Original post is on The ROS1ders website
The anticancer pill I take in my clinical trial, Xalkori (generic name crizotinib), was approved today by the FDA for my type of lung cancer: ROS1-positive non-small cell lung cancer. I’m one of the 50 patients whose results were included in the clinical trial data.
In addition to being happy that I found an effective treatment for my lung cancer–I’ve had No Evidence of Disease for 36 months and counting–I feel proud to be part of the research that is making new cancer treatments available for more patients.
Precision medicine, targeted therapies, and clinical trials are awesome.
Edit 2016-03-11 2 PM to add:
Some people have asked what this approval means to my participation in the clinical trial.
The short answer:
Nothing has changed for me. I’m still in the clinical trial, and I still get my drug free (but have to pay for my travel).
The long answer:
Last April, Xalkori for ROS1+ NSCLC received “breakthrough” FDA designation, which is one type of accelerated FDA approval. The accelerated approval process allows the FDA to grant approval before a Phase 3 clinical trial is completed, but still requires a Phase 3 trial to be completed eventually. So my clinical trial must continue until the Phase 3 trial is complete, or the FDA will pull its approval of Xalkori for ROS1 NSCLC.
Xalkori originally received breakthrough designation for ALK+ NSCLC, and was granted FDA approval through the accelerated process in August 2011 (the fastest drug approval to date). The Xalkori for ALK+ NSCLC phase 3 clinical trial still continues over four years later. So I suspect my clinical trial will be continuing for some time.
However, even if I left the clinical trial, Xalkori is already covered by most insurance plans, and today’s FDA approval means pretty much all plans will cover it. However, the copays vary considerably. Some plans cover it as a pharmacy benefit with a substantial out of pocket expense. Others cover it as a medical expense, with a standard deductible. I haven’t checked to see how (or if) my plan covers it.
I plan to stay in the clinical trial at the University of Colorado for the forseeable future. I like having regular access to some of the top experts in the world on ROS1 cancer and molecular testing for precision medicine. My writing income goes to fund their Lung Cancer Colorado Fund for lung cancer research. I also participate in their research as a patient advocate on the NCI-sponsored CU lung cancer SPORE (Specialized Program for Research Excellence) and get to learn about cutting-edge cancer research, which satisfies the geek in me. Besides, I’ve grown fond of several people I’ve come to know at CU. It’s become a second home of sorts.
So, yeah, this approval does not change my treatment. But hopefully it will make the treatment more available to more patients ASAP.
Woohoo! My clinical trial drug may get FDA approval soon! It’s about time.
The clinical trial in which I participate has been running for over three years. I take Xalkori (crizotinib) for my ROS1-positive non-small cell lung cancer. Early phase clinical trial results announced last year show around 72% of patients experienced measurable shrinkage of their tumors, and another 12% achieved stability. This is remarkable, considering most chemos have a response rate around 20%.
The average crizotinib response lasted about 17 months, with half of the patients still responding when the data was collected for the journal article. I personally know at least four people (including me) who responses have lasted over two years (two of them are not on the trial).
Today Pfizer announced it had received US FDA “breakthrough” designation for Xalkori treatment of ROS1+ non-small cell lung cancer. This means it is on the fast track for FDA approval for treatment of ROS1 NSCLC (after already being approved for treatment of a different lung cancer mutation).
My marvelous clinical trial drug may finally get FDA approval. It’s sort of moot, in a way, because the evidence of its effectiveness is so outstanding that most US insurance companies are already paying for crizotinib treatment of ROS1 NSCLC. But it is still cool.
Coincidentally, I have my clinical trial appointment today, and I’ll be talking with one of the lead investigators (my oncologist, Dr. Ross Camidge) about what this announcement means for those of us still on the trial.
Last Friday, November 7, I spoke at Virginia Mason Medical Center’s Grand Rounds on the topic of “Lung Cancer in Non-Smokers.” Grand Rounds is a common teaching tool in medical facilities that helps healthcare providers stay current and provide the best possible care. In our one-hour session, my pulmonologist Dr. Steven Kirtland talked about the epidemiology of non-smoker lung cancer (its frequency, possible causes, patient demographics), I shared my epatient story, and my oncologist Dr. Joseph Rosales talked about lung cancer mutation testing and targeted therapies. You can see my 20-minute presentation below.
