complicated. For them, it’s much more complex to address everything.

I think it’s really very complex, and I think we need a better understanding of all the nuances. Sometimes, we really do not consider, as you mentioned, that not every woman desires to have a baby.

The occurrence of breast cancer can wake up a desire that was not conscious but becomes conscious because you feel that you will not be able to do that. With the social support, the psychological support, and support groups – we have a very strong breast cancer support group for younger women — they could face these things. The young women support group was supportive of the POSITIVE trial: they helped to develop and financed a video, which was very helpful to promote POSITIVE.

I think that having a relationship or a network between patients, health professionals, social workers, and psychologists can help everyone, including those who want to become mothers, those who cannot, and those who do not want to.

Dr. Partridge: I think that’s great, Olivia. I think you rounded it out by just shining a light on these issues for our young patients and elevating it to being okay to talk about these issues. I think historically, it’s been: “You’ve got breast cancer, forget about this. We just need to get you to a better survival.”

We’re increasingly recognizing for patients of all ages, but particularly our young patients, that just surviving through breast cancer or cancer in general is not enough. We need to help people live the best and fullest life possible in their survivorship.
 

Education and communication: Key aspects moving forward

Dr. Pagani: I think another issue we need really to improve is health professional competence and knowledge. After you presented the POSITIVE trial in San Antonio, I had many calls with patients. They told me, “Well, I had this information, but my gynecologist, my oncologist, or my general practitioner still discouraged me.” This is a great barrier.

I think we need to do more to teach the health professionals. Otherwise, what we do is never enough because it will be blocked. They are scared and they do not want to go against their doctors. I think this is a very big conflict.

Dr. Partridge: That’s a really important point, and I appreciate you bringing it up. We as clinicians and educators who are building the research base need to really get it out there.

Dr. Pagani is a professor at the University of Geneva. Dr. Partridge is professor of medicine at Harvard Medical School and vice chair of clinical oncology at Dana-Farber Cancer Institute, both in Boston. Dr. Pagani reported conflicts of interest with PRIME, Roche, Eli Lilly, Novartis, Takeda, Pfizer, and Debiopharm. Dr. Partridge reported no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity.

Dr. Partridge: We’re here today to have a conversation about the unique or age-specific issues that face our young patients and survivors with breast cancer.

Olivia, let’s get started. What kinds of things do we need to think about when we’re seeing a young patient in clinic, beyond the usual things we think about for patients with breast cancer?

Dr. Pagani: The idea of selecting age as a determinant of care of young women is because they have specific issues, which are different from older, premenopausal patients but also older patients in general. We need to take care of many things, which can go from their job, family, fertility, and all these things are specific to these women and can impact their treatment, survivorship issues, side effects, and long-term problems. It’s a different world, compared with other patients with breast cancer.

Dr. Partridge: One of the areas that you and I have been very deep in the weeds in is the fertility issues. That’s obviously one of the things that’s pretty age-specific. There are some new data around that that we’re excited about. What do we think about when we think about trying to have a pregnancy or not after a breast cancer diagnosis?

Dr. Pagani: Yeah. I think it’s great times for that because we succeeded in building up a very important trial, which broke a taboo that was there for many, many decades: You had breast cancer so forget your pregnancy desire.

Despite many retrospective data from many groups that suggested pregnancy after breast cancer was not detrimental, there were so many obstacles for these women to address their pregnancy desire. I think we succeeded in explaining and showing in a quite solid way that if you desire a baby after breast cancer, you can try to have him or her.

Dr. Partridge: This was called the POSITIVE trial, with early findings published in the New England Journal of Medicine this past year, which was very exciting. Let’s dig a little deeper into that. Is this relevant for all patients with breast cancer or select patients with breast cancer who want to get pregnant?

Dr. Pagani: The accrual of the trial was open to all patients with stage I-III disease, but the majority of the patients were low risk, which means that the majority were node negative with small tumors. I think, so far, we can say that in low-risk women, pregnancy after breast cancer can be discussed and planned.

Summarizing, I think the evidence is for low-risk patients with early breast cancer. A minority had huge tumors or node-positive disease.

Dr. Partridge: It’s nice to be able to have these data to say a temporary interruption of endocrine therapy – not coming off forever, getting back on – was not associated with any worsening in terms of their breast cancer events in the future, which is great news for the women who are diagnosed when they’re trying to get pregnant and build their families or not having completed their families. It’s been fantastic.

What about for our patients with advanced disease who come in, and we’re treating them more to try and manage the cancer and improve their survival and quality of life, but cure may not be the goal. How do we manage the fertility issues for them?

Dr. Pagani: This is, I think, still an open issue despite overall survival for many women with advanced disease, especially HER2 positive or endocrine responsive; it is improving and it’s getting better and better. There are few women with oligometastatic disease that can be cured.

We are not yet there. At the Advanced Breast Cancer conference, we started to open the door to say that fertility should be discussed with patients with advanced breast cancer as well. We cannot recommend to patients with advanced breast cancer to pursue a pregnancy.

We have no data. For sure, this needs to be taken into account and discussed openly with all the patients who desire to discuss this.

Dr. Partridge: Yes. To help people to either grieve their losses or find alternative ways to build their family, I think, is something that we focus on.

How to optimize the plan of care for young patients

Dr. Partridge: Shifting gears into the psychosocial, we know that our young women of all stages have a harder time adjusting to a breast cancer diagnosis for good reason. It’s not normative at all to be dealing with a lot of the slings and arrows that our young women deal with at the age that they do. How do you manage that in your clinic, Olivia?

Dr. Pagani: Well, I think it’s always tough. One of the problems, which is also true for early breast cancer in general, which I think is common to you as well, is that in our society many women get breast cancer before even having thought of their family planning. That’s many of them in our reality.

In other countries, maybe they have already two to three children. In our countries, they are aged 30-35 years with no children, no stable relationship, and then are faced with all these things, and their pregnancy desire can be blown up because they understand there is no time, especially if they are metastatic. This can be devastating.

We are not very good at that yet. I think we need to develop better tools, better competence, and knowledge to support them to this extent as well.

Dr. Partridge: I know that whether people want kids or not, the diagnosis of breast cancer has financial toxicity and the inconvenience of going through this kind of experience while managing a busy life. Many of our patients, especially our young patients, are trying to develop their careers, to graduate from schools, and to grow a nest egg. They’re not retired yet, on average.

