Tomorrow’s Medicine Today

 

From PEN-Powered Activity Guide V, beloved medical oncologist Dr. Bora Lim of The University of Texas MD Anderson Cancer Center walks us through what a clinical trial is, the phase of how drugs get approved, and how the pandemic crisis has amplified the criticality of clinical trials.

What is a Clinical Trial?

What is a Clinical Trial? from Patient Empowerment Network on Vimeo.

How Do Drugs Get Approved?

How Do Drugs Get Approved? from Patient Empowerment Network on Vimeo.

Will Pandemic Transform Future of Clinical Trials?

Will Pandemic Transform Future of Clinical Trials? from Patient Empowerment Network on Vimeo.

Clinical Trials as an Empowerment Tool

Clinical Trials as an Empowerment Tool from Patient Empowerment Network on Vimeo.

Cancer, COVID, and Change

“There’s something to be said for not being a patient,” one of my doctors said.

“It feels so good,” I said during our telemedicine appointment, “to be away from the hospital for eight weeks in a row.” It’s the longest hospital break I’ve had since being diagnosed with cancer last summer. Before mid-March, I’d been to four to ten medical appointments every month. Being a cancer patient felt like a full or half time job. Because of the pandemic, I’m now treated by my oncology team from the comfort of my own home.

I don’t miss shuffling from room to room or floor to floor and sitting in waiting rooms for hours. I love not needing to ask for rides or take cabs or public transportation while my white counts are low. I don’t miss being poked,  prodded, weighed, and measured or having my vital signs documented in hallways while removing my coat, wig, and shoes. I love not having to roll up sleeves for the vials of blood to be drawn or to pull down my pants so the doctor can put a stethoscope to my belly and bowels.

Because of the increased health risks at hospitals, new access to telemedicine, and flexibility around clinical trial protocols, I can see my oncologist, face to face, through Zoom. Questions can be answered ,via email, a text, or a phone call. Clinical trial drugs are overnighted to me.

I enjoy the time and money I’m saving and the convenience of getting all care from home. But I also miss the real-life hugs, handshakes, and high fives that used to come with seeing the clinical team in person.

COVID Challenges

Many cancer patients are losing jobs, homes, loved ones, and health insurance. For those newly diagnosed with cancer, surgery, scans, and treatments must be done all alone. Those in active treatment are often terrified of catching COVID-19 while immunocompromised. Others are afraid hospital visits will expose our family members to COVID.

It’s startling how much hospital protocols and procedures have changed. When I look back or think about what comes next, I worry. I hope the pictures and stories below capture what it’s like to be an oncology patient and how swift and severe the COVID-related changes over the last few months have been and continue to be.

From Person to Patient

My partner drove me to the hospital on the morning of my surgery. We checked in before 6a.m. and waited, with others, in the lobby.

Eventually, we were called up and walked, single file, through halls by someone escorting us to the pre-op area. Each one of us was assigned a bed (pictured) and a nurse (not pictured). The photo is of the pre-op area.

My partner got to visit me before surgery. He was there when the surgeon, nurses, fellows, and anesthesiology came to prepare me for surgery.

If surgery were scheduled today, my partner wouldn’t be able to stay with me.

The Shock of a Post-Op Diagnosis

This is me in post-op. My partner took this photo on his phone and was able to share it with my family and friends to let them know I made it through surgery. They were worried because it went hours longer than expected.

In the photo, I’m high as a kite and happy to be alive. I’ve just downed the iced coffee my partner snuck in (as planned and with permission from the nurse). In the photo, I am still in shock that my surgery was five hours long, it’s afternoon, and that cancer was found. I don’t yet know how serious my diagnosis will be. That will come twelve hours after surgery when the surgeon explains my cyst was actually a cantaloupe-sized cancerous tumor, aggressive, advanced, and usually chronic. Mercifully, my partner is with me as she explains that she had to do a total hysterectomy, removing ovaries, fallopian tubes, lymph nodes, and my omentum and lays out the timeline for chemotherapy.

My partner held my hand and crawled into my bed to hold me while I sobbed. But he provided far more than essential emotional support. He helped me stand and keep my balance, helped me get to my first trip to and from the restroom. He was there to advocate for me when I dozed off and to get the nurse when my call button went unanswered. He was the one who provided my loved ones with updates. He was the one who snuck my favorite health foods to help “wake up” my digestion enough to allow me to be discharged after one day.

It’s hard to imagine what that traumatic and challenging day would have been without him. I can’t imagine recovering from major surgery and receiving such devastating news alone but it’s what many diagnosed with cancer during COVID now endure.

At-Home Adjusting & Recovery:

Going home after surgery is comforting and scary. My right leg was giving out from under me because my obturator nerve “got heat” during my surgery. I had trouble standing in the shower or lifting my right leg onto the bed or into a car. I had extensive swelling and bruising on my right side and pelvic area and had a bit of a reaction to the bandage tape. I didn’t know what was normal. And after a phone call to the hospital, I was asked to come back in for a check-up.

Today, I’d either have had a telemedicine appointment or need to decide if an in-person visit with a medical professional is worth possible exposure to COVID. These are the types of decisions we are all facing but it’s especially scary when one is already vulnerable and fighting for life.

Early Treatment: Chemo Buddies are Not Optional

Getting chemotherapy infusions is time-consuming, scary, and intense. Everyone reacts differently to the many drugs given with chemotherapy (such as Benadryl, steroids, Pepcid, and anti nausea drugs). Everyone reacts differently to the chemotherapy, marked hazardous,  that require the nurse to wear gloves, masks, and protective clothing to prevent contact in case of accidental spills. Some drugs make you sleepy, and parts of your body numb. Others make you feel amped, wired, and agitated.

Some cause nauseous, headaches, or allergic reactions, immediately and others not for days or weeks.

Having a chemo-buddy like Beth was a huge help. She was the one who asked for window seats in the infusion center, who made sure I got warm blankets. She massaged my feet and reminded me to listen to guided imagery. She sat with me in waiting rooms as we waited for my labs to come back to make sure my white and red blood counts weren’t too low, my liver counts not too high, and that the chemo was making my tumor marker scores go down.

She was the one who touched the elevator buttons for me, the one who walked me to the car and handed me off to my fiancé at the end of the day. She was the one who got me water, coffee, or snacks.

I felt safer whenever I had a chemo buddy with me and Beth would also take notes and make sure I didn’t skip any of my questions just because the oncologist seemed in a hurry.

Beth was not only a source of support but provided an extra pair of hands to plug in my iPhone, to hold my bags, food, or books. She was the person I could share tears, laughs, and heart to hearts with. She listened as I worried about my daughter, as I struggled to balance work and parenting.

She was there to support me as I talked endlessly about healthy eating, fasting, supplements, and complementary medicine. But the greatest comfort of all was knowing she would be there if passed out, fell, or had an allergic reaction to all the treatment drugs. At my last treatment, I was alone and Beth at home. It was hard.

In-Between Hospital Visits: Public Services & Personal Support

 

Social distancing during treatment is hard even for introverts like me who need a lot of alone time. When physically weak, short visits with loved ones who bring food, hugs, and gifts are life-affirming and life-changing.

Those who show up do so for cancer patients as well as our families. They help us to take care of our kids, partners, pets, plants, and housework. They help us manage as we face fear and loss, whether losing jobs or body parts, or hair and having few or no visits is hard. Today, barber shops where we might get our heads shaved are closed.

The wig shops and stores we go to for hats and head coverings are often closed.

We can’t go out to eat with loved ones, or do yoga on good days. We can’t have parties for our loved ones to create normalcy or new rituals. We can no longer go out in the public either. We can’t do things such as sitting alone writing in a journal and drinking a smoothie when swallowing food is too hard.

We can’t travel to remind ourselves there is still beauty and magic in the world and to enjoy our loved ones and lives as much as possible.

These are not all small things or luxuries in coping with the brutal effects of cancer treatment and chemotherapy. They can change the cancer and recovery experience and all that helps keep us strong. 

Later Treatment

We need others when we are sick. We might need help standing, walking, or eating. We might need rides, treatments, or blood or platelet transfusions. We might need help articulating symptoms and side effects. To have fewer in-person visits when so medically vulnerable can be anxiety-producing.

