Unexpected Survival Signal: Aprepitant Use During Chemotherapy Linked to Improved Breast Cancer Outcomes

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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

Transcript generated from video captions.

Hello. I'm Dr Maurie Markman, from City of Hope. I'd like to discuss over the next few minutes an absolutely provocative — and I don't use that term loosely — report that I would humbly suggest may, or perhaps even should, change standard of practice in the care of patients with breast cancer. The paper was published in the Journal of the National Cancer Institute, entitled, “Aprepitant Use During Chemotherapy and Association With Survival in Women With Early Breast Cancer.”

This is a very complex, important, and provocative topic, and I'm only going to have a short time to summarize these results, but again, I would suggest this is a topic worthy of very serious consideration in terms of the implications.

Aprepitant, as many of you know, is a standard antiemetic that has been used for many years. It’s very effective and very well tolerated. There’s not any question about that. It’s a supportive-care medication that may be used or not used; a variety of drugs might be used in its place.

However, there are preclinical data —I cannot go into any kind of detail here—that have revealed that aprepitant in these preclinical settings will slow breast cancer growth and progression.

What we're looking at in this report is retrospective data linking a nationwide registry of 13,811 women diagnosed with early breast cancer between 2008 and 2020 in Norway. These are population-based data that were very well documented because that's how things work in Scandinavian countries in general, but in Norway in particular. They know what patients receive nationally, over time, and there's follow-up.

The point is that they had knowledge of the diagnoses and the therapy. These women that I'm referring to had received chemotherapy and antiemetics, which, of course, is standard of care and has been for decades. These women were followed for the development of metastatic disease and death from 1 year after diagnosis to the end of 2021, which was the duration of this particular report.

During this period of time, of these 13,811 women, 7047 were given aprepitant, which is, interestingly, 51% or about half of the population. Here's the bottom line: Aprepitant use resulted in superior distant disease-free survival, with a hazard ratio of 0.89, and breast cancer-specific survival, with a hazard ratio of 0.83.

Increasingly interesting, only nonluminal breast cancer had this demonstrated benefit, with a hazard ratio of 0.69. Again, that's a hazard ratio for metastatic disease or death of 0.69 if aprepitant was used. It was strongest in triple-negative breast cancer, with a hazard ratio of 0.66. Let me repeat that: a hazard ratio of 0.66 for the reduction in the risk of distant disease or death. This was a difference that was able to be documented with the use of aprepitant or not.

Finally, in this analysis, survival outcomes were not observed with any other class of antiemetics, only aprepitant. In the nonluminal breast cancer population, the longer duration of aprepitant use — presumably multiple cycles over time — was associated with increasingly favorable survival outcomes. This was a trend analysis, so the longer it was used, the more superior the outcomes.

I’m not surprised. To get this paper published in a high-impact journal, the authors had to conclude that clinical trials are required to confirm these findings. Really?

If you're a patient, a family member, or an oncologist caring for a woman with triple-negative breast cancer, you are going to wait for a phase 3, randomized trial to be conducted and reported maybe in 5 or 10 years? When you're talking about a drug that is widely used and is safe, you're going to make a decision to wait for the clinical trial before you conclude that aprepitant should be used in this setting, based upon these excellent data?

I would challenge that and ask, on average today, certainly in patients that I'm seeing or counseling, aprepitant should become a component of the standard of care unless there's a contraindication to the use of the drug, based upon these excellent registry and population-based data.

We don't have to wait for randomized phase 3 trials to answer every question if what we see here makes sense, based on a plausible biological explanation and well-analyzed data. Obviously, other databases can look at this and see if they come up with different answers, but we do not need to wait for a phase 3, randomized trial before we incorporate something that we believe the data support as having a favorable impact on the outcome of patients we are seeing today.

I thank you for your attention.

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