Category Archives: clinical trial

Cure Talk

I was recently interviewed by Priya Menon for Cure talk. Cure talk is one aspect of trialx, a website devoted to clinical trials which is also home to Dory, an interactive guide to help patients locate appropriate clinical trials.

As I am currently researching my own next best options (primarily so that I may ask more intelligent questions when I next meet with Dr. Shaw) I gave Dory a run through. Although disappointed that I could not refine my search so that it was limited to ALK mutations, I did find a trial for an HSP-90 inhibitor that I was previously unaware of.

Also, I perused the fine print, and I feel that the site is very up front about what kind of aggregate information it gathers and for what purpose. The interview follows:

Me: How did the idea of a lung cancer blog come about?

Linnea: My oncologist at the time suggested I write a blog. I had already been toying with the idea, and he knew I was interested in becoming more involved with advocacy. I believe he also felt the arc of my story–almost losing hope only to be ‘saved’ by an experimental therapy–could be inspirational to other patients with advanced lung cancer.

Me: How has your blog, ‘Life and breath: Outliving lung cancer’ helped you in your cancer management?

Linnea: Authoring the blog has helped me cope with my own diagnosis in more ways than I could have imagined. Initially, I felt that at the very least it would serve as a chronicle of my experiences, a small legacy for my children. I hoped the blog could be something more. As someone who had been the recipient of some very good luck; being in the right place (at a major hospital which supported innovative research) at the right time (a biopsy revealed that I had an ALK mutation just as a phase I clinical trial for the first ALK inhibitor was enrolling), I felt compelled to spread the news. It was my desire both to share some of what I was learning about my disease, but also to show that it was possible to not only live with a terminal illness, but to live well. This dual set of goals lent my life more purpose. In addition, some of those who read the blog began to leave comments and before long, I had a whole new network of friends and supporters. Having lung cancer can be a very isolating experience, but the blog has helped me to build a community, one which stretches around the globe.

Me: You have been fighting lung cancer for over 7 years now…you might be a witness to the progress of medical research in the field. Do you think enough is being done?

Linnea: From a patient’s perspective, there is never enough. That said; the study and treatment of lung cancer has been energized by the discovery of genetic mutations and emerging targeted therapies. VATS (video assisted thoracic surgery) is, in many cases, replacing the traditional lobectomy, resulting in a shorter recovery period. Chest CT scans are now acknowledged as superior to x-rays in screening for lung cancer in those at risk. Advocacy groups have lobbied heavily to have more research dollars earmarked for lung cancer, and their efforts have paid off; the Department of Defense has allocated funds for lung cancer research for the past three years. Sadly, even with these positive trends, we are no closer to a ‘cure’ and the five-year survival rate remains a dismal 15-16%.

Me: You are a non-smoker. Has the stigma associated with smoking and lung cancer touched your treatment or life in anyway?

Linnea: Yes. When someone hears that I have lung cancer, they almost always ask if I smoked. It is a curious question. If I were to respond yes, would an awkward silence ensue? When I say no, I didn’t smoke, they usually shake their heads sadly. The unspoken implication is that if I did smoke, I may be responsible for my disease. As I am a non-smoker with lung cancer, it is clear I have just been unlucky. In other words, it is a query that is certain to make the person with lung cancer feel bad, whether or not they smoked. And, the reason people feel it is okay to ask is because of the strong association between lung cancer and cigarettes.

My status as a non-smoker has come into play medically as well. Had I been a smoker, I believe I would have been diagnosed at an earlier, more treatable stage. Instead, my symptoms, which included a chronic cough and shortness of breath, were attributed to adult onset asthma.

Me: What were your feelings when you decided to enroll in the Phase I trial of Xalkori?

Linnea: At that time, my health was failing; I had run out of reasonable treatment options. This was underscored by the fact that one possible course of action suggested by my oncologist was to do nothing more. When presented with an opportunity to enroll in the trial, I eagerly embraced it. I was well aware of the risks involved as well as the fact that a positive response was a long shot. However, if I did nothing, I would die anyway. Participation in the trial offered a sliver of hope, and as long as I had hope, my resolve to live strengthened.

Linnea Duff

Linnea Duff: Do not give up hope.

