"Be conservative in what you do; be liberal in what you accept from others.” Jon Postel

"Knit on, with confidence and hope, through all crises." Elizabeth Zimmerman

Thursday, October 13, 2016

Mutation Envy

Seen in a lung cancer foundation’s chatroom recently:

A: I wish I had a mutation.
B: I’ve got one. If you want it, you can have it.

This is something we don’t talk about in the lung cancer community, at least not out loud: that we might be envious of someone else’s cancer mutation. While personalized medicine is still an ideal rather than a reality, some lung cancer patients find themselves on the frontier of a different approach to medicine, one where each person’s treatment is based on her or his disease’s genetic profile.

in 2003, a medicine called gefitinib was approved by the FDA for treating lung cancer in all patients who had had chemotherapy. After additional research, this approval was rescinded in 2005, because the drug did not extend life over the population of patients as a whole. Doctors noticed, however, that the medication helped a minority of patients a lot, even as it didn’t help other patients at all. When researchers investigated why this was so, they discovered that the patients who responded to gefitinib had an epidermal growth factor receptor mutation in their cancer, or EGFR. The discovery set off a flurry of research into mutations in lung cancer tumors, and the current state of this research looks like this:

Source: “ALK Positive Lung Cancer” presented by Shirish M. Gadgeel, MD, at the Targeted Therapies in Lung Cancer Patient Forum, University of Colorado Cancer Center, August 20, 2016.

These mutations are nearly always somatic, not inherited, existing only in the cancer, and not in the rest of the body. Three of these mutations, EGFR, ALK and ROS1, have at least one FDA approved targeted treatment, and clinical trials are searching for effective treatments for others. In the case of EGFR mutations, the one I know best, there are now three generations of targeted therapies available, one of which treats a new mutation that arises during initial treatment. Mutations upon mutations!

Upsides and downsides, advantages and disadvantages, it’s always a mixed bag in Cancerland if you are stage IV and trying to live with your cancer as a chronic disease. Having a mutation can give you an edge and extend your life by giving you access to targeted medications that are easier on the body than standard chemo, but different people with the same mutation respond differently to treatment. Some may be stable for years on a targeted therapy, while others may develop resistance rapidly. There are no guarantees. I had a shock of realization when I saw these targeted treatments described as “palliative” in an article. They can hold the disease back and improve quality of life, but they do not cure.

Resistance is inevitable when you rely on targeted treatments. It has happened to me. After three months of treatment with erlotinib, my cancer had almost entirely melted away. At six months, however, it proclaimed, “I’m back”, and by ten months, when I changed treatments, it had grown to be larger than it was on diagnosis. I’ve heard of one case of a man who seems to have had a total response to erlotinib that has lasted for 10 years and who chose recently to go off treatment. He is a remarkable exception, and is truly stepping out into unknown and unique territory. It is more usual for patients to get an initial reduction in their cancer followed by stability  that lasts until resistance develops and the cancer starts growing again. If you are lucky, there will be a next generation drug you can switch to for another good year or so. If not, you join the rest of the lung cancer patients sitting in the chemo infusion chair.

Just because you have a mutation does not mean that you can find a treatment specific to that mutation. The science of identifying mutations and finding effective treatments is in its relative infancy. A good example is KRAS. As of this writing, no targeted therapy has proven effective in trials, and standard treatment (and prognosis) is the same as for a patient with no targetable mutation. Thus, “Take my mutation. Please.”

Ironically, having a targetable mutation may mean other good treatments are less likely to help you. Immunotherapy is a case in point. This is the hottest development on the lung cancer scene, and two FDA approved drugs are now available for patients who have had chemo. A very recent study demonstrates that one of these drugs, pembrolizumab, is more effective than chemo in newly diagnosed patients, a finding which is going to rapidly change how lung cancer is treated. Meanwhile a third drug has successfully completed trials and is expecting imminent FDA approval. However, subgroup analysis indicates that response rates to immunotherapy in people with the EFGR mutation are lower than they are to crappy second line chemo, and indications are that the ALK and ROS1 folks are in the same situation. For those of us with these mutations, immunotherapy is probably a Hail Mary treatment to try after everything else has stopped working.

