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Clinical trials play a pivotal role in gynecologic cancers, offering patients innovative therapies while contributing to groundbreaking medical advancements, an expert said during the CURE® Educated Patient® Gynecologic Cancers Summit.

Understanding what a clinical trial is and how they are performed may allow patients to feel safe and hopeful during cancer treatment, said Dr. Sarah Crafton, a gynecologic oncologist at Allegheny Health Network in Pittsburgh, Pennsylvania during her presentation.

"Clinical trials are the research studies that test how well new medical approaches work in people," Crafton noted. "The important thing to emphasize is that it’s a nonspecific definition. It can be about anything in medicine ... prevention, diagnosis, how well treatments work."

A clinical trial is a research study that test new medical approaches in people and provide information including prevention methods, correct diagnosing or the treatment itself.

These trials are then conducted in different phases:

Preclinical phase: Laboratory testing which provides information on doses and toxicity levels.

Phase 1: Small number of patients to test safety and dosage.

Phase 2: Larger group of patients to assess effectiveness and side effects.

Phase 3: Compares new treatment to standard practices of care.

Phase 4: Monitors long-term effects after approval.

Phase 1 trials are typically shorter, lasting a few months to a year. Phase 2 and 3 trials can last several months to a few years. Phase 4 trials may continue for many years to monitor for long-term effects.

Participating in clinical trials offers patients access to new treatments before they’re widely available, Crafton said. Additionally, patients will receive close monitoring by medical professionals, creating a safe and comfortable environment. Participants should also be aware of their contribution to medical advancements through clinical trial participation.

"Clinical trials can be really impactful from the beginning of the time of diagnosis," Crafton said. "…Clinical trials also exist and occur to assess how well surgeries work, different surgery techniques. And these are all things that may happen from the time of diagnosis. So, from the patient perspective, please never think it’s too early or too late to ask your provider about what my trial options may be.”

The first step to participate in a clinical trial is informed consent, which does not only entail paperwork.

“Informed consent is often thought of as a stack of papers that explain a lot of information about the trial, but the informed consent process goes far beyond that paper.”

This process involves conversations and exchanges of information with a patient’s provider and clinical research team.

“This is when you have the opportunity to get information and have your questions asked that talk about why the study is being done, what medication or agent is being used, and why, how long do you expect to be on the trial,” Crafton highlighted. “Importantly, are there any possible risks or discomforts you could experience? What have other patients experienced? And, really, really important, what are the possible benefits?”

Of note, researchers conducting clinical trials put safety as a top priority throughout the duration of the study.

“When you are enrolled on a clinical trial, how we know that medications are working is serially assessing over and over again, all kinds of clinical information, just like when you're seeing your doctor for regular treatment, vital signs, labs, pictures, imaging such as CT scans or MRIs, all of these are ways that we can make sure that you are also continuing to be safe on the trial medications, just like the regular standard of care,” Crafton stated.

Crafton urged patients to ask their oncologist about clinical trial opportunities at any time during a cancer diagnosis and treatment.

“From the time of diagnosis or through the entire disease course, keep an open dialogue with your provider, and constantly ask about what trials exist,” she added. “If not at that institution, are there any institutions nearby that they can be screened for trials?”

In addition to patients talking to their oncologists, they may search the internet for information regarding clinical trials that may fit their eligibility criteria. Websites such as ClinicalTrials.gov are helpful for this purpose, Crafton said.

“This is a public website,” she noted. “Anyone can look things up on it. And … you can type in the disease you’re looking for. You can type in the location and filter by mileage in order to find trials open near you. This is something your provider can do, but you, as the patient, can also look for.”

For more news on cancer updates, research and education, don’t forget to 

subscribe to CURE®’s newsletters here.

Patients can benefit from clinical trials in gynecologic cancers, and knowing that they can advocate for themselves for potential consideration for study enrollment. 

Navigating Clinical Trials in Gynecologic Cancers

The Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) plus chemoradiotherapy (CRT) for the treatment of patients with stages 3 to 4A cervical cancer. The first approval of an anti-programmed death receptor-1 (PD-1) therapy in combination with chemoradiotherapy for this patient population, this was the third FDA approval for the treatment of cervical cancer with Keytruda and the 39th indication for Keytruda in the United States, according to a news release from Merck, the manufacturer of the drug.

