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

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.

Thursday, February 4, 2016

World Cancer Day: Honoring My Online Patient Community

Today is World Cancer Day, and my thoughts turn to my relationships with other lung cancer survivors. How does one meet other people dealing with the same disease you have? It’s not easy. Doctors and nurses are bound by confidentiality regulations, so they can’t introduce us to each other. I live in thinly populated northern New York, so there aren’t many people in my situation near me. There aren’t support groups near me, indeed there don’t seem to be many support groups for lung cancer anywhere. The joke is that organizers can’t keep the groups together because the participants keep dying.

When I needed to find others who really, really understand, I turned to the Internet. Lung cancer patients have built friendly, lively, and supportive communities online. We friend each other on Facebook, we follow each other on Twitter, we find out about each other’s blogs and read them. We have organized Twitter chats where we trade information and thoughts with patients, medical professionals, and advocates. A handful of people who are very generous with their time have built a website, lcsmchat.com, that pulls us together. We also meet on patient support forums and websites like inspire.com, smartpatients.com, and cancergrace.org.

I will inevitably leave someone off my list of people with whom I have an online relationship that is important to me, but here are some people who give me strength and make me smile:

Janet. She is everywhere, posting information on research and patient empowerment on all of the online communities that I frequent, flying hither and yon to do presentations, organizing Twitter chats and other group projects. Her blog is the first lung cancer blog I followed. Besides being a retired engineer, she is also a science fiction writer.

Linnea. She has an artist’s eye and posts the most marvelous links on Facebook, from the mysteries of nature to high fashion. She has been living with lung cancer for 11 years, and has participated in three phase 1 clinical trials, where she has been one of the first people in the world to take a new drug. That is bravery.

Craig. He has the same mutation I have, and was in a clinical trial for the newly approved Tagrisso, a drug that may be my next line of therapy. He’s currently in a rough patch, beating back new progression with chemo and trying to line up his next clinical trial. He gives great blog, filled with honesty and humor. 

Celia. She is in the same clinical trial that I am in, and about to celebrate two years of stability. Once a month she blogs about her treatment with great humor. She’s also a retired engineer, so her blog is strong on facts. She has reached out to many on the inspire.com forums with information and tactful empathy.

Denise. She is another longer term survivor of lung cancer who is very well informed and generous in reaching out to others with information and treatment ideas on the patient support forums. She has a big heart and lots of good ideas. She suggested today’s blogging activity by several lung cancer bloggers on this theme.

Neal. She’s a new online friend with a very entertaining blog. She’s also learning how to knit!

Tori. One of the first blogs I found, she’s a mother of young children going through a second major cancer in her lifetime. She also wields humor skillfully, and is very open about the emotional side of what her cancer means to her loving family. She and her husband recently opened the Pointless Brewery and Theater in Ann Arbor, MI, and I was glad to be a backer of their Kickstarter campaign.

Nancy. I met her on SmartPatients.com. She and her husband ended an idyllic retirement in the midst of her illness to make a new home for their daughter and grandchildren. She also deals with a long-term autoimmune disease on top of her lung cancer. We spent a few hours together enjoying lunch and a long chat this summer, and we are looking forward to seeing each other again in a few months at the National Hope Summit.

  Nancy and I do lunch.

Deana. She is @FacesofLungCancer on Twitter, and is a pioneer in using the Internet to pull everyone involved with lung cancer together to create the community we have today. She is tireless and skilled and warm.

Naomi and Kelli, the two people I interviewed in November 2015. We shared much with each other as we created the interviews together, and I’m deeply grateful to them both for being so open to me.

Then there are the people I interact with on inspire.com’s forums. Judy, who is an encyclopedia of knowledge and bracingly candid, answering questions posed by everyone who posts. Louise, who posts fun videos and snarky e-cards to cheer us up, and also reaches out to others with the deepest empathy I’ve ever witnessed. Kate, whose husband was in the same trial I’m in for a while. 