I’m now on my third targeted therapy for EGFR mutations. I took erlotinib from August 2014 through June 2015, and developed the resistance mutation T790M during this first line of treatment. I then enrolled in a clinical trial for rociletinib. This drug did an impressive job of shrinking my cancer by 43%, but it was also very toxic. Fortunately I was able to slide on over to osimertinib when I was booted from the trial in February 2016. This EGFR and T790M inhibitor had been FDA approved only three months earlier! I’ve been on it for eight months now, which frankly is longer than I expected to benefit from the drug, because I had already taken a T790M inhibitor for eight months. I’m stable and feeling great. We shall see what we shall see when I have scans in December.

The future I am hoping for is one with many effective treatment options so that it doesn’t matter anymore whether you have a mutation in your cancer, or which one it is. I’m looking forward to the day when all patients with stage IV lung cancer can live a goodly portion of their expected lifespans with good quality of life. Then we won’t be envious of anyone, or at least of each other.


For a comprehensive and detailed discussion of lung cancer mutations and treatments, I recommend the following article, written by Lecia V. Sequist, MD, MPH and Joel W. Neal, MD, PhD.

The history of gefitinib:

On pembrolizumab’s successful trial as a first-line treatment:

On nivolumab vs. docetaxol, with data showing poor response to nivolumab in EGFR patients included in discussion portion:

General presentation by J. Soria, includes slide from Hellman presentation at WCLC 2015 showing poor response to pembrolizumab in EGFR patients (original presentation slides behind paywall) - 48th slide:

Tuesday, September 20, 2016


Several years ago I set about writing a condensed biography to use on my blog and on other social media sites. As I’ve changed the bio over the years, I have kept one phrase: “I’m very content to be one of the little people, whose names aren’t recorded in history books and who are remembered only by family and friends after they die.” Perhaps memories of my voice and my face may fade, but it seems that my name will be around for a while. I had a kitchen dedicated to me on September 9, 2016.

Planning for the kitchen was well underway at the time I retired. Since then, my former boss and Executive Director of the agency, Patrick Ames, put together the funding for the project. What made the project possible was a change in funding rules that allowed USDA Rural Development to partner with the agency.

The dedication ceremony was as good an experience as I could have imagined. There were speeches by State elected officials, a County executive, Patrick, the Board President, and me. The other speeches talked about how the kitchen will be used in the future and about the partnerships that made it possible. I talked about the history of the facility and how the kitchen gives this Cooperative Extension agency its heart. There is more about the background of the project in the attached newspaper links.

Best of all for me were the people who came to remember me - friends, former coworkers, and family. My sister Julia took a day off from work during a busy time to bring our 90 year old mother to the dedication. Mom is a retired Cooperative Extension Foods and Nutrition Agent, and it seemed especially fitting to see her standing in the kitchen.

From left: Julia Figueras, Jan Hickman, Anita Figueras, Robert Best
Photo credit: Judy Andrus Toporcer, www.WizenedEye.com

Newspaper articles:



Wednesday, July 13, 2016

Going Blind

Feet on the sidewalk
I feel kinda sick
Hands out front
I need a white stick
Blurred in the morning
Bruised at night
Falling in the darkness
Could've been a fight

My blind life
I can’t see the road
I can’t see the light
 - My Blind Life by Chris Dreja, sung by The Yardbirds

Those lyrics are exaggerated, but I am going blind. Thanks to rociletinib, the experimental drug I took for eight months, I have rapid onset cataracts.

From Wikipedia 

Fortunately, this problem can be pretty easily fixed. Massachusetts General Hospital sent all of its patients who took rociletinib and developed cataracts to a specialist from Tufts University, but we are lucky to have a very skilled eye surgeon locally. He has scheduled me for surgery as early as possible; I get my right eye fixed on July 26, and my left eye fixed on August 9.

It’s a fascinating experience. The first sign was in late April, when my eyeglasses no longer corrected for distance vision. After years of not seeing anything in focus without glasses, it was weird to have my distance vision apparently improve. That has changed as a white mist deepens over the whole world almost daily. Now my near vision is weakening. I have turned on accessibility options on my electronic devices, which is a big help. Sock and fine lace knitting have been put aside for now, and I have begun a sweater in much bigger yarn. Going from 8 stitches per inch to 4 stitches per inch is just like turning on accessibility options - double the font size!

