Clinical Trials Offer Promising New Cervical Cancer Treatment Options
Guest
: Leslie Randall, MD
From the Show: VCU Health System
Clinical trials give patients access to promising new therapies before they are approved by the Food and Drug Administration (FDA) for commercial use. For some patients, they may offer an additional line of treatment after all other therapies have failed. In this episode, Dr. Leslie Randall, gynecologic oncologist and researcher at VCU Massey Cancer Center, discusses several promising clinical trials testing new treatments for cervical cancer, the fourth most common cancer in women worldwide.
Transcription:
Caitlyn White (Host): Clinical trials give patients access to promising new therapies before they are approved by the Food and Drug Administration for commercial use. For some patients, they may offer an additional line of treatment after all other therapies have failed. In this episode, Dr. Leslie Randall, gynecologic oncologist and researcher at VCU Massey Cancer Center, discusses several promising clinical trials testing new treatments for cervical cancer, the fourth most common cancer in women worldwide.
Welcome to Healthy with VCU Health, where experts from VCU Health share their knowledge, cutting-edge research and the latest innovations to help you achieve optimal health and wellness. Take control or your health. I’m your host, Caitlyn White. So, Dr. Randall, how is cervical cancer typically treated?
Leslie Randall, M.D. (Guest): The treatment of cervical cancer depends on a few things. The main thing being the cancer stage. When a patient comes in with cervical cancer, it’s usually been diagnosed by an OB-GYN or a primary care doctor or biopsy. And we do a physical exam, like a pelvic exam to see what stage it appears the cancer is in. Sometimes that also requires a PET scan or a CT scan and sometimes even surgery to decide on the staging.
Once we have the staging, for the earlier stage patients, we do surgery. And the surgery consists of removing the uterus and cervix, which is a hysterectomy, usually with lymph node biopsies. And then some patients who want to preserve their fertility chances can have a specialized procedure that saves the uterus so that they can have a baby in the future. Not everyone is eligible for that type of surgery, and that takes a very thorough workup to decide if that’s the right option for someone.
If the cancer has spread outside of the cervix, there are two different options. One is either radiation treatment with low dose chemotherapy, or if the spread is significant, then we would do like a larger dose of chemotherapy.
Host: And what are some of the newest types of therapies emerging from the research?
Dr. Randall: The new therapies in cervical cancer are very exciting. To talk about new therapies, we have to talk about one treatment, and that is a prevention method: the HPV vaccine. HPV vaccine is not new, but it hasn’t been universally implemented. So it’s important to remind ourselves about the almost 100% effectiveness of the HPV vaccine to prevent cervical cancer. I’d much rather prevent cervical cancer than treat it.
But there are new exciting treatments for cervical cancer. The first one is, in 2013, we added an anti-vascular drug called bevacizumab or Avastin to the treatment of cervical cancer. And that showed an improvement in long-term survival. That’s the last advance that we’ve had in cervical cancer in quite some time. And so, recently, with the advent of immunotherapy, which has really revolutionized the treatment of lots of different types of cancer, we’re really starting to study this now in cervical cancer. And immunotherapy makes sense for cervical cancer because it’s caused by a virus. The virus infects the cervical area, and it recruits the immune system to basically eradicate the virus and prevent cancer, but sometimes the immune system is impaired, or it doesn’t do its job and cancer develops. And so it makes a lot of sense to try and restore that immune system with immunotherapy to help fight off cancer and to help treat it.
We have immunotherapy really going into each different type of treatment that we talked about for cervical cancer depending on the stage – giving it after surgery, giving it during radiation and giving it during chemotherapy to try to help all these treatments work better.
Host: Now why are clinical trials so important to the treatment of cervical cancer?
Dr. Randall: We can’t really learn if something works or not without a clinical trial, and any new treatment that we have carries risks with it. And so we don’t want to add risk to treatment if it’s not going to be helpful to patients. We do these trials to find out if treatments are safe and if they are effective. And if they’re not, then we don’t pursue them in the future. If the trial shows that a therapy didn’t work or was too toxic for patients to tolerate, then we decide that it’s not worth giving as a treatment.
If we just gave new treatments without doing clinical trials, we would be giving treatments to patients without knowing how beneficial they are or not. And so, I strongly believe in clinical trials. I don’t think that we should just try things to see if they work without doing that in a way that helps us know for sure if they really help or not. The other benefits of being on a clinical trial is that patients get followed more closely if they are on a clinical trial. Research that shows that patients enrolled on clinical trials actually have better long-term survival than patients who are not enrolled on clinical trials.
Host: VCU Massey Cancer Center has one of the largest offerings of cancer clinical trials in the whole state of Virginia. Can you give us an example of some of the trials available at Massey now?