It takes courage to reach out (and a device that connects to the Internet), but more and more of us are doing so and discovering that we are not alone. The information we share with each other is valuable, and the friendship we share is priceless, and our community has no borders.

#WorldCancerDay #lcsmchat #lcsm

Monday, November 16, 2015

Profiles in Lung Cancer: Kelli “Cat” Joseph, Survivor

Profiles in Lung Cancer: Kelli “Cat” Joseph, Survivor

Lung Cancer Awareness Month 2015
Day 16: Kelli “Cat” Joseph, Survivor
“If there was ever a time in history to get lung cancer, that time is now.”

Each day during Lung Cancer Awareness Month (November), a lung cancer blogger will share a profile of someone involved with lung cancer. The person profiled might be a patient, caregiver, advocate, researcher, or healthcare provider.

My own observation about the online lung cancer advocacy community: although smoking causes an awful lot of lung cancer, most advocates whose work I know about are never-smokers. Why aren’t more people with a history of smoking involved in advocacy work? I don’t know. The stigma against lung cancer runs deep in our culture, so shame and guilt may keep people silent, even when it’s in their own best interest to speak up.

I’ll say up front that I am an ex-smoker. I quit in 1981 after accumulating a 7 pack-year history. My cancer’s driver mutation is not usually seen in smokers so smoking probably didn’t cause it per se, but no one knows whether or not the first mutation that started me down this path happened back then, waiting patiently for other mutations to join it and create a cancerous cell. This post is Kelli’s show, not mine, but I have first hand experience from both myself and my loved ones of how cultural influences can make it easy to smoke, and of how hard it is to quit.

Kelli “Cat” Joseph is open about being an ex-smoker, and she is also open about believing that smoking caused her cancer due to the type she has. She quit her tobacco addiction 6 years before she was diagnosed with lung cancer. I’m very happy that she was asked to be interviewed during Lung Cancer Awareness Month to share her perspective on and experience with this disease. 

I interviewed Kelli over the phone, writing furiously as she shared her experience and ideas. She also shared her warmth and humor with me, and I hope you can see a glimmer of them in the interview.

Kelli, tell us about yourself.

I’m a 48 year old lung cancer survivor, currently NED (no evidence of disease). I am a wife to a gorgeous, caring, patient husband, and we are parents to a beautiful, loving, smart teenage boy who has been so resilient throughout the ups and downs of this cancer ordeal. He is amazing. I’m also a business owner. I have a bar called The Cuckoo’s Nest.

That sounds like a recipe for being very busy. Is it fun to be a bar owner?

Yes it is, and it’s even more fun now that the bar is smoke free. When I think of how much second hand smoke I breathed in from the age of 17, I’m very happy that smoking in my bar is now against the law.

What is your diagnosis, and what treatments have you had?

I was diagnosed with squamous cell lung cancer on Friday the 13th, January 2012 after a year of being treated for asthma. Nope, I didn’t have asthma after all. I had a lower and middle lobectomy of my right lung, followed by 35 rounds of radiation. Then I had a recurrence in a lymph node on my heart in 2013. My local doctors wouldn’t touch it so I went back to Northwestern University in Chicago, where the awesome surgeon who did my original surgery said she could take care of it. She did a VATS (video assisted thoracic surgery) procedure that involved going into the pericardial sac. I struggled with pneumonia and shingles for a year while recovering from this surgery. I’m also thankful for the fantastic, groundbreaking lung cancer oncologist who keeps me alive today. I’ve been NED since my last surgery.

What is a typical day for you?

I keep up with lung cancer social media as best as I can, but my family and business keep me busy. I do my best to enjoy each day. I couldn’t do any of this without help from family and friends because tiredness and nerve pain are still issues for me.

What is something that we might not know about you?

I’ve been heavily involved with an online smoking cessation support community for 12 years. Not everyone with lung cancer was a smoker, but the majority were and the more people I help quit now, the less disease we’ll have in the future.