I agree that we have a large amount of work to do. The one thing I try and do is always bring in our social workers and our psychosocial supportive care providers for our young patients; not that I don’t bring them in for everybody that needs them, but our young patients on average seem to need them a little bit more just because it can be just so hard on them from a psychosocial and emotional standpoint, don’t you think?

 

 

Dr. Pagani: Yes, I think so. Do you have any specific program going on at Harvard?

Dr. Partridge: We do. We’ve built a program for young women that focuses on their unique and specific needs that capitalizes on groups that are already there. We have a social work department. We just have smoothed the pathway, and we send our young people in there more quickly and have some dedicated support groups and one-to-one interventions where patients can guide other young patients. We’ve built out the supportive care for these young patients and programming.

The other big area we’ve developed that’s not unique to young age but certainly enhanced in our young patients is genetics. We have a big genetic component at our cancer center. The young patients, more so than any other group, need to have the genetic counseling and the genetic testing not only to know about future risks and about their families but also to inform their treatment decisions these days. Do you want to comment on that?

Dr. Pagani: Yes, of course. Genetic counseling, especially for the most common BRCA1 and BRCA2, can change their local treatment (e.g., bilateral mastectomy instead of conservative surgery) but they have also to take care of their ovaries. They need to think of prophylactic oophorectomy, which makes fertility and pregnancy even more complicated. For them, it’s much more complex to address everything.

I think it’s really very complex, and I think we need a better understanding of all the nuances. Sometimes, we really do not consider, as you mentioned, that not every woman desires to have a baby.

The occurrence of breast cancer can wake up a desire that was not conscious but becomes conscious because you feel that you will not be able to do that. With the social support, the psychological support, and support groups – we have a very strong breast cancer support group for younger women — they could face these things. The young women support group was supportive of the POSITIVE trial: they helped to develop and financed a video, which was very helpful to promote POSITIVE.

I think that having a relationship or a network between patients, health professionals, social workers, and psychologists can help everyone, including those who want to become mothers, those who cannot, and those who do not want to.

Dr. Partridge: I think that’s great, Olivia. I think you rounded it out by just shining a light on these issues for our young patients and elevating it to being okay to talk about these issues. I think historically, it’s been: “You’ve got breast cancer, forget about this. We just need to get you to a better survival.”

We’re increasingly recognizing for patients of all ages, but particularly our young patients, that just surviving through breast cancer or cancer in general is not enough. We need to help people live the best and fullest life possible in their survivorship.
 

Education and communication: Key aspects moving forward

Dr. Pagani: I think another issue we need really to improve is health professional competence and knowledge. After you presented the POSITIVE trial in San Antonio, I had many calls with patients. They told me, “Well, I had this information, but my gynecologist, my oncologist, or my general practitioner still discouraged me.” This is a great barrier.

I think we need to do more to teach the health professionals. Otherwise, what we do is never enough because it will be blocked. They are scared and they do not want to go against their doctors. I think this is a very big conflict.

Dr. Partridge: That’s a really important point, and I appreciate you bringing it up. We as clinicians and educators who are building the research base need to really get it out there.

Dr. Pagani is a professor at the University of Geneva. Dr. Partridge is professor of medicine at Harvard Medical School and vice chair of clinical oncology at Dana-Farber Cancer Institute, both in Boston. Dr. Pagani reported conflicts of interest with PRIME, Roche, Eli Lilly, Novartis, Takeda, Pfizer, and Debiopharm. Dr. Partridge reported no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Dr. Partridge: We’re here today to have a conversation about the unique or age-specific issues that face our young patients and survivors with breast cancer.

Olivia, let’s get started. What kinds of things do we need to think about when we’re seeing a young patient in clinic, beyond the usual things we think about for patients with breast cancer?

Dr. Pagani: The idea of selecting age as a determinant of care of young women is because they have specific issues, which are different from older, premenopausal patients but also older patients in general. We need to take care of many things, which can go from their job, family, fertility, and all these things are specific to these women and can impact their treatment, survivorship issues, side effects, and long-term problems. It’s a different world, compared with other patients with breast cancer.

Dr. Partridge: One of the areas that you and I have been very deep in the weeds in is the fertility issues. That’s obviously one of the things that’s pretty age-specific. There are some new data around that that we’re excited about. What do we think about when we think about trying to have a pregnancy or not after a breast cancer diagnosis?

Dr. Pagani: Yeah. I think it’s great times for that because we succeeded in building up a very important trial, which broke a taboo that was there for many, many decades: You had breast cancer so forget your pregnancy desire.

Despite many retrospective data from many groups that suggested pregnancy after breast cancer was not detrimental, there were so many obstacles for these women to address their pregnancy desire. I think we succeeded in explaining and showing in a quite solid way that if you desire a baby after breast cancer, you can try to have him or her.

Dr. Partridge: This was called the POSITIVE trial, with early findings published in the New England Journal of Medicine this past year, which was very exciting. Let’s dig a little deeper into that. Is this relevant for all patients with breast cancer or select patients with breast cancer who want to get pregnant?

Dr. Pagani: The accrual of the trial was open to all patients with stage I-III disease, but the majority of the patients were low risk, which means that the majority were node negative with small tumors. I think, so far, we can say that in low-risk women, pregnancy after breast cancer can be discussed and planned.

Summarizing, I think the evidence is for low-risk patients with early breast cancer. A minority had huge tumors or node-positive disease.

Dr. Partridge: It’s nice to be able to have these data to say a temporary interruption of endocrine therapy – not coming off forever, getting back on – was not associated with any worsening in terms of their breast cancer events in the future, which is great news for the women who are diagnosed when they’re trying to get pregnant and build their families or not having completed their families. It’s been fantastic.

What about for our patients with advanced disease who come in, and we’re treating them more to try and manage the cancer and improve their survival and quality of life, but cure may not be the goal. How do we manage the fertility issues for them?

Dr. Pagani: This is, I think, still an open issue despite overall survival for many women with advanced disease, especially HER2 positive or endocrine responsive; it is improving and it’s getting better and better. There are few women with oligometastatic disease that can be cured.

