Natalie’s Stage 4 Non-Small Cell Lung Cancer Story
Interviewed by: Nikki Murphy Edited by: Chris Sanchez
Natalie, who hails from Atlanta, GA, was diagnosed with stage 4 non-small celllung cancer in June 2020. Her diagnosis followed a challenging 6-month period of inconclusive tests and misdiagnoses due to her age and non-smoking status. Her doctors initially attributed her symptoms, primarily fatigue and a persistent cough, to less serious conditions such as allergies or asthma. Despite undergoing multiple diagnostic procedures, including x-rays, CT scans, biopsies, and PET scans, Natalie only received her cancer diagnosis after one of her lungs collapsed during a biopsy.
Natalie was overwhelmed by the stage 4 diagnosis, associating the prognosis with a death sentence. Her cancer had already spread to both lungs and her lymph nodes, and her oncologist confirmed that there was no definitive cure. Natalie immediately began chemotherapy and immunotherapy treatments. While she managed the physical side effects, particularly severe fatigue, she continued working throughout her treatment, with few people aware of her diagnosis.
Over the course of 4 years, Natalie underwent 2 clinical trials after her cancer progressed, neither of which were successful. The first trial, at Emory Hospital, left her feeling worse than she did on chemotherapy and required multiple hospital visits. The second trial, in Nashville, produced no significant side effects. After these trials failed, she returned to chemotherapy, which has stabilized her cancer’s growth for now.
Beyond the physical challenges, Natalie has also struggled with the mental toll of her stage 4 non-small cell lung cancer. Therapy, her husband’s unwavering support, and her close-knit group of friends and family have been essential to her well-being. She acknowledges that at times she considered giving up treatment due to exhaustion but found renewed determination through the support of her loved ones and her desire to live and experience more of life.
Recently, Natalie’s pulmonologist informed her that she might be a candidate for a double lung transplant, a procedure that could potentially offer her a cure. She is in the early stages of the process and hopes that her cancer remains confined to her lungs so she can be placed on the donor list.
Natalie emphasizes the importance of advocating for lung cancer awareness, noting that anyone with lungs is at risk, not just smokers. She encourages others facing similar challenges to try to keep going, acknowledging the mental and physical difficulties of battling cancer. Her message is one of resilience and the importance of not giving up, even when the path is painful and difficult.
Name:
Natalie B.
Age at Diagnosis:
33
Diagnosis:
Non-small cell lung cancer
Staging:
Stage 4
Initial Symptoms:
Persistent cough
Fatigue
Treatment:
Chemotherapy (Carboplatin, Alimta)
Immunotherapy (Keytruda)
Clinical trials
Radiation (palliative)
This interview has been edited for clarity. This is not medical advice. Please consult with your healthcare provider for treatment decisions.
Filipe’s Stage 4 Lung Cancer with EGFR exon 19 Deletion Story
Interviewed by: Taylor Scheib Edited by: Katrina Villareal
Filipe was diagnosed with stage 4 lung cancer at 36. He reflects on the challenges and critical decisions that shaped his treatment path. Being a nonsmoker, he was shocked by his diagnosis following a severe headache that prompted a brain MRI, revealing multiple metastases in the brain and a primary tumor in the lung. Despite disbelief and seeking second opinions, doctors confirmed the advanced stage of his condition.
The treatment began with brain surgery to address a 4 cm metastasis. Biomarker testing revealed an EGFR mutation, enabling targeted therapy that initially worked well. However, disease progression after nine months necessitated further interventions, including chemoablation for kidney metastases and SBRT for lung activity. Eventually, a new line of treatment with a bispecific antibody offered hope when options dwindled.
Managing side effects became a significant focus, especially as the current treatment led to severe skin issues and nail problems. Adjusting the treatment schedule provided some relief. Emphasizing the importance of second opinions and advocating for personalized care, Filipe highlights the need for patients to be informed and assertive. Despite setbacks and fears of running out of options, he remains hopeful, crediting research and innovation in lung cancer treatments for extending his life.
Name: Filipe P.
Age at Diagnosis:
36
Diagnosis:
Lung Cancer (NSCLC)
Staging:
Stage 4
Mutation:
EGFR exon 19 Deletion
Symptom:
Headache
Treatments:
Surgery: to remove brain metastasis
cryoablation: to remove kidney metastasis
Targeted therapy
SBRT
Bispecific antibody
Thank you to Johnson & Johnson for supporting our patient education program! The Patient Story retains full editorial control over all content.
This interview has been edited for clarity and length. This is not medical advice. Please consult with your healthcare provider to make treatment decisions.
I was diagnosed with stage 4 lung cancer at the age of 36. I’m married and I have a daughter. I have electronic hobbies.
Before my diagnosis, life was well. I was an IT systems administrator for an insurance company. My daughter was five years old when I was diagnosed.
The MRI revealed seven brain metastases and a 4 cm metastasis on the back of my head.
How I Found Out I Had Lung Cancer
I used to say I’m healthy all the time. I don’t have behaviors that justify my diagnosis, so it was a shock.
I was very lucky because my diagnostics took one day. When I had a headache, I went to the doctor and the first thing the doctor asked me to do was a brain MRI. When I was in the MRI machine, the technician asked me to wait because he wanted to call the doctor. I asked him why because the result takes at least one week. He said the doctor needed to see it.
The MRI revealed seven brain metastases and a 4 cm metastasis on the back of my head. For the doctors, it was very easy to diagnose because there was evidence. I had brain surgery two weeks after my MRI. They told me that the primary cancer would probably be lung because lung cancer usually metastasizes to the brain very quickly. They did a CT scan and biopsied the primary site and confirmed that I had stage 4 lung cancer.
At the appointment with the doctor, my wife was with me. When he said that it was cancer, I didn’t want to believe it because I never smoked in my life. I was healthy. I usually don’t go to the doctor, so it was very awkward for me. I started thinking about second opinions, but the doctor said there was no doubt about it. It was a shock.
Preparing for Brain Surgery
I went to the hospital. They double-checked everything with a CT scan and confirmed that it was lung cancer.