I have given up driving until after surgery. I certainly should not be driving at night. Trying to drive my husband home from the hospital after dark last week was a failure, as the parking lot looked like a lawn and I struggled to see where the road was. (He had broken his thumb while we were splitting wood, and he was the one to drive home.) Right now we are having an enforced staycation as he recovers from arthroscopic knee surgery. We had an epic grocery shopping trip this past weekend, and are all set to stay home for a while. Friends stand ready to help as needed.

I feel a great deal of sympathy for the genteel ladies in 18th and 19th century novels, who lose their ability to support themselves with fine needlework when their vision weakens. I’ll say this for knitting: many experienced knitters can knit by feel alone. To a limited extent, I can as well.

Cost/benefit analysis of medical procedures is something I think about, and here I am, having more expensive medical procedures when the length of time I’ll be able to use those shiny new intraocular lenses is a great unknown. Still, this is a major quality of life issue, and I am grateful for excellent health insurance which will pay for these surgeries without a quibble.

Sunday, July 3, 2016

Conference Fever

Does it sound strange to spend a weekend with 300 lung cancer patients and caregivers? Does it sound gloomy or frightening? It turns out that if you are a patient or caregiver, such a weekend could be a highlight of your year, one filled with hope and fellowship.

In late April, Robert and I set out on a two week trip that combined conference going with vacation. Our first stop was Burlington, VT, where we attended a day-long Lung Force Expo. This was an interesting day, filled with good information about managing one’s health with a serious lung disease and with information about the great promise of lung cancer screening. I was able to meet some fellow patients and some doctors who are relatively close to me in what is a terrific little city to visit. It also served as a warm up event for what was coming up next: the annual HOPE Summit put on by LUNGevity in Washington, DC.

We flew from Burlington to DC, thanks to a travel grant from LUNGevity that paid for my airfare and for two nights at the hotel where the conference was held. I am very grateful for this travel assistance, awarded to many first year attendees, because it made it possible for us to find out how valuable conferences can be. It was also terrific to avoid the all-day car trip that would have been necessary otherwise. Robert has been dealing with a painful knee for several months, and flying was a lot less wear and tear on our bodies. 

It was heartwarming to arrive at the conference site and enjoy mutual instant recognition with many of the people I have met on the Internet since I started reaching out to the lung cancer community. The feeling of comfort grew as the three days passed. The conference organizers made sure to mix us up so that we would meet as many people as possible, and I discovered that I could sit next to anyone and enjoy a friendly, informative, supportive exchange. Lung cancer patients are a tribe, and conferences are where we gather to celebrate and support each other.

They are also where we gather to learn. In the course of three days, I attended an intensive day devoted to improving advocacy and outreach and sessions on research, nutrition, clinical trials, and story sharing. There were also some sessions for caregivers that Robert attended, though he said those sessions were much more emotionally searing than the concurrent sessions for patients and survivors.

Besides the formal sessions, there were serendipitous meetings with other attendees in the unscheduled times. Where else could we meet a couple in the bar where the man had been in the same clinical trial I was in and had had all the same side effects, plus rapid onset cataracts (which I was beginning to develop)?They emailed me the name of the doctor who had fixed his eyes, in case I needed to see a specialist in the future. Where else could I introduce myself to one of the doctors who discovered the driver mutation that I have, and enjoy a very warm and informative short conversation?

What did we look like as a group? LUNGevity had a very talented professional photographer there named Randy Elles, and he took this wonderful group picture. Both Robert and I are in this picture.

Randy Elles also took portraits of anyone who visited his photo booth, and he took this picture of Robert and me:

What was Robert’s take on these experiences? He’s been letting me be the one who digs up information, and he agreed to go with me to these conferences without being excited by the prospect of attending workshops. When I asked him, he said “I wasn’t bored.”

It turns out that there many conferences, many more than I could possibly afford to attend. A few weeks after the HOPE Summit, the Lung Cancer Alliance held a conference in Washington DC where participants got to go to Congress and advocate for increased research funding. How cool would that be? Recently, Free to Breathe held a Lung Cancer Leadership Conference in Minnesota, also focused on advocacy and including updates on research into the biology of metastasis. Then there are all of the professional conferences such as the ASCO conference held in Chicago in June, many of which are very happy to admit patient attendees (and collect an entrance fee in the process that can be pricey).