In Seattle, home of Starbucks, everyone drinks coffee. Can YOU tell which of them has lung cancer? In this picture, it’s the person on the far right: me.
In March 2011, I was healthy, a bit overweight, and exercising regularly. However, I’d had a nagging cough for a few months. To make my husband happy, I mentioned the cough to our doctor. Two months, two rounds of antibiotics, one x-ray, and a bronchoscopy later, I spent a very anxious four days waiting for biopsy results.
When I heard, “lung cancer,” I could barely believe the diagnosis. I called my sister to tell her the news, poured a big glass of wine, and lost myself in a favorite science fiction movie.
I had never lived with smokers, never worked in a smoking environment, never smoked anything (except a salmon). I knew nothing about lung cancer. The facts I found online were not encouraging. As we moved through the various staging procedures, my family and I experienced increasing levels of fear:
- “It’s OK, it’s just one tumor. VATS surgery will probably take care of it.”
- “Well, OK, lymph nodes are involved, but still inside one lung. We can remove the lung, right?” (OMG)
- “There’s a lymph node between the lungs, severe inflammation and obstructive pneumonia. Stage 3a. No surgery.” This is serious. After my mediastinoscopy, my sister left the hospital convinced I was dying.
I was reassured to hear Dr, Rosales say he considered me curable. I was eager to start aggressive lung cancer treatment. But the universe, it seemed, objected to the treatment plan. The interior of my tumor had died and become colonized by bacteria. Even though we finally found an antibiotic that knocked out the infection, my recovery took weeks. During that time, I developed a clot on my PICC line and required daily self-injected blood thinner. Heaven forbid I should be a boring, vanilla cancer patient! I worried my lung cancer was growing while I waited to start treatment.
I hit bottom a few days after my second bronchoscopy. I awoke at 3 AM coughing up a lot of blood, and Dr. Kirtland told me to go to the ER. I was released later that morning, just in time to drive 30 miles to my first radiation treatment. The linear accelerator was down two hours for repairs, but I did eventually get zapped. My husband and I drove to a nearby restaurant for a very late lunch, and came out to find our car had a flat tire. Not a very reassuring start.
The next few months revolved around my daily appointments. Perhaps the toughest part was telling my autistic adopted son that he might lose another mother to cancer. My bucket list became laser-focused on helping him prepare to live on his own. Despite fatigue and severe esophagitis, I was able to attend my niece’s wedding a month later. You haven’t lived until you’ve had Ahi tuna encrusted in coffee beans–pureed for a liquid diet. At one point I was taking ten different meds to control pain and side effects. My butt was dragging, my blood values tanked after one full dose of chemo, and I broke out in hives during my second red cell transfusion. But gradually, I started feeling better.
It all seemed worthwhile when my first post-treatment CT scan showed my lymph nodes had resolved and the primary tumor had shrunk about 90%. I wanted that tumor OUT, if possible. I had 15 appointments in 16 days to determine if the surgery would be an acceptable risk–we only had a short window in which to do surgery before radiation changes would make it too risky. Juggling that schedule generated a lot of additional stress — my family’s life revolved completely around my cancer. I wished Virginia Mason had a Lung Cancer Navigator to coordinate all the appointments between seven different professionals at four different facilities, communicate results, explain terms and options in more detail, and ensure timely follow-up. The last procedure, a PET scan, showed a hot spot on my collarbone. Dr. Kirtland quickly arranged an MRI scan for the next morning, and a surgical open biopsy on the following day. To find the tiny suspicious lymph node, the surgeon used an innovative combination of FDG tracer and a Geiger counter. Two nodes contained cancer.
I was now a metastatic lung cancer patient. The panic bowled me over like a 50-foot wave. Alone at home, I became a puddle of hopelessness–for about an hour. Then I shifted gears and got busy asking questions in an online lung cancer forum. The support I received there was essential for maintaining hope while I processed my new diagnosis. They helped me accept there was no point undergoing a risky lung surgery with a tough recovery when it wouldn’t cure me.
Together Dr. Rosales and I decided to start a new chemo after a couple of months, to give me time to recover from my first line treatment. I appreciated that he listened to my concerns about the delay, and that he was careful not to give me an expiration date that might take away hope. I didn’t want to die before applying for my Boeing pension, so I asked how long I had left. Dr. Rosales estimated about two years.
