REGONIVO: My Experience

Unless you are a patient or caregiver starting or considering REGONIVO in the future, there is no need to read this post. This is what my experience has been on this combination for the last 3 months, and would only be of interest to those pursuing or considering REGONIVO.

I am infused 1x a month with Opdivo. This does not follow study protocol, and when my oncologist told me it would be a monthly infusion, I immediately questioned it and was concerned it may impact the outcome. He sent me research information on revised Opdivo infusion protocol, which calmed me down and made me trust in those that have far more knowledge and credentials that 1x a month would be fine.

I followed study protocol with the 80mg Stivarga dose 1x a day for 21 days on, 7 days off. The biggest challenge I had was taking my pills with a low fat breakfast as instructed to by Bayer. I opted for low fat yogurt, and followed it up 2-3 hours later with something a bit more hearty. I normally eat a hearty breakfast.

They checked my CEA at 1 week (day 1), 4 weeks, and 6 weeks. I do not have my CEA for 12 weeks (week of CT scan) yet:
Week 1: 31.9
Week 4: 15.6
Week 6: 8.8
Week 12: TBD

Loss of appetite
This is a listed side effect for Stivarga, and I can assure you if it’s something food related, I’m going to get hit by it. Unless you have experienced loss of appetite, you can not understand what this is like. I have literally wandered the grocery store searching the aisles for anything that looked appealing. I have read over all the glorious flavors of ice cream in the freezer section. But when your desire to eat has been taken, no magical pint of Ben and Jerry’s is going to bring it back. This loss of appetite of course let to my biggest hurdle of my first 3 months - my weight.

Weight loss
Weight loss is nothing new to me since my diagnosis. My weight has come and gone depending on treatment, nausea, and appetite. But this is by far the worst experience I’ve had yet. In the first 4 weeks I lost 12 pounds. As this was more than 10% of my original weight (114) I was considered to have wasting syndrome, something that qualified me for medical cannabis under the laws of the state in which I live. My oncologist entered me into the program as he felt the use of medical cannabis was the only tool he found to be truly helpful for patients experiencing extreme weight loss. The process was easy and I had my CBD/THC tincture by the end of the week.

Because I would be legally considered to be “under the influence” while using the medical cannabis, I opted to only use it when I was alone (not at work and without kids). I found it did nothing to stimulate my appetite, but it very much did stimulate a 4 hour nap every time. I do still take it when the timing is right in hopes that it might have even the slightest impact, but I do not see it being the solution to my growing (or rather shrinking) problem.

As of 12 weeks I have lost 22 pounds, and we are discussing next steps with my health care team to help me continue on with my treatment plan while also getting the calories I’m going to need to add to and maintain a healthier weight when the desire to eat those calories is non-existent.

This hit me hard the first month. I’m not sure if it was the lack of appetite (and therefore deprivation of calories/energy) that led to fatigue, or if the fatigue (and decrease of movement) that led to the weight loss. I have noticed that there is a direct correlation between calories in and energy out, so I’m hoping with a plan to get far more calories in, I can start to gain weight and get my energy back.

Hand foot syndrome
I knew that hands and feet could be impacted my Stivarga and had been warned about blisters. My pharmacist recommended I pumice off any calluses I had to avoid this. My hands and feet were in great shape when I started, so I was surprised to get hand foot syndrome. I’ve resumed trimming my hands and feet to keep skin peeling under control, and find it’s just the annoyance of dead skin at the foot of my bed more than anything. I did lose my entire foot pads over the first 3 months, so peeling is now minor to just new skin.

Sore throat/raw mouth
Though not prohibitive to eating, the sore throat that is a known side effect of Stivarga is at times painful, and does deter me from eating foods that are hard, difficult to chew, and swallow. There were times I just over chew small bits and swallow with a grimace, but generally on days it is worse I opt for soft foods. Lots of yogurt, smoothies, and store bought smoothies and protein drinks. My mouth is raw as if I’d taken a swig of scalding coffee and swished it around. This has left me averse to eating things that are acidic, using mint toothpaste, and avoiding cough drops to tame my cancer cough.

This was my experience during my first 12 weeks on REGONIVO. I ask that you not DM me with questions, as I have thoroughly explained everything I experienced here. Thanks.

REGONIVO: 12-Week Update

Amazing if not miraculous news. The new drug combination I’ve been on for the last 3 months is working, and as my oncologist said when revealing my scan results today, “I think we’ll really be celebrating in 3 months. This is just getting warmed up.” I was pretty hopeful going in today, and comforted by the first 8 weeks of tumor marker blood tests (CEA). They dropped significantly at the 4-week and 6-week mark, and are a good indicator for me about what's going on inside the ol' lungs.12 weeks later we have the visual proof to back it up with great CT scan results.
Graph of CEA test results over last 6 months.