Right now I am working on the logistics of attending a different kind of conference, the Targeted Therapies in Lung Cancer Patient Forum, to be presented by CancerGrace in August. There will be no sessions on advocacy or fund raising, simply a group of oncologists getting up-to-date information to a group of patients. We have Robert’s knee surgery and my cataract surgeries to get through between now and August 20, but I am increasingly confident that I will be able to attend. I can hardly wait to get together with my tribe again - and to learn information specific to my lung cancer variant that just might extend my life.

And, I’ve estimated the cost of a return trip to the HOPE Summit next year, and I’m working it into the family budget.

Monday, April 25, 2016

Anita's Excellent Adventure: I Speak Before the FDA ODAC

During a clinical trial clinic visit in January, my trial coordinator at Roswell Park Cancer Institute asked me if I would be interested in speaking before the FDA’s Oncologic Drug Advisory Committee about my experience as a patient taking the experimental drug rociletinib. Clovis Oncology, the company that makes and is testing the drug, was hoping to receive accelerated approval to start being able to sell this drug on the market, and a hearing scheduled for Tuesday, April 12 before this important advisory committee was key. The company was looking for patients to speak about their experience with the drug. 

I immediately said yes. Such opportunities are rare, and it’s exciting to have an opportunity to be part of the important process of drug approval beyond taking a drug as an experimental subject. As a bonus, the hearing would be held in Silver Spring, MD, near where our daughter lives, and I would get to see her and her husband.

In February, I talked with an executive from Clovis, and he confirmed that the company would like me to speak, and would pay my travel costs. The following week I found out that my cancer had started to progress after two dose reductions of the trial drug, and I was no longer in the clinical trial. I immediately emailed my contact at Clovis, told him I’d been booted from the trial, and suggested that I might no longer be a good candidate to speak before the ODAC. I received a most gracious response back saying that they still wanted me to speak. To quote from the email, “If you are still up for it, it would be an honor and a privilege to have you speak to the Committee.” I was up for it.

A woman from an independent consulting firm contacted me to make arrangements. She arranged my flights and sent me a general outline of how these presentations are usually structured. This way Clovis did not know what I was going to say; my talk was not going to be reviewed or approved, and I was to speak candidly.

I didn’t fly first class, but this was a very comfortable trip. Clovis sponsored a dinner at the hotel where the other patients were staying with their families on Monday night, and we enjoyed meeting each other and sharing a delicious meal. Besides me, there were family members of a man who had died but who had five good months on the drug, an 84 year old man who had a nearly complete response, an army officer in his 40’s who had been diagnosed with stage 4 lung cancer while serving in Afghanistan, and Celia, a fellow blogger who I’ve been reading for many months. You can read her post about this experience at https://celpeggy.wordpress.com/2016/05/01/my-co-1686-speech-speech/. When I first found out about this opportunity for patients to speak about their experience, I thought to myself that Clovis really needed to have Celia speak to the ODAC, because she has been stable on rociletinib for more than 2 years, a remarkable run. And there she was!

Here’s a picture of me with Celia, my daughter Ana, and her husband Michael:


All of the patients and families, and a representative from Clovis on the far right. We came to speak from California, Oregon, Florida, New York, and Maryland.

The next morning there was a car at Ana and Michael’s apartment at 7:00 AM sharp to take us to the FDA headquarters at Silver Spring. The hearing wouldn’t start until 8:30, but our group needed all that time to get checked through security, which is as tight as at an airport, to sign in, and to find our seating section. Ana and Michael sat behind me. We would be speaking during the public comment period, and I drew number 4.

The hearing was very formal, with a uniformed designated federal officer and chairperson at the head table, members of the ODAC at two tables set up perpendicular to the head table, and a group of chairs for the drug company’s delegation to the left. A stand and microphone were set up near the designated row for open public hearing speakers. It was a big room with quite a few seats for the public and press to attend, and it was full, because there was a lot of interest in this particular hearing.

After opening statements, Clovis Oncology had 45 minutes to make its case. Using a powerpoint presentation, it presented data collected and analyzed from two phase 2 clinical trials, one of which was my trial. Clovis’ representatives discussed the pressing need for additional treatments for non-small cell lung cancer and rociletinib’s efficacy and safety. Dr. Ross Camidge, a leading clinical oncologist an researcher, discussed how the drug could make a positive difference in a clinical setting. The numbers all looked good to me as a lay person without the tools needed to analyze statistics on the fly.