We also have less in-person celebrations with our clinical teams when we finish a line of chemotherapy or have a cancer-free scan. We no longer have informal pet therapy either with the cheerful and cuddly animals of friends, family, and neighbors.

I can’t imagine going to chemo alone, depleted, and with low white counts.

The increased risks, vulnerabilities, and lack of human company and tactile comforts feels indescribably epic.

Maintenance Treatment & Clinical Trials

My immunotherapy infusions (or placebo) have been put on hold for the past two cycles. I asked if I could remain in my clinical trial if I refused to come to the hospital for treatment until the risk of getting COVID is decreased. Luckily, I’ve been allowed to stay home. Clinical trial protocols, in general, are much more flexible as a result of the pandemic. My medication (or placebo pills) are mailed to me. Before March, in-person prescription filling was required and always took hours.

However, I’ve been weighing what I’ll do if I have to weigh virus-related risks against the possible benefits of clinical trial treatment. If I’m required to be treated at the hospital I may drop out of the trial. This is one of the many difficult decisions oncology patients often face but it’s made more complicated because of the coronavirus. .

Have Some Changes Been for the Good?

The losses, challenges, and changes are worrisome and real. That said, not all the COVID-related changes for oncology patients are bad. The whole world is wearing masks, staying home, socially distancing, and worrying about health, wellness, death, and dying.

Instead of being stared at when I wear a mask, I’m now in good company, because much of the world is doing the same. Many of us are consumed with health issues and worried about health, mortality, and immune functioning.

To be reminded, once again, that health and life aren’t guaranteed to anyone, that we are all facing mortality, and must appreciate every day we have, is strangely comforting. While I’m reminded of our collective vulnerability, to hear health concerns, risks, and challenges confronted as the world and nation’s collective concern is a reminder that none of us are being personally picked on for failing at being human, we are just, in the end, all excruciatingly fragile and mortal.

“I feel like I’ve been slow-dancing with death since last summer but now I feel less alone,” I told my friend Kathy. “It’s like others have joined you on the dance floor,” Kathy said. “Yes,” I said, which once again makes me feel like a person rather than a patient and there’s something to be said about not being a patient….


Resource Links:

  1. The National Cancer Institute  guide: Coronavirus: What People with Cancer Should Know.
  2. American College of Surgeons: (ACS) Guidelines for Triage and Management of Elective Cancer Surgery Cases During the Acute and Recovery Phases of Coronavirus Disease 2019 (COVID-19) Pandemic
  3. Sample of patient visitation changes hospitals have implemented from Mass General Hospital.
  4. Telehealth at Dana Farber.
  5. Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

In this moment

“Is there a pressure to be positive all the time?” my friend Kathy asked.

It’s a good question. I said, “No,” and then “Yes,” and added in a “Maybe.”

But it’s not a simple yes, no, or maybe. It’s actually Yes-No-Maybe all at the same time. My kid is on Facebook and so is my family. My friends are on Facebook and they want the best or at least to know I’m not suffering. I’m aware of that and of them. But that doesn’t mean I show up fake or put on fronts. I don’t.

The pressure to be positive isn’t external. I am safe to be real with SO MANY people and that luxury is a gift beyond measure. The desire to be positive comes from within but it’s not motivated by pressure. It’s real. In general, I ACTUALLY FEEL positive.

And also, when my oncologist asks how my partner or daughter are doing, I say:

“Well, I’m cranky, lethargic, have chemo-brain, and obsessed with recurrence so that’s fun for them…”

That’s also real.

Real is positive.

So, when people say I’m strong, a rock star, a warrior, and a fighter, I can’t say I feel I am any of those things. My day to day to life has been changed and though I feel 100% half-ass as a mom, partner, friend, relative, and employee – I also know I’m doing the best I can.

I don’t even have much time to think of how I’m doing because I’m so busy doing, if that makes sense.

It’s like I woke up after surgery standing in the middle of a highway I didn’t drive myself on. The focus is dodging the cars going 75 m.p.h. on my left and right while feeling groggy and confused. When I manage to make it to the sidewalk or the rest area, the relief I feel is real. I’m happy to be alive and out of danger. It’s a genuine and consuming experience. I’m relieved any time I’m not in the road and also aware I could be dropped back on that highway in another minute, day, week, or year.

That’s the complexity and reality of living with cancer (#ovarian, high-grade serious, stage 3) that, even when it’s effectively treated, still recurs 75% to 85% of the time. To have no evidence of disease isn’t the type of blessing I’ve been in the habit of counting.

For decades, I have had the luxury of physical wellness and had never stayed overnight in a hospital. Health isn’t something I take for granted anymore but that doesn’t make me a warrior as much as it makes me someone changed by cancer more than by choice.

I used to think people were sick with cancer, and either mounted a “successful” fight and returned to living or lost “the fight” and died. It seemed either/or and as those were the two extreme outcomes.

I knew my mother HAD cervical cancer in her early 20’s and survived. I knew that my Nana and her two siblings had cancer in their 60’s, and did not. They died.

I know cancer is always a full-on fight for the person with cancer and those that live with and love them (us), but fights are won or lost and that is the problem with the “fight cancer” narrative. It’s way too simplistic for the complexity of cancer, cancer treatment, cancer survivorship, palliative care, and grief.

It omits the vast amounts of time that many of us live with cancer. We live with it in active form, or in remission, or in fear of recurrence, and sometimes with recurrence after recurrence. That way of living may last one or two years or one or two decades. We may have years we seem to be “winning” the fight and years we seem to be “losing.”

But winning and losing is far too simplistic. Some live and have loss. Some die and should be counted as winners.

I’d never known some fight the same cancer repeatedly, or “beat” it before getting another kind and another and another. I didn’t know that people cancer can be a lifelong disease and that some kinds are genetic time bombs in our bodies and families that can put us at risk even if we never smoked.

I didn’t know that one can have or five surgeries, that the side effects can start at the head (loss of hair, headaches, chemo brain, no nose hair, dry mouth, hearing loss), for example, and go all the way to the feet with lymph edema, joint pain, neuropathy, and that all the organs in between can be impacted as well.

I didn’t know that most cancer side effects are not from cancer but the treatments to fight, eradicate, and prevent more cancer.

I didn’t know that in addition to chemo, one might contend with liver or kidney issues, with high or low blood pressure, with changes to the way heart beats, the digestive symptom works.

I didn’t know that cancer surgery might include a hysterectomy and removing some or several organs, lymph nodes and body parts I’d never heard of. I didn’t know how it’s impossible to know what is from cancer, chemo, menopause or the piles of pills one is prescribed.

I didn’t know how much the body can endure and still keep going. I didn’t know I’d have a body that would have to learn and know all that I was mostly ignorant about -even though cancer is a disease not unknown to my own family members.

I am still learning and knowing and going. I hope what I learn keeps others from having to have first-hand knowledge of the cancer experience.

And even as I say that I know the ways I’ve been changed are not all bad, hard, or grueling.

I didn’t know that at, even in the midst of being consumed by all things basic bodily functioning (breathing, heart beating, eating, pooping, sleeping, and staying alive), one can also be grateful, satisfied, and appreciate life and loved ones.

I know it now and feel grateful daily.

Five months after my diagnosis, I’m what’s called NED (No Evident Disease). It means that after surgery, and then 5 rounds of chemo, a carbo/taxol combination every 3 weeks, there is no sign of ovarian cancer. My CA 125, a cancer marker in the blood, is back to normal. Things are looking better today and I’m grateful, optimistic, relieved, but also know that my life is forever changed, and I’ll never be out of the woods.

Despite my NED status, my chances of being alive in 10 years are 15%.

Despite my NED status, my chances of being alive in five years are less than 30%.

Did you know 70% of those with ovarian cancer die within five years of being diagnosed?

I’m not a statistic, but a person – still, it’s hard not to do the calculations.

5 years from my diagnosis I’ll be 57, and my daughter 21.
5 years from my diagnosis, my partner will be 62.
Will we get to retire together, ever?  Will I get 5 years?

It’s hard not to wonder if some or all of those five years are what most would consider “good” years and how I will manage well no matter what? And how my loved ones will fare…

So I focus on moments, days, and now.