In the next ten weeks, my mother died, I started taking prednisone for radiation pneumonitis, and a new three-inch tumor grew very visibly on my collarbone. My extended family gathered for what we thought might be my last Thanksgiving. I had no desire to celebrate Christmas that year. My most memorable gifts were a newly-installed power port and a hint that my hair was coming in curly.
In my online lung cancer forum, I learned about a clinical trial called the Lung Cancer Mutation Consortium Protocol. It tested lung cancer tumor tissue for mutations in ten different genes. I consulted with my Virginia Mason doctors, but they hadn’t heard of it. I found the trial listing on clinicaltrials.gov, then contacted the trial sites until I found one accepting patients. The University of Colorado Cancer Center agreed to test my existing biopsy samples even though I could not fly to Denver due to concerns my hollow primary tumor might cause a pneumothorax. My entire team was disappointed when all tests were negative. I continued networking with experienced lung cancer patients, and when Dr. Rosales and I discussed chemo options, I suggested Avastin based on some new research. We mutually agreed on Alimta plus Avastin–he was willing to be more aggressive in my treatment because he knew I understood the risks.
Ten days after I started the new chemo in January, my collarbone tumor was visibly shrinking. I was extremely encouraged despite a sudden worsening of my pneumonitis and my new appreciation for ‘roid rage. Still, I was glad to finish chemo after six rounds–I was losing my voice frequently, and towards the end I felt like I always had the flu. I began to understand how some people could decide to stop cancer treatment. But I couldn’t argue with the results: all the original tumors were gone, the new tumor had shrunk 90%, and no new tumors appeared. We decided to treat this one remaining tumor as an oligo-recurrence and go for a possible cure — radiation therapy might knock my cancer out for good. My skin burned raw, but I made it through.
The next PET scan showed no activity around my collarbone. Yay! However…it also showed two new nodules in my “good” lung, both outside the radiation field. Seems I progress whenever I stop chemo. Another bronchoscopy was scheduled two weeks out, after my husband and I returned from a weekend with my nephew in Denver.
Here’s where the tone of my story changes.
Months before, one of my online lung cancer friends told me of a new mutation called ROS1. I fit the profile of typical patients who had it, and a Phase 1 ROS1 trial still had slots left, but only a lab in Boston could test for it. No one at Virginia Mason knew about it. On my last full day in Denver, I realized the University of Colorado Cancer Center was not far from my nephew’s house. I might be able to personally thank the people who had helped me get my previous mutation testing done. I sent an email Sunday afternoon, and was amazed to get an email back that evening saying I could meet the next day with Dr. Bunn, the Center’s Director. He told me they could now test for additional mutations, including ROS1. I gave him permission to test my remaining slides.
A week later, Dr. Kirtland performed a bronchoscopy on the larger of my new nodules. He got a good sample, but couldn’t find any cancer cells. The biopsied nodule could be inflammation, BOOP, or cancer. The other nodule was too small to biopsy.
The very next day, Dr. Bunn emailed me to say I had “an impressive ROS1 rearrangement” and University of Colorado had an opening in a crizotinib trial for me, if I wanted it. Crizotinib is a twice-daily pill that targets cells expressing certain mutations, including ROS1. It produced a terrific response rate in the initial trial with substantially fewer side effects than chemo for most patients. He also said I could join the trial later if I didn’t have active cancer now. I was so excited that I almost screwed up forwarding the email to Dr. Rosales.
The following morning, Dr. Rosales called, also excited by my ROS1 news. If the new nodule was cancer, he agreed I should enter the ROS1 trial rather than start taking Alimta.
That afternoon, Dr. Kirtland called. He had taken my case to the Tumor Board, and their consensus said the biopsied nodule was radiation changes. I was to restart prednisone. (My husband asked, “What will he give ME when YOU restart steroids?”) In a month I would have a CT to determine if the nodules responded to prednisone, or continued growing. I’d come to accept that living with stage IV lung cancer brought uncertainties, but that didn’t make the waiting easier.
The CT scan showed the larger nodule had not changed, but the smaller nodule had grown nearly fifty percent. The good news was that I could once again ramp down off prednisone. The bad news was that the smaller nodule was likely cancer–I needed to either restart Alimta, or join the crizotinib trial.