Me: What is your advice to lung cancer patients regarding clinical trials investigating lung cancer medications?

Linnea: The decision to participate in a clinical trial is a very personal one. The thought of being administered an experimental drug is unnerving to many. In truth, clinical trials can offer access to cutting edge treatments long before they are made widely available. And although there are attendant risks, each participant in a trial is monitored very closely. This careful monitoring extends to diagnostic tests, and as a participant, you become exceptionally well informed about the state of your health.

One of the most important questions to ask before considering a trial is whether or not it is ‘blinded’. Should that be the case, you will not know whether you have been given the experimental drug or a standard treatment. If you experience progression and are not in the experimental cohort, you will want to inquire as to whether or not you will have the option of then receiving the trial drug. Other important considerations are financial (will your insurance cover trial related expenses), accessibility to a trial site (are you willing to travel if it is not offered locally) and time commitment: particularly at the onset, there will be long days as well as more frequent appointments.

Me: Are you currently participating in any clinical trials of new drugs?

Linnea: Yes. I am currently enrolled in a second phase I clinical trial for a second-generation ALK inhibitor, Novartis’ LDK378. I have been on trial for more than six months now and hope to stay on as long as possible. However, should I experience significant progression; I will not hesitate to enroll in yet another clinical trial.

Me: You have been managing your terminal cancer for years now and are an inspiration to many. What is your advice to people being diagnosed with terminal lung cancer?

Linnea: First, if at all possible, seek treatment at a major cancer center. If your oncologist is well informed as to the latest research in regard to lung cancer, it will give you an edge on survival. Keep in mind that some patients travel long distances for consultations but are often able to arrange for treatment locally.

Be your own advocate. Learn as much as you can about your particular type of lung cancer. For instance, if you have adenocarcinoma, make certain you are tested for mutations. If you decide to use the internet for research, remember this: there is a lot of good information out there but it is easy to get overwhelmed:  most of what you will read about advanced or terminal lung cancer is not encouraging. You are an individual, not a statistic.

Don’t try to go it alone; both physical and emotional support are often essential. In addition to family members and friends, consider joining a support group (available online as well). A diagnosis of lung cancer (at any stage) can be very isolating, and ‘networking’ with other patients can be a source not just of comfort, but also information. Most major hospitals will have social workers in thoracic oncology; they are there to lend support and can also be an excellent resource.

Understand that depression is a normal response to living with a terminal illness. It might be appropriate for you to seek counseling and/or to take advantage of ‘chemical support’; both antidepressants and drugs for anxiety are available.

Finally, stay hopeful and don’t forget to live and to make the most of every day. You can’t control what happens to you, but you can choose how to respond to it.

I thank Linnea for her time and am overwhelmed with her zest for life in spite of all hurdles. Thank you Linnea, for your wonderful words.  Priya Menon

YES! The results of the latest scan are in

I have been feeling well for the past week. My cough has resolved, my energy is up and the chills are gone. All good signs.

This past Monday I underwent the bronchoscopy. Quite uneventful aside from the nasty numbing stuff they squirt up your nose and down your throat prior to the exam. “This is going to feel like you’re drowning” counseled the attending nurse with no apparent irony. And it did.

On Thursday I was back in Boston for my chest CT scan. Although I’d been given a bye on barium for the past two years of the crizotinib trial, I am once again required to drink two ‘milkshakes’. As I’ve explained in some previous detail, I am oblivious to most of the discomforts involved in my day to day medical care. You don’t even want to know how many times I get jabbed with a needle. However, I have never liked putting something in my mouth that I don’t want there. I am, in fact, almost phobic in this regard. Oral contrast is tough for me, and hopefully I can once again talk upper management out of the necessity of such an (onerous) detail.

I had taken the bus in, and David picked me up at the hospital after my exam and we continued on to Randolph, where my oncologist, Dr. Alice Shaw, was being honored by the American Lung Association. Also in attendance were three of Alice’s other patients, including Chris and his wife Karen, pictured on the rather dramatic staircase of the venue. They have an adorable daughter who is just two, and Chris has done quite well on crizotinib. I wish him many more years of success.