My quit smoking sponsor’s birthday is August 1st which is also World Lung Cancer Day, and he was devastated when I was diagnosed. This year I decided to go all out to celebrate World Lung Cancer Day: I went sky diving. I loved it, and I’m going to do it again!

Here’s an odd story from my life: 18 months before I was diagnosed my beloved cat Rocco died of lung cancer. (Yes, I had smoked in the house when he was young.)

What do you want us to know about lung cancer?

The polarization between lung cancer victims who were smokers vs. non-smokers needs to end now so that we have a chance to get more funding. Funding for AIDS increased when people with AIDS stepped forward and said we don’t deserve this, no one deserves this. We need all lung cancer people to unite and step forward in the same way. We perpetuate the stigma when we ourselves in our LC community are shameful about smoking history.

Every lung cancer patient has had the experience of telling someone he or she has lung cancer, and having that person respond by asking “Did you smoke?”, rather than by saying they are sorry, or asking how you are doing. How do you respond to that question? Does it sting?

This question doesn’t sting me, because I hold myself accountable for my prior actions. I love this question because it gives me a chance to advocate against cigarettes. I grin and say, “Yes I did. If you smoke or have a loved one who smokes, please, please quit or help them to quit!” Hey, I don’t mind being a bad example, I’ve been one all my life one way or another. I’ll admit, there are ways of being a bad example that are a lot more fun.

The lung cancer advocacy effort focuses on a message that “anyone can get lung cancer”, and can get perturbed when major cancer organizations focus on smoking cessation as part of lung cancer awareness campaigns. How can we better balance positive attention to our disease with an important message of disease prevention that could save many lives?

Common sense would dictate that if we could eliminate smoking, we could eliminate 80% of lung cancer cases. Just think of how many resources that would free up to help non-smoking lung cancer victims. We need to come together and support lung cancer prevention as well as better treatments.

I support low dose CT scans for everybody starting at age 30, with repeat scans every five to ten years for those who have negative scans. Anybody can get lung cancer, so let’s screen everybody, not just people over age 55 with a long-term smoking addiction. I hope that’s something the entire LC community can also support.

What brings you hope?

If there was ever a time in history to get lung cancer, that time is now. New discoveries are happening in leaps and bounds. Government funding is increasing but we still have a lot of work to do to make it comparable to the funding that is awarded to other, less deadly cancers.

Twitter handle: @thecuckoosnest

Yesterday’s interview with Lucy Kalanithi was on Lisa Goldman’s blog Every Breath I Take.

Tomorrow’s interview with Kim Ringen will be on Tori Tomalia’s blog A Lil Lytnin’ Strikes Lung Cancer

All profiles can be found the day after posting on the #LCSM Chat blog at http://lcsmchat.com/. A list of links to all the profiles on the original bloggers’ pages can be found at on the #LCSM Chat site on the Profiles in Lung Cancer page.

Wednesday, November 4, 2015

Profiles in Lung Cancer: Naomi Farley, Caregiver

Profiles in Lung Cancer: Naomi Farley, Caregiver

Lung Cancer Awareness Month 2015
Day 4: Naomi Farley, Caregiver
“Hope is so important...”

November is Lung Cancer Awareness Month, and each day a lung cancer blogger will share a profile of someone involved with lung cancer. The person profiled might be a patient, caregiver, advocate, researcher, or healthcare provider.

I knew that I wanted to interview Naomi Farley when I saw that she is a caregiver and that her husband Corky is in a clinical trial. When I talked to her on the phone and read her answers to my questions, I discovered that there are parallels between Naomi and Corky’s life and the life that my husband Robert and I share. Both couples have been together about 40 years, and each family has a child mid-20’s in age. Corky and I share the same EGFR driver mutation, and both Corky and I have retired due to our lung cancers. Finally, Corky and I are in the same clinical trial, a TIGER trial testing the efficacy of CO-1686, also known as Rociletinib, for EGFR patients who have developed a T790M mutation during treatment. Corky's trial is at USC Norris and mine is at Roswell Park, a continent apart from each other. He’s in cycle 10, and today I’m on the road to Roswell Park for day one of cycle 8.