Dr. Randall: Yeah, I’m so glad that you asked this question. We’re really excited about our clinical trial portfolio. It’s a huge priority for us is to build these opportunities and these options for patients in our treatment area. I joined VCU Massey Cancer Center in January, and one of my goals was to build this program in cervical cancer trials. Cervical cancer disproportionately affects our area. It disproportionately affects women of color and of lower socioeconomic status and we have a great opportunity here at VCU to care for those patients and all the patients in our area.
I work at the national level with a group called the Gynecologic Oncology Group Foundation, and I run their clinical trials portfolio for cervical cancer, and under their GOG Partners program we work with industry to bring new treatments to patients. Right now, we have four clinical trials open for cervical cancer, and that portfolio is growing. One our trials is with radiation, giving a drug called pembrolizumab, which is an immunotherapy, during radiation and then after radiation as a kind of maintenance to keep cancer away. [Learn more about this trial.]
The second trial is testing a treatment for women who have metastatic cancer that has spread throughout the body or who have recurrent cancer after having surgery or radiation in the past. This is standard of care treatment with or without a drug called atezolizumab, which is also an immunotherapy. This trial is an international trial. We’re working with groups from Europe, Japan and Korea to try this treatment. We’re the lead site in the United States here at VCU for that trial. [Learn more about this trial.]
The last trial is with a very new drug. It is a dual immunotherapy, and it’s one infusion but you get two drugs. This therapy attacks two different aspects of the immune system to help the immune system work better to treat the cancer. It has shown really promising results in its early phases, and the drug received FDA fast track designation just last week. We’re really excited about that. This is a small trial – it’s only 40 patients. The trial is designed to get a better signal of how effective the therapy is before we move it into the later, phase three studies to hopefully get that drug FDA approved so that patients can get access to it. We are also the U.S. lead site for that trial. [Learn more about this trial.]
There are very exciting things happening here at VCU Massey Cancer Center in cervical cancer research.
Host: Great. Dr. Randall anything else you want to add?
Dr. Randall: It’s very exciting to have movement in cervical cancer research. There have not been very many advancements in the past. Cervical cancer is a disease that has been ignored, and for me, as a cervical cancer leader in a national group, I’ve seen where we’ve been with really no advances in cervical cancer treatment to where we are now. Now there are too many different treatments in research to even talk about it on this podcast. We don’t have enough time. But it’s really exciting to see cervical cancer be valued. Women with cervical cancer now have opportunities to access these new treatments that women with breast cancer, colon cancer and lung cancer have had access to. Now cervical cancer gets its day for research.
Host: Well thank you so much for your time and for this interesting information, Dr. Randall. And thank you for listening to Healthy with VCU Health. To learn more about treatments for cervical cancer at VCU Massey Cancer Center, visit www.masseycancercenter.org or call 804-828-9080. I’m Caitlyn White. We’ll see you next time.
Caitlyn White (Host): Clinical trials give patients access to promising new therapies before they are approved by the Food and Drug Administration for commercial use. For some patients, they may offer an additional line of treatment after all other therapies have failed. In this episode, Dr. Leslie Randall, gynecologic oncologist and researcher at VCU Massey Cancer Center, discusses several promising clinical trials testing new treatments for cervical cancer, the fourth most common cancer in women worldwide.
Welcome to Healthy with VCU Health, where experts from VCU Health share their knowledge, cutting-edge research and the latest innovations to help you achieve optimal health and wellness. Take control or your health. I’m your host, Caitlyn White. So, Dr. Randall, how is cervical cancer typically treated?
Leslie Randall, M.D. (Guest): The treatment of cervical cancer depends on a few things. The main thing being the cancer stage. When a patient comes in with cervical cancer, it’s usually been diagnosed by an OB-GYN or a primary care doctor or biopsy. And we do a physical exam, like a pelvic exam to see what stage it appears the cancer is in. Sometimes that also requires a PET scan or a CT scan and sometimes even surgery to decide on the staging.
Once we have the staging, for the earlier stage patients, we do surgery. And the surgery consists of removing the uterus and cervix, which is a hysterectomy, usually with lymph node biopsies. And then some patients who want to preserve their fertility chances can have a specialized procedure that saves the uterus so that they can have a baby in the future. Not everyone is eligible for that type of surgery, and that takes a very thorough workup to decide if that’s the right option for someone.
If the cancer has spread outside of the cervix, there are two different options. One is either radiation treatment with low dose chemotherapy, or if the spread is significant, then we would do like a larger dose of chemotherapy.
Host: And what are some of the newest types of therapies emerging from the research?
Dr. Randall: The new therapies in cervical cancer are very exciting. To talk about new therapies, we have to talk about one treatment, and that is a prevention method: the HPV vaccine. HPV vaccine is not new, but it hasn’t been universally implemented. So it’s important to remind ourselves about the almost 100% effectiveness of the HPV vaccine to prevent cervical cancer. I’d much rather prevent cervical cancer than treat it.