Chris and Karen

Bright and early yesterday morning, Alice called and said she had reviewed the scans and that they looked really good, and as well the bronchoscopy was completely negative for any findings. Some hours later she forwarded the CT report, which frankly sounds even more positive than what I’d expected from her description. It reads:


Lines/tubes: None. Lungs and Airways: There is improved consolidation in the left upper lobe and lingula with residual ground-glass opacities, which had been previously chronic and progressive and are considerably improved from 8/31/2011, consistent with improvement in lymphangitic carcinomatosis.

There is a stable 3-mm nodule along the minor fissure. The surrounding smaller nodules have resolved. Pleura: There is a stable small left pleural effusion.

Heart and mediastinum: The thyroid gland is normal. No significant mediastinal, hilar or axillary lymphadenopathy is seen. The heart and pericardium are within normal limits. There is mild pericardial thickening, which appears more prominent compared to 8/31/2011.


History of non-small cell lung cancer status post left lower lobectomy. Improvement in lymphangitic tumor spread in the left lung. Stable indeterminate 3-mm nodule along the minor fissure. Slightly increased mild pericardial thickening.

I like how many times improved or a variation thereof is used in the first paragraph (three), and the addition of considerably is even better. Stable appears twice in the second paragraph. And in IMPRESSIONS, the key words are improvement, stable, and slightly increased. This is a very good, considerably improved, report. Yippee!

And now for some definitions of less than familiar terms:

lymphangitic carcinomatosis:  A condition in which cancer cells spread from the original (primary) tumor and invade lymph vessels (thin tubes that carry lymph and white blood cells through the body’s lymph system).

This is the definition from the National Cancer Institutes online dictionary. From Medscape reference we get this explanation:  The lungs are one of the most common targets for metastatic disease.  Most pulmonary metastases are nodular, but a significant minority is interstitial. Lymphangitic carcinomatosis (LC) refers to the diffuse infiltration and obstruction of pulmonary parenchymal lymphatic channels by tumor.

Interpretation? I believe it is simply another way to describe metastatic lung cancer.

I also looked up the significance off mild pericardial thickening (the pericardium is the membranous sac enclosing the heart), and will discuss it with Alice before I attempt to interpret this finding.

Bottom line; it is a very good report. I have to wonder if I really did have an infection that the latest course of levaquin vanquished. Whatever the underlying cause of my initial malaise as well as the less than stellar PET scan, it is now evident that the LDK378 is having it’s way with my cancer. I’m tripping over myself with gratitude, and well, excitement. The personal impact is obvious, but I’m focusing on the big picture as well; perhaps LDK378 will prove to be yet another viable treatment option for those who harbor an ALK mutation. That would be really be something.

Let me introduce: Evan

Picture taken of my girlfriend (Anne) and I in Vail. March 2010.

My name is Evan Spirito. I am 24 years old and I have NSCLC driven by a mutation in my ALK gene. I was diagnosed in January of 2009 when I was 21.

The cancer originated in my left lung and, by the time I was diagnosed, it spread to my lymph nodes as well as a couple brain metastases. I had the brain mets “zapped” right away with proton beam radiation and then I started chemotherapy. I experienced good results on the Patel Regimen (Carboplatin/Alimta/Avastin) for 6 cycles and then remained on maintenance chemo for several months following. Unfortunately, my cancer started to come back in the spring of 2010.

The results of my genetic testing came back in the meantime and confirmed that my cancer was driven by the ALK mutation. I was put on the Crizotinib trial and again experienced good results with very little side effects. I stayed on the trial for about a year before my cancer once again showed progression in the spring (March 2011).

I started on the STA9090 trial next, however, it proved to be largely ineffective on my disease with the addition of nearly intolerable side effects. After about a month “wash out” period, I began my latest and current trial (LDK 378).

Linnea and I share the same oncologist (Dr. Shaw). She reached out to me a few weeks ago and we discovered that we had quite similar experiences/treatments in our individual battles with cancer. Linnea was about to start the LDK trial herself and, as far as I know, we are two of only a handful of patients currently on the trial.