My new mantra remains, “In this moment….”

It’s how I approach all of my days.

I do think and worry about the future, and even plan for the worst while also planning for the best. Because the best is always possible.

What if, I’m the 15% and live for 10 or more years? What if I make it to 62? What if a new way to detect, manage, or treat ovarian cancer is discovered? What if I discover some synergy in remedies and medicines not yet combined?

Maybe I will see my kid graduate college or start a career. Maybe I’ll help her shop for furniture in a new apartment. No one knows the future. No one guaranteed more than now.

Maybe I’ll get to go to Europe with my partner, elope and return married, or stay forever engaged.

Maybe I’ll attend a mother-daughter yoga retreat with friends like I’ve always wanted to do.

Maybe I’ll spend a month at a cabin writing and eating good food with my besties?

Maybe I’ll be able to be there for my family members and friends the way they have been there for me?

Maybe I’ll get to walk my dog at the same beach and park, with my guy, my brother and sister-in-law, and our dogs and kids?

I don’t know how much time I’ll get or what life holds.

I know when my Nana died in her mid 60’s it seemed way too soon. I know that now, if I make it to my mid 60’s, it will be miraculous.

I don’t put as much into my retirement savings.

I think more about how to spend time, and money, now.

These are not negative thoughts they are the thoughts of someone contending with cancer and wide awake while pondering my own mortality.

“You won’t die of this,” some have said. “Cancer won’t kill you.”

But no one knows that for sure. It’s not an assurance the oncologists offer.

People mean well when they say such things but I no longer bite my tongue when I hear these words.

I say, “I might die of this,” (and I think, but don’t say, and you may as well).

I do remind people that we are all going to die and few of us will get to choose the time or place or method. It’s not wrong to acknowledge mortality. It’s not depressing and it does not mean one is giving up. I want to be responsible, and quickly, as I don’t have the luxury to be as reflective as I used to be because cancer is all-consuming.

I’ve barely had a moment to reflect on the past five months never mind the last five decades. I am trying to stay on top of the bare minimum requirements of being alive. I can’t yet keep up with emails or phone calls or visits. Projects and goals and plans of all kinds have shifted, paused, halted, or been abandoned.

My energy is now a resource I have to monitor and preserve. My will is not something I can endlessly tap into or call upon to motor me and keep me motivated. There’s no resource I have yet to tap into or call upon. Each day, I must consciously and repeatedly work to fill the well. And now, when friends and family who work while sick, I no longer think they are tough or strong. I think of how we routinely punish and ignore our bodies. I notice how often we run on fumes, require more of ourselves than we have as though we will never tire out.

I think of all those who must or feel they must keep going no matter what, without pause or rest, oblivious to the toll it will take or of those who have systems that can’t fight their germs. And I think of employers who sometimes require it because they offer no paid time off.

I used to run myself ragged. I used to say, “I’m digging deep, into my bone marrow if I have to.” I wasn’t being literal.

Now, when my iron and my platelets go low, I think of my old words in new ways. Now, even my bone marrow isn’t what is used to be.

I’m entirely who I always was and completely different.

It’s both.

I am more and less of who I was.

My life and days are simple and structured now and also heavy, layered, and complex. Who and what fills my day, by choice and not by choice, is radically different.

Cancer changed my life. That’s irrefutable and will be whether I live or die in the sooner or in the later.

I speak with and interact with doctors, nurses, life insurance and disability insurance and pharmacists more. I spend more money on supplements, clean eating, and make more time to walk, exercise, and sleep. There’s so much less I am capable of.

But sometimes, even without hair, I feel totally like myself.

Sometimes, like this week, my daughter caught me in the middle of life, reading a book, petting the cat, on my bed in my heated infrared sauna blanket. I was relaxed and at ease.

I shared this photo and someone commented on how my “cat scan” was quite feline, – the image brought a whole new meaning to the “cat scan” image.

I laughed and laughed and laughed. I’m still laughing.

In this moment, in many moments, I’m humbled by the enormity of all things cancer and being alive. That’s real. That’s there. It can be intense.

But also, in this moment, I’m laughing.

And laughing, it turns out, is my favorite way to live.

Confused About Immunotherapy and Its Side Effects? You Aren’t Alone

“You don’t look like you have cancer.”

More than one patient undergoing immunotherapy to treat cancer has reported hearing statements like that. Immunotherapy is one of the recent advances in cancer treatment that belie the stereotypes about the effects of cancer treatment. 

The side effects of immunotherapy are different from those associated with chemotherapy and radiation. However, that does not mean immunotherapy does not have side effects. Patients and care partners need to be aware of these potential side effects and to be vigilant in addressing them with their oncologists because they can signal more serious complications if left untreated.

What is Immunotherapy?

Despite the increase of immunotherapy treatment options in recent years and considerable media attention paid to advancements in this field, there remains confusion about immunotherapy and its side effects. Many cancer patients are unaware of whether immunotherapy treatments are available for their specific diagnosis. Others don’t know that genetic profiling of their tumors is usually required to determine if immunotherapy is an option and not all treatment centers routinely conduct genetic profiles of tumors. A  survey by The Cancer Support Community found that the majority of patients who received immunotherapy knew little to nothing about it prior to treatment and were unfamiliar with what to expect.

Immunotherapy works by manipulating the patient’s immune system to attack cancer cells. It is perceived as gentler and more natural than chemotherapy and radiation, without the same destructive effect on the body’s healthy tissues.  This, combined with a lack of prior understanding of immunotherapy, can lead patients and care partners ill-prepared for possible side effects.

Furthermore, immunotherapy is a category of therapies, not a single type of treatment. There are a variety of immunotherapy drugs, most of which are administered via infusion.  Side effects will vary by drug, the cancer and its location, treatment dose, and the patient’s overall health.

The following are the most common types of immunotherapy.

  • Checkpoint inhibitors use drugs to block proteins in the patient’s immune system that would otherwise restrain the immune system, often referred to as taking the “brakes” off the immune system.
  • CAR-T therapy modifies the patient’s T-cells in a lab to enhance their ability to bind to cancer cells and attack and kill them.
  • Oncolytic virus therapy uses genetically modified viruses to kill cancer cells.
  • Another therapy uses cytokines (small proteins that carry messages between cells) to stimulate the immune cells to attack cancer.

Immunotherapy can be part of combination therapy. It might be combined with chemotherapy. It might be used to shrink a tumor that is then surgically removed.  Or multiple immunotherapy drugs might be used simultaneously.

What Are The Side Effects?

With immunotherapies, side effects typically occur when the immune system gets too revved up from the treatment. The most common side effects for immunotherapy treatments are fatigue, headache, and fever with flu-like symptoms. Some people also experience general inflammation often in the form of a rash. Many melanoma patients report blotchy skin discoloration, called vitiligo, during treatment. These milder side effects can usually be managed with over-the-counter remedies and adjustments to daily activities.

For checkpoint inhibitors, the fastest growing segment of immunotherapy treatments, mild side effects occur in 30% – 50% of patients. Serious side effects typically occur in less than 5% of patients. (See “Understanding Immunotherapy Side Effects” from the National Comprehensive Cancer Network and the American Society of Clinical Oncology.)

Less common side effects are blisters, joint pain, thyroid inflammation, and colitis (inflamed colon resulting in diarrhea with cramping). Some patients who receive CAR T-cell therapy develop a condition known as cytokine release syndrome, which causes fever, elevated heart rate, low blood pressure, and rash. 

In rare cases, immunotherapy has resulted in lung inflammation, hepatitis, inflammation of the pituitary, and detrimental effects on the nervous and endocrine systems. In most cases, the conditions clear up when treatment ends.  However, there have been outcomes in which immunotherapy caused diabetes or tuberculosis.

“Overall there are fewer side effects [with immunotherapy],” explained Dr. Justin Gainor, a lung and esophageal cancer specialist at Mass General during an Immunotherapy Patient Summit hosted by the Cancer Research Institute. “But the immune system can affect anything from the top of the head down to the toes. Any organ has the potential to be affected.”

As the application of immunotherapy has expanded, so has our understanding of the potential side effects. Like most medical treatments, how one person responds to immunotherapy can be different from another even when the cancer diagnosis and drug therapy are the same.