Then the hearing was turned over to the FDA, who had 45 minutes to discuss their analysis of Clovis’ findings. They had a lot of concerns, especially about the drug’s safety and about the company’s proposal to increase the drug’s recommended dose by 25%. They were also concerned about the design of the phase 3 trial that is already in progress, saying that they doubted that the trial would prove one of the two objectives that the company wants to prove: what is the best dose of rociletinib.

The safety discussion was personally interesting to me, because the FDA is very concerned about the high incidence of QT interval prolongation observed during the trial. This is the side effect that ended up getting me booted from the trial  because I could not tolerate an effective dose of the drug (although the reason listed for me is probably disease progression). I was getting EKGs every three weeks, but once this drug is approved for clinical use, patients are unlikely to be so closely monitored. QT interval prolongation is silent, you do not feel it, and it can cause sudden death. I also learned why I had both hyperglycemia and QT prolongation. As rociletinib breaks down in the body, it produces two metabolites that are associated with these side effects. These metabolites are broken down by NAT2 acetylation. 40-60% of white and black people are slow NAT2 acetylators. The metabolites build up in the system for these people, resulting in side effects. I’ll bet you a dollar that I am a slow NAT2 acetylator.

After the FDA presentation, the hearing became a question and answer period, with members of the committee asking Clovis representatives for further explanations of their data. There were a lot of questions, and this section of the meeting ran over time. I’m afraid that the poor Clovis team must have been in a pool of sweat during and after this ordeal, as many of the questions were quite specific about aspects of the studies such as sample sizes.

My daughter the biostatistician was eating up this discussion. Later on she explained that many of the questions were probably based on statistical computations that committee members would be capable of making from the data presented. Her own back-of-the-envelope computation led her to think that the sample sizes in the phase 3 trial that is underway would be plenty big enough to prove efficacy compared to the standard of care treatments that rociletinib is being compared to, but not big enough to settle the question of best effective dose.

After the questions were done, we had a short break, then our group gave our statements, along with a doctor who spoke in favor of the drug and a representative from a public interest group who spoke against it. My nervousness transformed into nearly calm focus, and I spoke clearly. My statement was honest about my side effects, informative about how my medical team found a successful way to control hyperglycemia. and positive about my good quality of life and belief that patients and doctors need options due to the individuality of cancer.

After we spoke, the hearing switched gears, At this point, the FDA asked the committee members to make statements about their opinion as to benefit versus risk with this particular drug. The comments were cautious and concerned, and many of the speakers said that they were moved by our statements. Then the FDA asked the committee to vote on whether the FDA should wait until the phase 3 study was completed before approving rociletinib. The committee voted 12-1 in favor of the question. This was a very disappointing end to the hearing for Clovis Oncology. Drug approval may still happen, but not for more than two years in the future, as the phase 3 trial is not expected to conclude until 2018.

As we waited for our car, there was Dr. Ross Camidge on the sidewalk waiting with us. I went over and shook his hand, and thanked him for everything he is doing to advance the treatment of lung cancer. It was like meeting a rock star.

Our work was done, so I went home with Ana and Michael. After lunch, we went to the zoo. It was a pleasant sunny day, not too hot, and we were rewarded by seeing many animals out and about.

Moving otters are hard to photograph!

The lady lions were enjoying the vocalizations of a young male next door.

The next day, a car picked me up and took me to the airport, and my excellent adventure was nearly at an end. An hour later, I was in Syracuse, getting kisses from both my husband Robert and Samwise the labradoodle.

Thank you, Clovis Oncology, for giving me this opportunity to speak on the record about my experience with taking your experimental drug. Thank you for investing in the clinical trail that gave me eight months of good quality life. Your representatives were kind and supportive, and I wish you a path to success.

New adventures start up again, beginning tomorrow!

Saturday, April 2, 2016

One Stop Shopping: The Benefits of Care at a Comprehensive Cancer Center

There are two types of centers that treat cancer: community cancer centers, and comprehensive cancer centers. I recently had an experience that made it clear to me that if you can get yourself to a comprehensive cancer center, you will likely find that the additional travel and related expenses are worth it.