I know that the many patients are hoping to join the trial soon and looking for more information on what to expect, so, I wanted to share my experience thus far on the LDK trial:

The trial is comparable to my experience on Crizotinib, which was the best/easiest treatment I’ve had to date. The first couple visits are quite long (as Linnea described in her latest post) but after that it gets better. You will dose once a day and go in once a week for lab work and a check up. I have not seen any noticeable side effects from taking the pill apart from one vomited dose in the first week.

For me, the most annoying part of the trial is the eating requirements. Fasting for 2hrs before and after dosing is no fun but if you work out a consistent schedule it will not be an issue. I tried, and may try again, dosing right when I woke up (before eating), then going back to bed for 2hrs before eating breakfast. If your stomach can manage, it might be worth a try.

In my case, it took a solid 7-10 days before I really began to feel the pill working. Sure enough, my first set of scans revealed a major decrease in my disease, which is very encouraging. Things were going rather smoothly until I suffered a minor set back in the form of a chest infection, but with any luck the antibiotics should take care of that and hopefully I’ll be back on track in another week or so.

While being treated for the infection, Dr. Shaw did notice “slight progression” in my disease; however, not enough to take me off the LDK trial. So, as of right now I will continue with the trial for as long as its continues to keep the cancer down.

I hope this little bit of information helps but I’m also aware that every situation is different. As always, take it one day at a time, focus on what’s important going forward, believe in the treatment and it will work!

Evan is an incredibly brave and strong young man (yes, you can get lung cancer when you are only twenty-one).  As the LDK378 trial is yet so nascent, there is very little in the way of anecdotal informational provided by actual participants.  He was kind enough not only to agree to meet me but to generously share his own experience thus far here. Hopefully it will prove useful to other ALK ‘mutants’ who may be considering the LDK trial.

Thanks Evan!

Let’s ride

Ok. So. About that LDK378 trial…The gallery above is from my first day two weeks ago. Please note the woodchuck.  And Sarah, giving me the high five after my lead-in dose.  And how tired David looks; it was a very long day. Long enough that I had time to wander the halls, peruse the Wall of Hope and hang out in the lovely Healing Garden. Long enough that it was barely light when we left the house and quite dark when we returned home.

I’m going to directly lift from the Research Consent Form (a many paged document that you must read and sign prior to enrollment in a trial) to describe the specifics of day one:

PK run-in period (3days) in Part 1 of the study 

Pharmacokinetics (PK) is the study of the actions of a drug in the body over a period of time (eg, how it is absorbed, distributed, broken down, and excreted).

The PK run-in is a 3 day period (before you begin daily study treatment with LDK378) where you will be given a single dose of LDK378 and then have repeated blood tests to see how your body handles the drug. (The tests are called pharmacokinetics or PK tests.) About 1/3 teaspoon of blood with be drawn at each PK blood draw.

  • Day one of PK run-in:  You will have blood drawn, take one dose of LDK378, and then have blood drawn 7 more times with the 8 hours after taking LDK378.
  • Procedures performed on Day 1 of the PK run-in:
  • Physical examination
  • Vital signs
  • In addition, blood pressure and heart rate will be measured before every PK blood sample is drawn.
  • 3 consecutive  EKGS after the single dose of LDK378 and another EKG 4 hours after the dose of LDK378.
  • Additional blood for research blood test to measure biomarkers and the amount of circulating tumor cells in your blood (about 4 teaspoons). Biomarkers are substances such as proteins that may give information about how LDK378 is affecting your body.

So that is the technical run-down. In reality, it all felt rather festive.  Just as my t-shirt proclaimed, this wasn’t my first rodeo and I kind of knew what to expect. 

Not long after the first dose, I experienced some cramping and Irene performed anti-diarrhea acupuncture. That was it for drama; no other discernible side effects. 

Wouldn’t it be wonderful if my personal history of lung cancer treatments someday represented the paradigm; thus far, they have only gotten easier and become more effective.

Consider: almost immediately following my diagnosis in 2005, I endured a rather brutal lower left lobectomy. That was followed by four grueling sessions of cisplatin and taxotere. In 2008 I spent two months taking tarceva with all of the side effects and none of the benefits.

And then came crizotinib (now Xalkori). Not only were the side effects minimal, it stamped out the cancer raging in my lungs and kept it at a low smolder for almost three years.