The essential thing patients and care partners need to know about side effects is they should always be reported to their oncologist or nurse oncologist.

Why Patients Should Talk to Their Provider About Immunotherapy Side Effects

Because immunotherapy has created newer therapy options, there isn’t the volume of experiences as with older treatments. The infinite number of variables that patients provide once a treatment moves beyond clinical trials and into the general patient population generate more diverse outcomes.  And, as most therapies are less than 10 years old, there hasn’t been an opportunity to study the long-term effect of these therapies. This is why oncologists advise patients and their caregivers to be extra vigilant in noting any changes experienced during and after treatment.

Many side effects are easy to treat but medical providers want patients to be forthcoming in discussing any and all side effects. This is in part to improve understanding of side effects, but also because a mild cough or a case of diarrhea might be harbingers of a more systemic issue that will grow worse if left untreated.

Patients should not be hesitant to discuss side effects because they fear they will be taken off immunotherapy.  Sometimes a pause in treatment might be necessary, but the earlier the oncologist is made aware of a side effect, the less likely that will be necessary.

In addition, patients undergoing immunotherapy should always take the name(s) of their immunotherapy drugs and the name of their oncologist when seeing medical professionals outside of their cancer treatment team. This is especially important when visiting the ER.  Because immunotherapy drugs are newer and highly targeted to certain cancers, many medical professionals remain unfamiliar with drug interactions and treating related side effects.

Immunotherapy On The Rise

Immunotherapy treatments have resulted in reports of remission in cases that would’ve been deemed hopeless just five or 10 years ago.  The Federal Drug Administration (FDA) has approved various immunotherapy treatments for melanoma, lung cancer, head and neck cancer, bladder cancer, cervical cancer, liver cancer, stomach cancer, lymphoma, breast cancer, and most recently bladder cancer.  (Here is a list of  immunotherapies by cancer type from the Cancer Research Institute.)

“It’s revolutionized how we treat our patients,” says Dr. Gainor of Mass General about immunotherapy’s impact on lung and esophageal cancer.

Advances in immunotherapy research and trials continue to generate optimism and excitement. A clinical study in Houston is looking at using immunotherapy to prevent a recurrence. Researchers in Britain recently announced a discovery that might lead to advances in immunotherapy treatments to a much broader array of cancers.

While there is excitement around the field of immunotherapy and it has resulted in unprecedented success in treating some previously hard-to-treat cancers, it remains an option for a minority of cancer diagnoses.  It works best on solid tumors with more mutations, often referred to as having a high-mutational load or microsatellite instability (MSI) high. And it is not universally successful for every patient.

With hundreds of clinical trials involving immunotherapy alone or in combination with other therapies, it is certain more treatment options are on the horizon. As more therapies are developed and more patients with a greater variety of conditions undergo immunotherapy, we will also increase our understanding of potential side effects.

Side effects should not dissuade patients and care partners from considering immunotherapy if it is available or from advocating for genetic tests to deteimine if it is an option. Many patients undergoing immunotherapy have previously undergone chemotherapy and report that the side effects are fewer and milder by comparison.  The important thing is that patients and their partners know what to expect and communicate with their treatment team.

If the next 10 years in immunotherapy research and development are anything link eth elast 10, we can expect more exciting advancements in the battle against cancer. For more perspective on what’s ahead for immunotherapy see the Cancer Research Institute’s article: Cancer Immunotherapy in 2020 and Beyond.

Mayo Clinic Radio: Ovarian Cancer Treatment Options

On the Mayo Clinic Radio podcasts, Dr. Amanika Kumar, a Mayo Clinic gynecologic surgeon, explains how thorough assessment of a patient can help direct the treatment for ovarian cancer. This interview originally aired Aug. 24, 2019.

Ovarian Cancer Treatment

This was originally published on Lab Tests Online here.


When abnormalities are found and ovarian cancer is suspected, a surgical biopsy is required to confirm the diagnosis. If cancer is found, surgery to remove the cancerous tissue is performed (oophorectomy). Depending on the stage of the disease, additional tissues may have to be removed. One of four stages of cancer is identified depending on the spread of the tumor. They are:

  • Stage 1 – cancer is confined to one or both ovaries (about 20% of ovarian cancers diagnosed with best prognostic outcomes)
  • Stage 2 – cancer has spread to the uterus and/or fallopian tubes
  • Stage 3 – cancer has spread to the abdomen lining or surrounding lymph nodes (most common stage seen at time of diagnosis)
  • Stage 4 – cancer has spread to other organs beyond the abdomen

Follow-up treatment usually involves chemotherapy, hormone therapy, targeted therapy, sometimes radiation treatments, and monitoring of CA-125AFP, or hCG for response to treatment and recurrence.

Ovarian cancer treatment is constantly evolving. New drugs, immunotherapies, gene therapies, and bone marrow transplants are being studied for their effectiveness. A woman’s healthcare provider and/or cancer team can help determine the treatment course that is right for her.

Does Cannabis Oil Have a Role in Cancer Treatment?

Does Cannabis Oil Have a Role in Cancer Treatment? from Patient Empowerment Network on Vimeo.

Is it just a trend or could cannabis oil truly have a role in cancer care and treatment? Dr. Sangmin Lee share his perspective.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

The use of cannabis oil is becoming prevalent. Does this have a role in cancer care and treatment?

Dr. Lee:

Absolutely. So, we use it for a lot of side effect management. So, cannabis can be helpful, in terms of appetite and nausea, for example. So, we often use it in conjunction to manage some of the side effects that patients can have throughout their treatment.

You should consult with your medical team, and of course, I should say that laws differ state by state, so it doesn’t apply to every state. But when it’s available, it can be a valuable addition.

Patricia:

Sure. Discuss that with your physician.

Are Clinical Trial Participants Monitored More Closely?

Are Clinical Trial Participants Monitored More Closely? from Patient Empowerment Network on Vimeo.

Dr. Sangmin Lee discusses the monitoring of clinical trial participants and the measures taken for patient safety.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

How about this next one? I am monitored more closely in a clinical trial.

Dr. Lee:

In some cases, it’s true. Clinical trials do have certain monitoring visits, in terms of doctor’s visits, laboratory tests, and physical exams.

The purpose of that is to make sure that it is safe. So, the purpose of monitoring closely, in a lot of cases, is for the patient’s safety. We are testing drugs in a lot of clinical trials, for which the complete safety profile, as well as efficacy profile, is not known. So, the purpose of closer monitoring is to make sure whatever we’re doing is safe, and if there are any unexpected side effects, then it allows us to address the side effects, as well. So, it’s mainly for patients’ safety.

Will Clinical Trials Cost You? The Facts.

Will Clinical Trials Cost You? The Facts. from Patient Empowerment Network on Vimeo.

Dr. Sangmin Lee reviews the financial impact associated with clinical trials, including a discussion of what expenses are covered for participants.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

All right, how about this one: I may have unexpected costs if I join a clinical trial.

Dr. Lee:

So, typically, that’s actually, usually not true, because how it works is that the clinical trial drugs, and that there may be extra procedures or visits associated with clinical trials.

And what usually happens is that the sponsor of the clinical trial provides the cost of the drug, intervention, and anything extra that are required for the clinical trial. So, in the end, the cost of participating in a clinical trial should not be any more than receiving standard care treatment.

In some rare cases, there may be stipends associated with the clinical trial, especially with travel. So, if you participate in a clinical trial, and you live far away, then you should ask to see if there is any stipends available, especially for travel.

Is It Safe? Breaking Down the Clinical Trial Process

Is It Safe? Breaking Down the Clinical Trial Process from Patient Empowerment Network on Vimeo.

The idea of a clinical trial can be intimidating and confusing for many patients. Dr. Sangmin Lee explains the phases of clinical trials, including the safety protocols in place to protect patients.

Dr. Sangmin Lee is a hematologist-oncologist specializing in blood disorders and blood cancers at Weill Cornell Medicine and New York Presbyterian Hospital. More about Dr. Lee here.

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Transcript:

Patricia:

What is the process for getting medicine to patients during clinical trials?