Why my oncologist thought things would be more impressive 3 months from now is due to activity evident on the scan. Something called cavitation. In layman’s terms, the tumors are dying from the inside. And this was no more evident to us as he scrolled through a side-by-side comparison with my last scan. Aside from seeing overall shrinkage in all my tumors, in the middle my largest tumor was a huge dark circle. I didn’t think to take a photo because we were just so amazed at the size of the black hole. The core of my largest tumor was dead. 

This is a brand new treatment option for colorectal cancer patients with microsatellite stable (MSS) tumors, and a phase II trial is now open and recruiting patients. I have opted to do this drug combination off-label because at the time I started there wasn’t public talk of a trial opening, I needed something, and this looked so promising. I was at the right time in my treatment timeline. Off-label simply means that I had to request the immunotherapy drug Opdivo from its manufacturer Bristol Myers Squibb because it was not FDA approved for my tumor type. 

Since starting, many other colorectal cancer MSS patients have done the same, and many are enrolling in the trial. I am so hopeful for tumor markers to come in soon for others. We may have an immunotherapy combination that can work for some MSS patients, which has been something long sought after by researchers.

I will admit that I didn’t expect this to work for me when I started. It just wouldn’t seem right or fair that once again I would respond to another line of treatment (my 4th), that I would continue to have the privilege to live, and that I would continue to be so damn lucky while too many of my friends weren’t. I thought at this point my tumors would have figured out a way to mutate into something impenetrable. But we have learned from Star Wars, regardless of what the cocky Empire thinks, the Rebellion always finds a way in.


You Try Pronouncing Regorafenib and Nivolumab Really Fast

In June an abstract was presented at ASCO from a phase 1 study out of Japan. It combined 2 drugs currently being used in cancer treatment in the US, and the results of the study were promising - promising enough to get the serious attention of GI oncologists and patients. Serious enough that I took screenshots of the presentation slides I saw come across Twitter from those in the Twitterverse that were in attendance. 

The study treated gastric and colorectal cancer patients with microsatellite (MSS) tumors with a combination of Nivolumab and Regorafenib. Regorafenib, or Stivarga as it’s known for people who can’t spell or pronounce fancy drug names like myself, is already in line as standard therapy for colorectal cancer MSS patients. Though approved by the FDA, Nivolumab (Opdivo) is not approved for my cancer type (MSS) because to date there has been no clinical data to support that this tumor type would respond to this immunotherapy.

In the study, the response rate in colorectal cancer patients with MSS tumors was 29%. As this was a phase 1 study, the number of patients enrolled was small (50 over all, 25 colorectal). These results were exciting, unexpected, and encouraging enough that there is talk of opening this as a phase III trial in the US. But I ain’t got time to wait for that!

The timing couldn’t have been more perfect, as I was a couple of weeks from starting my first clinical trial with its one-and-done short run of 42 days, and would need to line up my treatment plan after its completion. 

The week ASCO concluded (and the same week these results were presented in the abstract) I traveled down to MD Anderson in Houston to check out their trials. While meeting with the oncologist (and his fellow) about potential phase 1 trials available, he brought up this study. Of course I had the screenshots of the presentation slides on my phone and whipped them out! As he talked, the fellow pulled up the abstract to read, and within minutes we were all in agreement that mimicking this trial was the way to go. Fortunately I have an oncologist who is equally trusting of my ideas who immediately put this plan into action. 

Since these two drugs are in circulation in the US, I could duplicate the study. As Nivolumab was not approved for my tumor type, my insurance company would not cover the cost and I’d have to get it “off-label.” This means asking the drug manufacturer to give me the drug for free. The process wasn’t complicated, and in-house staff at my cancer center took care of it. Within days it was done.

Once I wrap my current trial with a scan on Monday, July 30, I will begin this treatment plan on Friday, August 2. The side effects from Regorafenib can be rough, but ironically the best results of the study came with the lowest dose of the drug. Knowing this, I'm hoping the suffering is kept to a minimum - as the drug is known for destroying hands and feet.

I wouldn’t exactly call this going rouge, as the results from the phase I study have clearly inspired US researchers to actively create their own study. I’m just getting a head start. I know that if I expect to survive this disease or (at the very least) continue to prolong my life - I have to take risks and venture off the paved path. 

Those of us with MSS tumors have been sitting on the sidelines for a while watching everyone else get to successfully play in the game, and a study like this can only be likened to the coach telling us to get off the bench and start warming up. I just hope I can do my fellow MSS patients proud as I get called in early to play.


How Now Mad Cow

I finally pulled the trigger on a trial, and I will admit it wasn't easy.