I began care at a community cancer center, the Richard E. Winter Cancer Center in Ogdensburg, NY. I love this center and my doctor there, and continue to have a relationship with it - that’s where I get my bi-monthly Xgeva shot. Community cancer centers are necessary and valuable, especially for standardized treatments, but they offer little access to clinical trials and highly specialized services. I need my local center, because if I need a standard chemo treatment, it’s crazy for me to travel 5 hours one-way for the same treatment I can have only an hour from home. My doctor there is very sharp and good at seeing me and my situation holistically, but she is a general oncologist treating all kinds of cancers, and there is no way that she can keep up with the literature for my particular type of cancer, especially when it’s one where there have been a lot of discoveries and new treatments over the past few years.

Once I decided to enter a clinical trial, that meant going to a comprehensive cancer center, because that’s where the trials generally are. I’m fortunate that there is a center “only” 5 hours from my home, Roswell Park Cancer Institute in Buffalo, NY. Logistically this is relatively easy for me, because I have family nearby in Rochester. We stay at my mother’s, and it’s a win-win - access to a top institution and more time with my mom.

What are the advantages of a comprehensive center besides access to clinical trials? I see a lung cancer specialist rather than a general oncologist, and she is completely up to date in her knowledge about new developments in research and treatment. All of the other staff in the thoracic center, nurses and mid-level practitioners, are very experienced with lung cancer patients and know what questions to ask. The CT scan reports are better, because the radiologists are also specialists. 

I recently had a clinic experience that brought home another advantage: just about everything I need is accessible in one facility, and all of the departments work together to take care of patients with needs. I showed up at the clinic two weeks into my new prescription of Tagrisso, and I had a number of side effects that could have been signs of something serious. I had a nasty looking red rash on my legs and some edema, which could indicate that the drug was affecting my heart. I was also already scheduled for a MRI of my brain because I had had a pesky headache for a few weeks. When I saw my doctor in the morning, she issued orders and what was supposed to be a leisurely day became a busy one. By the end of the day, I had received: a full round of blood work, a doctor visit, EKGs, a trip to the dermatology department where the rash was biopsied, an echocardiogram, a brain MRI, and a follow-up with my doctor. Besides being able to get everything I needed in one place in one day, everyone everywhere was kind, calm, and professional, never indicating that squeezing me into their day caused inconvenience.

By the way, the echocardiogram was probably the most interesting test I’ve ever had. The technician was a very warm and friendly woman, and she enjoyed showing me my heart in action, saying things like, “And here is the miracle of all four ventricles visible at once!”

By the time I left, I had good indications that my heart is not being affected by the Tagrisso. Whew! A call the next day let me know that my brain is free of metastasis, and the dermatologist called the next week to say no big problems were found in the skin biopsy.

While I continue my relationship with my community cancer center, I cannot imagine discontinuing travel to Roswell Park now that the clinical trial is over for me.

Here is a map of institutions that are members of the National Comprehensive Cancer Network (NCCN). Source: http://www.nccn.org/members/network.aspx

Monday, February 29, 2016

A Tale of a Trial

If there are demerit points for bloggers, I’ve surely earned quite a few by going through a clinical trial from entrance to exit without blogging about the experience at all. I will do my best to make up for this omission of potentially useful information with a synopsis of my experience.

If you have decided that a clinical trial might be your best next option, the first step is finding a clinical trial for which you match the profile of a qualified participant and that is at a logistically possible location. When my search for a clinical trial began in earnest in March 2015, I knew that there were two possible drugs that might be my best second line of treatment. One drug, AZD9291, had closed its trials and was moving towards FDA approval. The second drug, CO-1686, also called rociletinib, had an open trial at Roswell Park Cancer Institute in Buffalo, NY. I met the initial qualifications and I have family in Rochester, just an hour and a half from Roswell. So, game on!

How does a clinical trial start? With paperwork: the informed consent form. The trial I participated in was titled “A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)”, and the consent form was 26 pages long. I click right through online consent forms for software upgrades and the like, but I read every page of the consent form the night before the day when I would sign it, April 9, 2015.

For this trial, the next step after signing the consent form was a biopsy of my cancer to see if I had developed a T790M mutation during my first line of treatment. We biopsied a hot lymph node in my neck on April 27, 2015. Then I waited. And waited. And waited for results. It took about three weeks time, which were long weeks, as it was becoming pretty evident that my first line of treatment was failing. Finally the word came on May 15 that I was positive for T790M. 