CURE® spoke with Dr. Linda R. Duska, a gynecologic oncologist at University of Virginia Health and the United States principal investigator on KEYNOTE-A18, the study which served as the basis of the recent FDA approval, about why Keytruda has proven to be such an effective cancer treatment, particularly when administered in concert with chemoradiotherapy.

“We think that it works by turning the immune system on and improving the immune response to the tumor, not just in the tumor but also in the tumor microenvironment, so (meaning) the space in your body where the tumor lives,” Duska said. “So, if you have a tumor where maybe (Keytruda) doesn't work so well but then you mix the pembrolizumab with radiation, maybe the radiation releases something in the tumor that makes the (Keytruda) work better. ... We don't know (for sure), but that's a theory.”

There is a study currently underway, Duska said, to determine if Keytruda has to be given during chemoradiation treatment, or if it can be given to patients as a maintenance therapy.

“We don't know the answer to that question, but we're going to,” Duska said.

At least 10% of the patients who participated in KEYNOTE-A18 and were treated with Keytruda and chemoradiotherapy experienced side effects included nausea, diarrhea, vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, abdominal pain, pyrexia (fever), hyperthyroidism, dysuria (painful urination), rash and pelvic pain, according to the FDA.

“These immunotherapies, not just (Keytruda), but all of them, we call them checkpoint inhibitors (and) what they do is they turn the immune system on,” said Duska. “And that's why (with) the side effects that we see most often, I tell my patients (they) are -itises, like thyroiditis, or colitis or pneumonitis. We're turning the body's immune system on, not just against the tumor, but also globally against the body, really. And so that's why we see that side effect profile. But cervical cancer is caused by a virus, it's caused by the human papilloma virus, and so it almost makes intuitive sense that a virally driven tumor would respond to immunotherapy.”

Keytruda received its first approval from the FDA, for the treatment of some patients with melanoma, a decade ago in 2014. Since then, its nearly 40 approvals have been for patients with diseases including some non-small cell lung, head and neck, urothelial, colorectal, gastric and esophageal cancers.

Keytruda has also been approved, in combination with chemotherapy, for patients with persistent, recurrent, or metastatic cervical cancer and as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1, according to Merck.

Keytruda Has Received Nearly 40 FDA Approvals. How Does It Work?

 Looking back, how far have we come in the understanding of genetics in gynecologic cancer.

 We've come miles and miles and it's you know, taking a moment to reflect back is important to understand how far we've come. So if we just take a moment and think back, BRCA, or the BRCA gene was only discovered in the 1990s. And now, only about what 20 to 30 years later, we've made significant strides in understanding the genetics of gynecologic cancers, and also in developing targeted treatments that work for these cancers.

 Absolutely. And so earlier, we talked about access to care. What kind of gaps in access to genetic testing are we seeing? And if so, what are they?

 So one of the biggest problems that we have is that there's just a limited number of genetic counselors, all over the country. So getting in to see one can be can be really tough. For many oncologists, you know, to mitigate that many oncologists are doing their own genetic counseling and testing, just so that the patient gets the care that they need. For some people, there's sometimes insurance barriers, but the companies that do genetic testing have gotten better and better, and testing has become much cheaper than it used to be even 10 years ago. So it's much more accessible to all patients.

 Absolutely. And so I'm happy you just brought up costs, because we hear a lot about these home tests now. But the verdicts not out yet on them. So can you discuss the at home testing and maybe why people should still make sure they're seeing a genetic counselor?

 Yes, definitely, at home testing is widely accessible. And you know, you get it with a click of a button. But just as important as testing is the counseling, and that is not there for when you do the at home test so what's important in genetic counseling is that you understand what the test is actually being done, what your results may be, and how that may affect your life moving forward. Like what if you got a diagnosis of a hereditary cancer syndrome? What does that mean for your risk of getting X, Y, and Z cancer? And also, does this affect your ability to get life insurance, disability insurance in the future? These are all the things that go into genetic counseling, that are really important for everyone to understand before you get a test done. So I really caution people who get testing done without counseling, because that’s an important piece of the picture.

 Who should be getting genetic testing? And why is it important for these individuals to make sure that they go see at least go see a genetic counselor?