Will the LDK378 do the same? I am hopeful. The day after my lead-in dose, I was able to walk to the top of a steep hill without stopping numerous times to catch my breath; something I’d not been able to do for some time now. I felt great.

And then, I started to feel crappy again. Which is part of why I haven’t written yet.

However, before any conclusions are leapt to, I need to add that there were several extenuating circumstances. Two weeks before my lead-in dose, I had been on a ten day course of levaquin for a sinus infection. It was the first time I’d had antibiotics in months, and a curious thing happened.

The cough and accompanying rattle in my lungs, which had persisted almost since my bout with the flu, disappeared. I had assumed both symptoms were due to the progression of my lung cancer and was actually quite startled when they cleared up.

My lead-in dose was on a Wednesday, and I didn’t have another dose (the start of continual dosing) until the following Monday. In the meantime, the feeling of low level crappy returned; aches, chills, fatigue and a cough. What the hey!

Several months ago I found an imbedded deer tick but in subsequent days did not develop a bullseye rash. However, just to rule out lymes disease as a potential cause of my current symptoms, I was tested. In addition, my circulating hormone levels and thyroid were checked; all three were normal. Alice (Dr. Shaw) called on Sunday to see how I was feeling and mentioned that the pre trial PET scan had shown more uptake in my lungs than she had anticipated.We discussed the possibility of a smoldering low level pneumonia, as areas of inflammation can light up a PET scan and be confused with cancer. Finally, yesterday I saw the ENT to rule out a lingering sinus infection. My nasal passages were clear, but we decided it might be smart to go back on another ten days of levaquin and see what happens.

So here’s hoping. The side effects from the LDK378 would seem to be non-existent. If the antibiotics do their magic, perhaps I can really get back in the saddle again. I am so ready.

Saddle up



Wednesday morning, September 7th. Lead in dose of LDK 378 and dressed for success.

It was a long day (eleven hours not including the commute), but went quite well. Per trial protocol, I returned to MGH Thursday, Friday and Saturday morning for PK’s and blood draws. After a day off, I’ll be back again bright and early tomorrow to begin regular dosing.

I’m going to fill in the blanks, but not tonight. This tuckered cowboy is hitting the sack.

FDA approval for crizotinib and a new name: Xalkori

On Friday, August 26th; crizotinib received FDA approval. It is now called Xalkori. Nice little features on both the ABC  (scroll down to find Xalkori) and NBC evening news a couple of nights ago. That’s my oncologist/goddess Dr. Alice Shaw providing commentary, and in the NBC piece, the images of the before and after chest CT scans are my lungs (an online friend recognized them and emailed me!). They do get around (my lungs and Alice).

I should also mention that there was a story about Pfizer’s coup in the Wall Street Journal on Tuesday with a picture of and a few quotes from yours truly. My Dad Ollie, who read the WSJ faithfully, would have been pleased to see me there.

I’ve noticed some criticism on the blogsphere, as Xalkori comes with a hefty monthly price tag ($9600), but Pfizer has taken steps to provide financial aid for those who need it. Also called out has been the fact that only 4-6% (or according to this latest data, almost 10%) of people with NSCLC have a mutation of the ALK gene. However, there are so many cases of lung cancer world wide (according to WHO, 1.4 million deaths yearly from lung cancer), that when you do the math, it is a truly significant number of patients who shall potentially benefit.

So yes, Xalcori is big news for Pfizer as well as those of us with lung cancer and the FDA is to be applauded for streamlining the often ponderous approval process.

And now, on a more personal level; what’s up with me.

On August 19th I took my final dose of crizotinib (Xalkori). I am now ‘washing out’ in preparation for my next party trick (make that a miracle). Yesterday I peed in a cup, had bloodwork, a physical, an EKG, a chest and abdominal CT (with contrast–blech) and a PET scan as well. I was given one of those nifty cards identifying me as residually radioactive for 24 hours (just in case I encountered someone with a geiger counter).

I am scheduled for my lead in dose of LDK378 next Wednesday and that’s when the circus really starts.