The first CT scan showed lesions on my liver. Fortunately, it was benign, but they found cancer in my bones, my left lung, and my head. They told me that I needed brain surgery right away because the 4 cm metastasis on my brain wouldn’t go away with other therapies. The brain is the last place a patient wants to have surgery.
The doctor said it was a very easy surgery. When they removed the bone, they were able to immediately take it out.
I started at a private hospital where I was diagnosed. They wanted me to undergo radiotherapy for my brain. I asked for a second opinion at a cancer center and they said the brain metastasis would not respond to radiotherapy and that I needed to have brain surgery. Because I’m a nonsmoker patient, I will probably have a mutation and if I’m eligible to undergo targeted therapy, usually the metastases respond very well to this kind of therapy.
I started to be treated at the cancer center. I had brain surgery to remove the biggest metastasis. After it was confirmed that I had the EGFR mutation, I started with a targeted therapy that’s very common for EGFR patients.
Second opinions are very important. There is a small margin of error in this disease. If you don’t choose the treatment well, you may not be able to choose another treatment. Listening to the doctors is very important. Get a second opinion or even a third opinion.
There were no other options for me at the time. I was very lucky because the metastasis was on the surface, so the doctors didn’t need to navigate into my brain to remove it. It only took 50 minutes. The doctor said it was a very easy surgery. When they removed the bone, they were able to immediately take it out. They didn’t need to do a whole lot.
Brain surgery is tough to think about, but it needs to be done. I wrote a letter saying goodbye to my family for them to open in case I die. Fortunately, everything went well and 24 hours later, I was standing up and walking.
Learning About Biomarkers
At the time, I didn’t understand why biomarkers were so important. Knowing your biomarker will define what kind of treatment you can have. It’s an expensive exam, but it’s very much needed because the biomarker will allow you to choose the best treatment for your cancer. The biomarker could save your life.
Targeted Therapy Worked for Nine Months
The average progression-free survival of the targeted therapy that I underwent is 18 months. I had a very short run. It only worked for nine months. The first few months were very good because it cleared four brain metastases. It also cleared my bone and reduced the cancer in my primary site.
After three months, I started to have early progression. A metastasis appeared in my kidney. We did a needle biopsy and a biomarker test to confirm if it was the same cancer because it’s very unusual for lung cancer to metastasize on the kidney. When it was confirmed that it was the same cancer, we did cryoablation on the kidney. We froze the metastasis with argon to kill the cancer cells. I also had SBRT on my lung because my lung started to have activity on the primary site based on a PET scan.
After nine months, in August 2023, I had severe progression. At the time, I had no other options on the market.
Knowing your biomarker will define what kind of treatment you can have.
Finding Another Line of Treatment
I was very lucky because my current treatment, which is a bispecific antibody, is only used for EGFR exon 20 and I am exon 19. I was very lucky because I had no options left. Amivantamab appeared and I had a great response to it.
I was very lucky because the drug came out. It’s frightening to think about running out of options and only relying on drugs that aren’t effective for your disease.
It’s similar to the sensation of when you receive the diagnosis thinking that you’re going to die, but this time, I have more information. I know exactly what my options are and even though they’re very few, I’m more aware of what’s happening. In the beginning, everything is new and you start to collect more information. But when I had the progression, I knew exactly what was going to happen.
Side Effects of the Current Line of Treatment
With targeted therapy, you can take one pill a day at home and have a normal life. With amivantamab and chemotherapy, you need to stay at the cancer center for six hours every three weeks. It’s not targeted, so it attacks the cancer cells but also the healthy cells, so you need to deal with the side effects.
It’s not as comfortable as targeted therapy. You need to reorganize your life according to the infusion days. If the toxicity is too high, I can postpone for one week, so sometimes I do four-week intervals instead of three. The major side effect is the skin and that’s why I have these pimples all over my body. I also have a lot of nail problems.
The side effects started to manifest weeks after taking the drug. It started with pimples and because I’m on blood thinners as well, everything was full of blood. After two or three months, I reached the peak of my side effects, and the side effects started to smoothen. Right now, only the nails are my major problem.
I used to have various scalp problems, pimples, and blood, but after almost 11 months, it’s only the nails and scalp. I control it with topical corticoids. I used to put a lot of cream, but it wasn’t enough. I need to take corticoids when I have treatments; otherwise, the skin becomes very red and has sunburn-like pain.
The rash is very tough because, for example, when I take a bath, I cannot use a towel and rub my skin. After all, it hurts a lot. I need to dry it very carefully with a towel. I stopped wearing white because you will see blood sometimes. The pain is also associated with that. Sometimes I’m unable to do normal things when I experience the peak of my side effects. For example, I cannot wear sneakers because it’s closed and I have nail problems on my feet, so I wear flip-flops all the time. The main problem is it doesn’t heal. Whatever you do, it doesn’t heal 100%. It can get better, but it never heals.
The toxicity starts to accumulate. In the beginning, it’s only one or two nails. Nowadays, it’s all of them. I only have one finger without problems. The rash is tough, but at some point, it starts to be manageable because you know your body, so you know what to do and know to avoid some troubles.
I’m a stage 4 lung cancer patient with brain metastasis. Forget the skin.
Communicating with My Doctors About the Side Effects
Doctors need to be careful with how to deal with their patients. They usually say that if they cannot control the side effects, treatment may be stopped and the patient starts to hide their side effects because they’re afraid of stopping treatment.
My dermatologist told me that in the beginning. If my skin becomes very bad, we need to stop treatment. I asked her, “What is the threshold?” I’m a stage 4 lung cancer patient with brain metastasis. Forget the skin. I started to understand when things go very bad with the rash and why we may need to stop treatment.
Treatment can be flexible. Instead of every three weeks, you can do it every four weeks, like I do now. One week can make a lot of difference for patients. A patient needs to know that everything is flexible.
I’m very happy with my current doctor, who’s my third doctor. You need to advocate for yourself. With all due respect, doctors need to understand that they are working for us and not the other way around. The patient has the power. He can stop treatment. He can postpone treatment. It’s our life, so we have a say and we need to be heard. Otherwise, we can change the doctors or change the medical team. Everything can change.
