Kathy D. Miller, MD

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

Notable advances in breast cancer, presented at the American Association for Cancer Research Annual Meeting 2023, are discussed by Dr Kathy Miller, Ballvé Lantero Professor of Oncology at Indiana University Health, Indianapolis. 

She begins with two studies looking at PARP inhibitors in combination with immune checkpoint inhibitors. 

The TALAVE study suggested that talazoparib induction followed by talazoparib plus avelumab could enhance the benefits of PARP inhibition. In contrast, a study of olaparib vs olaparib plus atezolizumab suggested that the combination offered few clinical improvements at the cost of additional toxicities. 

Dr Miller next discusses the combination of olaparib and the novel agent sapacitabine in BRCA-mutated breast cancer. Although hematologic toxicities were an issue in this small trial, some patients experienced prolonged benefits. 

Finally, she presents early results with a whole tumor cell therapeutic vaccine, before examining some of the future challenges around antibody-drug conjugates. 

--

Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serves on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

Notable advances in breast cancer, presented at the American Association for Cancer Research Annual Meeting 2023, are discussed by Dr Kathy Miller, Ballvé Lantero Professor of Oncology at Indiana University Health, Indianapolis. 

She begins with two studies looking at PARP inhibitors in combination with immune checkpoint inhibitors. 

The TALAVE study suggested that talazoparib induction followed by talazoparib plus avelumab could enhance the benefits of PARP inhibition. In contrast, a study of olaparib vs olaparib plus atezolizumab suggested that the combination offered few clinical improvements at the cost of additional toxicities. 

Dr Miller next discusses the combination of olaparib and the novel agent sapacitabine in BRCA-mutated breast cancer. Although hematologic toxicities were an issue in this small trial, some patients experienced prolonged benefits. 

Finally, she presents early results with a whole tumor cell therapeutic vaccine, before examining some of the future challenges around antibody-drug conjugates. 

--

Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serves on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

Notable advances in breast cancer, presented at the American Association for Cancer Research Annual Meeting 2023, are discussed by Dr Kathy Miller, Ballvé Lantero Professor of Oncology at Indiana University Health, Indianapolis. 

She begins with two studies looking at PARP inhibitors in combination with immune checkpoint inhibitors. 

The TALAVE study suggested that talazoparib induction followed by talazoparib plus avelumab could enhance the benefits of PARP inhibition. In contrast, a study of olaparib vs olaparib plus atezolizumab suggested that the combination offered few clinical improvements at the cost of additional toxicities. 

Dr Miller next discusses the combination of olaparib and the novel agent sapacitabine in BRCA-mutated breast cancer. Although hematologic toxicities were an issue in this small trial, some patients experienced prolonged benefits. 

Finally, she presents early results with a whole tumor cell therapeutic vaccine, before examining some of the future challenges around antibody-drug conjugates. 

--

Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serves on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

Dr Kathy Miller of Indiana University Health in Indianapolis discusses key takeaways in early breast cancer from the American Association for Cancer Research (AACR) Annual Meeting 2023. 

She begins with a novel imaging agent that allows surgeons to visualize residual disease during lumpectomy and reduce the risk for positive margins. It is now being investigated in patients who undergo neoadjuvant therapy. 

Next, Dr Miller focuses on a study of skin toxicity in patients undergoing fractionated radiotherapy, which found that rates varied widely by race/ethnicity. 

She also examines the implications of these findings and other research presented at AACR addressing the effect of genetic ancestry on the biology of breast cancers. 

Finally, Dr Miller looks at a study of disease progression in ductal carcinoma in situ (DCIS), which found that 80% of cases were the result of clonal recurrences of residual cells left behind at the time of treatment. 

--

Kathy D. Miller, MD, Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serve on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

Dr Kathy Miller of Indiana University Health in Indianapolis discusses key takeaways in early breast cancer from the American Association for Cancer Research (AACR) Annual Meeting 2023. 

She begins with a novel imaging agent that allows surgeons to visualize residual disease during lumpectomy and reduce the risk for positive margins. It is now being investigated in patients who undergo neoadjuvant therapy. 