We are not yet there. At the Advanced Breast Cancer conference, we started to open the door to say that fertility should be discussed with patients with advanced breast cancer as well. We cannot recommend to patients with advanced breast cancer to pursue a pregnancy.

We have no data. For sure, this needs to be taken into account and discussed openly with all the patients who desire to discuss this.

Dr. Partridge: Yes. To help people to either grieve their losses or find alternative ways to build their family, I think, is something that we focus on.

How to optimize the plan of care for young patients

Dr. Partridge: Shifting gears into the psychosocial, we know that our young women of all stages have a harder time adjusting to a breast cancer diagnosis for good reason. It’s not normative at all to be dealing with a lot of the slings and arrows that our young women deal with at the age that they do. How do you manage that in your clinic, Olivia?

Dr. Pagani: Well, I think it’s always tough. One of the problems, which is also true for early breast cancer in general, which I think is common to you as well, is that in our society many women get breast cancer before even having thought of their family planning. That’s many of them in our reality.

In other countries, maybe they have already two to three children. In our countries, they are aged 30-35 years with no children, no stable relationship, and then are faced with all these things, and their pregnancy desire can be blown up because they understand there is no time, especially if they are metastatic. This can be devastating.

We are not very good at that yet. I think we need to develop better tools, better competence, and knowledge to support them to this extent as well.

Dr. Partridge: I know that whether people want kids or not, the diagnosis of breast cancer has financial toxicity and the inconvenience of going through this kind of experience while managing a busy life. Many of our patients, especially our young patients, are trying to develop their careers, to graduate from schools, and to grow a nest egg. They’re not retired yet, on average.

I agree that we have a large amount of work to do. The one thing I try and do is always bring in our social workers and our psychosocial supportive care providers for our young patients; not that I don’t bring them in for everybody that needs them, but our young patients on average seem to need them a little bit more just because it can be just so hard on them from a psychosocial and emotional standpoint, don’t you think?

 

 

Dr. Pagani: Yes, I think so. Do you have any specific program going on at Harvard?

Dr. Partridge: We do. We’ve built a program for young women that focuses on their unique and specific needs that capitalizes on groups that are already there. We have a social work department. We just have smoothed the pathway, and we send our young people in there more quickly and have some dedicated support groups and one-to-one interventions where patients can guide other young patients. We’ve built out the supportive care for these young patients and programming.

The other big area we’ve developed that’s not unique to young age but certainly enhanced in our young patients is genetics. We have a big genetic component at our cancer center. The young patients, more so than any other group, need to have the genetic counseling and the genetic testing not only to know about future risks and about their families but also to inform their treatment decisions these days. Do you want to comment on that?

Dr. Pagani: Yes, of course. Genetic counseling, especially for the most common BRCA1 and BRCA2, can change their local treatment (e.g., bilateral mastectomy instead of conservative surgery) but they have also to take care of their ovaries. They need to think of prophylactic oophorectomy, which makes fertility and pregnancy even more complicated. For them, it’s much more complex to address everything.

I think it’s really very complex, and I think we need a better understanding of all the nuances. Sometimes, we really do not consider, as you mentioned, that not every woman desires to have a baby.

The occurrence of breast cancer can wake up a desire that was not conscious but becomes conscious because you feel that you will not be able to do that. With the social support, the psychological support, and support groups – we have a very strong breast cancer support group for younger women — they could face these things. The young women support group was supportive of the POSITIVE trial: they helped to develop and financed a video, which was very helpful to promote POSITIVE.

I think that having a relationship or a network between patients, health professionals, social workers, and psychologists can help everyone, including those who want to become mothers, those who cannot, and those who do not want to.

Dr. Partridge: I think that’s great, Olivia. I think you rounded it out by just shining a light on these issues for our young patients and elevating it to being okay to talk about these issues. I think historically, it’s been: “You’ve got breast cancer, forget about this. We just need to get you to a better survival.”

We’re increasingly recognizing for patients of all ages, but particularly our young patients, that just surviving through breast cancer or cancer in general is not enough. We need to help people live the best and fullest life possible in their survivorship.
 

Education and communication: Key aspects moving forward

Dr. Pagani: I think another issue we need really to improve is health professional competence and knowledge. After you presented the POSITIVE trial in San Antonio, I had many calls with patients. They told me, “Well, I had this information, but my gynecologist, my oncologist, or my general practitioner still discouraged me.” This is a great barrier.

I think we need to do more to teach the health professionals. Otherwise, what we do is never enough because it will be blocked. They are scared and they do not want to go against their doctors. I think this is a very big conflict.

Dr. Partridge: That’s a really important point, and I appreciate you bringing it up. We as clinicians and educators who are building the research base need to really get it out there.

Dr. Pagani is a professor at the University of Geneva. Dr. Partridge is professor of medicine at Harvard Medical School and vice chair of clinical oncology at Dana-Farber Cancer Institute, both in Boston. Dr. Pagani reported conflicts of interest with PRIME, Roche, Eli Lilly, Novartis, Takeda, Pfizer, and Debiopharm. Dr. Partridge reported no conflicts of interest.
 

A version of this article first appeared on Medscape.com.

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Fatalities from breast cancer have ‘improved substantially’

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Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

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Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

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DCIS isn’t an automatic indication for mastectomy in HER2+ BC

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Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

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Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

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Survival, QoL trump PFS for most patients with cancer

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Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

 

 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

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Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

 

 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

 

 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

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FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE

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Commentary: Meningioma, Radiotherapy Interruptions, Therapy Persistence, and Lymphocytes in BC, August 2023

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Dr. Abdou scans the journals so you don't have to!

Yara Abdou, MD
Degeneffe and colleagues conducted a large systematic review and meta-analysis of 51 studies looking at 2238 patients to evaluate the association between meningioma and breast cancer (BC). They found that women diagnosed with meningioma have approximately 10-fold higher odds of developing BC compared with the general population (odds ratio 9.87; 95% CI 7.31-13.32). Three prior studies have established a similar risk association for the co-occurrence of these two diseases. They made several hypotheses to explain this association, such as the hormone receptor expression in both diseases, the overactivation of the MYC oncogene, and the possible role of ionizing radiation. Further studies are needed to explain and validate these findings.