The Fear of Running Out of Treatment Options
Running out of options is scary. Research is very important. Without research, people would run out of treatments. Treatment can save lives. I’m an example of that. I believe that if it wasn’t for the drug I’m currently on, I wouldn’t be here, so it’s very important to have options.
Cancer is a monster, but there is hope.
My Biggest Advice for Lung Cancer Patients
There has been more development in lung cancer in the last five years than in the last 50, so there are a lot of things happening. Don’t look at the statistics. The data online is outdated. There is a lot of hope. Cancer is a monster, but there is hope.
Special thanks again to Johnson & Johnson for its support of our independent patient education content. The Patient Story retains full editorial control.
At 37, Samantha was diagnosed with HER2 non-small cell lung cancer. Her symptoms started with a cough and chest pressure, so she went to urgent care. A cancer diagnosis was one thing, but a lung cancer diagnosis with no smoking history was mind-numbing to her. This is Samantha’s story of navigating a lung cancer diagnosis young and discovering a rare biomarker too.
Name: Samantha M.
Age at Diagnosis:
37
Diagnosis:
Non-Small Cell Lung Cancer (NSCLC)
Staging:
Stage 4
Mutation:
HER2
Symptoms:
Persistent cough
Chest pressure
Fatigue
Weight loss
Treatments:
Chemotherapy
Immunotherapy
Thank you to Bayer for its support of our patient education program! The Patient Story retains full editorial control over all content.
This interview has been edited for clarity and length. This is not medical advice. Please consult with your healthcare provider for treatment decisions.
I went on a women’s trip in March 2024. When I came back from the trip, I developed a cough and noticed some pressure on my chest.
Introduction
I was born in California, raised in Hong Kong and the UK, and went back to the US around 12 years ago. I’m an active, outdoor adventurer. I love hiking, backpacking, camping, and anything to do with nature and being outside.
My husband Justin and I have been married for seven years. He is my absolute world and soulmate. I also have a nine-year-old German Shepherd.
Pre-diagnosis
Initial Symptoms
I went on a women’s trip in March 2024. There were 20 of us going on this adventure together even though I had never met them before. We were going to travel to India for 10 days. Before the trip, everything felt completely normal.
When I came back from the trip, I developed a cough and noticed some pressure on my chest. The air is not the best in India. A lot of people developed a cough, so I didn’t think anything of it, but the chest pressure was bothering me.
Two weeks after my trip, I was still hiking 4 to 5 miles a day, but there was a lot of pressure going on. I went to urgent care where a doctor listened to my chest and said, “Let’s do a chest X-ray to see what’s going on.”
The results showed that my entire left lung was full of fluid and fully collapsed. He said, “You need to go to the emergency room immediately.” I was still very naive then, thinking it was something I contracted from my trip.
They said, ‘We had a chance to look at a biopsy of one of the lesions in your liver and the fluid in your lungs, and it’s looking to be more and more like cancer.’
Diagnosis
Getting a Cancer Diagnosis
I went to the emergency room and they admitted me right away. They put in a chest tube, which was not a pleasant experience, and ended up draining 3 liters of fluid from my lung. They took that off for testing and did multiple CT scans. Even though I was admitted to the hospital, I was getting information about my scans through the apps. My result came through before the doctor even spoke to me. It said multiple lesions on the liver and lungs.
The infectious disease doctor came in and started asking me a ton of questions. They thought I might have tuberculosis because I’d lived and traveled to a lot of foreign countries, so they were very confused and running tons of tests.
Unfortunately, on day three of the hospital admission, they said, “We had a chance to look at a biopsy of one of the lesions in your liver and the fluid in your lungs, and it’s looking to be more and more like cancer.” They couldn’t give me a guarantee at that point, but this was looking like it. They said, “We’re going to discharge you. We’ll wait for confirmation, but we’re lining up an oncology appointment for you right away.” That’s when my world spiraled.
Playing the Waiting Game
We were living in Missoula, Montana, where my husband was stationed. The wait for the general oncologist was two weeks. There was no specialist there. After all, it was such a small town. That period was awful. It was confirmed through the app that I did have cancer, but I had no doctor to bounce anything off or ask questions.
At that point, it didn’t say what stage I was, and not being too familiar, I didn’t know what stage 1 versus stage 4 meant. I had no idea. I didn’t know anything other than I had non-small cell lung cancer.
I was spiraling on Google, which is not your best friend at this time of diagnosis. I figured out I was stage 4 and learned the five-year survival rate. I was doing more digging and came across mutations all this information on mutations.
I was eventually diagnosed with HER2 mutation, which was one I had never heard of.
When I went into that initial oncology visit, I had a list of questions, but the number one was if I could get a biomarker test for genetic mutations. He said, “Absolutely. It was on my list. You’re good because I know a lot of oncologists in these smaller towns are still not aware of these biomarker testing and treat lung cancer when someone could have a targetable mutation.”
I learned a lot about mutations during that two-week waiting period. I was eventually diagnosed with HER2 mutation, which was one I had never heard of. I didn’t come across it on any websites. It was a two-week window of the unknown with the fear and concern that I didn’t have long to live.
At my first oncology appointment in Missoula, he told me that I was stage 4, I was terminal, and had nine months to live. He told me before he even knew what mutation I had. No one should be told how long they have to live like that. It doesn’t help anyone. It set my mind back a long way. It was devastating.
Reaction to the Diagnosis
My husband, who was a 19-year veteran at this point, used to be a combat medic in Iraq and Afghanistan, so he’s seen a lot and I had never seen him cry ever. When I got that diagnosis in Missoula, he went outside the hospital and broke down. That was hard to see and almost harder for me than receiving the news personally. We’re so young. It was heartbreaking because he’s my soulmate. Knowing that I’m not going to be around and be with him when we’re 80 years old is gut-wrenching.
It hit him hard. He’s been an incredible caregiver. He’s been to every single appointment. He now handles the app for me and looks at all of my results. He’s been exceptionally supportive. I couldn’t ask for a better caregiver, but I would say it’s probably had more of an impact on him than on me.