Next, Dr Miller focuses on a study of skin toxicity in patients undergoing fractionated radiotherapy, which found that rates varied widely by race/ethnicity. 

She also examines the implications of these findings and other research presented at AACR addressing the effect of genetic ancestry on the biology of breast cancers. 

Finally, Dr Miller looks at a study of disease progression in ductal carcinoma in situ (DCIS), which found that 80% of cases were the result of clonal recurrences of residual cells left behind at the time of treatment. 

--

Kathy D. Miller, MD, Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serve on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

Dr Kathy Miller of Indiana University Health in Indianapolis discusses key takeaways in early breast cancer from the American Association for Cancer Research (AACR) Annual Meeting 2023. 

She begins with a novel imaging agent that allows surgeons to visualize residual disease during lumpectomy and reduce the risk for positive margins. It is now being investigated in patients who undergo neoadjuvant therapy. 

Next, Dr Miller focuses on a study of skin toxicity in patients undergoing fractionated radiotherapy, which found that rates varied widely by race/ethnicity. 

She also examines the implications of these findings and other research presented at AACR addressing the effect of genetic ancestry on the biology of breast cancers. 

Finally, Dr Miller looks at a study of disease progression in ductal carcinoma in situ (DCIS), which found that 80% of cases were the result of clonal recurrences of residual cells left behind at the time of treatment. 

--

Kathy D. Miller, MD, Ballvé Lantero Professor of Oncology, Indiana University Health, Indianapolis, Indiana 

Kathy D. Miller, MD, has disclosed the following relevant financial relationships: 

Serve on independent Data Monitoring Committees for ongoing trials for: Merck; Genentech/Roche; AstraZeneca; Celcuity 

This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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

This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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

This transcript has been edited for clarity.

Vidyard Video

Hello. It’s Dr. Kathy Miller from Indiana University.

I have to admit that time has snuck up on me this year. It is already time for the American Society of Clinical Oncology Annual Meeting.

I found it hard to keep track of time this year with the pandemic. Many of the things that help mark the passage of time haven’t happened, have happened at different times of the year than is typical, or have happened in different ways that just haven’t had the same impact in my brain.

Just recently, I was taking a look through the breast cancer program at ASCO and there is a special clinical science symposium that I want to make sure you know about and tune into. It’s the sort of session that might not otherwise reach you.

This has been a year of incredible turmoil and critical thinking about issues of race, ethnicity, justice, and how we can make sure that the medical care we’re providing is inclusive and equitable. How we can make sure we are giving the best outcome to all of our patients.

This special clinical science symposium this year includes several presentations that will delve into how genetically determined ancestry and socially determined race might impact the outcome of our patients. This is a tangled web that is difficult to unpack and separate, but there are clear distinctions here: The genes we inherit do affect how we metabolize drugs, what side effects we might have from drugs, and what drugs might be the best choices for us.

Our socially determined race affects how the world interacts with us. Those biases, be they conscious or unconscious, can affect where we live, where we go to school, how people treat us, what opportunities we have, and how the medical system treats us. They’re related, but they’re not the same. Tune into that clinical science symposium to begin thinking about those differences and how we can make sure we give our patients the best care.

There are other high-profile presentations that you’re going to want to see as well, looking at how we can optimize therapy in patients with HER2-positive disease and beginning to think about who might not need chemotherapy to have an excellent outcome in early-stage disease.

Also, we will be thinking about those patients with triple-negative disease who have residual disease after neoadjuvant chemotherapy. We were all caught off guard with the results of the CREATE-X trial, quite frankly, several years ago.

This year we will hear the results of a postneoadjuvant trial coordinated by the Eastern Cooperative Oncology Group comparing platinum therapy with capecitabine. Tune in to think more about whether capecitabine really should be the standard of care in this population.

As always, I’m interested in your thoughts before or after ASCO. What stood out for you this year in breast cancer? Drop us a comment and let us know about these sessions and what else you found worthwhile.

Dr. Miller is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. Her career has combined both laboratory and clinical research in breast cancer.

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