I was on the phone the next morning to the University of Colorado, inquiring about how to join the ROS1 trial. Their doctors said I might be able to join the trial without having another biopsy. Virginia Mason medical records and radiology really hustled to pull my records together. After four days, I was flying to Denver with the intention of staying until I was accepted into the trial, and wondering why the heck I was traveling a thousand miles away from my home and family to try an experimental cancer treatment that might not work. My concerns were not eased by the delays caused by Hurricane Sandy, which shut down the trial sponsor Pfizer’s headquarters in New York City during my screening period. My acceptance into the trial came at the last possible minute.
I took my first crizotinib pill two years ago last Thursday. My first scan eight weeks later showed both nodules were gone, indicating they likely were both cancer. As of last Monday’s scan, I have had No Evidence of Disease (known to cancer patients as “NED”) for 22 months and counting. I may be able to stay on this drug for months or years longer. Yet targeted therapies like the one I take do not offer a permanent cure. In time I’ll probably develop resistance to the drug. There IS no cure for metastatic lung cancer. No one can say how long I will live. Sometimes that weirds me out. Yet I’m hopeful that when this trial drug stops working, another clinical trial will be a good match for me.
It’s an odd existence, living from scan to scan in eight-week increments. I still sometimes experience scanxiety, as we patients call it. I often hide out in the bedroom for days before a scan so my scanxiety doesn’t bite anyone. There is no logical reason for this feeling. My scans have been clean for months, and I have no symptoms that would indicate the next scan should be any different. If I do have a recurrence, I know I have some treatment options. Even if I had no treatment options, I am not afraid of dying. Apparently my subconscious simply overpowers my conscious positive thoughts. It probably doesn’t help that whenever I’m leaving for a scan, my son hugs me hard and says, “Please don’t die Please don’t die Please don’t die.”
Several events conspired to give me severe scanxiety a year ago. It felt like a panic attack. Not only was the timing near the anniversaries of my two cancer recurrences, but a friend on a targeted therapy had developed brain mets weeks after a brain MRI, a neighbor had died when her lung cancer spread to her brain covering, and the online ROS1 buddy who had first told me about my clinical trial appeared to be progressing after two years on crizotinib. A network of lung cancer patients provides invaluable support, but it requires accepting that friends will die frequently.
I feel overwhelmingly grateful for everything and everyone that has helped me survive as long as I have: medical science that discovered new ways to treat my condition, compassionate healthcare providers at Virginia Mason and in Denver, insurance that paid for most of my care, family and friends who supported me, a knowledgeable online lung cancer community, and all the prayers and good wishes lifting me up throughout my cancer journey. I’m acutely aware that many lung cancer patients do not have these supports and opportunities.
Being given a second chance at life, however long it might be, tends to give one a different perspective. Seeing the sunset paint Mount Rainier fills my heart. Chatting with my sister over a latte keeps me smiling for a week.
A second chance at life also makes one introspective. Why was I spared when others died? Why does my mutation have an effective treatment when others don’t? Why am I able to see one of the best lung cancer doctors in the world when many patients can’t afford proper treatment? Why am I still here?
I had been blessed with gifts that helped me survive my cancer journey thus far. In my previous career of aerospace engineering, I was a “translator” of sorts: I researched science and technology developments and helped others understand their benefits. Thanks to these skills, I’m able to understand lung cancer treatments and research. I’m able to explain what I’ve learned, both verbally and in writing, in everyday terms. And I’m able to advocate for myself with healthcare providers.
I have chosen to use these gifts to help other lung cancer patients by going public with my lung cancer in my blog, in online forums, and in public speaking. Most patients don’t know about the new treatments like the one I’m taking–even some doctors don’t know. Lung cancer patients need more than compassion. They need information about second opinions, mutation testing, side effects, treatment options, and clinical trials. They need HOPE.
Going public has also helped more people understand that ANYONE with lungs can get lung cancer—and NO ONE deserves to die from it. Lung cancer kills about as many people as the other top four cancers combined, yet it receives fewer federal research dollars per death than any of them. Why is that? Are lung cancer patients not worth saving? The answer becomes clear when you google the words “lung cancer people.” No throngs of ribboned supporters; few smiling survivors. You see diseased lungs, death … and smoking. Lung cancer has an image problem. The first question I hear when I mention my disease is: “Did you smoke?” People blame patients for getting lung cancer. The breast cancer community has changed how the world sees their disease. The lung cancer community must do the same. We’ve all done things that impact our health. Yes, it’s healthier not to smoke. But it’s not a sin that warrants the death penalty.