Honestly, I had a breakdown… I thought that was the end of my journey because there was no primary targeted treatment for HER2.
Seeing a Lung Cancer Specialist
My husband said, “We’ll see this oncologist here, but let’s get you to a research hospital. Let’s see if the army will move us.” Within a month, the army approved the move. We were 45 minutes away from the Huntsman Cancer Institute. They have been so supportive and my work has also been so supportive.
I’m very grateful because I know a lot of people are not in that situation, especially those who are young, have cancer, and work full-time jobs. We put our house up for sale and within a month of my diagnosis, we had fully moved to be settled and to see a lung oncologist in Salt Lake City.
I learned to advocate for myself constantly. I was pretty forceful in messaging the Huntsman saying, “I need to get in as soon as possible. The general oncologist referred me. This is their letter.”
I was fortunate to get the best thoracic oncologist at the Huntsman. They looked at my chart and saw the severity of my stage 4 diagnosis. They got me in very quickly and wanted to redo my scans. They did a CT scan and a PET scan, which I hadn’t had at that point. They said, “We’re sending biomarker testing off the blood and also take a sample from Missoula and submit that as a tissue sample.”
They didn’t want to start any treatment until my biomarker test results came back, which took about two weeks. Meanwhile, my lung was continuing to fill up with fluid, so I had to get drained regularly. I was still active and nothing was stopping me. I was hiking at 10,000-foot elevation and I had no issues, but I felt very, very tired.
My biomarker test results came back and said HER2. I had never heard of HER2 in my life. I thought, “What on earth is this? What am I going to do with this?”
Honestly, I had a breakdown because I had been part of groups that talked about EGFR and ALK, all these great drugs, and people doing so well as young people on these targeted therapies. I said, “This is it. I keep on getting hit over and over again with bad luck and this is the final straw.” I thought that was the end of my journey because there was no primary targeted treatment for HER2.
Learning About the HER2 Biomarker
I started researching on Google, which wasn’t the best idea because when you search lung cancer and HER2, it says you do not have a very good prognosis at all and that wasn’t what I wanted to hear. That and not seeing anything about a primary targeted therapy was heartbreaking.
Finding Hope While Learning from Other Patients’ Experiences
I was introduced to someone who is part of an exon 20 group. I spoke to her within 24 hours of knowing that I had HER2 and she spent about an hour explaining everything: what was on the horizon as far as treatment was concerned, what was currently under clinical trials, and all of this hope.
I went from absolute turmoil, thinking this was literally the end, and that I have the worst prognosis to there could actually be some hope here and that changed my entire attitude. A lot of HER2 patients, when they find out about their mutation, aren’t told about the hope. They aren’t told about what’s coming. People have no idea unless they’re educated by other people.
I wanted to start treatment, so we decided on traditional chemo and immunotherapy and started that within a week.
Treatment
Treatment Options for HER2 Mutation
My oncologist is incredible. He called me right away and said, “Look. This isn’t what I was expecting either, but this is what we have.”He was trying to find silver linings. He said, “You have to come in every three weeks to get treatment, but your mutation works with immunotherapy. Your mutation can work with traditional chemo.” He was giving me some hope and that’s all I needed to hear.
He wasn’t an expert in HER2. I don’t think he has any other HER2 patients, but I was also fortunate because my coworker’s husband’s best friend is a HER2 expert and he’s been an incredible resource who I can text and get information or reassurance. Having those two resources has been invaluable.
My oncologist laid out what chemotherapy and immunotherapy I would be on. He also offered up a clinical trial, which split chemo and immunotherapy separately by a week, instead of combining them for a couple of rounds. He thought that I would be a good candidate.
Meanwhile, the HER2 expert who I was talking to was telling me about an amazing clinical trial for a drug for HER2 that was looking for people who had not been treated yet.My oncologist didn’t know about that trial, so I brought it up with him and he was kind enough to look into the research, look into the statistics, and weigh the options for me.
He said, “At the end of the day, it’s up to you which one you would like to proceed with, but here are my thoughts.” He was leaning towards traditional chemo and immunotherapy because immunotherapy had foundational success in the long run. The clinical trial was still in its early days in knowing what the outcome would be in the long term.
I also didn’t want to wait. Joining a clinical trial in another hospital involved flying, getting scans again, etc. I wanted to start treatment, so we decided on traditional chemo and immunotherapy and started that within a week.
As weird as it is to say this as a stage 4 cancer patient, chemotherapy and immunotherapy can do wonders.
Response to Treatment
I was responding extremely well and I’m very fortunate that I don’t have that many side effects at all. I have a couple of days of low energy, but other than that, I have been able to live my life, hike, and work.
I spoke to my husband and as weird as it is to say this as a stage 4 cancer patient, chemotherapy and immunotherapy can do wonders.There’s a horrible misconception that chemo and immunotherapy are awful and they don’t do anything. I get very upset about that because it has changed my life and has done amazing things for my body. I haven’t felt this well in years.
Looking back, even though I didn’t have very apparent symptoms, I was tired all the time.I would take naps during the day. I would be exhausted after 10 hours of sleep. I lost five pounds when I’ve never lost weight in my life. There were very subtle signs and if you look at pictures of me, I didn’t look well.
I’m feeling great right now. It’s like a double-edged sword because I have stage 4 cancer,but the chemo and immunotherapy are reducing my cancer burden so much that I feel like normal Samantha again.
Having Hope with a HER2 Biomarker
There’s a lot of hope. A HER2 mutation is not an immediate death sentence by any means. We don’t have a targeted therapy right now but that doesn’t mean it’s the end of the line. There are options out there.
Knowing that there are targeted therapies coming out very soon through clinical trials with statistics that show that they work exceptionally well is invaluable.
There’s a lot of hope. A HER2 mutation is not an immediate death sentence by any means.
Words of Advice
You see online that if you eat healthy and you exercise, there’s a very low chance you’re going to get cancer and I don’t like that at all. It makes me very angry and very upset because that makes people who are fit and healthy and doing all the right things think that they’re notgoing to be touched by cancer.