It was very easy for me to say yes (to that clinical trial dress), but what wasn't easy was finding a trial in a timely manner - or at least timely enough to keep my anxiety from creeping in to every corner of my life. To say it was a weird few months is an understatement, and my head space was clouded over in ways I've never experienced. I found myself withdrawing from the world - not because I was in a depressed state, but because I didn't have an ounce of anything to give as long as my mind was consumed with the reality that I had no treatment options on the table.

It has been nothing short of bizarre to have had a plan for 7+ years, and then all the sudden be left stranded on an island waiting for the phone to ring. All the while knowing cancer was continuing to grow, and the horrid cough I had reminding me daily that things were not improving.

I opted for a phase 1 trial primarily because that's what is available to me and my tumor type. As they say, beggars can't be choosers, and I was at the point of begging. I know most patients cringe at the idea of a phase 1 trial, as it's when the drugs are first tested in humans and the main purpose is to determine proper dosage (meaning how much of the trial drug can be given before side effects/toxicity because an issue).

The catch is the drugs they are studying have been shown to work in a lab, and by "lab" I mean in animals. Are you offering yourself up to be a human guinea pig? Absolutely. But are you also offering yourself up to be the first to get drugs that could work? Absolutely!!!

What I found most surprising once I jumped into the clinical trial pool was how hard it was to actually get into a phase 1 trial - primarily because of space available and the timing in which that space becomes available. Phase 1 trials have limited numbers of patients, and it's often doled out at a "one at a time" rate. Meaning in some cases I couldn't start a trial until the previous participant had completed their run.

Over 3 months after my last round of chemo the stars finally did align, and a trial I signed up for over 2 months prior locked in my spot. Ironically it was a trial I had considered last summer, and opted to pass on due to the option of revisiting a previous therapy. I'm playing the long game here, and I knew going in my goal would be to buy as much time as I could. By "buy time," I don't just mean life, I mean time for trials to progress, data to come in, trial arms to open, and new trials to begin.

In my case, the trial I was considering last summer changed it up a little from when I first considered it. They went from doing an intratumeral injection of the virus (injecting it right into the tumor) to doing an IV infusion of the virus (a drip from the bag) and found they were getting better results from the IV infusion. It's a clear example that "buying time" bought me a potentially better outcome.

The trial itself, one I've taken to calling Mad Cow Disease, is one and done. It is what's called oncolytic virus therapy, and if you click on that hyperlink you can better understand the use of viruses to fight cancer. I was infused with the virus, spent 24 hours in the hospital dealing with magnified flu-like symptoms, and spent the following week trying to get through the day without an all out crashing nap. We'll see if anyone I work with reads this, as I'll admit to putting my head on my desk for a power nap at work while listening to a webinar because I just couldn't go a minute more without face planting on the nearest flat surface. And they thought my door was shut just to filter out the ambient noise.

Roughly 6 weeks after my infusion I'll have a scan to see if it worked, and then I'm free to move about the clinical trial world again. I do have a few spoons in the pot, and something exciting that's brewing that I'm not prepared to talk about until it's actually underway. But the relief I have now is that I at least have options - something I spent 13+ weeks feeling like I didn't have, and that's a very frightening place to be.


The Layers of Palliative Care

By treating the patient as a whole, we ensure the common gaps in care do not get overlooked and the burden of cancer is reduced.

I was on the phone with a colon cancer patient who was looking for help and guidance. She had grown frustrated with her oncology team, and gradually explained the long list of complaints and opportunities where they had let her down. After validating many of her concerns, I told her, "It sounds to me like you are looking for palliative care, and they just aren't offering it."

In my world, palliative care is a term thrown around as frequently as my rounds of treatment, but it was the first time she had heard the word. As I began to explain it, I could hear her disappointment turn to hope over the phone. There was a word to describe the patient experience she wanted but wasn't getting.

Not everyone knows what palliative care is, and most don't know how to put it into practice as advocates in their own care. It is the relative new kid on the health care block, and many medical teams are not trained to care for the patients with this approach. So, what is this magical thing called palliative care, and how can we incorporate it into our own health care plan?

As I see it, palliative care is tending to whole patient and not just their disease. For me, my care plan involves layers, that when woven together, reduce the stress I feel as a patient. And the less stress I feel, the better I'm going to fight my disease and improve the quality of my life.

Here's what my palliative care plan looks like:

The internal layer is about fighting my cancer. It's about infusions, scans, clinical trials and working to keep my disease stable. For others, it could include radiation and surgical treatment. It may even involve second opinions, and a multidisciplinary approach to beating back disease.

The next layer is about managing side effects. I meet with my pharmacist at almost every infusion to talk about nausea, blood counts and what we can to manage my day-to-day quality of life through medication. At times, this layer has included meeting with a dermatologist and podiatrist to discuss treatment-related skin and foot issues, and an acupuncturist to help treat neuropathy.