Dr. Lee:

So, clinical trials are basically what’s needed to prove that drugs work. So, a lot of times, we test drugs in a test tube in AML cell lines, and they show great promise. But just because a drug works in a test tube setting, doesn’t actually mean that it will work in humans, because human bodies are much more complicated. So, we need to test promising drugs in humans to make sure they are safe and effective.

And that’s what the purpose of clinical trials are. Once they demonstrate safety and efficacy, then a drug then gets to be approved, and is available commercially. So, that’s the purpose of clinical trials.

To be involved in clinical trials, what it involves is, basically, you have to meet a sort of criteria, called eligibility, because different clinical trials have different criteria for selection. So, we have to look into that. And then, once you fit an eligibility or selection criteria, then you typically undergo certain diagnostic tests to enroll on a clinical study. And then, you get whatever drug or intervention that is designed to test in that setting.

So, there are numerous steps to actually enroll in a clinical study.

Patricia:

And like you mentioned, there’s a long way between rat studies and human trials. What are the phases of clinical trials?

Dr. Lee:

So, there are three phases for clinical trials, commonly. There’s phase one, and phase two, and phase three. Phase one is the earliest part of the clinical trial process. So, goal of a phase one study is to make sure a drug is safe in a human. So, phase one studies are usually the first time that you are testing the drug in humans, and the main purpose is to demonstrate that it’s safe. So, typically, in a phase one study, typically, you test a drug at a lower dose or dose levels to demonstrate safety. What it means is that you’re enrolling a few patients at a time.

Once a drug is proven to be safe, then you move on to phase two, which is basically testing the drug in more patients. And the purpose of phase two is to get a preliminary assessment of how effective a treatment would be.

So, typically, a phase two study involves many more patients in that setting. And then, if a phase two study shows that a drug is very promising, then the drug may move on to phase three, where, basically, in phrase three, you are comparing one intervention or a drug compared to the standard of care. And, typically, in a phase three setting, a computer decides randomly which intervention you get, whether it’s an intervention or new drug versus standard of care. And standard of care may include either placebo or chemotherapy intervention, that is standard of care. So, it’s not always placebo in phase three.

Clinical Trial Mythbusters: Do Patients Have A Voice While Participating in a Clinical Trial?

For survivors Roberta Alberle and T.J. Sharpe and so many others, cancer was an unwelcome intruder that suddenly demanded their attention. Both became proactive and engaged, vocal patients, doing research about their treatment options and gaining access to clinical trials that made a HUGE difference.

Watch to learn:

  •       Do patients still have a voice during the clinical trial process?
  •       What is a clinical trial navigator?
  •       How can patients help their healthcare team be more effective in locating trials for them?
  •       More about clinical trial resources

Clinical Trials Mythbusters: Do Patients Have A Voice While Participating in a Clinical Trial? from Patient Empowerment Network on Vimeo.

 

Clinical Trial Mythbusters: Are Clinical Trials a Gamble for Me or My Loved One?

Is a clinical trial right for me or is it a gamble with my health? How will my loved one be affected? Do the risks outweigh the benefits? Watch as a panel of experts, including an oncologist, trial coordinator, and patient advocate as they debunk some of the myths around clinical trials. Listen to hear the patient voice and perspective for getting the best care-making decisions about clinical trials.

Watch to learn:

  • What are common clinical trial myths?
  • Why should patients participate?
  • How can patients navigate the system?
  • How can I or my care partner work with my medical team?

Clinical Trial Mythbusters: Are Clinical Trials a Gamble for Me or My Loved One? from Patient Empowerment Network on Vimeo.

 

Clinical Trial Mythbusters: Are Clinical Trials a Last Resort Treatment Option?

Are clinical trials only for patients who run out of treatment options? Watch as our expert panel answer questions as they debunk common myths around clinical trial participation. Tune in to hear the patient perspective and expert advice for making decisions about clinical trials.

Watch the video and learn:

  • What is a trial and when should I consider one?
  • What are common clinical trial myths?
  • If my cancer center does not offer a trial, what should I do?
  • How can I stay informed?
  • Is there financial assistance to be in a trial?

Clinical Trial MythBusters: Are Clinical Trials a Last Resort Treatment Option? from Patient Empowerment Network on Vimeo.


Transcript:

Andrew Schorr:

Hello and welcome to this Clinical Trials MythBusters program.  I’m Andrew Schorr from Patient Power joining you all the way from Barcelona, Spain.  We’re here for a conference.  You’re about to meet folks from across the U.S. and wherever you’re joining us.  Thank you so much for joining us.

Thanks to our wonderful partner, the Patient Empowerment Network, and also the Coalition for Clinical Trial Awareness and the Alliance for Patient Access.  And thank you to our sponsors, they all start with A, Astellas, Amgen and AbbVie.  They help make this program possible.

We have a lot to talk about in helping debunk the myths about clinical trials and hopefully raising awareness and understanding for you and your family, so you can consider a clinical trial and see whether it’s right for you.  And I can tell you, in so many areas of cancer now there’s exciting research going on. But if you want to get the possibility of tomorrow’s medicine today, and it happened for me with chronic lymphocytic leukemia, being in a Phase II trial way back in 2000, 10 years before the drug combination I received was approved.  I know it was life-saving for me.

And I want you to meet our first guest.  It was life-saving for him, and that is Pat Gavin.  Pat joins all the way from Marne, Michigan, which is outside Grand Rapids.  Pat, thank you so much for joining us on this program.

Pat Gavin:

Thanks for having me, Andrew.  Glad to be here.

Andrew Schorr:

Now, Pat, I want to go over a little background about you.  I believe that you’ve been treated for three cancers, right?  Pharyngeal head and neck cancer, in 2007, right?

Pat Gavin:

Right.

Andrew Schorr:

And also you were treated for melanoma 2008, and then in 2014 prostate cancer.  Now, you were in a Phase II trial for that pharyngeal head and neck cancer.  Do you believe it made a big difference for you?

Pat Gavin:

Well, that trial is absolutely the reason I’m here today.  My oncologist described it as we had the experience of witnessing a miracle.

Andrew Schorr:

Let’s meet one of our medical specialists who is joining us, who has been on our Patient Power programs before and our lung cancer programs, and that’s Dr. Charu Aggarwal.  She joins us from Penn Medicine, the Abramson Cancer Center in Philadelphia.  She’s a lung cancer specialist and also a head and neck cancer specialist, very active in trials.  Dr. Aggarwal, thank you for joining us.

Dr. Aggarwal:

Thank you, Andrew.  Thank you for having me here.  I’m delighted to be part of this program.

Andrew Schorr:

Dr. Aggarwal, you have a lot of research going.  It takes patients wanting to participate for us to ever have approved medicines, right?

Dr. Aggarwal:

Absolutely.  And I think that’s key in clinical trial participation, to get drugs to patients early.

Andrew Schorr:

All right.  And certainly in the area of lung cancer and many other cancers now there’s a lot happening, and smart researchers like Dr. Aggarwal are trying to prove some things that really seem like they would make a lot of sense, but we patients have to participate, be their partner.  I’ve seen that.

Dr. Aggarwal, lung cancer is a good example, but you’re an oncologist, and you see many different areas that are changing fast.  What would you say to patients about the opportunity, like I said, did it give me tomorrow’s medicine today?  Or, Pat, who feels he’s alive because of that.  You must see that a lot.  Doesn’t always work out, but it’s happening more and more, isn’t it?

Dr. Aggarwal:

It is definitely happening more and more.  Clinical trials are really accelerating our ability to get patients, like you said, tomorrow’s medicine today.  In the last five years, we’ve had upwards of eight to 10 drugs approved for lung cancer alone, and it would not have been possible without patients’ participation on clinical trials.

As we understand the biology of diseases better and as more medicines are available to us, the only way to access them and the only way to get FDA approval is through clinical trials.  And we’ve certainly seen that for lung cancer, but we’ve also seen that for head and neck cancer, and immunotherapy is now possible because of clinical trial participation.

Andrew Schorr:

Right.  And I’m living with two cancers, chronic lymphocytic leukemia, where there are many new drugs now, and now we’re looking at trials with combinations of new drugs.  And then I have another condition, scarring in the bone marrow, myelofibrosis, and I was very grateful that a new drug had been approved for that. And I’ve taken that drug now four-and-a-half years, a genetic inhibitor, and I’ve met patient number one, who is in that trial, and I give him a big hug.