Naomi’s connection with lung cancer:  

I am my husband Corky’s caregiver. Corky was a coach running an after school athletic program when he was diagnosed with stage 4 adenocarcinoma. He has never smoked in his life. Our oncologist tested him right away for a genetic mutation, and found he has the EGFR mutation. Corky went on Tarceva as soon as we had his biopsy results. Tarceva was effective for 2 1/2 years until earlier in 2015 when he enrolled in the Clovis CO-1686 clinical trial. He is now in Cycle 10 of the Clovis trial (end of October 2015) and doing very well. 

What is a typical day for you and your husband?  

I go to work as a mortgage banker and my husband gets up, checks blood pressure and blood sugar and then takes his first dose of the day. He journals his meds and vitals. One to two nights a week he coaches an adult basketball league but he is retired and has not worked with kids since his diagnosis.  He is a night person, so he’s up late at night reading, researching online and watching sports.

Tell us something we might not know about you and Corky:  

There is always some kind of game on at our house: baseball, basketball, football, golf, track and field. If we want to watch a movie it's going to be after the game(s). 

What do you want us to know about lung cancer?   

The initial diagnosis is such a shock and very frightening, but we want people to know that with the rapid development going on with target therapies and immunotherapy it becomes more of a long term disease management lifestyle. And we hope that people getting diagnosed today learn of these options quickly as we did, because hope is so important when one is diagnosed with LC and it is stage 4. No one deserves this. My husband never smoked but still the assumption from outsiders is that he must have. We have learned how difficult it is to raise awareness of lung cancer due to the stigma. 

How do you and Corky divide the work that comes with managing a serious illness? Who does the research, takes care of record keeping, and asks the hard questions of the medical team?  

We share the work involved with this diagnosis. During the period when the doctors were staging his adenocarcinoma, he developed severe pain due to bone metastasis and was on morphine for 4 months. He went from being an active coach running an after-school athletic program to a week of hospitalization for pain management and then finally stability after treatment with a targeted therapy. This returned our lives to a new normal. He was not able to continue coaching and spent several months in a fog. As a result I managed the initial record keeping, but he soon recovered, recorded all of his meds, and started asking questions, reading, and researching. He wants me at all of his doctor appointments to help take notes and ask questions of the doctors because there are so many details to remember. We work as a team. I think it is so important for the doctors to hear from the patient, but I do a lot of gentle "filling in".

Tell us what it’s like to be in a clinical trial. How did you find out about the trial that your husband is in? What hoops did you jump through to get started? What is a typical day at the trial clinic like?

Being in a clinical trial is hectic at times but we are so grateful to be in it. We are also very conscious of how lucky we are to be close to USC Norris. We first heard about the trial from an acquaintance but at that time the first targeted drug was still working and the trial was not available near us.  After 2 1/2 years on Tarceva, our doctor said that Corky’s options were to go on a chemo cocktail every 3 weeks or wait a little longer for the trial to open at USC. The decision was left to my husband and he held out long enough to have another biopsy, which showed that he has the T790 mutation needed to qualify him for the trial. He entered the Clovis trial in early April 2015. I think many people would have been nervous about waiting (I was), but my husband Corky's courage paid off. Having another biopsy is a leap of faith that participants in clinical trials must go through. The doctors thought it likely he had the right mutation but it cannot be guaranteed. Hopefully in the not-too-distant future there will be blood or urine tests that will reveal mutations rather than requiring biopsies. There is a lot of fantastic research going on.

The first several weeks we were back and forth to the clinic often. Again, we’re so fortunate to live close by. We were told the specific trial he is in closed a few months after he enrolled, so we continued to feel fortunate. Within a month of starting treatment he could feel positive effects with no more severe coughing. Our first scan showed significant shrinkage, however since then the scans show stable rather than shrinkage. But stable is good. There are lots of side effects that are different from Tarceva’s side effects, but with persistent stable results we continue to feel grateful. 