People must be aware that cancer does not discriminate. It doesn’t care if you’re fit and healthy. It will be in whoever it wants to be and that’s a fact.
Listen to your body. Be in touch with changes. If you have a lump, if you have a weird cough that has continued for months, if you have a weird mole that you’re not sure about, don’t wait.
If your gut is telling you something is wrong and your doctor says it’s fine and not to worry about it, get a second opinion. Push and be that person and getthe answers you need to get. You have to advocate for yourself.
Special thanks again to Bayer for its support of our independent patient education content. The Patient Story retains full editorial control.
Each year, The Patient Story attends a handful of cancer conferences to meet with experts on the frontlines of cancer care and report on developments that matter to patients. We’ve reported on ASH, SABCS, and ASCO. But what exactly is ASCO, and why should patients care about an annual conference for medical professionals?
The American Society for Clinical Oncology (ASCO), established in 1964, plays a pivotal role in the global fight against cancer. It unites over 40,000 professionals from more than 100 countries across various oncology subspecialties and disciplines around the world, creating a comprehensive network of experts committed to advancing cancer care. This premier organization is at the forefront of fostering innovative research, disseminating critical educational resources, and advocating for high-quality patient care. By emphasizing a multidisciplinary approach, ASCO ensures that its members are well-equipped to handle the complexities of oncology, thereby enhancing patient outcomes and contributing to the reduction of cancer’s worldwide impact.
ASCO’s strategic objectives are focused on accelerating the pace of cancer research, optimizing educational opportunities for oncology professionals, and improving patient care through the integration of the latest scientific discoveries and treatment modalities. The society leverages its extensive network and resources to support initiatives that drive progress in cancer treatment and care delivery. For instance, ASCO’s annual meeting serves as a global platform for sharing groundbreaking research findings and discussing innovative treatment approaches, reflecting the society’s commitment to bringing the benefits of cutting-edge cancer research to patients and practitioners alike. Through such endeavors, ASCO not only facilitates the dissemination of vital knowledge within the oncology community but also significantly contributes to the overarching goal of diminishing the global cancer burden.
The American Society for Clinical Oncology (ASCO) plays a crucial role in transforming the landscape of cancer care by pushing for legislative reforms aimed at eliminating obstacles to high-quality cancer treatment. By advocating for changes in healthcare policies and practices, ASCO ensures that cancer care becomes more accessible and equitable for patients across the globe. These efforts are particularly vital in addressing disparities in cancer treatment and ensuring that all patients, regardless of their socioeconomic status, have access to the latest and most effective therapies.
Moreover, ASCO places a strong emphasis on the value of open, honest communication and the establishment of a continuous, trusting relationship between oncologists and their patients. This philosophy is fundamental to delivering patient-centered care, which prioritizes the preferences, needs, and values of patients and their families. By fostering a care environment that is both compassionate and comprehensive, ASCO influences the treatment journey of cancer patients in profound ways. It ensures that the care provided is not only technically advanced but also emotionally supportive, thereby enhancing the overall quality of life for patients during their treatment journey. Such an approach has been shown to improve patient outcomes and satisfaction, illustrating ASCO’s pivotal role in making cancer care more patient-centered and effective.
Cancer clinical trials are pivotal to the advancement of cancer care, serving as the primary method through which new treatments are developed, tested, and perfected. The American Society for Clinical Oncology (ASCO) champions these trials, recognizing their indispensable role in pushing the boundaries of medical science to discover more effective cancer therapies. By rigorously evaluating the safety and efficacy of novel treatments, clinical trials contribute significantly to enhancing patient care options and outcomes. They are the stepping stones that lead to the approval of new drugs, therapies, and treatment protocols that can offer hope to millions of patients worldwide. The ASCO Hub provides information on clinical oncology.
ASCO actively encourages participation in clinical trials among cancer patients, emphasizing the dual benefits of gaining access to cutting-edge treatments while contributing to vital research that can save lives in the future. This encouragement is based on the understanding that clinical trials are essential not only for the individual patient’s potential benefit but also for the collective progress in the fight against cancer. A notable example of this is the development of targeted therapies, which have revolutionized cancer treatment by focusing on specific genetic mutations within cancer cells, significantly improving patient outcomes in certain cancer types. Participation in clinical trials also empowers patients by placing them at the heart of their own care, making them active contributors to the advancement of medical knowledge and the quest for a cure.
ASCO conferences serve as pivotal arenas where the latest in cancer research is unveiled, offering insights into groundbreaking therapies, innovative treatment approaches, and the newest trends sweeping through the field of oncology. These conferences act as melting pots of knowledge, bringing together the brightest minds in cancer research from across the globe. They facilitate an essential exchange of information and foster partnerships that are critical in propelling the advancement of cancer care. One notable example is the introduction of novel immunotherapy treatments which have revolutionized how certain types of cancer are treated, showcasing the potential to significantly enhance patient survival rates and quality of life.
Moreover, recent ASCO meetings have spotlighted the strides made in precision medicine and personalized treatments, marking a shift towards more tailored and effective care strategies. These advancements underscore the importance of understanding the genetic makeup of an individual’s cancer, allowing for therapies that are specifically designed to target the mutations driving the disease. We recently interviewed Dr. Cathy Eng, the David H. Johnson Endowed Chair in Surgical and Medical Oncology at Vanderbilt-Ingram Cancer Center on the latest advances in colorectal cancer treatments and clinical trials and the use of biomarkers. This approach of using the genetic makeup of a person’s specific disease not only improves the efficacy of treatments but also minimizes the side effects, presenting a beacon of hope for patients who previously had limited options. The breakthroughs shared at ASCO conferences exemplify the relentless pursuit of knowledge and innovation in the oncology community, offering new avenues for diagnosis, treatment, and ultimately, the cure of cancer.
The escalating expenses associated with cancer treatment present a formidable challenge, affecting not only patients but also their families, healthcare providers, and the broader healthcare infrastructure. In response to this critical issue, the American Society for Clinical Oncology (ASCO) established the Cost of Care Task Force. This initiative focuses on exploring and advocating for effective strategies to alleviate the financial strain imposed by cancer care on patients and the healthcare system at large. By prioritizing cost-conscious care practices, ASCO is committed to ensuring that financial considerations do not detract from the quality or accessibility of patient outcomes. For example, ASCO promotes the integration of discussions about the cost of care into treatment planning conversations, enabling patients and their families to make choices that align with both their healthcare needs and financial realities.