Now, Pat, what do you think are some of the myths?  You know, you meet people all the time.  What do you think are some of the things that people just think are true but really aren’t?  Maybe you could tick some off.

Pat Gavin:

Well, one of the big myths out there is that there’s going to be a placebo arm, and there are not placebo arms to treatment trials, unless the standard of care would be a wait and watch, which is relatively rare.  So you’re always going to get either standard of care or a combination that includes standard of care and the test drugs or the—test drugs.  You’re never going to be left out there with just taking a sugar pill.

Andrew Schorr:

Right.  So let me go over that with Dr. Aggarwal.  People I think are—have heard about trials for other illnesses, but we’re talking about cancer now.  Your patients don’t get just a little white pill with nothing in it, right?  They either get quality care, standard of care, or they get something new.  Is that correct?

Dr. Aggarwal:

That’s correct.  So the era of placebo?controlled trials is almost over, and I say almost because in the metastatic setting or in the stage IV setting or incurable setting we almost always never use placebo anymore.  We are either randomizing patients to standard of care or meeting standard therapy, the chemotherapy, be it a pill, be it targeted therapy or immunotherapy, and we compare patients to that approach and introduce the experimental approach on the other hand.

Now, if there are patients that have standard of care as observation, then, of course, that observation arm does become our randomized arm.

Andrew Schorr:

Okay.  And may I ask what Pat was taking, or like I know in leukemia we have people who are in watch and wait.  So we have some people who are in watch and wait, okay.  So I get that.

Pat, what’s another myth, do you think?  So one was where you get a placebo, so we heard no.  So what’s another myth, do you think?

Pat Gavin:

I think there’s always a feeling that I’m going to be just a guinea pig, and that’s the one thing I think I hear most often from people is I don’t want to be a guinea pig.  I want to make sure that I’m getting a treatment and not being exposed to things that are unsafe.  Of course, there’s always a certain amount of risk with any trial that we participate in, but the chances of some of the things happening that you might see on the comedy TV shows just aren’t going to be there.

Andrew Schorr:

Okay.  Dr. Aggarwal, let’s go over that.  So, first of all, you’re at a major university center, University of Pennsylvania and Abramson Cancer Center.  What sort of panels in decision?making of smart minds are there going to whether you’re even going to go ahead with a certain trial?  I think you call it an investigational review board.  Tell us a little about the process of deciding whether you’re going to have a trial at your institution at all.

Dr. Aggarwal:

Yes.  So there’s a very thorough review of clinical trials, and these are vetted through several committees both in terms of ethical review as well as scientific review.  And, you know, when my patients say to me I don’t want to be a guinea pig, I really try and figure out what is it about the trial that they don’t want to do?  Is it the fact that they don’t want to get the investigational drug, or is it the number of tests that are involved in association with receiving that drug?

And I think, you know, most of the time, 80 to 90 percent of the time, I’m able to answer patients’ questions and concerns regarding their guinea pig concern, and most of the times actually it’s related to the fact that they don’t want to undergo extra tests or procedures that they wouldn’t have otherwise.

As soon as they hear that this is actually a drug where it may benefit them and they’re not just going to get a sugar pill, most patients are actually interested in clinical trial participation, because they’re here to really help themselves and to get something that can help their cancer.

Andrew Schorr:

So, Pat, another concern—well, I guess one limitation of people being in trials is people don’t even know about them, you know, not only don’t understand what a trial is but have not even been told that it’s an option, and that’s a problem in the U.S. today, isn’t it?

Pat Gavin:

Absolutely.  I even think it was a problem for me.  I didn’t know that a trial was going to be available in my home town.  If it wouldn’t have been for my oncologist recommending it to me, I probably wouldn’t have joined.  Fortunately, today I think patients are getting more knowledgeable about trials that are out there, and they’re hearing more and have the interest in joining a trial, and they’ll recommend it to their oncologists and tell them that they are interested.  But not knowing about them is a big problem.

Andrew Schorr:

Okay, Pat.  So for our viewers today, what question or questions would you urge cancer patients or family members to ask today so that they have the awareness of trials that might be right for them?

Pat Gavin:

Well, the first thing I would do is I would offer to my oncologist that I’m interested in being in a trial.  And I would ask what type of trials are available for people with my cancer, and what would you recommend as far as the trials that you see out there that you think is right for what I’m facing today?

Andrew Schorr:

Okay.  All right.  Well, now joining us I think is Mary Ellen Hand, who has been at the Rush University Medical Center in Chicago for many years and also works with lung cancer patients but has been in oncology for many years.  Mary Ellen, first of all, thank you so much for being with us.

Mary Ellen Hand:

You’re welcome.  Sorry for the technical difficulty.

Andrew Schorr:

It’s okay.  Thank you for being with us, Mary Ellen.  So from your point of view, what’s a myth that comes up a lot for people?  We’ve been talking a little bit with our other guests about whether with you get a placebo, no, whether you’re a guinea pig, no.  Are there other myths that you can think of that you really want to talk about now?

Mary Ellen Hand:

I think that people sometimes come to this thinking I don’t want to do something because I don’t—as you’re saying, a guinea pig or be in uncharted territory as opposed to having an opportunity to have a therapy that may be more impactful in their disease and help control their cancer better.

And, secondly, I will have people who have an out?of?network insurance or something that doesn’t allow them the flexibility to maybe even come to our institution or somewhere else for their therapy, and they think cancer trials are free care, anything you get if you’re on a trial is free.  And what is true is that ordinary customary charges for things like blood tests and scans and doctor appointments and the medicines that are approved are billed to your insurance, and what the company might provide that’s being tested would be the thing that’s provided free to you.  And so I think that that’s a misconception that many people have.

Andrew Schorr:

Okay.  Now, can a major medical center like yours help a patient discover the financial issues related to them, maybe even work with their insurance company to see are there options for them related to being in a trial?

Mary Ellen Hand:

I think over the last couple years in particular things have become much more complicated for people.  You know, some people sign up for Medicaid or Medicare replacement policies in the different states.  There’s Medicaid with places—Medicaid policies that don’t allow people flexibility.  But certainly that’s our job is to help people find out where they could go and if they’re eligible for a trial to help them get to that trial, and some of that is people who have—fit a particular niche.

And some people need to be well enough to travel, you know, if they need to—if the trial is out of our ZIP code.  Here in Chicago we’re very collegial in head and neck cancer and lung cancer and, you know, multiple other cancers.  You know, if the trial exists five miles from here, we’ll facilitate the patients getting on that trial there.

I think that medical records, one of the many—one of the most common medical records systems is available at many institutions across the country, so people can have access to the reports for another hospital.  Otherwise, there are coordinators and people who can make sure that all of that gets to the research nurse and gets in the hands of the person who is going to take care of that.

And then at our hospital, and I’m sure across the country, we make sure that they get the imaging so that they have something to compare it to, and then that’s uploaded into your chart, you know, at the other facility so that everybody has the right information to take care of the patients.

 

Andrew Schorr:

Okay.  Dr. Aggarwal…

Dr. Aggarwal:

I would just add…

Andrew Schorr:

Go ahead, please.

Dr. Aggarwal:

I would just add that this is a very common concern about the financial responsibility for clinical trials.  And here at Penn we are actually trying to make this process very, very transparent so that when I discuss a clinical trial with a patient actually our consent forms reflect what will be the standard of care costs and what will be sponsored by the clinical trial.

And, in fact, we do facilitate meetings with a financial counselor so that if a patient has concerns about what will be covered versus what will not be covered will be discussed at length with a financial counselor.  And that actually has gone a long way in allaying some of the concerns that patients have when going on clinical trials.  So, you know, it goes hand in hand with what Mary Ellen was saying, that I think once patients hear from the oncologist that there’s another level of—from a finance person I think that really goes a long way.

And I would urge patients to actually discuss and ask the facility where they’ll be treated if there is such a person who can discuss with them, because most academic cancer centers do have this facility.