In the meantime, I am feeling pretty crappy. I saw Alice (Dr. Shaw) yesterday, and she thinks that quite probably, the crizotinib was still conferring some protection, which is good news if in the future we want to add it to my arsenal again. Now that I’m off treatment, my energy level has really dipped and my shortness of breath is catching up to me. Today I made myself go on a walk, as I’ve been breaking my own rules lately (never stop moving). It was also Peter’s first day at the Academy, and he’s going to require a lot of support as he adjusts to a very rigorous academic schedule, so I’ve got to stay on my toes.

What can I say? It is a stressful time for all of us, but we are doing our best to stay positive and hopeful. Because that’s how it’s got to be.

A few steps closer

We were in Mattapoisett this weekend for a dedication ceremony at the local historical society.  My mother-in-law, Polly Phipps, donated a nautical chart painted by the artist Clifford Ashley and the restored artwork was unveiled and celebrated for the jewel it is. This canvas mural had graced the ceiling of the ‘whaling room’ in the family home for almost a century, on a glassed in porch with a whale tooth for a doorstop and paneled walls where harpoons once hung (a number of which can now be found in the New Bedford Whaling Museum).

In addition to the cultural shebang and schmoozing with the family (my husband wryly noted that at least half the one hundred or so in attendance were related to him), we enjoyed time at the waterfront, lobster rolls, fried clams, a Chippi from Mirasol’s and a leisurely stroll through Ikea with Jem and Pete (sans David; he’s allergic to Ikea).

We needed to scurry back to Amherst on Sunday evening as David had to fly to Albuquerque on Monday morning and I had my weekly appointment at the Benson Henry Institute in Boston.

So that’s the garden variety news for the moment, but I’ve got a few things to report on the cancer front.

Sadly, Dr. David Servan-Schreiber, author of Anticancer, has passed away after surviving brain cancer for almost 19 years. One of his contributions to the literature on cancer was the facile way in which he broke down the science supporting his theories, making the information comprehensible and user friendly. I found inspiration in  both his holistic approach to disease, as well as his prolonged survival. Nineteen years was amazing; I would have wished him more.

And now two tidbits more curious than anything. First, researchers at the University of Oxford in England have announced that tall women are at a greater risk for cancer. In fact, for every four inches over a base height of five foot one, the risk increased 16%. Blimey. I thought adolescence and shopping at Shelley’s Tall Girl Shoppe were enough of a disadvantage. Of course, if you read the article carefully, smoking related cancers are not included (I’m not clear if that addresses those of us with lung cancer who didn’t smoke). Another study is mentioned which indicates that long legs are associated with an increased lifespan. So, there you go–it all balances out, and life really is fair.

The curiouser:  A molecular and cell biologist at UC Berkeley, David Duesberg, posits that cancer is actually an example of speciation, and can in fact be compared to a parasite.  It is an interesting if rather creepy concept but I feel there are more than a few holes in it. I also have a personal quarrel with this quote from oncologist Dr. Mark Vincent, another proponent of the view that cancer is an evolved species:

“I think Duesberg is correct by criticizing mutation theory, which sustains a billion-dollar drug industry focused on blocking these mutations,” said Vincent, a medical oncologist. “Yet very, very few cancers have been cured by targeted drug therapy, and even if a drug helps a patient survive six or nine more months, cancer cells often find a way around it.”

Excuse me? Six  or nine months? Ce n’est pas vrai! Leave the (billion?) dollar drug industry alone! Some of our very lives depend on said industry…

Which brings me to my final bit of news. On Monday Alice (Dr. Shaw) called to tell me that she’d already placed my name in queue for the Novartis LDK 378 and that two slots had opened up. If I were not to fill a slot, it was possible that I might wait several months for another chance.

I mulled it over for twenty-four hours. Physically my decline has been slow, but these things have a tendency to pick up speed and lately I am aware of building momentum.

When I emailed my affirmative  to Alice, she responded immediately in support of my decision.

That night I felt an anxiety lift that I hadn’t even known I’d been feeling. My sense of relief lasted until the following morning, when I really began to think about the implications of my situation. I felt a little bit afraid, and not so much about enrolling in a another phase I clinical trial, but about what would happen if I didn’t.

I’ve visited my mortality enough times now that you might think we’d become a tad familiar.

But no. I prefer to remain strangers as long as possible.

In a few weeks, I will be traveling down an unfamiliar path once again.  I’m hoping it leads to another miracle.