Moreover, ASCO’s collaborative efforts with other stakeholders in the cancer care ecosystem are pivotal in developing and disseminating resources aimed at educating patients about the financial dimensions of cancer treatment. These resources are designed to empower patients with the knowledge they need to navigate the complexities of cancer care financing, from understanding insurance coverage to exploring assistance programs. By fostering an informed patient community, ASCO enhances the capacity of individuals to make treatment decisions that are both medically and economically sound. This approach not only supports patients in managing their care but also contributes to the broader goal of making high-quality cancer treatment more accessible and sustainable for all involved parties.
ASCO’s Initiatives for Evidence-Based Decision Making
The American Society for Clinical Oncology (ASCO) takes a leadership role in fostering evidence-based decision-making within the oncology community. Through pivotal initiatives like the “Choosing Wisely” campaign, ASCO seeks to curtail the prevalence of unnecessary diagnostic and therapeutic procedures in cancer care. This campaign encourages both oncologists and patients to engage in open discussions about the necessity and potential value of specific interventions, thereby ensuring that each patient receives care that is not only effective but also directly aligned with their unique health circumstances and treatment goals. For example, ASCO’s guidelines advise against the routine use of advanced imaging technologies in the early staging of certain cancers where evidence does not support their benefit, emphasizing the importance of individualized care planning based on robust clinical evidence.
Moreover, ASCO’s commitment to evidence-based practices extends to the development and dissemination of comprehensive clinical guidelines. These guidelines serve as a valuable resource for oncologists, providing them with the latest research findings and expert consensus on the most effective approaches to cancer treatment and care. By prioritizing interventions that have been rigorously evaluated and proven to enhance patient outcomes, ASCO not only advances the quality of care but also contributes to the sustainability of healthcare systems by mitigating unnecessary costs associated with ineffective or marginally beneficial treatments. This dual focus on improving patient care and optimizing resource use reflects ASCO’s holistic approach to addressing the complexities of cancer treatment in the modern healthcare environment.
Membership and Resources
Membership in ASCO provides oncology professionals with unparalleled access to a comprehensive suite of educational materials, the latest scientific publications, and exclusive networking opportunities. This membership is designed to support their ongoing professional growth and ensure they remain at the forefront of oncology practice and research. By joining ASCO, members gain entry into a dynamic community committed to the continuous advancement of cancer care. They are provided with tools and resources necessary to navigate the complexities of modern oncology, including guidelines for evidence-based practice, updates on the latest research findings, and opportunities to participate in groundbreaking clinical trials.
Furthermore, ASCO’s global network offers a unique platform for collaboration and knowledge exchange among cancer care professionals from around the world. This network fosters mentorship opportunities, encourages the sharing of best practices, and facilitates partnerships that can lead to innovative solutions in cancer treatment and patient care. For instance, through ASCO’s annual meetings and specialized conferences, members can connect with peers, discuss the latest trends and breakthroughs in oncology, and contribute to the global effort to conquer cancer. This vibrant community not only enhances the professional journey of its members but also significantly impacts the quality of care provided to patients worldwide.
ASCO’s Commitment to Patients
The American Society for Clinical Oncology (ASCO) stands at the forefront of transforming cancer care and patient experience through its persistent dedication to research, education, and the implementation of patient-centered practices. This commitment is evident in ASCO’s active role in pioneering innovations that drive significant improvements in treatment outcomes and quality of life for individuals facing cancer. By fostering a holistic approach that spans from the latest breakthroughs in oncology research to the intricacies of patient care, ASCO ensures a supportive and informed journey for patients and their families. This includes not only access to cutting-edge treatments but also the provision of comprehensive resources designed to empower patients with knowledge and support at every stage of their cancer journey.
Furthermore, ASCO’s initiatives extend beyond clinical advancements, addressing critical aspects such as the cost of care, the importance of evidence-based decision making, and the advocacy for policies that benefit the cancer community at large. One notable example of ASCO’s impact is its involvement in the “Choosing Wisely” campaign, aimed at reducing unnecessary treatments and procedures, thus optimizing patient care and resource utilization. Through these efforts, ASCO demonstrates a deep-seated commitment to not only enhancing the therapeutic landscape but also ensuring that patients navigate their treatment with dignity, respect, and access to the best possible care options. This multifaceted dedication underscores ASCO’s pivotal role in the ongoing fight against cancer, making it a beacon of hope and a source of strength for patients, their families, and the oncology community.
You’re an advocate. You’re an advocate for yourself… Everybody has a place and everybody has a role.
The Belmont Report: Protecting People in Clinical Trials
Written By:
Matthew Romeo
Clinical trials advance cancer research and help current and future generations find new treatments for disease. However, when patients enroll in a clinical research trial, they want to know that they are safe and that the trial won’t do more harm than good.
Enter the Belmont Report, a set of fundamental ethical principles and guidelines that assist researchers in resolving ethical principles when conducting research involving human subjects. In this article, we look at the history and content of the Belmont Report and its implication on cancer research.
The Belmont Report was created due to several contributing factors that made the need for a code of ethics in medical research using human subjects essential.
The extreme human rights violations during World War II, followed by the events of the Tuskegee study, prompted Richard Nixon to create the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission ultimately produced the Belmont Report.
The Nuremberg Code
Following the horrors of World War II and the information unraveled in the Nuremberg Trials, the international scientific community discovered a need for a code of ethics when conducting research on human subjects.
The Nuremberg Code, published in 1947, was created as a guide to satisfy moral, ethical, and legal concepts surrounding human experimentation. The document laid out 10 essential points for conducting ethical research. Amongst other things, the points included the following:
Requirement for voluntary consent
Qualifications for researchers conducting experiments
The importance of ensuring the benefits of an experiment outweigh the risks
Participants’ right to terminate the experiment
Investigators duty to terminate an experiment if they believe it will result in harm to the subjects
While the Nuremberg Code was a good start for providing ethical guidance in conducting human research, it soon became apparent that further action was needed.