Andrew Schorr:

So many people are treated, you know, by a local oncology clinic, but often they can work in partnership with an institution like yours, Chicago, Philadelphia, others around the country.  How does that work?  How can that work where they can be in your trial but maybe some testing or some other things, or do they have to commute to your institution maybe from a distance all the time?  Let’s start with you, Dr. Aggarwal.  Can there be more partnership, or are more trials available now in the community as well?

Dr. Aggarwal:

So a lot of partnerships exist between community physicians as well as academic physicians, so I see patients for my community oncology colleagues all the time, and the goal really is to make access easier, you know, the access to clinical trials and drugs easier.  So while the administration of the drug and the monitoring of the drug may happen at the academic center, there are many tests and imaging procedures that can occur in the community.

And the goal is also to make this easier for patients.  So if a patient is 25 miles away, I try not to drag the patients here just for a clinical exam or just for a scan.  You know, so I would facilitate them getting scans closer to home with their outpatient oncologist and then ask them to perhaps bring a CD with them for review.  They can get their blood work done closer to home.

So there are lots of things and lots of procedures where we work synergistically with their community physician hand in hand to try and facilitate all of these procedures so that they don’t have to keep traveling all the time.  So we certainly do that.

Andrew Schorr:

In Chicago, too, Mary Ellen?

Mary Ellen Hand:

Certainly.  You know, there are some things that the study requires.  If an infusion needs to be done onsite, that’s what happens.  You know, we have patients who travel across the country that might have a genomic mutation.  They may be looking for second or third generations of drugs, and so those people may travel.  So they have their local oncologist, meaning near, whether that’s someone in the community or someone in the academic center.

I think that’s another thing, is that patients are concerned that their doctor, whom they’ve forged this relationship with and the nurse, they think they will be upset if they go somewhere else.  And then instead of knowing that it’s a great opportunity for us to advance the body of knowledge but it’s also—we’re always encouraging and hopeful that people can get onto a clinical trial.

And so I think it makes them feel really good that people have these connections.  I think they like to know they’ve talked, they like to know that everybody’s on the same page and this many more layers of care take care of that.

Andrew Schorr:

Pat, let’s pick up on that.  So…

Mary Ellen Hand:

Their problem, their knowledge, all of us together, so.

Andrew Schorr:

Right.  Well, Pat, let’s talk about that.  So people have a doctor, maybe the one who diagnosed them, and they have a close relationship with them, and they’re afraid of losing them.  What do you say to people?  Mary Ellen spoke about that but from your perspective.

Pat Gavin:

Well, I think it depends somewhat on the trial and where they’re going to be available.  I received all of my care through the clinical trial locally at the Lacks Cancer Center here in Grand Rapids.  It was a trial like many others that are in the national clinical trials network, and the NCI-sponsored trials are generally available at the NCORP sites, and there are a lot of those around the country.  I was fortunate to have one of the original ones here in Grand Rapids by the Cancer Research Consortium, and those trials are available in academic centers, they’re available in community cancer centers like I had.  So it depends on the trial.

Now, some of the pharma trials may be a little more isolated and localized to specific hospitals for some of their early?phase trials.  Talk to your oncologist again.

Andrew Schorr:

We are getting questions.  And so I mentioned I have chronic lymphocytic leukemia.  This came in from George, who also has CLL.  He said, I’ve had no treatment, but it’s likely that it will be needed very soon, and it seems that Medicare patients are treated somewhat unfairly when it comes to available financial assistance for oral chemo, oral drugs that are now in trials often, Mary Ellen.

And so he says, are we likely to run into problems with clinical trials if you’re on Medicare?  So, Mary Ellen, any guidance about that, Medicare patients and trials?

Mary Ellen Hand:

No.  I think that we’re an aging America, so I think that we want to be sure that patients who are on Medicare have access to clinical trials.  So I think what he’s speaking particularly to is the co?pay of some of these medications is so very high, and co?pay assistance programs are not always built to support and help them in this.  But I think that if he’s going to be eligible for a clinical trial, he should, you know, number one see if he’s eligible. And then hopefully the place that he’s at will be able to help navigate that for him so that he can be—you know, be eligible to participate in that trial.

Andrew Schorr:

Okay.  One other question, Dr. Aggarwal.  This one comes from Stacey.  Stacey also has leukemia, and we’ve had oral drugs being developed a lot now for various leukemias, this is CLL.  And so there’s a clinical trial underway combining two of these oral agents, ibrutinib (Imbruvica) and venetoclax (Venclexta), is underway at MD Anderson in Houston, and the same trial is supposed to begin at Northwestern in Chicago near where Mary Ellen is, and that’s in May.

And she says since there’s a four? to five?month period before the introduction of venetoclax following ibrutinib, what would be the chance that I could join the trial at Northwestern in May, or would this be something I would have to direct to the doctor leading the trial?  She’s wondering about since the drugs get combined but sort of one after the other, can you sort of start, and how does that work?

Dr. Aggarwal:

So I would say that each clinical trial is different in terms of how they’re designed and what eligibility criteria are outlined.  I would really encourage participation—or I would encourage her to speak with this—speak about this trial with a physician or contact the PI of the clinical trial at MD Anderson…

Andrew Schorr:

Principal investigator.

Dr. Aggarwal:

…principal investigator to try to get some clarification of that.  There are some trials that prohibit previous therapies or previous ibrutinib, for example, prior to enrolling in a combination clinical trial, and there are some trials that allow prior participation.  In some instances, they may see progression on ibrutinib prior to combination therapy that is ibrutinib and venetoclax.  So I think it’s a matter of finding what the check boxes on the trial are, and talking to the principal investigator would be the best way to go about it.

Andrew Schorr:

Okay.  Here’s a question for Pat.  So, Pat, one of the things I wonder about is there are people who are on modern therapy now like for instance some of these drugs we mentioned, people are doing well on ibrutinib or people are doing well on venetoclax, or people are doing well on some of the lung cancer drugs.  Now, none of us know how long they’ll last, so they say, well, why should I even think about trials if it’s not broken now?  What would you say to them?

Pat Gavin:

We have to as patients look at clinical trials as a form of treatment, and it should be something that should be considered right from the beginning.  I hear people saying that, well, I’m going to go with what I’ve got so far, and if that doesn’t work and nothing else is an option, then I’ll use it as a last resort.  Now, in some cases a clinical trial may be a last resort, but in other cases, like you mention, there may be things about early treatment that would disallow you from participating in a clinical trial later on, so it’s best to be talking about clinical trials as an option right from the beginning.

Andrew Schorr:

Well, you know, this is a series we’re doing, and so we’ve covered some ground today, and I just want to recap a couple of things.  We talked about the phases of trials.  We talked about financial issues, and there are counselors to help you related to that.  Pat and I told the story of each of us thinking we wouldn’t be alive if we hadn’t been in a trial.  We talked about genomics.  So we’ve covered a lot in our first one, and we have another program coming up late in June.  Dr. Aggarwal, was this a good start?

Dr. Aggarwal:

This was an excellent start.  I think we definitely look forward to more patient participation on further trials, further programs like this.

Andrew Schorr:

Okay.  And, Mary Ellen, do you think we made a good start today, and hopefully people will now consider trials?

Mary Ellen Hand:

I think that it’s always just good to have more education, so whatever venue we can give that to people, whether it’s talking one on one with their physician or nurse or whether it’s online, to give people permission that they can get more information.

I think the other important thing to know is the criteria we talked about is you can’t—if you are truly getting a second opinion, you should get it before you start something, because you don’t want to have started a treatment that you get one dose of something that blocks you from access to a clinical trial.  Or you don’t want to have your genomic testing done yet, and yet you’ve started chemotherapy.  So sometimes it’s just educating people that, you know, if they’re not very sick, there’s time to get more information.

Andrew Schorr:

Good, good point.  Pat, what’s a final comment from you?  What do we want to leave people with, hopefully have more people think about trials, get access to them and have greater participation?

Pat Gavin:

Well, every time I talk I say I’m alive today by the grace of God and the fact that I participated in a cancer clinical trial.  They make a difference.  They’re the reason why you and I are alive today.  They need our support.  If clinical research is going to advance, we have to have patients in clinical trials.