I took my first dose of the experimental drug on June 11, 2015. This day began a new schedule that would take top priority in my husband’s and my lives for the next 8 months: travel to Roswell every 3 weeks, plus additional travel for CT scans. We could not have done this without support. A dear friend offered to housesit and take care of our pets, and he came to our home nearly every time we went to Roswell. My mother gave us a home away from home in Rochester, treating us to home cooked meals and relaxed evenings reading and watching the news. As an unexpected bonus, special cancer treatment coverage included in my health insurance paid all of my copays and reimbursed us for our travel expenses, because Roswell is a center of excellence in cancer treatment.

After the trial began, there was more paperwork. I was responsible for keeping a log of when I took each dose of my medication. I also logged daily tests of my blood sugar levels. These logs were turned in at each clinic visit, along with all pill bottles and any unused medication. On clinic days I filled out surveys and signed a few additional informed consent forms.

Side effects: there were quite a few, and at times my ability to adapt was put to the test. They included:
  • Hyperglycemia. This began within two weeks of beginning treatment, and for a while I experienced very high blood sugar readings, reaching into the 300’s and 400’s. I spent one night in the observation unit at a local hospital having my blood sugar levels reset with insulin, as the medications prescribed to control the hyperglycemia had not yet become effective. At first I was prescribed metformin and glimepiride, and they were not effective at making my blood sugars become stable. The metformin also made me feel terrible, with exhausting malaise and diarrhea. I cut way back on my intake of carbohydrates which helped with the blood sugar levels, but in combination with the metformin caused me to lose weight rapidly. My trial oncologist decided to work with my family doctor to get my hyperglycemia under control, and he put me on a different drug, Jardiance. This drug worked. My blood sugar levels stabilized, and so did my weight as my diet returned to normal. I also shed that pesky malaise.
  • Muscle cramps. At night time, my legs and feet would cramp painfully. I learned not to stretch in bed, and to walk the cramps away. This was annoying but tolerable.
  • Stuffed up ears. In August, I had an upper respiratory infection which resulted in swollen eustachian tubes that took months to unplug. This side effect probably was the most annoying one I experienced. I didn’t like not hearing clearly, and my husband surely got tired of me asking him to repeat nearly everything he said to me. I believe the slow healing from the infection was caused by lower than normal counts of both red and white blood cells.
  • QT interval prolongation. This is the side effect I could not control, and which resulted in the end of the trial for me. Long QT intervals in the heart rhythm are bad, potentially resulting in sudden death. Twice my QT interval went over the upper limit defined in the trial protocol, and as a result twice my dosage of the experimental medication  had to be reduced. My final reduction was in mid-December 2015, a week after CT scans showed my cancer to be stable. I was now taking half the dose that I was taking at the start of the trial. CT scans done 8 weeks after that dose reduction revealed that my cancer had started to grow again, both in the primary tumor and lymph nodes, plus I had a brand new pericardial effusion. The conclusion: I could no longer tolerate an effective dose of the medication. 
My listing of side effects above might sound discouraging. I need to add that I had many, many days when I felt good during this trial. Overall, I would rate quality of life as decent to good to great, depending on the day,  particularly considering the alternatives available to me during the time of the trial. I have absolutely no regrets, and a great deal of gratitude that this treatment was available to me.

Sayonara, clinical trial. Patients say they are kicked off of or booted from a trial, and that’s what it feels like. I didn’t expect the trial to end for me when I went to Roswell on February 18. I had to make a decision as to my next step right then and there, and that was nerve wracking. Chin up, though. I got through the day, and I have not shed a tear. I would sign up for another clinical trial in a heartbeat.

Fortunately there is a good option for my third line of treatment - that drug that had closed its trials back in March 2015. It is now FDA approved, newly named as Tagrisso, and available by prescription. I started taking it just under a week ago, and already I feel better. This is a good alternative because we think the growth of the cancer was due to me not being able to take enough of the drug, not to the cancer becoming resistant to the drug. If resistance was the issue, Tagrisso would be less likely to be effective because it goes after the same target as rociletinib.

I have more trial related news, but that is best saved for a new blog post as this one is quite long enough, and doesn’t even have any pretty pictures to accompany it.