“Trials happen in early-stage disease. They can be as a first-line treatment, when someone is first diagnosed, and also with advanced disease, where the goal of the trial is how to improve the standard treatment either by adding new medication or changing medications completely based on data from studies in advanced disease.”
From 1932 to 1972, the United States Public Health Service (PHS) conducted a study to observe the effects of syphilis if it remained untreated. During this period, the PHS observed the impacts of syphilis on nearly 400 black men.
The main problem of the study was that the patients were not informed of the true intent. In fact, they were blatantly lied to as they were told that they would be treated for the disease in return for meals, medical exams, and burial insurance. However, throughout the study, patients were denied access to penicillin, the treatment for syphilis.
The lack of information provided and disregard for the patients’ well-being led to a class action lawsuit and increased scrutiny of human subject protection policies.
National Research Act (1974)
The National Research Act of 1974 was passed due to the public attention surrounding the PHS Tuskegee Study. The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing a code of ethics and conduct for research involving human subjects.
While the Nuremberg Code provided the guidelines for ethical human subject research, the National Research Act codified those requirements into US law. The National Commission produced the Belmont Report in 1979, which remains one of the most important reports in protecting the safety of human subjects in medical research.
The 3 Basic Ethical Principles
The main product of the Belmont Report was the publication of three basic ethical principles to help guide and resolve ethical problems surrounding research with human participants. The three principles are:
Respect for Persons: All people should be respected. This includes children and individuals who may not be capable of making informed decisions due to mental or physical disabilities.
Beneficence: Research should not intentionally harm humans. In addition, researchers should look to maximize the potential benefits of a study and minimize the potential risks.
Justice: The benefits and burdens of research should be distributed fairly.
Although the Belmont Report was published almost half a decade ago, its guiding ethical principles still remain relevant today. In the next couple of sections, we will look at how these guiding principles have been applied to the way clinical trials are managed.
“A big part of what we do is help to educate and really clarify what clinical trials are.”
The three ethical principles are phenomenal foundational ideas; however, they are just that: ideas. Understanding how the idea translates to actual clinical trials is essential for research participants to feel safe agreeing to participate in trials.
Here are a few of the ways that the three principles have been applied to research:
Respect for Persons -> Informed Consent: Patients have the right to make the decision to participate or not to participate in a trial. To consent to participate in a trial, potential participants must receive information about the trial, be able to comprehend the impacts of a trial, and voluntarily agree to the trial. All three factors must be present to provide informed consent.
Beneficence -> Assessment of Risks and Benefits: Researchers need to thoroughly examine the benefits and potential risks of a study. Without clear supporting evidence that a trial will do more good than harm, the study can’t move forward.
Justice -> Selection of Participants: Researchers are required to implement a fair and equitable method for selecting study participants. When possible, participants should be from a diverse set of backgrounds.
These three applications have become standard practice in conducting research. All three applications should be clearly evident in all trials.
Institutional Safeguards
Researchers can generally be trusted to have the safety and well-being of their patients in mind. However, research and academic institutions have created several fail safes to ensure that patients are well protected.
Institutional Review Boards
The Institutional Review Board (IRB) is a group specifically formed for the purpose of ensuring that people participating in clinical trials are protected and that all federal laws are followed. Before they are formed, IRBs are approved and overseen by the Office of Human Research Protections.
Before a clinical trial can start recruiting patients, they must receive approval from an IRB. The trial is then continuously overseen by the IRB to ensure compliance.
Data Safety Monitoring Boards
A Data Safety Monitoring Board (DSMB) is a panel of experts that are typically brought on during a phase III clinical trial. The DSMB observes the progress of a clinical trial and stops it if:
It becomes clear the treatment is much better or much worse than the current standard of treatment.
There are extreme safety concerns that make it obvious that the risks of the trial outweigh the benefits of the trial.
Clinical Investigators
While both the DSMB and IRB are not directly involved with the study, the clinical investigator, sometimes referred to as the principal investigator, is directly overseeing all aspects of a clinical trial.
The clinical investigator is responsible for ensuring that all trial participants understand any risks involved with participating in a study and for ensuring their safety throughout the trial.
“Never think of trials as being exposed to random things. They’re very well thought out. More often than not, you have a high level of reassurance.”
As a result of the Belmont Report and the resulting events that followed, clinical trials have become much safer for participants. Doctors are required to inform patients of all the potential risks of enrolling in a clinical trial and ensure that the potential benefit of the trial outweighs the risks.
While it’s impossible to guarantee that a trial will be completely safe, patients can be assured that they’ll have all the information they’ll need to make the decision that is right for them.
American Cancer Society. Protecting People in Clinical Trials. Accessed at https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/protection-for-study-participants.html on October 15, 2023
Columbia University. Ethics and the IRB. Accessed at https://www.tc.columbia.edu/institutional-review-board/irb-blog/2020/the-history-of-the-belmont-report/#:~:text=The%20Belmont%20Report%2C%20a%20founding,a%20rich%20history%20of%20development.&text=“Good%20judgment%20comes%20from%20experience,experience%20comes%20from%20poor%20judgment.”&text=The%20Institutional%20Review%20Board%20(IRB,for%20research%20with%20human%20subjects on October 15, 2023.
HHS. The Belmont Report. Accessed at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html on October 15, 2023
University of North Carolina. Nuremberg Code. Accessed at https://research.unc.edu/human-research-ethics/resources/ccm3_019064/ on October 15, 2023
ERAU. History of Ethics. Accessed at https://erau.edu/-/media/files/university/research/irb-history-of-ethics.pdf on October 15, 2023
FDA. Institutional Review Board Frequently Asked Questions. Accessed on https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions October 15, 2023.
Dr. Fonseca has been a practicing hematologist for almost three decades, now interim executive director at Mayo Clinic. As a veteran specialist of the myeloma field, he shares his insights on the latest in emerging treatments and clinical trial studies.