Andrew Schorr:

Right.  So if we want progress and cures for the cancers that we’re living with, we’ve got to work with folks like Mary Ellen, Dr. Aggarwal and the other folks involved in research around the world, really.

Well, I’m over here in Europe, today in Barcelona.  This is a worldwide broadcast we’re doing.  Pat Gavin, I want to thank you so much for joining us from near Grand Rapids and wish you good health, Pat.  Thank you for being with us.

Pat Gavin:

Thanks.

Andrew Schorr:

And, Mary Ellen Hand, thanks for joining us again on our programs and in Chicago and 34 years of devotion to us, Mary Ellen, you keep going.  Thank you for being with us.

Mary Ellen Hand:

You’re welcome.

Andrew Schorr:

Okay.  Dr. Charu Aggarwal from Penn Medicine, the Abramson Cancer Center in Philadelphia, thank you for being with us again on one of our programs.  And thanks for the research that you’re moving forward with and your devotion to patients with cancer.  We hope that—well, we know it makes a big difference, and we look forward to you having great discoveries in partnership with patients moving forward.

Dr. Aggarwal:

Thank you for having me.

Andrew Schorr:

Great program.  Our next program will be coming up on June 21st, and we’re going to discuss are clinical trials a gamble?  So how do you decide as a patient, you and your family?  We’ll talk about that in June.  Thank you so much for being with us.

5 Lessons Learned from an Ovarian Cancer Survivor

Editor’s Note: Blog written by MyLifeLine.org founder and ovarian cancer survivor, Marcia Donziger. She shares 5 of the lessons learned after she was diagnosed with ovarian cancer at age 27. 


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Marcia Donziger

In 1997 I was 27, happy, free, and traveling the world as a flight attendant. Newly married and ready to have a baby, I felt strong and invincible. My future was unfolding just as I expected it to. Until the symptoms appeared ever so subtly. Squeezing cramps around my waist. It hurt to pee. After a few weeks, I marched my invincible self into my doctor’s office, told her I diagnosed my own bladder infection, and may I please have antibiotics.

She decided to investigate a little further. After an ultrasound, she discovered a grapefruit-sized tumor growing on my left ovary. “Could it be cancer?” I asked. “No,” my doctor assured me, “you’re too young to have cancer.”

Surgery was scheduled to remove my “benign tumor.” I was excited to get it over with, so I could go on with my life and have babies. After 5 hours of surgery, I woke up in the recovery room, my body uncontrollably thrashing in pain. My doctor hovered over me and broke the news, “I’m sorry. You have ovarian cancer. You’ve had a complete hysterectomy. We took everything out.”

What I heard loud and clear was “Cancer. You can’t have children.”

The diagnosis came as a shock. Stage IIIC ovarian cancer had taken over my abdomen, resulting in an emergency hysterectomy that I was not prepared for. The intense grief hit immediately. The loss of my fertility was most crushing. I had always wanted to be a mom.

Halfway through chemo treatments, I celebrated my 28th birthday, but there wasn’t much to celebrate. My marriage was dying. Cancer puts tremendous stress on a couple. Some couples can handle it together like champs. We didn’t. We divorced 1 year from the date of my diagnosis.

After treatment ended, I looked in the mirror to see what was left. I was 28 years old, ravaged physically and emotionally, divorced, and scared to date as a woman unable to have children. Who would love me now?

Now, almost 20 years later, I feel strong again (although not invincible).

With the benefit of time and perspective, I’ve distilled that traumatic cancer experience into 5 life lessons:

  1. Trust grandma’s reassurance, “This too shall pass.” As an ovarian cancer survivor herself, my grandma is living proof of this timeless wisdom. Stressful events don’t have to be permanent. We don’t have to be victims. Although cancer is extremely painful and unwelcome, the bright spot is we are forced to build character traits such as resiliency, emotional courage, and grit.
  2. Create your own joy in the midst of crisis. There are ways to uplift yourself during the chaos of cancer treatment. For example, I took a pottery class throughout my chemo months to find solace in distraction and art, which helped soothe my soul and ease the journey. What would make you happy? Do some-thing just for you.
  3. Stop doing what you don’t want to do. If you were doing too much out of obligation beforehand, try to change that. You are only obligated to make yourself happy. No one else can do that for you. The key is to use this wisdom to prioritize your time and honor yourself, so you can be healthy for others. Drop what doesn’t serve you. Drop the guilt. Life will go on.
  4. Connect with others. The emotional trauma is hard to measure in a medical test, but it’s real. Anxiety and depression can go hand-in-hand after cancer—it did for me. In response to the emotional challenges I experienced, years later I founded MyLifeLine.org Cancer Foundation to ease the burden for others facing cancer. MyLifeLine.org is a cancer-specific social platform designed to connect you with your own family and friends to ease the stress, anxiety, and isolation. Gather your tribe on MyLifeLine. You are not alone.
  5. You are lovable after cancer. No matter what body parts you are missing, you deserve love just as you are. Cancer tore down my self-esteem, and it took significant effort to build it back up. I am dedicated to personal and professional growth now. Look into your heart, your mind, your spirit. Try fine-tuning your best character traits, like generosity or compassion. Never stop growing and learning. We are not defined by the body.

To wrap up my story—I learned that when one door closes, another opens. Today I am the proud, grateful mother of 11-year-old twin boys. Born with the help of a surrogate mom and an egg donor, my dream finally came true of becoming a parent. Where there is a will, there is a way. Never give up on your dreams!


About MyLifeLine.org: MyLifeLine.org Cancer Foundation provides free websites to connect cancer patients with family and friends so patients feel supported. To learn more about how MyLifeLine.org can help you or someone you know affected by cancer, please visit www.mylifeline.org.

The Effects of Chemo and Ovarian Cancer

Real patient experiences shared privately at Treatment Diaries. Making sure you feel less alone navigating a diagnosis is important. Connecting you to those who can relate and provide support is what we do.


Had my first chemo January 20th. LOVE the pre-chemo “cocktail” they give. Relaxed me so much I slept through most of it. First four days after were fine. Next four, lots of nausea and threw up a few times. Doctor added two more anti-nausea meds and finally got it under control.

Using two chemo drugs; Carboplatin and Taxotere.

Two weeks after the first chemo my hair started falling out. Nausea and vomiting I can handle. Being tired a lot I can handle. Fingertips tingling I can handle. Hair falling out by the handful……..that was just demoralizing!

I put up with it for two days. Then, we shaved my head. I do mean WE. Went into work and sold raffle tickets. Winning ticket pulled got to shave my head! It was hilarious! Got pictures and lots of video. Plus, raised $322 to help with expenses, which I really needed.

My “work son”, Andrew, was the winner. Worked out good that way, I think. His mother is going through chemo for breast cancer, started losing her hair and shaved her head. He was having a hard time dealing with that. Shaving my head seemed to give him a new perspective.June TD quote

I freely admit, if I’d shaved my head at home by myself, I’d have bawled my eyes out the whole time. But, doing it at work made it easier. Everyone was cracking jokes and laughing….it was more like celebrating a milestone than doing something that was a reminder of something bad.

One thing I’ve noticed is that the “stubbies” don’t fall out as easy once they die as full strands do. Then, when I put on a scarf or hat, they get shoved down in the hair follicle and it’s uncomfortable. BUT, I found a great fix for it: LINT ROLLER! Yes, after my shower, I stand in front of the mirror and take a lint roller to my head. And laugh myself silly the whole time!

Turns out, I don’t look bad bald. So, I’ve opted not to bother with a wig. I use a scarf or hat outside, but go au natural indoors. And, I have to admit, I love how much time I’m saving in the shower! Especially on the days when I have no energy!

Second chemo was February 10th. Used my chemo port for the first time as well as an IV. That was interesting. And they gave me some kind of IV anti-nausea meds since the first dose hit me pretty hard. Worst side effect this time was that it messed with my taste buds. For about 10 days, all I could taste was sweet stuff. Couldn’t taste meat or spicy anything. Talk about frustrating! Grrrrrrrr!!!!!!!

Took the long way home afterward. Was stopped right next to a police officer at one light. He had about as much hair as I do right now. So, he’s looking over at me, I’m looking over at him…..we both were grinning at each other. Very cute moment.