 So let's just break it down to some basics. So there are certain genetic mutations that can lead to hereditary cancers. One of the most well-known ones and talked about ones is BRCA. But there are many other important ones. If someone gets diagnosed with one of these genetic mutations, they can be at risk for developing not just one but multiple cancers in their lifetime as well as having a risk of passing that on to their children. In the world of gynecologic cancers, all patients with ovarian cancer and when I say ovarian cancer, I mean, ovarian, fallopian tube and primary care to cancers should undergo genetic counseling and testing because they have up to a quarter risk of having a hereditary cancer syndrome. Certain young patients young meaning less than 50 years old with endometrial cancer should get genetic counseling and testing. Some patients who've had more than one cancer or have had one cancer and have had a strong family history of cancer may also warrant genetic counseling and testing. And then, you know, important to know is if you do get diagnosed with one of these hereditary cancer syndromes, there's a lot that can be done to prevent you from ever getting a cancer. So, heightened screening, risk reducing surgery can prevent subsequent cancer diagnosis. And for us, oncologists, that's always the best kind of cancer is the one that never happens.

 To bring it all together, what is your biggest piece of advice for maybe somebody who thinks they might be able to genetic risk for gynecologic cancer and, you know, maybe the next steps?

 So I encourage patients who are worried about that or think they may be at a heightened risk to speak to their doctor, whether that's their primary care doctor, their OBGYN, or if they're a cancer patient or oncologist, and have a real honest conversation and if warranted, you know, maybe even meeting with a genetic counselor to talk about their risks, and then actually getting the testing if appropriate.

Transcription edited for clarity and conciseness.

As part of its Speaking Out video series, CURE spoke with Dr. Navya Nair, on behalf of the Foundation for Women’s Cancer, about genetics in women’s cancer.

Discussing the Importance of Genetic Counseling in Women’s Cancer

 To start, can you discuss what some of the barriers to care are that we see with gynecologic cancers?

 Absolutely. Unfortunately, for many of our patients, we do see a number of barriers, whether that's to the diagnosis or to actual cancer treatment. One of the big barriers actually can be educational. So, for example, knowing that something is abnormal, such as postmenopausal bleeding, which spoiler alert is always abnormal, and always needs to be worked out. Other barriers can be related to accessing care, like geography, just living very far away from a health care system. Sometimes financial and insurance barriers, stop people, language barriers, and for our younger patients, sometimes even child care issues. What you do with your kid when you need to go to an appointment. And for many of our marginalized societies, sometimes there's a barrier in the sense that there isn't trust in the health care system, or the health care system hasn't done a good job in getting the trust of certain patient populations. So these are some of the barriers that we see every day.

 Absolutely. And so we hear a lot about how far we've come when it comes to treatment and things like that. But why are we still seeing these barriers?

 One of the big reasons, in my opinion is that our system is so good at taking care of really complicated or end-stage disease processes, but we're not so good at preventing diseases. Our preventative care systems and keeping people healthy aren't as well designed to get into every population. So, you know, whether it's certain urban populations or rural populations, our health care system just isn't as good at taking care of patients before they get sick. But rather, we're very good at taking care of people once they have a diagnosis.

 Absolutely. And so what are we doing to try to address some of these challenges? And can you also talk about Move the Message which the national awareness campaign through the foundation?

 Absolutely. So one of the big initiatives that the Foundation for Women's Cancer is doing as this national campaign called Move the Message, it aims to increase awareness of the five gynecological cancers, which include cervical, ovarian, endometrial, and uterine cancers, vaginal and vulvar cancers, and it's specifically designed to target on historically marginalized communities such as Black and Brown women as well as those living in rural areas. One of the big messages is just raising awareness about what's going on. Every five minutes, a woman is diagnosed with one of the five gynecological cancers. And that results in over 109,000 Americans with a new diagnosis each year. Many of our patients, unfortunately, aren't diagnosed until later stages of disease, which is why we're trying to increase awareness so that we can prevent cancer whenever possible, but if not, going to at least catch it at an earlier stage where it's more curable.

 How can we help to keep driving this education around, these barriers to care?

 Yeah, so there's a lot that you can access for free on the websites, if you go to movethemessage.org there are some great educational materials available to educate yourself, share with others. There's also a hashtag for the Move the Message campaign. You can post some of these awareness videos and tag five friends and encourage them to continue that process to really spread the word, the Foundation for Women's Cancer and the Society of Gynecologic Oncology, also a really welcoming to like-minded health care advocates and community-based organizations. They're really looking to partner with community organization to spread the message. So if this is something that you're interested in, the Foundation for Women's Cancer is very welcoming.