Data are limited regarding the effect of interrupting radiation therapy for patients with BC. A retrospective study by Chow and colleagues looked at 35,845 patients with nonmetastatic triple-negative BC from the National Cancer Database who had received external beam radiation therapy as part of the management of their BC. The analysis showed inferior overall survival in patients with a longer duration of radiation treatment (hazard ratio 1.023; 95% CI 1.015-1.031) The more days of interruption, the higher the likelihood of mortality seen. In reference to 0-1 days of interruption, patients with 2-5 interrupted days (hazard ratio 1.069; 95% CI 1.002-1.140), 6-10 interrupted days (hazard ratio 1.239; 95% CI 1.140-1.348), and 11-15 interrupted days (hazard ratio 1.265; 95% CI 1.126-1.431) did worse. These findings should encourage further studies to explore ways to minimize treatment interruptions among patients with BC.

A lack of adherence to adjuvant endocrine therapy has been associated with increased mortality among women with BC. The retrospective study by Zheng and Thomas  included 25,796 older women (> 65 years old) diagnosed with stage I-III hormone receptor–positive BC and looked at associations between adherence to and persistence with adjuvant endocrine therapy and mortality in this cohort. Their findings showed that the risk for all-cause mortality was reduced by 25% in patients with vs without cumulative adherence to endocrine therapy (hazard ratio 0.75; P < .001), although no association was seen with BC-specific mortality. Persistence with endocrine therapy, which was defined as having taken the treatment for ≥ 180 continuous days, was associated with 11% reduction in all-cause mortality and 37% reduction in BC-specific mortality. This study supports prior studies in highlighting the importance of endocrine therapy adherence among women with hormone-positive BC.

Tumor-infiltrating lymphocytes (TIL) are considered significant prognostic markers in patients with BC, although the prognostic effect of TIL in human epidermal growth factor reception 2 (HER2)–low BC has not been identified. A large-cohort, single-institution retrospective analysis by Sun and colleagues investigated the prognostic role of TIL in HER2-low early-stage BC. The analysis included 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low, and 595 were HER2-0. No differences in disease-free survival (DFS) were seen between the three cohorts. However, in patients with HER2-low BC, high (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS overall (hazard ratio 0.47; P = .035), and a 58% improvement in DFS was seen for the hormone receptor–positive/HER2-low cohort (hazard ratio 0.42; P = .032).

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University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

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University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

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University of North Carolina at Chapel Hill
Lineberger Comprehensive Cancer Center

Dr. Abdou scans the journals so you don't have to!
Dr. Abdou scans the journals so you don't have to!

Yara Abdou, MD
Degeneffe and colleagues conducted a large systematic review and meta-analysis of 51 studies looking at 2238 patients to evaluate the association between meningioma and breast cancer (BC). They found that women diagnosed with meningioma have approximately 10-fold higher odds of developing BC compared with the general population (odds ratio 9.87; 95% CI 7.31-13.32). Three prior studies have established a similar risk association for the co-occurrence of these two diseases. They made several hypotheses to explain this association, such as the hormone receptor expression in both diseases, the overactivation of the MYC oncogene, and the possible role of ionizing radiation. Further studies are needed to explain and validate these findings.

Data are limited regarding the effect of interrupting radiation therapy for patients with BC. A retrospective study by Chow and colleagues looked at 35,845 patients with nonmetastatic triple-negative BC from the National Cancer Database who had received external beam radiation therapy as part of the management of their BC. The analysis showed inferior overall survival in patients with a longer duration of radiation treatment (hazard ratio 1.023; 95% CI 1.015-1.031) The more days of interruption, the higher the likelihood of mortality seen. In reference to 0-1 days of interruption, patients with 2-5 interrupted days (hazard ratio 1.069; 95% CI 1.002-1.140), 6-10 interrupted days (hazard ratio 1.239; 95% CI 1.140-1.348), and 11-15 interrupted days (hazard ratio 1.265; 95% CI 1.126-1.431) did worse. These findings should encourage further studies to explore ways to minimize treatment interruptions among patients with BC.

A lack of adherence to adjuvant endocrine therapy has been associated with increased mortality among women with BC. The retrospective study by Zheng and Thomas  included 25,796 older women (> 65 years old) diagnosed with stage I-III hormone receptor–positive BC and looked at associations between adherence to and persistence with adjuvant endocrine therapy and mortality in this cohort. Their findings showed that the risk for all-cause mortality was reduced by 25% in patients with vs without cumulative adherence to endocrine therapy (hazard ratio 0.75; P < .001), although no association was seen with BC-specific mortality. Persistence with endocrine therapy, which was defined as having taken the treatment for ≥ 180 continuous days, was associated with 11% reduction in all-cause mortality and 37% reduction in BC-specific mortality. This study supports prior studies in highlighting the importance of endocrine therapy adherence among women with hormone-positive BC.

Tumor-infiltrating lymphocytes (TIL) are considered significant prognostic markers in patients with BC, although the prognostic effect of TIL in human epidermal growth factor reception 2 (HER2)–low BC has not been identified. A large-cohort, single-institution retrospective analysis by Sun and colleagues investigated the prognostic role of TIL in HER2-low early-stage BC. The analysis included 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low, and 595 were HER2-0. No differences in disease-free survival (DFS) were seen between the three cohorts. However, in patients with HER2-low BC, high (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS overall (hazard ratio 0.47; P = .035), and a 58% improvement in DFS was seen for the hormone receptor–positive/HER2-low cohort (hazard ratio 0.42; P = .032).

Yara Abdou, MD
Degeneffe and colleagues conducted a large systematic review and meta-analysis of 51 studies looking at 2238 patients to evaluate the association between meningioma and breast cancer (BC). They found that women diagnosed with meningioma have approximately 10-fold higher odds of developing BC compared with the general population (odds ratio 9.87; 95% CI 7.31-13.32). Three prior studies have established a similar risk association for the co-occurrence of these two diseases. They made several hypotheses to explain this association, such as the hormone receptor expression in both diseases, the overactivation of the MYC oncogene, and the possible role of ionizing radiation. Further studies are needed to explain and validate these findings.

