New England Journal of Medicine: ROS1 Mutations and Crizotinib (Xalkori) - Phase 1 Data

      Today I received an email from my oncologist about the phase 1 clinical trial data for lung cancer patients with ROS1 mutations who are on crizotinib, (Xalkori.)  The article and data were just published in the New England Journal of Medicine. 

     I knew that Xalkori was fast tracked by the FDA for patients with ROS1 mutations, which means it was released for use prior to the completion of the clinical trials.  The FDA sometimes does this because trial participants are doing so well on the drug and there's previous reassuring data for its use from some other study.  What I didn't understand is that it was released prior to the completion of phase 1.  (There are usually three phases of a clinical trial before a medication is approved by the FDA.)

     In any case, for those interested, it's an interesting article:

http://www.nejm.org/doi/full/10.1056/NEJMoa1406766?query=featured_home

I Don't Mean to be Greedy...

     One would think that after returning from the cancerGRACE Patient Forum in Boston on September 6th and after learning about new medications I can try when Xalkori stops working for me, I would feel more relaxed.  Initially, I did feel better about my future options.  On most days, I still feel relief that there is a new targeted therapy that I can try, (if/when I need it), and also another one which is expected to be FDA approved in the next couple of months.  I learned about other targeted therapy and chemotherapy strategies that clinicians are using for patients like me.  However, I've also found myself thinking about what these medications and strategies really mean for me. 

     When I was first found to have stage 4 lung cancer, the words "terminal cancer" hit my ears and began to come out of my mouth. I actually heard myself saying, "I have terminal cancer" and, "There is no cure for me."  I just Googled "terminal cancer" and here's what I found:  

"A malignancy which is expected to cause the patient’s death in a short period of time—i.e., weeks to several months"

     
     In the beginning, saying I have terminal cancer was accurate.  However, with Xalkori working well for me, I no longer say I have "terminal" cancer.  But then...what do I have?  How is my illness characterized?  Sadly, the words, "There is no cure for me," are still true and I hear myself saying that phrase, occasionally.  

     
     For right now, patients in my situation stay on a targeted or chemo therapy until it stops working.  Then we try another regimen and stay on that for as long as possible.  We go from one regimen to the next.  If we can get several months to a few years out of each regimen, perhaps we can cobble together enough time for researchers to come up with a cure.  Boy...I sure hope researchers are able to keep coming up with new targeted and chemo therapies to keep me alive for while.   
 

     I'm not ungrateful in any way. The cancer researchers who developed Xalkori are the ones who have made it so I don't have to say that I have terminal cancer. They have advanced the field so that stage 4 lung cancer can now be viewed as a chronic illness.  Much like people with diabetes watch their diets, monitor their blood sugars, and inject insulin - while waiting for a cure, I'll take my targeted therapy, will switch to a new therapy when needed, and will continue to wait for a cure. 

     I don't mean to be greedy...but a cure would be really awesome.



  

 

 

A Day with Lung Cancer Experts

      Back in June, lung cancer patient advocate extraordinaire, CraiginPA (his online handle), let me know about a lung cancer education conference for patients in Boston on September 6th. The focus of the conference..."acquired resistance,"  a subject near and dear to my heart lungs. ("Acquired [drug] resistance" occurs when a chemotherapy no longer works to control cancer growth, after it has worked for a while.)  With my oral chemo, Xalkori, there seems to be some variability in how well it works, how long it works and which side effects users experience.  However, the common fact for all patients on Xalkori is that it won't work forever. Some patients see benefits from it for only a few months while others have been successfully treated with it for a few years.  Why Xalkori works longer for some patients and not for others is unknown.  We know, from clinical trials, that when Xalkori is stopped, the cancer tends to come back quickly...aka a "cancer flare." 

     Knowing that one day Xalkori will stop working and that my cancer may grow back quickly has always frightened me.  Having the opportunity to learn what my options will be when that day comes seemed like something I couldn't pass up.  So, this past weekend Wynn and I traveled to Boston to attend the Cancer GRACE's Acquired Resistance Patient Forum for patients with lung cancer due to EGFR, ALK and ROS1 mutations.  

http://cancergrace.org/acquired-resistance-patient-forum-september-6-2014

     For as much as I was looking forward to this conference, the night before I wasn't able to fall asleep.  I was awake worrying that I would sit through a day of lectures and at the end I would be told that there is nothing for me.  That's not what happened... 

ROS1 mutation attendees

     It was an amazing day.  There were about 100 registrants, eight of us with ROS1 mutations.  The speakers were the Who's Who among clinical researchers in the field of lung cancer caused by EFGR, ALK and ROS1 mutations.  I pinched myself as I listened to these lung cancer ROCK STARS.  They told us how acquired resistance happens, what we should do when we experience drug resistance, and how best to transition to a new medication. We learned about the new medications that are now FDA approved and available for us to use next, and about new medications that are expected to be FDA approved in the next couple of months.   They even had a speaker from the FDA who explained to us how medications get approved, how they become "fast tracked" and thus available prior to the completion of a clinical trial because trial participants are doing so well, and why some medications don't come to market because they are found to be unsafe.  (Think thalidomide.)  It's good for cancer patients, who may become desperate for a new medication, to have some understanding of the difficult job the FDA has.  After lunch, we were divided into smaller groups, by mutation, and we met with the experts doing research in those areas.  They told us about their work, clinical trials that are available or coming up soon, and we had the opportunity to ask questions.   

     Here are a couple of things I learned that I'd like to share with other Lung Cancer Ninjas:

1)  The Bonnie Addario Lung Cancer Foundation has partnered with the Norris Comprehensive Cancer Center at USC to study lung cancer in young individuals.  If you were diagnosed at <40 years, please consider participating.
Check out:
https://www.openmednet.org/site/alcmi-goyl
and
http://www.lungcancerfoundation.org/media/press-releases/new-clinical-study-aims-to-investigate-the-genomics-of-young-lung-cancer/

2)  The next Cancer GRACE Patient Forum will be in Chicago on October 26, 2014.  The focus will be Immunotherapy for the treatment of melanoma, lung and kidney cancers.  Check out:

http://www.jotformpro.com/form/42266827790969

      There's one last thing I need to mention.  I met many incredible lung cancer patients, and those that love them:  Tori, Beth, Craig, Carole, Andy, Kris, Nicole, Maria, Bernard.  Their cancer stories were heart-breaking.  Everyone I met, like me, is a non- or never-smoker.  Some of the people I met were diagnosed in their 20's and 30's...one at age 18 years, a freshman in college.  Sh*t....I thought I was young.  The single risk factor we all share?...we have lungs.  I learned that if you have lungs, you can get lung cancer.