The Patient Story:There were two big studies discussed at ASH focused on screening: iSTOP in Iceland, and the PROMISE study led by Dana Farber that started a couple of years ago, which focused on diverse populations. Can you describe the importance of those studies?
Why iSTOP Matters
This [iSTOP] is an incredibly important trial. Their goal was to do the whole screening for the country of Iceland. And what they went about to do was set up a system whereas people would be offered to be screened for the presence of monoclonal proteins. And they have a very robust partnership with the laboratory methodology to be able to test this at a high level and with great precision.
This is where phase III trials meet real world data, and really establishes some very interesting findings.
Dr. Rafael Fonseca
They went about to do a population based study, and at the end of it all, it was very, very large– 75,000 people. This is where phase III trials meet real world data, and really establishes some very interesting findings.
There were three or four key takeaways. One is that we know there’s a small fraction of the population with smoldering multiple myeloma, so they have established that through screening. It’s less than one percent that they estimated, but it’s still measurable. And that is important because as we have clinical trials where people are saying we should think about treating smoldering, we’re going to have to be more and more careful about that.
One of the randomizations was how to approach patients and then what to do afterwards. What they’re trying to see is if you have an early intervention, and you detect this early, then you can prevent some of the complications.
That’s very important because a myeloma patient who progresses to development of lytic bone lesions, especially if that results in a fracture, or renal problems, can have lifelong consequences. Then, as they live many years now after diagnosis, that’s very undesirable.
It also establishes the baseline for the prevalence of monoclonal gammopathy of undetermined significance (MGUS) in that population. So what we need to do is to think about how this extrapolates. I think there’s a susceptibility according to the various regions, but for what they tried to test, it was a remarkable study.
Why PROMISE Matters
PROMISE is a very large study led by the team of Dr. Ghobrial from Dana-Farber. And they’re able to show higher prevalence than expected for monoclonal gammopathy. In populations at risk, although the numbers will evolve, the number I keep in my head is about 10%. That’s in people who have family members who have monoclonal gammopathy or individuals of African-American ancestry, who have a higher incidence for this.
I hold the belief that many of us have slightly abnormal plasma cells somewhere in our body because we get exposed so many times through our lifetime that the opportunity for a mistake is actually quite high.
Dr. Rafael Fonseca
The other finding that was remarkable was that they found that a small fraction of patients that have abnormalities that would be a little bit more like a pre-MGUS, and some of those were reported as transient.
Now, there’s no reason to believe that humans don’t have some old clones. We know that for other tumors. So it was only logical that in time it would be found in patients who have things like MGUS. I hold the belief that many of us have slightly abnormal plasma cells somewhere in our body because we get exposed so many times through our lifetime that the opportunity for a mistake is actually quite high.
But you know, the studies are descriptive for the most part right now. But I really commend the efforts of the team of Dr. Ghobrial as well, too, in trying to establish this new baseline.
Takeaways for Current Patients
The Patient Story:What are the takeaways for current patientsregarding screening?
You know, there is no agreement at the moment regarding screening strategies or recommendations. And the reason for that is that these are conditions for which we don’t necessarily have treatments that will completely eradicate the process.
You screen for polyps because if you can excise those polyps, then you decrease the risk of colon cancer. But with the bone marrow, it’s very hard to do that because you can’t go in and just pull out the abnormal cells and then leave the rest of the bone marrow.
There is no question that, as time goes by and as the cells grow, there’s a greater likelihood that one might have a complication.
Dr. Rafael Fonseca
However, the question will change as was shown by the iSTOP study, because now the question is, “Can you do something to prevent a complication from happening?” There is no question that, as time goes by and as the cells grow, there’s a greater likelihood that one might have a complication.
So if you detect early, you might not be able to move on fully to the curative approach, although there are some clinical trials that are asking that question. But you might be able to establish a more careful monitoring strategy so that the next time you meet that person, it is for another laboratory testing, and not because the person has been admitted to the hospital with a fracture or with renal failure.
I think with most of the patients we see that have this condition, there’s somewhat surprise findings. You know, they’re going for a physical, and they’re found to have an elevated protein or someone orders a protein electrophoresis for other reasons, and now they know they have it. So we monitor them, but we don’t do this at large.
Genetic Screening
Now we get the question often from family members. “My mom or my dad has myeloma. What can I do to test?” So we give them the names of those tests, but without much information as far as what to do. And I feel like patients and families should know as well that we don’t have the best pathways yet defined, as it’s still early on.
[Testing] is a double-edged sword, because now you know you have it, then that creates a little bit of stress and anxiety. But on the other hand, you can prevent those complications.
Dr. Rafael Fonseca
But for instance, if you were in a family where there’s two or three members who have myeloma, that would be a pretty strong signal that there’s some familial clustering and then the person might want to test. And why not, if they find something to monitor? It’s a double-edged sword, because now you know you have it, then that creates a little bit of stress and anxiety. But on the other hand, you can prevent those complications.
Interestingly, at this meeting, we had a presentation by a team that looked for germline genetic changes that may predispose people to myeloma. They found that about 9% of patients have some genes that potentially could be contributing to the development of myeloma. Again, it’s very early, but that would be another path to explore as well.
Identifying Risk for Black Patients
The Patient Story: With PROMISE, there was a focus on Black patients, and a recognition that the high risk population over 50 years old was twice as likely as the general population to have MGUS. If you are a Black patient, what do you need to know about elevated risk, and do you need to talk to your primary care doctor?
You know, it could be right, but I don’t think we are ready yet to make recommendations. I think for readers in the audience who may have this question or that concern, it’s a fair request that your doctor does that testing if you are interested. As I mentioned earlier, we don’t have guidelines. I can’t pull them out and say, “This is what needs to be done.”
But I think people rightfully are concerned and would like to know. And the obvious question is, “Why?” And the “why” is so that you can have a good screening strategy. I hope that within the next five to ten years, we will have more specific guidance as far as what to do because again, if we can prevent complications, that would be pretty good.
Cancer treatments save lives, but they also come with side effects. Hear straight from patients who’ve been treated for cancer - what they experienced and what helped them get through it...