Precision medicine allows me to live with lung cancer as a chronic illness instead of a death sentence. True, it’s not the same life I had Before Cancer. I can’t do the active sports that I used to do. Chemotherapy left me with peripheral neuropathy and cognitive changes. Radiation scarred my lungs and damaged the nerve bundle for my right arm. A year of steroids packed on the fat while decreasing muscle tone. Crizotinib causes edema and graces me with antisocial gut behaviors. Some combination of side effects keeps my red blood cell count just below normal. When I exercise on the treadmill, I can’t get manage a brisk walk for more than 30 seconds without breathing fast and hard.
I’m not complaining, mind you–I’m happy to be alive and have a relatively normal life on targeted therapy. It even allowed me to play a casual game of softball in Cheney Stadium at my 40th high school reunion. The moment I put the glove on my left hand, my body recalled those years on the softball diamond. After some initial fumbles, I could catch, throw, pitch and hit. And I got to first base before the ball did. I could not have even reached first base while on chemo.
As a three-year lung cancer survivor, I’ve already lived beyond my prognosis. I will stay with targeted therapy and other clinical trials as long as my quality of life makes it worthwhile. Lung cancer research has found more new treatments in the past few years than ever before, and the pace of discoveries is accelerating. As people begin to realize that ANYONE can get lung cancer (including never smokers like me), the stigma will hopefully begin to fade, and research funding will increase.
We lung cancer patients deserve hope, and a cure. Every one of us.
I hoped it wouldn’t happen. But it did.
I stepped on the bathroom scale, and my weight was higher than “that number.” You know, that number all women have in their heads (even if we say we don’t), the one I can’t possibly weigh because it absolutely, positively, undeniably means I’ve hit an unhealthy benchmark.
I’ve tried to be patient with myself. I know much of the sixty pounds I’ve gained since my cancer diagnosis can be blamed on chemo-induced menopause, metabolic changes, reduced activity due to side effects of lung cancer treatment, a year of steroids, and edema caused by my current targeted therapy, crizotinib. (Notice I’m not mentioning my fondness for chocolate—allow me the comfort of a small rationalization.)
Yet the scale kept creeping upward until it hit “that number” a week ago. I suppose I subconsciously acknowledged the possibility when I donated all my large-sized clothes a couple of months ago, when I had to buy 2X jeans to be comfortable.
I had hoped I could ignore it, that I could just say I’m happy that I’m still alive three years after my cancer went metastatic, that I could settle for being “that number.” But BMI doesn’t lie. My every-8-week PET scans consistently show fatty liver. I am not just overweight. I am OBESE, and putting myself at risk for lots of nasty health conditions. This doesn’t make a whole lot of sense, given I’ve worked so hard to beat the lung cancer odds. All my cancer doctors say it’s OK if I want to lose weight intentionally, in a reasonable manner.
Over a decade ago, I lost 50# and kept most of it off until I got cancer. However, I’ve not had much success with moderate measures since my cancer diagnosis. I’m going to have to be strict with myself, and keep it going for months. I’m not looking forward to it, but that’s how it is.
So into the weight loss trenches I go. Tossing out the tempting goodies and hiding the Halloween treats. Aiming to eliminate simple carbohydrates. Saying no to some foods I prepare for my family. Tracking my fat, carbs and protein with the LoseIt app on my phone. Tracking my steps and calories burned with my Fitbit band (good thing the two devices talk to each other). Keeping my calorie deficit above 500 calories per day. Exercising at a moderate pace over 30 minutes per day.
You’d think my body would appreciate this. You’d think it would reward me by showing at least a little weight loss after the first few days of self-discipline. Instead, I gained. But I have a legitimate excuse, honest:
Apparently my edema doesn’t agree with my new diet. Sigh.
Denver gifted me with a warm, bright day today — clear skies, 60 degrees, a hint of breeze — perfect for sitting on a sun-drenched bench and basking in the glow of another clean scan. I’m still No Evidence of Disease (NED) status. Woohoo!