A typical day at Norris starts at 7 AM with 8 hours of fasting prior and a stop at the lab where they draw 10-12 vials of blood. Then we see the doctor and research nurse. Vitals are taken, discussion of how he is feeling along with any side effects are noted, and then he is hooked up to the EKG machine. Once that is done we head out to a nice garden area to eat, take the morning dose and wait 2 hours. Then back we go to the clinic for another EKG before getting our supply for the next 3 weeks and heading home. The entire process usually takes 4 to 4 1/2 hours. 

We are now seeing the doctor every 3 weeks. Scans are every 6 weeks up until cycle 10 so every other clinic visit had a scan visit in between. You never know what side effects will develop. My husband developed bronchial spasms in reaction to the contrast dye given during CT scans after many, many scans and now has scans with no contrast. We just passed the 3 year anniversary of his diagnosis and are very grateful for the fact that he has been on targeted therapies from the beginning. Last week we found out the scans will be less often from now on.

Everyone at Norris is so upbeat and positive and kind. Even though we are surrounded by people facing incredible challenges, there is hope everywhere around us. 

What brings you hope?  

Research and our oncologist’s calm assurance that if this stops working we will try something else. Learning about others who are living with this diagnosis. 

What is your Twitter handle?  I’m Nay on Twitter, and my handle is @ChancesR3.

Yesterday’s post in this series was on Lisa Goldman’s blog Every Breath I Take.
Tomorrow’s post will be on Dann Wonser’s blog Dann’s Cancer Chronicles

All profiles can be found the day after posting on the #LCSM Chat blog at http://lcsmchat.com/. A list of links to all the profiles on the original bloggers’ pages can be found at on the #LCSM Chat site on the Profiles in Lung Cancer page.

Saturday, September 26, 2015

Knitting Blog: Well Traveled Socks Even Before Being Worn

It’s been too long since I last blogged, and I’ll have a quick update at the end of this warm-up post.

Late last fall my sister had a wonderful opportunity to go on a cruise on the Danube. It was a working vacation, because she was representing the public radio station where she works, but her price to be there was commensurate with the fact that she was on the job. She had a great time, and brought back a skein of yarn for me.

Opal Sock Yarn, from its motherland!

Opal makes the most interesting pre-printed sock yarns, with a wide variety of ever-changing patterns. This one appeared to be designed to be a bit chaotic, from the tiny thumbnail picture on the yarn’s wrapper:

These were a pretty fast project, taking me 4 months to knit while interspersed with other knitting projects. Then again, sock knitting is what I do on the road and in medical waiting rooms and I spend a lot of time in such places these days.

Focus on the socks:

Gosh, my pattens came out a lot like the ones on the ball band!

Here are gratuitous pics of me combining sock modeling and dog loving. All pics taken by my husband Robert.

Knit on size 1.5 needles (2.5 mm) in a basic toe-up design so that I could knit up all the yarn. They are on the tall side. I probably should have added a few increases towards the tops to make them fit my calves a bet better, but on the other hand, these are not going to fall down. I love them. Thanks, Julia, for the very cool yarn.

Now to my health update: I have passed the 15 week mark taking the trial drug CO-1686, and everywhere there is cancer inside me, there has been shrinkage, 43% on average. The side effects have slowed me down, however. For a while I had raging hyperglycemia and had to take metformin, which made me feel awful. I have lost about 15 pounds and had little energy for weeks. I’m using a different drug, Jardiance, to manage my blood sugars now, and am feeling much better. Here’s hoping that the pics above are as skinny as you will ever see me. Yes, my body image aesthetic has changed, and I think that being a bit plump, on the upper edge of the healthy BMI range, is beautiful. Gaining weight is a lot harder than losing it these days, and regaining those 15 pounds is going to be a long-term project.