The next layer involves care that doesn't immediately impact my ability to physically fight the disease, but my ability to live my life to the highest quality despite the disease. That includes seeing a physical therapist to manage the lymphedema I developed in my left leg several years after my primary surgery. For others, it could be meeting with a mental health professional to help process the emotional repercussions of diagnosis, a dietician to help manage treatment-related nutritional needs, or a social worker that will help navigate services available for patients through the health care system or community organizations.

The outside layer extends beyond me to include my family, and the community and online support programs available to us. For me, it includes local organizations that offer family support programs such as camps for my kids and art therapy nights. Online support communities help me know I'm not alone in my fight and offer the peer-to-peer mentorship that is unique to my cancer and specific treatment plan. Support programs could include free or reduce cost service to patients that fall outside of the medical realm yet fill gaps in care and help reduce the burden of cancer on an individual and a family.

It is important for a cancer care team to know about the various layers of care they can bring to a patient fighting a chronic or terminal disease, and begin to look at treating them as a whole. It's also important for a patient to advocate for themselves, and understand what services are available to them within reach of their community. As we work from the outside layers in, we're going to create an environment that enables patients to give everything they have to fighting and managing their disease, and ultimately produces better outcomes.

This article was originally written for CURE MagazineYou can find this article and others I have written on their website


Parenting, Interrupted: Three Tips on Being a Parent With Cancer

As a parent facing cancer, we just want to know that our children will emerge on the other side of our diagnosis and be alright.

I cross paths with many parents newly diagnosed with colorectal cancer. In the midst of trying to wrap their heads around a cancer diagnosis, they are also trying to integrate this most unwelcome guest into their homes.

It is completely unfair and not right that you find yourself facing a cancer diagnosis when you have nothing but hopes and dreams for the way parenting and childhood is supposed to be. You have done everything you can to protect them from the pretend monsters under the bed and the real monsters lurking in the world. Yet, here at your doorstep is the most real and feared monster of them all, and you have no choice but to let it in.

How is cancer supposed to fit into this Instagram-perfect life you've created for your family? Too many times I've looked down at my kids coloring on the floor of my infusion room and wanted to scream, "IT'S NOT SUPPOSED TO BE THIS WAY!" It's not supposed to be this way for my friend who was diagnosed while still pregnant, or my friend who lost her husband while their baby was still in diapers, or my friend who has a special needs son who will depend on her for the rest of his life. Despite the way it supposed to be, but we have no choice but to parent through cancer.

For parents facing a cancer diagnosis, I offer three bits of advice:

1. Grieve

Grieve the loss of parenting as you expected it would be. Grieve the loss of moments, time, milestones and innocence.

While sitting in a hospital bed recovering from my initial cancer surgery, I had to watch cellphone video of my baby taking his first steps. I'd left that nursing baby at home, not realizing that he would start to walk, and the stress of surgery, drugs and additional weight loss from a liquid diet would dry up my milk and force me to wean him.

In its first week, cancer had stolen significant parenting milestones from me. Little did I know it was foreshadowing of the years to come, when school performances, field trips and holidays would be trumped by infusion appointments and side effects that left me unable to parent like I wanted.

2. Control

Let go of control. Let go of the hard-and-fast rules with which you parent. Let go of the state of your house, that pile of laundry or even making your bed. You can try to hang on, or you can save your energy for fighting this disease.

I laughed as I piled the groceries on the belt in the checkout line. There were enough pre-packaged ready-to-eat meals to last a week. I would have silently shamed this version of precancerous me had I seen her a few years before, when I was busy making homemade organic baby food and nursing my babies on demand.

Precancerous me had the energy to passionately care about what my kids ate, what they wore and the amount of time they spent in front of the television. Cancerous me just wanted to crawl in bed and make the next few days as effortless as possible, and spare what little energy I had for making sure my kids were fed, happy and had their mom.

3. Empower

Giving your kids control in an out-of-control situation will empower them and make them feel like they are part of the solution.

My 4-year-old couldn't drive me to appointments, or take notes while my oncologist rattled off the names of drugs I still don't know how to spell. But he knew where I stashed all my nausea meds, and which puke bowl to grab me when I needed it. He has always had an age-appropriate role in my care and has done his part to make me feel as well as he could.

By making your kids feel like they are part of the process, you are making them feel like they are part of the solution. My preschooler wasn't able to fix my disease, but he was able to support my fight against it.

As instinctive as it may be for parents to want to help their kids before they help themselves, we have to listen to the flight attendant and put the oxygen mask on us before we put it on them. We have to make sure we're breathing through this, so we can show them that they can keep breathing through this, too.

Regardless of the outcome of the diagnosis, we must remember that children are resilient. They won't remember what we missed, but they will always remember when we were there.

This article was originally written for CURE Magazine. You can find this article and others I have written on their website