Data are limited regarding the effect of interrupting radiation therapy for patients with BC. A retrospective study by Chow and colleagues looked at 35,845 patients with nonmetastatic triple-negative BC from the National Cancer Database who had received external beam radiation therapy as part of the management of their BC. The analysis showed inferior overall survival in patients with a longer duration of radiation treatment (hazard ratio 1.023; 95% CI 1.015-1.031) The more days of interruption, the higher the likelihood of mortality seen. In reference to 0-1 days of interruption, patients with 2-5 interrupted days (hazard ratio 1.069; 95% CI 1.002-1.140), 6-10 interrupted days (hazard ratio 1.239; 95% CI 1.140-1.348), and 11-15 interrupted days (hazard ratio 1.265; 95% CI 1.126-1.431) did worse. These findings should encourage further studies to explore ways to minimize treatment interruptions among patients with BC.

A lack of adherence to adjuvant endocrine therapy has been associated with increased mortality among women with BC. The retrospective study by Zheng and Thomas  included 25,796 older women (> 65 years old) diagnosed with stage I-III hormone receptor–positive BC and looked at associations between adherence to and persistence with adjuvant endocrine therapy and mortality in this cohort. Their findings showed that the risk for all-cause mortality was reduced by 25% in patients with vs without cumulative adherence to endocrine therapy (hazard ratio 0.75; P < .001), although no association was seen with BC-specific mortality. Persistence with endocrine therapy, which was defined as having taken the treatment for ≥ 180 continuous days, was associated with 11% reduction in all-cause mortality and 37% reduction in BC-specific mortality. This study supports prior studies in highlighting the importance of endocrine therapy adherence among women with hormone-positive BC.

Tumor-infiltrating lymphocytes (TIL) are considered significant prognostic markers in patients with BC, although the prognostic effect of TIL in human epidermal growth factor reception 2 (HER2)–low BC has not been identified. A large-cohort, single-institution retrospective analysis by Sun and colleagues investigated the prognostic role of TIL in HER2-low early-stage BC. The analysis included 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low, and 595 were HER2-0. No differences in disease-free survival (DFS) were seen between the three cohorts. However, in patients with HER2-low BC, high (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS overall (hazard ratio 0.47; P = .035), and a 58% improvement in DFS was seen for the hormone receptor–positive/HER2-low cohort (hazard ratio 0.42; P = .032).

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Commentary: Node irradiation, HER2+ treatment, and diet in BC, August 2023

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Dr. Roesch scans the journals, so you don't have to!

Erin Roesch, MD
Multiple previous trials have demonstrated the benefits of regional nodal irradiation (RNI) among patients with node-positive breast cancer, including postmastectomy and after breast-conserving surgery (BCS). The NCIC MA.20 trial, which included primarily patients with one to three involved nodes, demonstrated disease-free survival (DFS) improvement with the addition of RNI to whole-breast radiotherapy (DFS of 82.0% in the RNI group vs 77.0% in the control group; hazard ratio for DFS 0.76; P = .01).1 However, the selection of patients for RNI is variable and may depend on patient and tumor characteristics as well as surgery and the systemic therapies applied. In the NCIC MA.20 trial, nodal-irradiation was associated with better overall survival among those with estrogen receptor (ER)–negative breast cancer but not among those with ER-positive disease. A secondary analysis of the SWOG S1007 trial, which randomly assigned patients with hormone receptor (HR)–positive/human epidermal growth factor receptor 2 (HER2)–negative breast cancer with one to three involved nodes and a 21-gene recurrence score ≤ 25 to endocrine therapy alone or chemotherapy plus endocrine therapy, investigated the use of radiotherapy and patterns of locoregional recurrence (Jagsi et al). Of those patients who received radiotherapy with complete information on targets (N = 3852), 59% (N = 2274) received RNI. At median follow-up of 6.1 years, the cumulative incidence of locoregional recurrence was low among all groups: 0.85% after BCS and radiotherapy with RNI, 0.55% after BCS with radiotherapy without RNI, 0.11% after mastectomy with postmastectomy radiation therapy (PMRT), and 1.7% after mastectomy without radiotherapy. Receiving RNI was not associated with invasive DFS for pre- or postmenopausal patients. These data support the importance of prospective studies, including the NCIC MA.39 trial,2 designed to identify optimal locoregional therapy in patients with limited nodal burden and favorable disease biology.

The addition of pertuzumab to trastuzumab plus chemotherapy has demonstrated improvement in pathologic complete response (pCR) rates compared with trastuzumab plus chemotherapy in early-stage HER2-positive breast cancer.3 The framework of oncology is built on clinical trials through their rigorous design, enrollment, and synthesis of data; however, real-world studies are an integral component of cancer research because they provide a more representative sample of the general population treated in routine clinical practice. Neopearl was a retrospective, observational, real-world study that evaluated the efficacy and safety of trastuzumab plus chemotherapy with or without pertuzumab among 271 patients with stage II-III HER2-positive breast cancer (Fabbri et al). The addition of pertuzumab led to an increase in pCR rate (49% vs 62%; odds ratio 1.74; P = .032) and improvement in 5-year event-free survival (81% vs 93%; hazard ratio 2.22; P = .041), and the benefit on univariate analysis was restricted to patients with positive axillary nodes. Furthermore, there were no significant differences in adverse events, including cardiac, between the two groups. These results serve to strengthen the available data regarding the clinical efficacy and favorable safety profile of dual HER2-targeted therapy combined with neoadjuvant chemotherapy.

Lifestyle factors, including physical activity and diet, are becoming increasingly recognized as important determinants of various cancer-specific outcomes and overall health. Furthermore, because these are modifiable, there is often motivation on behalf of an individual to change behaviors that can affect their outcome. Adherence to the Mediterranean diet (MD) has been associated with reduced risk for breast cancer development and lower mortality among women with breast cancer.4,5 Data from a prospective multicenter European cohort including 13,270 breast cancer survivors demonstrated that low compared with medium adherence to a MD before a breast cancer diagnosis was associated with a 13% higher risk for all-cause mortality (hazard ratio 1.13; 95% CI 1.01-1.26). A three-unit increase in the adapted relative MD score was associated with an 8% reduced risk for overall mortality (hazard ratio3-unit 0.92; 95% CI 0.87-0.97); this result was sustained in the postmenopausal population and strengthened in metastatic disease (Castro-Espin et al). The connection between diet and cancer outcomes is complex, and future research evaluating specific dietary interventions and the underlying biologic pathways by which nutrition exerts its effects will be important to inform our counseling for patients with breast cancer in the survivorship setting.