As part of its Speaking Out video series, CURE spoke with Dr. Navya Nair, on behalf of the Foundation for Women’s Cancer, about access to care in women’s cancer.

Addressing Barriers to Care, Improving Access in Women’s Cancers

 What are the challenges that we see when a patient goes from active treatment, and then you know, they're done and they have to go back to their primary care physicians.

 So, you know, having a patient who just went through cancer diagnosis and intensive treatment, getting back into the game or routine health care and preventative screening so often patients while they're undergoing their cancer treatment can fall behind on their other health maintenance. Tests and so getting them back, get back in plugging them back into routine health care. Um, it's really important, sometimes challenging, having a great relationship with primary care doctors and engaging them even when a patient is on cancer treatment can help that transition back.

 With that, what are some of the long-term effects that a female with a gynecologic cancer might experience and can you explain the role that a primary care doctor will play in those long-term effects?

 There can be a number of long-term effects after cancer diagnosis and treatment. Sometimes patients have chronic pain issues. Often sexual health can be an issue and side effects like vaginal dryness, decreased libido, body image issues, can also be a problem, especially after dealing with certain types of gynecologic cancers like vulvar cancer. So, not just physical health is important, but also mental health is you get through a cancer diagnosis and resume routine life.

 We've heard a lot about survivorship care plans, but I think they're still not rolled out everywhere. So can you talk about what these are and you know, hopefully educate our patients a little bit more maybe if they can ask their doctors about what it is and why that might be best for them.

 Absolutely. survivorship care plans are instated after a patient has finished their cancer treatment and what the plan is moving forward to that all providers in that patient's care team know what's happening moving forward. And that includes what surveillance testing or exams they may need for their cancer. And also getting them like I said, plugged back into routine health care screening for other cancers. Others getting their pap smear after a colon cancer diagnosis or, or getting their bone density scan, these are all the things that go into survivorship care plans.

 To bring it all together, what is your biggest piece of advice for patients to kind of just stay vigilant with their health care after treatment ends for their women's cancer?

 So at the end of their treatment, I encourage all patients to have a really honest and open conversation with their oncologist about what they need to do moving forward for their cancer surveillance. So are there things that they need to pay attention to their body, so that if there's a symptom or something that happens that's concerning for cancer recurrence, they know to get back in with their oncologist. And then the other big piece is having a great relationship with a primary care doctor and knowing what health maintenance thinks they need moving forward and staying on top of all of that.

 What would you say is your biggest piece of advice for a woman with a gynecologic cancer?

 My biggest piece of advice would be to be a fierce advocate for yourself off and if you are so inclined to be a fierce advocate for others, a lot of progress in the field of gynecologic cancer has been made by survivors of these diseases. So for example, there was there is a network of women created that are cancer survivors called ECONO, which stands for endometrial cancer Action Network for African American and they have been so involved and so engaged in figuring out ways that we can improve cancer treatment for patients that are at high risk for these diseases and, and have out of that group, there's been the first randomized control trial looking at social support and how that can affect cancer outcomes. So be an advocate for yourself. And if you feel so inclined, be an advocate for others and support them. If they have a cancer diagnosis, need to get through that.

As part of its Speaking Out video series, CURE spoke with Dr. Navya Nair, on behalf of the Foundation for Women’s Cancer, about survivorship in women’s cancer.

Transitioning from Active Care to Survivorship in Women’s Cancer

 Can you explain how maintaining a healthy lifestyle helps before a diagnosis, during treatment and beyond that?

 Absolutely. So maintaining a healthy lifestyle is just so important in all stages, cancer prevention, and even after a diagnosis and while someone's undergoing treatment. So a healthy diet. So well balanced diet with lots of fruits and vegetables, lean meats, getting regular cardiovascular exercise, avoiding toxins like tobacco, limiting alcohol use can reduce your risk of ever getting a cancer diagnosis. So for example, we know that tobacco use is directly linked to lung cancer risk. Having a healthy BMI reduces your risk of getting endometrial cancer. So these are how some of these healthy lifestyles can prevent you from getting a cancer.