But there are new exciting treatments for cervical cancer. The first one is, in 2013, we added an anti-vascular drug called bevacizumab or Avastin to the treatment of cervical cancer. And that showed an improvement in long-term survival. That’s the last advance that we’ve had in cervical cancer in quite some time. And so, recently, with the advent of immunotherapy, which has really revolutionized the treatment of lots of different types of cancer, we’re really starting to study this now in cervical cancer. And immunotherapy makes sense for cervical cancer because it’s caused by a virus. The virus infects the cervical area, and it recruits the immune system to basically eradicate the virus and prevent cancer, but sometimes the immune system is impaired, or it doesn’t do its job and cancer develops. And so it makes a lot of sense to try and restore that immune system with immunotherapy to help fight off cancer and to help treat it.
We have immunotherapy really going into each different type of treatment that we talked about for cervical cancer depending on the stage – giving it after surgery, giving it during radiation and giving it during chemotherapy to try to help all these treatments work better.
Host: Now why are clinical trials so important to the treatment of cervical cancer?
Dr. Randall: We can’t really learn if something works or not without a clinical trial, and any new treatment that we have carries risks with it. And so we don’t want to add risk to treatment if it’s not going to be helpful to patients. We do these trials to find out if treatments are safe and if they are effective. And if they’re not, then we don’t pursue them in the future. If the trial shows that a therapy didn’t work or was too toxic for patients to tolerate, then we decide that it’s not worth giving as a treatment.
If we just gave new treatments without doing clinical trials, we would be giving treatments to patients without knowing how beneficial they are or not. And so, I strongly believe in clinical trials. I don’t think that we should just try things to see if they work without doing that in a way that helps us know for sure if they really help or not. The other benefits of being on a clinical trial is that patients get followed more closely if they are on a clinical trial. Research that shows that patients enrolled on clinical trials actually have better long-term survival than patients who are not enrolled on clinical trials.
Host: VCU Massey Cancer Center has one of the largest offerings of cancer clinical trials in the whole state of Virginia. Can you give us an example of some of the trials available at Massey now?
Dr. Randall: Yeah, I’m so glad that you asked this question. We’re really excited about our clinical trial portfolio. It’s a huge priority for us is to build these opportunities and these options for patients in our treatment area. I joined VCU Massey Cancer Center in January, and one of my goals was to build this program in cervical cancer trials. Cervical cancer disproportionately affects our area. It disproportionately affects women of color and of lower socioeconomic status and we have a great opportunity here at VCU to care for those patients and all the patients in our area.
I work at the national level with a group called the Gynecologic Oncology Group Foundation, and I run their clinical trials portfolio for cervical cancer, and under their GOG Partners program we work with industry to bring new treatments to patients. Right now, we have four clinical trials open for cervical cancer, and that portfolio is growing. One our trials is with radiation, giving a drug called pembrolizumab, which is an immunotherapy, during radiation and then after radiation as a kind of maintenance to keep cancer away. [Learn more about this trial.]
The second trial is testing a treatment for women who have metastatic cancer that has spread throughout the body or who have recurrent cancer after having surgery or radiation in the past. This is standard of care treatment with or without a drug called atezolizumab, which is also an immunotherapy. This trial is an international trial. We’re working with groups from Europe, Japan and Korea to try this treatment. We’re the lead site in the United States here at VCU for that trial. [Learn more about this trial.]
The last trial is with a very new drug. It is a dual immunotherapy, and it’s one infusion but you get two drugs. This therapy attacks two different aspects of the immune system to help the immune system work better to treat the cancer. It has shown really promising results in its early phases, and the drug received FDA fast track designation just last week. We’re really excited about that. This is a small trial – it’s only 40 patients. The trial is designed to get a better signal of how effective the therapy is before we move it into the later, phase three studies to hopefully get that drug FDA approved so that patients can get access to it. We are also the U.S. lead site for that trial. [Learn more about this trial.]
There are very exciting things happening here at VCU Massey Cancer Center in cervical cancer research.
Host: Great. Dr. Randall anything else you want to add?
Dr. Randall: It’s very exciting to have movement in cervical cancer research. There have not been very many advancements in the past. Cervical cancer is a disease that has been ignored, and for me, as a cervical cancer leader in a national group, I’ve seen where we’ve been with really no advances in cervical cancer treatment to where we are now. Now there are too many different treatments in research to even talk about it on this podcast. We don’t have enough time. But it’s really exciting to see cervical cancer be valued. Women with cervical cancer now have opportunities to access these new treatments that women with breast cancer, colon cancer and lung cancer have had access to. Now cervical cancer gets its day for research.
Host: Well thank you so much for your time and for this interesting information, Dr. Randall. And thank you for listening to Healthy with VCU Health. To learn more about treatments for cervical cancer at VCU Massey Cancer Center, visit www.masseycancercenter.org or call 804-828-9080. I’m Caitlyn White. We’ll see you next time.