Additional References

  1. Whelan TJ, Olivotto IA, Parulekar WR, et al, for the MA.20 Study Investigators. Regional nodal irradiation in early-stage breast cancer. N Engl J Med. 2015;373:307-16. doi:10.1056/NEJMoa1415340
  2. ClinicalTrials.gov. Regional radiotherapy in biomarker low-risk node positive and T3N0 breast cancer (TAILOR RT). National Library of Medicine. Last updated November 23, 2022. https://www.clinicaltrials.gov/study/NCT03488693
  3. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): A randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25-32. doi:10.1016/S1470-2045(11)70336-9
  4. Buckland G, Travier N, Cottet V, et al. Adherence to the mediterranean diet and risk of breast cancer in the European prospective investigation into cancer and nutrition cohort study. Int J Cancer. 2013;132:2918-27. doi:10.1002/ijc.27958
  5. Haslam DE, John EM, Knight JA, et al. Diet quality and all-cause mortality in women with breast cancer from the Breast Cancer Family Registry. Cancer Epidemiol Biomarkers Prev. 2023;32:678-686. doi:10.1158/1055-9965.EPI-22-1198
Author and Disclosure Information

Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

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Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Author and Disclosure Information

Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Dr. Roesch scans the journals, so you don't have to!
Dr. Roesch scans the journals, so you don't have to!

Erin Roesch, MD
Multiple previous trials have demonstrated the benefits of regional nodal irradiation (RNI) among patients with node-positive breast cancer, including postmastectomy and after breast-conserving surgery (BCS). The NCIC MA.20 trial, which included primarily patients with one to three involved nodes, demonstrated disease-free survival (DFS) improvement with the addition of RNI to whole-breast radiotherapy (DFS of 82.0% in the RNI group vs 77.0% in the control group; hazard ratio for DFS 0.76; P = .01).1 However, the selection of patients for RNI is variable and may depend on patient and tumor characteristics as well as surgery and the systemic therapies applied. In the NCIC MA.20 trial, nodal-irradiation was associated with better overall survival among those with estrogen receptor (ER)–negative breast cancer but not among those with ER-positive disease. A secondary analysis of the SWOG S1007 trial, which randomly assigned patients with hormone receptor (HR)–positive/human epidermal growth factor receptor 2 (HER2)–negative breast cancer with one to three involved nodes and a 21-gene recurrence score ≤ 25 to endocrine therapy alone or chemotherapy plus endocrine therapy, investigated the use of radiotherapy and patterns of locoregional recurrence (Jagsi et al). Of those patients who received radiotherapy with complete information on targets (N = 3852), 59% (N = 2274) received RNI. At median follow-up of 6.1 years, the cumulative incidence of locoregional recurrence was low among all groups: 0.85% after BCS and radiotherapy with RNI, 0.55% after BCS with radiotherapy without RNI, 0.11% after mastectomy with postmastectomy radiation therapy (PMRT), and 1.7% after mastectomy without radiotherapy. Receiving RNI was not associated with invasive DFS for pre- or postmenopausal patients. These data support the importance of prospective studies, including the NCIC MA.39 trial,2 designed to identify optimal locoregional therapy in patients with limited nodal burden and favorable disease biology.

The addition of pertuzumab to trastuzumab plus chemotherapy has demonstrated improvement in pathologic complete response (pCR) rates compared with trastuzumab plus chemotherapy in early-stage HER2-positive breast cancer.3 The framework of oncology is built on clinical trials through their rigorous design, enrollment, and synthesis of data; however, real-world studies are an integral component of cancer research because they provide a more representative sample of the general population treated in routine clinical practice. Neopearl was a retrospective, observational, real-world study that evaluated the efficacy and safety of trastuzumab plus chemotherapy with or without pertuzumab among 271 patients with stage II-III HER2-positive breast cancer (Fabbri et al). The addition of pertuzumab led to an increase in pCR rate (49% vs 62%; odds ratio 1.74; P = .032) and improvement in 5-year event-free survival (81% vs 93%; hazard ratio 2.22; P = .041), and the benefit on univariate analysis was restricted to patients with positive axillary nodes. Furthermore, there were no significant differences in adverse events, including cardiac, between the two groups. These results serve to strengthen the available data regarding the clinical efficacy and favorable safety profile of dual HER2-targeted therapy combined with neoadjuvant chemotherapy.

Lifestyle factors, including physical activity and diet, are becoming increasingly recognized as important determinants of various cancer-specific outcomes and overall health. Furthermore, because these are modifiable, there is often motivation on behalf of an individual to change behaviors that can affect their outcome. Adherence to the Mediterranean diet (MD) has been associated with reduced risk for breast cancer development and lower mortality among women with breast cancer.4,5 Data from a prospective multicenter European cohort including 13,270 breast cancer survivors demonstrated that low compared with medium adherence to a MD before a breast cancer diagnosis was associated with a 13% higher risk for all-cause mortality (hazard ratio 1.13; 95% CI 1.01-1.26). A three-unit increase in the adapted relative MD score was associated with an 8% reduced risk for overall mortality (hazard ratio3-unit 0.92; 95% CI 0.87-0.97); this result was sustained in the postmenopausal population and strengthened in metastatic disease (Castro-Espin et al). The connection between diet and cancer outcomes is complex, and future research evaluating specific dietary interventions and the underlying biologic pathways by which nutrition exerts its effects will be important to inform our counseling for patients with breast cancer in the survivorship setting.