Now, you also asked how this can help once someone has a diagnosis and they're in treatment. You know, having a healthy body allows you to get through some of these really tough treatments. And, you know, I often explained to my patients that a big cancer surgeries often is like running a marathon and having a really fit body before allows you to get through that better and have less complications. And much like surgery, chemotherapy, radiation, these are all things very tough on the body that having a strong body. And the other important part that I didn't talk about yet is having a healthy mind and having strong support systems outlets for stress and anxiety. In some kind of practice of reflection, whether you do yoga meditation, is mental health is just as important as physical health, especially when dealing with cancer.

 Absolutely. So from the exercise standpoint, we know exercise is good. But can you give some examples of how people can stay active because I think there's always a misperception that you know, we you need to run a mile or two miles but I think we can go simpler than that. So can you give us some examples for our patients?

 Absolutely. Yes, so it's important to get a heart rate up. So however you like to do that. So for some people they like to run. Some people hate to run maybe you prefer to swim or both. Go for vigorous walks. Go for a bike ride. The goal is to get your heart rate up for 30 to 60 minutes about three to four times a week.

 Absolutely. And then similarly with diet, why is diet important when it comes to when you're in treatment, but also those long-term effects? And are there examples of the types of diets that our patients should be seeking?

 So really, it's a well-balanced diet with, you know, balance of the different food groups. And certain things like if we're looking at patients, risks and outcomes related to surgery, having a healthy amount of protein in your diet improves your ability to recover from surgery. But the goal is really having a well-balanced diet and maintaining that as much as you can during and after treatment.

 Absolutely. And so to bring it all together, what is your biggest piece of advice for a patient with a gynecologic cancer who is maybe interested in making changes toward a healthier lifestyle, now that they've received a diagnosis?

 I would say my biggest advice would be to pick one or two things that that you want to try to change. Don't try to change everything at once. Because it's too hard on any one person. So pick one or two things that you're interested in changing. Try to do that. It often works better when people make a change as a family unit. So if you are trying to eat healthier, or go for more regular exercise, try to make that a family activity, because it's more likely to stick if you do that together.

As part of its Speaking Out video series, CURE spoke with Dr. Navya Nair, on behalf of the Foundation for Women’s Cancer, about maintaining a healthy lifestyle in women’s cancer.

Expert Offers Advice on Maintaining a Healthy Lifestyle Before, During and After Cancer Treatment

Understanding the signs and symptoms of cancer of the uterine lining

In the world of cancer, there are some big names such as lung, breast, skin, and colon to name a few; however, there are some that don’t get quite as much attention, despite their devastating effect on people and their families. Among these lesser discussed cancers, is 

, or cancer that starts in the lining of a woman’s uterus, which is the most common gynecological cancer in the United States. This disease was projected to account for over 65,000 new diagnoses in 2020 and take as many as 12,590 lives. Let’s take some time today to learn about late-stage endometrial cancer, its risk factors and symptoms, treatments, and what new research is telling us about this dreaded disease.

Endometrial cancer has a somewhat complicated list of factors that influence its development – some are true risk factors, while others help prevent it.

Family history of endometrial or colon cancer

One thing that research has shown is that the number of periods that a woman experiences in her lifetime has an influence on the development of endometrial cancer. The higher the number of periods, the higher the risk. While this is something that we ladies really can’t control, the knowledge of an early menarche (when a young woman gets her first period) or a late menopause gives us the proverbial heads up that we are at an increased risk, and to be aware of warning signs. Interestingly, the more pregnancies that a woman experiences, the lower her risk of endometrial cancer. The progesterone produced during pregnancies has been found to be protective against this type of cancer. Likewise, the hormones found in oral contraceptives and in combination (estrogen and progesterone) hormone replacement therapy (HRT) appear to be protective as well. It should be noted that estrogen only HRT is not protective against endometrial cancer and may increase the risk.

From a standpoint of ethnic background, Caucasian women are more likely to be diagnosed with endometrial cancer than Black ladies; however, Black ladies are more likely to succumb to endometrial cancer than Caucasian, due to the fact that they tend to be diagnosed at later, more advanced stages.

Understanding the signs and symptoms of cancer of the uterine lining By Kathryn E. Vinson, MS, CCRC In the world of cancer, there are some

Gynecologic Cancer

LIVING WITH CANCER

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