You’d think I would have had enough radiation for one week, but that spring sunshine was simply irresistible after such a long winter.
I had a PET-CT scan as well as a brain MRI and lab work yesterday, and had my once-every-eight-weeks visit with my clinical trial oncologist Dr. Camidge at University of Colorado this afternoon. Today I started cycle 19 on the drug Xalkori. Each cycle is 4 weeks, so I’ve been on this drug trial for 76 weeks now, which is almost 17 months.
I’ve been NED for nearly 15 months on Xalkori. According to interim results published about this clinical trial last year, only myself and one other person achieved NED on this trial. It’s possible I don’t have many cancer cells available to mutate and develop resistance to the drug. My particular flavor of lung cancer (ROS1-driven NSCLC) hasn’t been studied very long — the first article about it was published in January 2012 — so little data exists to know what will happen in my case. Xalkori may continue to suppress my cancer for years. It’s cool to hear my doctors say they have no idea of how long I might have left, and know they’re being honest with me. I’m an outlier for those gloomy stage IV lung cancer statistics.
I feel so fortunate to be blessed with more time to enjoy family and the miracle of life. I aim to make good use of it.
Speaking of making good use of my time … should I mention I have to work on tax returns after I fly home? Nah.
Here’s an inspiring and hopeful talk about finding cancer treatments.
Targeted therapies are revolutionizing the way cancer is treated. One of the leaders of this revolution is Dr. Ross Camidge, Director, Thoracic Oncology Clinical Program at University of Colorado Hospital. He recently gave a talk to Colorado State University’s biotech students, using examples of his lung cancer research to inspire the students to careers in biomedical science.
RECAP — Mantras of the Cancer Revolution:
The revolution in cancer treatment happened when the effectiveness of crizotinib for ALK+ lung cancer was discovered. “The whole drug development industry in cancer changed overnight. It wasn’t about finding one drug that was going to work a little bit in everybody. It was about findiing a drug that worked amazingly well in a small number of people.”
Camidge stated the following “mantras of the cancer revolution”:
1. One size does not fit all
(personalize cancer treatment based on each individual’s cancer)
2. Don’t walk away from a good thing
(if the targeted drug is working, stay on it as long as possible)
3. If the cancer moves, follow it
(if the cancer moves into brain, make a drug to treat the brain)
4. Question everything
Disclosure: Dr. Camidge is my clinical trial oncologist. I feel incredibly blessed to have him leading my lung cancer team.
This morning, after I checked a few posts and messages in an online cancer forum, hubby Gerry and I made a Costco run. Our conversation en route was pleasant enough, but I found myself feeling increasingly grouchy. Today was a crispy, brilliantly sunny day in Western Washington. Why was I leaning towards dark?
When I started talking to Gerry about conversations on the cancer forum, I realized why. A friend in my ROS1 lung cancer trial who has been on Xalkori for a year longer than me and whose cancer is slower growing than mine, told me his last scan showed a possible progression.
He was calm and composed about this. Both he and I had been told the effectiveness of Xalkori against our ROS1 cancers won’t last forever, that we’ll eventually develop resistance to the drug. We both were given contingency plans for treatment once progression showed up. This wasn’t an earth-shaking, end-of-life event.
But yet, it was a noteworthy event for me. Those hypothetical discussions had just become real.
I’ve had clean scans for ten months. I usually feel good (I’m used to overlooking both the temporary and permanent side effects of treatment). I’m exercising and gradually regaining some of the muscle mass I lost in cancer treatment. I’m writing again. I’m going out with friends. I’m even planning some vacation travel for next year. Most days, I don’t think of myself as a cancer patient. I can sometimes even blog about my cancer without the gut-wrenching realization “I have CANCER” sneaking into my awareness. Life is … NORMAL (for unusual definitions of “normal”).
But normal will not last. Cancer survivor reality raised its ugly head. Someone among the thirty-some members of my ROS1 clinical trial — someone I know personally — probably has progressed. We ROS1ers are NOT invincible. Xalkori will NOT last forever. This time next year, I might be dealing once again with radiation, chemo, or a new trial drug. My grouchiness was similar to that caused by scanxiety: I had to face the reality that my cancer will likely come back.
Once I identified the source of my fears, the momentary darkness passed, and life went on.
We bought a nice bottle of Bailey’s Irish Cream at Costco.