Additional References

  1. Whelan TJ, Olivotto IA, Parulekar WR, et al, for the MA.20 Study Investigators. Regional nodal irradiation in early-stage breast cancer. N Engl J Med. 2015;373:307-16. doi:10.1056/NEJMoa1415340
  2. ClinicalTrials.gov. Regional radiotherapy in biomarker low-risk node positive and T3N0 breast cancer (TAILOR RT). National Library of Medicine. Last updated November 23, 2022. https://www.clinicaltrials.gov/study/NCT03488693
  3. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): A randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25-32. doi:10.1016/S1470-2045(11)70336-9
  4. Buckland G, Travier N, Cottet V, et al. Adherence to the mediterranean diet and risk of breast cancer in the European prospective investigation into cancer and nutrition cohort study. Int J Cancer. 2013;132:2918-27. doi:10.1002/ijc.27958
  5. Haslam DE, John EM, Knight JA, et al. Diet quality and all-cause mortality in women with breast cancer from the Breast Cancer Family Registry. Cancer Epidemiol Biomarkers Prev. 2023;32:678-686. doi:10.1158/1055-9965.EPI-22-1198

Erin Roesch, MD
Multiple previous trials have demonstrated the benefits of regional nodal irradiation (RNI) among patients with node-positive breast cancer, including postmastectomy and after breast-conserving surgery (BCS). The NCIC MA.20 trial, which included primarily patients with one to three involved nodes, demonstrated disease-free survival (DFS) improvement with the addition of RNI to whole-breast radiotherapy (DFS of 82.0% in the RNI group vs 77.0% in the control group; hazard ratio for DFS 0.76; P = .01).1 However, the selection of patients for RNI is variable and may depend on patient and tumor characteristics as well as surgery and the systemic therapies applied. In the NCIC MA.20 trial, nodal-irradiation was associated with better overall survival among those with estrogen receptor (ER)–negative breast cancer but not among those with ER-positive disease. A secondary analysis of the SWOG S1007 trial, which randomly assigned patients with hormone receptor (HR)–positive/human epidermal growth factor receptor 2 (HER2)–negative breast cancer with one to three involved nodes and a 21-gene recurrence score ≤ 25 to endocrine therapy alone or chemotherapy plus endocrine therapy, investigated the use of radiotherapy and patterns of locoregional recurrence (Jagsi et al). Of those patients who received radiotherapy with complete information on targets (N = 3852), 59% (N = 2274) received RNI. At median follow-up of 6.1 years, the cumulative incidence of locoregional recurrence was low among all groups: 0.85% after BCS and radiotherapy with RNI, 0.55% after BCS with radiotherapy without RNI, 0.11% after mastectomy with postmastectomy radiation therapy (PMRT), and 1.7% after mastectomy without radiotherapy. Receiving RNI was not associated with invasive DFS for pre- or postmenopausal patients. These data support the importance of prospective studies, including the NCIC MA.39 trial,2 designed to identify optimal locoregional therapy in patients with limited nodal burden and favorable disease biology.

The addition of pertuzumab to trastuzumab plus chemotherapy has demonstrated improvement in pathologic complete response (pCR) rates compared with trastuzumab plus chemotherapy in early-stage HER2-positive breast cancer.3 The framework of oncology is built on clinical trials through their rigorous design, enrollment, and synthesis of data; however, real-world studies are an integral component of cancer research because they provide a more representative sample of the general population treated in routine clinical practice. Neopearl was a retrospective, observational, real-world study that evaluated the efficacy and safety of trastuzumab plus chemotherapy with or without pertuzumab among 271 patients with stage II-III HER2-positive breast cancer (Fabbri et al). The addition of pertuzumab led to an increase in pCR rate (49% vs 62%; odds ratio 1.74; P = .032) and improvement in 5-year event-free survival (81% vs 93%; hazard ratio 2.22; P = .041), and the benefit on univariate analysis was restricted to patients with positive axillary nodes. Furthermore, there were no significant differences in adverse events, including cardiac, between the two groups. These results serve to strengthen the available data regarding the clinical efficacy and favorable safety profile of dual HER2-targeted therapy combined with neoadjuvant chemotherapy.

Lifestyle factors, including physical activity and diet, are becoming increasingly recognized as important determinants of various cancer-specific outcomes and overall health. Furthermore, because these are modifiable, there is often motivation on behalf of an individual to change behaviors that can affect their outcome. Adherence to the Mediterranean diet (MD) has been associated with reduced risk for breast cancer development and lower mortality among women with breast cancer.4,5 Data from a prospective multicenter European cohort including 13,270 breast cancer survivors demonstrated that low compared with medium adherence to a MD before a breast cancer diagnosis was associated with a 13% higher risk for all-cause mortality (hazard ratio 1.13; 95% CI 1.01-1.26). A three-unit increase in the adapted relative MD score was associated with an 8% reduced risk for overall mortality (hazard ratio3-unit 0.92; 95% CI 0.87-0.97); this result was sustained in the postmenopausal population and strengthened in metastatic disease (Castro-Espin et al). The connection between diet and cancer outcomes is complex, and future research evaluating specific dietary interventions and the underlying biologic pathways by which nutrition exerts its effects will be important to inform our counseling for patients with breast cancer in the survivorship setting.

Additional References

  1. Whelan TJ, Olivotto IA, Parulekar WR, et al, for the MA.20 Study Investigators. Regional nodal irradiation in early-stage breast cancer. N Engl J Med. 2015;373:307-16. doi:10.1056/NEJMoa1415340
  2. ClinicalTrials.gov. Regional radiotherapy in biomarker low-risk node positive and T3N0 breast cancer (TAILOR RT). National Library of Medicine. Last updated November 23, 2022. https://www.clinicaltrials.gov/study/NCT03488693
  3. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): A randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13:25-32. doi:10.1016/S1470-2045(11)70336-9
  4. Buckland G, Travier N, Cottet V, et al. Adherence to the mediterranean diet and risk of breast cancer in the European prospective investigation into cancer and nutrition cohort study. Int J Cancer. 2013;132:2918-27. doi:10.1002/ijc.27958
  5. Haslam DE, John EM, Knight JA, et al. Diet quality and all-cause mortality in women with breast cancer from the Breast Cancer Family Registry. Cancer Epidemiol Biomarkers Prev. 2023;32:678-686. doi:10.1158/1055-9965.EPI-22-1198
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Time to end direct-to-consumer ads, says physician

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One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Regional Meeting Focuses on Women’s Cancer Survivorship

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As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

 

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

 

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

 

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

 

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

 

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

 

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

 

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

 

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

 

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

 

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

 

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

 

 

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

 

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

 

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

 

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

 

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

 

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

 

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

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As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

 

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

 

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

 

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

 

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

 

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

 

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

 

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

 

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

 

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

 

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

 

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

 

 

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

 

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

 

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

 

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

 

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

 

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

 

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

 

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

 

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

 

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

 

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

 

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

 

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

 

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

 

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

 

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

 

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

 

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

 

 

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

 

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

 

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

 

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

 

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

 

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

 

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

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Low-carbohydrate, plant-rich diets may prolong survival in breast cancer

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Key clinical point: Women who survive stages I-III breast cancer (BC) may experience improved survival outcomes on adhering to a low-carbohydrate diet, particularly one that is plant-rich.

Major finding: Compared with women having the highest carbohydrate intake, lowest protein intake, and lowest fat intake after BC diagnosis, those adhering to an overall low‐carbohydrate diet (hazard ratio [HR] 0.82; Ptrend = .0001) and a plant‐rich low‐carbohydrate diet (HR 0.73; Ptrend < .0001) had a significantly lower risk for all-cause mortality.

Study details: Findings are from an analysis of two ongoing cohort studies, the Nurses’ Health Study (NHS) and NHS II, including 9621 women with stages I-III BC, of which 1269 women died from BC.

Disclosures: This study was sponsored by the US National Institutes of Health and University of Toronto. Two authors declared being the founder of or receiving personal fees, nonfinancial support, and grants from various sources. The other authors declared no conflicts of interest.

Source: Farvid MS et al. Associations of low-carbohydrate diets with breast cancer survival. Cancer. 2023 (Jun 10). Doi: 10.1002/cncr.34819

 

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Key clinical point: Women who survive stages I-III breast cancer (BC) may experience improved survival outcomes on adhering to a low-carbohydrate diet, particularly one that is plant-rich.

Major finding: Compared with women having the highest carbohydrate intake, lowest protein intake, and lowest fat intake after BC diagnosis, those adhering to an overall low‐carbohydrate diet (hazard ratio [HR] 0.82; Ptrend = .0001) and a plant‐rich low‐carbohydrate diet (HR 0.73; Ptrend < .0001) had a significantly lower risk for all-cause mortality.

Study details: Findings are from an analysis of two ongoing cohort studies, the Nurses’ Health Study (NHS) and NHS II, including 9621 women with stages I-III BC, of which 1269 women died from BC.

Disclosures: This study was sponsored by the US National Institutes of Health and University of Toronto. Two authors declared being the founder of or receiving personal fees, nonfinancial support, and grants from various sources. The other authors declared no conflicts of interest.

Source: Farvid MS et al. Associations of low-carbohydrate diets with breast cancer survival. Cancer. 2023 (Jun 10). Doi: 10.1002/cncr.34819

 

Key clinical point: Women who survive stages I-III breast cancer (BC) may experience improved survival outcomes on adhering to a low-carbohydrate diet, particularly one that is plant-rich.

Major finding: Compared with women having the highest carbohydrate intake, lowest protein intake, and lowest fat intake after BC diagnosis, those adhering to an overall low‐carbohydrate diet (hazard ratio [HR] 0.82; Ptrend = .0001) and a plant‐rich low‐carbohydrate diet (HR 0.73; Ptrend < .0001) had a significantly lower risk for all-cause mortality.

Study details: Findings are from an analysis of two ongoing cohort studies, the Nurses’ Health Study (NHS) and NHS II, including 9621 women with stages I-III BC, of which 1269 women died from BC.

Disclosures: This study was sponsored by the US National Institutes of Health and University of Toronto. Two authors declared being the founder of or receiving personal fees, nonfinancial support, and grants from various sources. The other authors declared no conflicts of interest.

Source: Farvid MS et al. Associations of low-carbohydrate diets with breast cancer survival. Cancer. 2023 (Jun 10). Doi: 10.1002/cncr.34819

 

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Tumor-infiltrating lymphocytes guide prognosis in early-stage HER2-low-positive breast cancer

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Key clinical point: The level of stromal tumor-infiltrating lymphocytes (TIL) can provide insights on disease-free survival (DFS) outcomes in human epidermal growth factor receptor 2-low-positive (HER2-low+) early-stage breast cancer (BC).

Major finding: High (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS in HER2-low+ BC (hazard ratio [HR] 0.47; P = .035) and 58% improvement in DFS in hormone receptor-positive/HER2-low+ BC (HR 0.42; P = .032).

Study details: Findings are from a single-institution retrospective analysis including 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low+, and 595 were HER2-0.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Shandong Province. The authors declared no conflicts of interest.

Source: Sun T et al. Tumor-infiltrating lymphocytes provides recent survival information for early-stage HER2-low-positive breast cancer: A large cohort retrospective study. Front Oncol. 2023;13:1148228 (Jun 20). Doi: 10.3389/fonc.2023.1148228

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Key clinical point: The level of stromal tumor-infiltrating lymphocytes (TIL) can provide insights on disease-free survival (DFS) outcomes in human epidermal growth factor receptor 2-low-positive (HER2-low+) early-stage breast cancer (BC).

Major finding: High (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS in HER2-low+ BC (hazard ratio [HR] 0.47; P = .035) and 58% improvement in DFS in hormone receptor-positive/HER2-low+ BC (HR 0.42; P = .032).

Study details: Findings are from a single-institution retrospective analysis including 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low+, and 595 were HER2-0.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Shandong Province. The authors declared no conflicts of interest.

Source: Sun T et al. Tumor-infiltrating lymphocytes provides recent survival information for early-stage HER2-low-positive breast cancer: A large cohort retrospective study. Front Oncol. 2023;13:1148228 (Jun 20). Doi: 10.3389/fonc.2023.1148228

Key clinical point: The level of stromal tumor-infiltrating lymphocytes (TIL) can provide insights on disease-free survival (DFS) outcomes in human epidermal growth factor receptor 2-low-positive (HER2-low+) early-stage breast cancer (BC).

Major finding: High (>10%) vs low (≤10%) TIL levels were associated with a 53% improvement in DFS in HER2-low+ BC (hazard ratio [HR] 0.47; P = .035) and 58% improvement in DFS in hormone receptor-positive/HER2-low+ BC (HR 0.42; P = .032).

Study details: Findings are from a single-institution retrospective analysis including 1763 patients with early-stage BC who underwent surgery, of whom 429 patients were HER2+, 739 were HER2-low+, and 595 were HER2-0.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Natural Science Foundation of Shandong Province. The authors declared no conflicts of interest.

Source: Sun T et al. Tumor-infiltrating lymphocytes provides recent survival information for early-stage HER2-low-positive breast cancer: A large cohort retrospective study. Front Oncol. 2023;13:1148228 (Jun 20). Doi: 10.3389/fonc.2023.1148228

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